Pfizer Inc
FDA Approved Drugs
Pfizer Inc
FDA Approved Drugs Database
FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.
- Total Records 856
- Latest Approval Date Mar 07, 2024
- Data Source FDA
- First Approval Date Jan 01, 1982
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FDA Approved Drug Records ( 856 records )
Drug Name
ABRILADA
Product Number
1
Dosage Form
-
Strength
40MG/0.8ML
Approval Date
-
Active Ingredient
ADALIMUMAB-AFZB
Application Number
761118
Product Number
1
Dosage Form
-
Strength
40MG/0.8ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ABRILADA
Product Number
2
Dosage Form
-
Strength
20MG/0.4ML
Approval Date
-
Active Ingredient
ADALIMUMAB-AFZB
Application Number
761118
Product Number
2
Dosage Form
-
Strength
20MG/0.4ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ABRILADA
Product Number
3
Dosage Form
-
Strength
10MG/0.2ML
Approval Date
-
Active Ingredient
ADALIMUMAB-AFZB
Application Number
761118
Product Number
3
Dosage Form
-
Strength
10MG/0.2ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ACCUPRIL
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1991-11-19
Active Ingredient
QUINAPRIL HYDROCHLORIDE
Application Number
19885
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1991-11-19
Regulatory Status
Discontinued
Drug Name
ACCUPRIL
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1991-11-19
Active Ingredient
QUINAPRIL HYDROCHLORIDE
Application Number
19885
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1991-11-19
Regulatory Status
Discontinued
Drug Name
ACCUPRIL
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1991-11-19
Active Ingredient
QUINAPRIL HYDROCHLORIDE
Application Number
19885
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1991-11-19
Regulatory Status
Discontinued
Drug Name
ACCUPRIL
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1991-11-19
Active Ingredient
QUINAPRIL HYDROCHLORIDE
Application Number
19885
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1991-11-19
Regulatory Status
Discontinued
Drug Name
ACCURETIC
Product Number
1
Dosage Form
-
Strength
12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-12-28
Active Ingredient
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE
Application Number
20125
Product Number
1
Dosage Form
-
Strength
12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-12-28
Regulatory Status
Discontinued
Drug Name
ACCURETIC
Product Number
2
Dosage Form
-
Strength
12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-12-28
Active Ingredient
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE
Application Number
20125
Product Number
2
Dosage Form
-
Strength
12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-12-28
Regulatory Status
Discontinued
Drug Name
ACCURETIC
Product Number
3
Dosage Form
-
Strength
25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-12-28
Active Ingredient
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE
Application Number
20125
Product Number
3
Dosage Form
-
Strength
25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-12-28
Regulatory Status
Discontinued
Drug Name
ADRIAMYCIN PFS
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
1991-01-30
Active Ingredient
DOXORUBICIN HYDROCHLORIDE
Application Number
63165
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
1991-01-30
Regulatory Status
Discontinued
Drug Name
ADRIAMYCIN PFS
Product Number
2
Dosage Form
-
Strength
200MG/100ML
Approval Date
1991-01-30
Active Ingredient
DOXORUBICIN HYDROCHLORIDE
Application Number
63165
Product Number
2
Dosage Form
-
Strength
200MG/100ML
Approval Date
1991-01-30
Regulatory Status
Discontinued
Drug Name
ADRUCIL
Product Number
1
Dosage Form
-
Strength
50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
FLUOROURACIL
Application Number
17959
Product Number
1
Dosage Form
-
Strength
50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ADRUCIL
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
1991-06-28
Active Ingredient
FLUOROURACIL
Application Number
81222
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
1991-06-28
Regulatory Status
Discontinued
Drug Name
ALBAMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
-
Active Ingredient
NOVOBIOCIN SODIUM
Application Number
50339
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ALDACTAZIDE
Product Number
4
Dosage Form
-
Strength
25MG;25MG
Approval Date
1982-12-30
Active Ingredient
HYDROCHLOROTHIAZIDE; SPIRONOLACTONE
Application Number
12616
Product Number
4
Dosage Form
-
Strength
25MG;25MG
Approval Date
1982-12-30
Regulatory Status
RX
Drug Name
ALDACTAZIDE
Product Number
5
Dosage Form
-
Strength
50MG;50MG
Approval Date
1982-12-30
Active Ingredient
HYDROCHLOROTHIAZIDE; SPIRONOLACTONE
Application Number
12616
Product Number
5
Dosage Form
-
Strength
50MG;50MG
Approval Date
1982-12-30
Regulatory Status
Discontinued
Drug Name
ALDACTONE
Product Number
8
Dosage Form
-
Strength
50MG
Approval Date
1982-12-30
Active Ingredient
SPIRONOLACTONE
Application Number
12151
Product Number
8
Dosage Form
-
Strength
50MG
Approval Date
1982-12-30
Regulatory Status
RX
Drug Name
ALDACTONE
Product Number
9
Dosage Form
-
Strength
25MG
Approval Date
1983-12-30
Active Ingredient
SPIRONOLACTONE
Application Number
12151
Product Number
9
Dosage Form
-
Strength
25MG
Approval Date
1983-12-30
Regulatory Status
RX
Drug Name
ALDACTONE
Product Number
10
Dosage Form
-
Strength
100MG
Approval Date
1983-12-30
Active Ingredient
SPIRONOLACTONE
Application Number
12151
Product Number
10
Dosage Form
-
Strength
100MG
Approval Date
1983-12-30
Regulatory Status
RX
Drug Name
ALPHADROL
Product Number
2
Dosage Form
-
Strength
1.5MG
Approval Date
1982-01-01
Active Ingredient
FLUPREDNISOLONE
Application Number
12259
Product Number
2
Dosage Form
-
Strength
1.5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ALSUMA
Product Number
1
Dosage Form
-
Strength
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Approval Date
2010-06-29
Active Ingredient
SUMATRIPTAN SUCCINATE
Application Number
22377
Product Number
1
Dosage Form
-
Strength
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Approval Date
2010-06-29
Regulatory Status
Discontinued
Drug Name
ALTACE
Product Number
1
Dosage Form
-
Strength
1.25MG
Approval Date
1991-01-28
Active Ingredient
RAMIPRIL
Application Number
19901
Product Number
1
Dosage Form
-
Strength
1.25MG
Approval Date
1991-01-28
Regulatory Status
Discontinued
Drug Name
ALTACE
Product Number
2
Dosage Form
-
Strength
2.5MG
Approval Date
1991-01-28
Active Ingredient
RAMIPRIL
Application Number
19901
Product Number
2
Dosage Form
-
Strength
2.5MG
Approval Date
1991-01-28
Regulatory Status
Discontinued
Drug Name
ALTACE
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
1991-01-28
Active Ingredient
RAMIPRIL
Application Number
19901
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
1991-01-28
Regulatory Status
Discontinued
Drug Name
ALTACE
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
1991-01-28
Active Ingredient
RAMIPRIL
Application Number
19901
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
1991-01-28
Regulatory Status
Discontinued
Drug Name
ALTACE
Product Number
1
Dosage Form
-
Strength
1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2007-02-27
Active Ingredient
RAMIPRIL
Application Number
22021
Product Number
1
Dosage Form
-
Strength
1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2007-02-27
Regulatory Status
Discontinued
Drug Name
ALTACE
Product Number
2
Dosage Form
-
Strength
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2007-02-27
Active Ingredient
RAMIPRIL
Application Number
22021
Product Number
2
Dosage Form
-
Strength
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2007-02-27
Regulatory Status
Discontinued
Drug Name
ALTACE
Product Number
3
Dosage Form
-
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2007-02-27
Active Ingredient
RAMIPRIL
Application Number
22021
Product Number
3
Dosage Form
-
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2007-02-27
Regulatory Status
Discontinued
Drug Name
ALTACE
Product Number
4
Dosage Form
-
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2007-02-27
Active Ingredient
RAMIPRIL
Application Number
22021
Product Number
4
Dosage Form
-
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2007-02-27
Regulatory Status
Discontinued
Drug Name
AMBODRYL
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Active Ingredient
BROMODIPHENHYDRAMINE HYDROCHLORIDE
Application Number
7984
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
AMCILL
Product Number
1
Dosage Form
-
Strength
EQ 125MG BASE/5ML
Approval Date
1982-01-01
Active Ingredient
AMPICILLIN/AMPICILLIN TRIHYDRATE
Application Number
62030
Product Number
1
Dosage Form
-
Strength
EQ 125MG BASE/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
AMCILL
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE/5ML
Approval Date
1982-01-01
Active Ingredient
AMPICILLIN/AMPICILLIN TRIHYDRATE
Application Number
62030
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
AMCILL
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1982-01-01
Active Ingredient
AMPICILLIN/AMPICILLIN TRIHYDRATE
Application Number
62041
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
AMCILL
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1982-01-01
Active Ingredient
AMPICILLIN/AMPICILLIN TRIHYDRATE
Application Number
62041
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
AMINOPHYLLINE
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
1982-01-01
Active Ingredient
AMINOPHYLLINE
Application Number
86606
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE;10MG
Approval Date
2010-02-05
Active Ingredient
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Application Number
78466
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE;10MG
Approval Date
2010-02-05
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE;10MG
Approval Date
2010-02-05
Active Ingredient
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Application Number
78466
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE;10MG
Approval Date
2010-02-05
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;20MG
Approval Date
2010-02-05
Active Ingredient
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Application Number
78466
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;20MG
Approval Date
2010-02-05
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;20MG
Approval Date
2010-02-05
Active Ingredient
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Application Number
78466
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;20MG
Approval Date
2010-02-05
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
EQ 5MG BASE;40MG
Approval Date
2011-07-05
Active Ingredient
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Application Number
78466
Product Number
5
Dosage Form
-
Strength
EQ 5MG BASE;40MG
Approval Date
2011-07-05
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Product Number
6
Dosage Form
-
Strength
EQ 10MG BASE;40MG
Approval Date
2011-07-05
Active Ingredient
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Application Number
78466
Product Number
6
Dosage Form
-
Strength
EQ 10MG BASE;40MG
Approval Date
2011-07-05
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Product Number
7
Dosage Form
-
Strength
10MG; 40MG
Approval Date
-
Active Ingredient
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Application Number
78466
Product Number
7
Dosage Form
-
Strength
10MG; 40MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ANSAID
Product Number
2
Dosage Form
-
Strength
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1988-10-31
Active Ingredient
FLURBIPROFEN
Application Number
18766
Product Number
2
Dosage Form
-
Strength
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1988-10-31
Regulatory Status
Discontinued
Drug Name
ANSAID
Product Number
3
Dosage Form
-
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1988-10-31
Active Ingredient
FLURBIPROFEN
Application Number
18766
Product Number
3
Dosage Form
-
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1988-10-31
Regulatory Status
Discontinued
Drug Name
APOGEN
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
1982-01-01
Active Ingredient
GENTAMICIN SULFATE
Application Number
62289
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
APOGEN
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE/ML
Approval Date
1982-01-01
Active Ingredient
GENTAMICIN SULFATE
Application Number
62289
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
AROMASIN
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1999-10-21
Active Ingredient
EXEMESTANE
Application Number
20753
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1999-10-21
Regulatory Status
RX
Drug Name
ARTHROTEC
Product Number
1
Dosage Form
-
Strength
50MG;0.2MG
Approval Date
1997-12-24
Active Ingredient
DICLOFENAC SODIUM; MISOPROSTOL
Application Number
20607
Product Number
1
Dosage Form
-
Strength
50MG;0.2MG
Approval Date
1997-12-24
Regulatory Status
RX
Drug Name
ARTHROTEC
Product Number
2
Dosage Form
-
Strength
75MG;0.2MG
Approval Date
1997-12-24
Active Ingredient
DICLOFENAC SODIUM; MISOPROSTOL
Application Number
20607
Product Number
2
Dosage Form
-
Strength
75MG;0.2MG
Approval Date
1997-12-24
Regulatory Status
RX
Drug Name
ATARAX
Product Number
1
Dosage Form
-
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
HYDROXYZINE HYDROCHLORIDE
Application Number
10392
Product Number
1
Dosage Form
-
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ATARAX
Product Number
4
Dosage Form
-
Strength
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
HYDROXYZINE HYDROCHLORIDE
Application Number
10392
Product Number
4
Dosage Form
-
Strength
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ATARAX
Product Number
5
Dosage Form
-
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
HYDROXYZINE HYDROCHLORIDE
Application Number
10392
Product Number
5
Dosage Form
-
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ATARAX
Product Number
6
Dosage Form
-
Strength
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
HYDROXYZINE HYDROCHLORIDE
Application Number
10392
Product Number
6
Dosage Form
-
Strength
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
AVINZA
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2002-03-20
Active Ingredient
MORPHINE SULFATE
Application Number
21260
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2002-03-20
Regulatory Status
Discontinued
Drug Name
AVINZA
Product Number
2
Dosage Form
-
Strength
60MG
Approval Date
2002-03-20
Active Ingredient
MORPHINE SULFATE
Application Number
21260
Product Number
2
Dosage Form
-
Strength
60MG
Approval Date
2002-03-20
Regulatory Status
Discontinued
Drug Name
AVINZA
Product Number
3
Dosage Form
-
Strength
90MG
Approval Date
2002-03-20
Active Ingredient
MORPHINE SULFATE
Application Number
21260
Product Number
3
Dosage Form
-
Strength
90MG
Approval Date
2002-03-20
Regulatory Status
Discontinued
Drug Name
AVINZA
Product Number
4
Dosage Form
-
Strength
120MG
Approval Date
2002-03-20
Active Ingredient
MORPHINE SULFATE
Application Number
21260
Product Number
4
Dosage Form
-
Strength
120MG
Approval Date
2002-03-20
Regulatory Status
Discontinued
Drug Name
AVINZA
Product Number
5
Dosage Form
-
Strength
45MG
Approval Date
2008-12-18
Active Ingredient
MORPHINE SULFATE
Application Number
21260
Product Number
5
Dosage Form
-
Strength
45MG
Approval Date
2008-12-18
Regulatory Status
Discontinued
Drug Name
AVINZA
Product Number
6
Dosage Form
-
Strength
75MG
Approval Date
2008-12-18
Active Ingredient
MORPHINE SULFATE
Application Number
21260
Product Number
6
Dosage Form
-
Strength
75MG
Approval Date
2008-12-18
Regulatory Status
Discontinued
Drug Name
AZULFIDINE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Active Ingredient
SULFASALAZINE
Application Number
7073
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
AZULFIDINE
Product Number
1
Dosage Form
-
Strength
250MG/5ML
Approval Date
1982-01-01
Active Ingredient
SULFASALAZINE
Application Number
18605
Product Number
1
Dosage Form
-
Strength
250MG/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
AZULFIDINE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
-
Active Ingredient
SULFASALAZINE
Application Number
20465
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
AZULFIDINE EN-TABS
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
1983-04-06
Active Ingredient
SULFASALAZINE
Application Number
7073
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
1983-04-06
Regulatory Status
RX
Drug Name
BACIGUENT
Product Number
1
Dosage Form
-
Strength
500 UNITS/GM
Approval Date
1982-01-01
Active Ingredient
BACITRACIN
Application Number
60734
Product Number
1
Dosage Form
-
Strength
500 UNITS/GM
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
BENYLIN
Product Number
4
Dosage Form
-
Strength
12.5MG/5ML
Approval Date
1982-01-01
Active Ingredient
DIPHENHYDRAMINE HYDROCHLORIDE
Application Number
6514
Product Number
4
Dosage Form
-
Strength
12.5MG/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
BENYLIN
Product Number
1
Dosage Form
-
Strength
12.5MG/5ML;30MG/5ML
Approval Date
1985-06-11
Active Ingredient
DIPHENHYDRAMINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Application Number
19014
Product Number
1
Dosage Form
-
Strength
12.5MG/5ML;30MG/5ML
Approval Date
1985-06-11
Regulatory Status
Discontinued
Drug Name
BERUBIGEN
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
1982-01-01
Active Ingredient
CYANOCOBALAMIN
Application Number
6798
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
BEXTRA
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2001-11-16
Active Ingredient
VALDECOXIB
Application Number
21341
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2001-11-16
Regulatory Status
Discontinued
Drug Name
BEXTRA
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2001-11-16
Active Ingredient
VALDECOXIB
Application Number
21341
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2001-11-16
Regulatory Status
Discontinued
Drug Name
BICILLIN C-R
Product Number
1
Dosage Form
-
Strength
300,000 UNITS/ML;300,000 UNITS/ML
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE
Application Number
50138
Product Number
1
Dosage Form
-
Strength
300,000 UNITS/ML;300,000 UNITS/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
BICILLIN C-R
Product Number
2
Dosage Form
-
Strength
150,000 UNITS/ML;150,000 UNITS/ML
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE
Application Number
50138
Product Number
2
Dosage Form
-
Strength
150,000 UNITS/ML;150,000 UNITS/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
BICILLIN C-R 900/300
Product Number
3
Dosage Form
-
Strength
900,000 UNITS/2ML;300,000 UNITS/2ML
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE
Application Number
50138
Product Number
3
Dosage Form
-
Strength
900,000 UNITS/2ML;300,000 UNITS/2ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
BICILLIN L-A
Product Number
1
Dosage Form
-
Strength
600,000 UNITS/ML
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G BENZATHINE
Application Number
50141
Product Number
1
Dosage Form
-
Strength
600,000 UNITS/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
BICILLIN L-A
Product Number
3
Dosage Form
-
Strength
300,000 UNITS/ML
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G BENZATHINE
Application Number
50141
Product Number
3
Dosage Form
-
Strength
300,000 UNITS/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
BOSULIF
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2012-09-04
Active Ingredient
BOSUTINIB MONOHYDRATE
Application Number
203341
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2012-09-04
Regulatory Status
RX
Drug Name
BOSULIF
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2012-09-04
Active Ingredient
BOSUTINIB MONOHYDRATE
Application Number
203341
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2012-09-04
Regulatory Status
RX
Drug Name
BOSULIF
Product Number
3
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2017-10-27
Active Ingredient
BOSUTINIB MONOHYDRATE
Application Number
203341
Product Number
3
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2017-10-27
Regulatory Status
RX
Drug Name
BOSULIF
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2023-09-26
Active Ingredient
BOSUTINIB MONOHYDRATE
Application Number
217729
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2023-09-26
Regulatory Status
RX
Drug Name
BOSULIF
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2023-09-26
Active Ingredient
BOSUTINIB MONOHYDRATE
Application Number
217729
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2023-09-26
Regulatory Status
RX
Drug Name
CALAN
Product Number
1
Dosage Form
-
Strength
80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1984-09-10
Active Ingredient
VERAPAMIL HYDROCHLORIDE
Application Number
18817
Product Number
1
Dosage Form
-
Strength
80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1984-09-10
Regulatory Status
Discontinued
Drug Name
CALAN
Product Number
2
Dosage Form
-
Strength
120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1984-09-10
Active Ingredient
VERAPAMIL HYDROCHLORIDE
Application Number
18817
Product Number
2
Dosage Form
-
Strength
120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1984-09-10
Regulatory Status
Discontinued
Drug Name
CALAN
Product Number
3
Dosage Form
-
Strength
40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1988-02-23
Active Ingredient
VERAPAMIL HYDROCHLORIDE
Application Number
18817
Product Number
3
Dosage Form
-
Strength
40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1988-02-23
Regulatory Status
Discontinued
Drug Name
CALAN
Product Number
4
Dosage Form
-
Strength
160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1988-02-23
Active Ingredient
VERAPAMIL HYDROCHLORIDE
Application Number
18817
Product Number
4
Dosage Form
-
Strength
160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1988-02-23
Regulatory Status
Discontinued
Drug Name
CALAN SR
Product Number
1
Dosage Form
-
Strength
240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1986-12-16
Active Ingredient
VERAPAMIL HYDROCHLORIDE
Application Number
19152
Product Number
1
Dosage Form
-
Strength
240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1986-12-16
Regulatory Status
Discontinued
Drug Name
CALAN SR
Product Number
2
Dosage Form
-
Strength
180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1989-12-15
Active Ingredient
VERAPAMIL HYDROCHLORIDE
Application Number
19152
Product Number
2
Dosage Form
-
Strength
180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1989-12-15
Regulatory Status
Discontinued
Drug Name
CALAN SR
Product Number
3
Dosage Form
-
Strength
120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1991-03-06
Active Ingredient
VERAPAMIL HYDROCHLORIDE
Application Number
19152
Product Number
3
Dosage Form
-
Strength
120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1991-03-06
Regulatory Status
Discontinued
Drug Name
CALMURID HC
Product Number
1
Dosage Form
-
Strength
1%;10%
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE; UREA
Application Number
83947
Product Number
1
Dosage Form
-
Strength
1%;10%
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CAMOQUIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
1982-01-01
Active Ingredient
AMODIAQUINE HYDROCHLORIDE
Application Number
6441
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CAMPTOSAR
Product Number
1
Dosage Form
-
Strength
40MG/2ML (20MG/ML)
Approval Date
1996-06-14
Active Ingredient
IRINOTECAN HYDROCHLORIDE
Application Number
20571
Product Number
1
Dosage Form
-
Strength
40MG/2ML (20MG/ML)
Approval Date
1996-06-14
Regulatory Status
RX
Drug Name
CAMPTOSAR
Product Number
2
Dosage Form
-
Strength
100MG/5ML (20MG/ML)
Approval Date
1996-06-14
Active Ingredient
IRINOTECAN HYDROCHLORIDE
Application Number
20571
Product Number
2
Dosage Form
-
Strength
100MG/5ML (20MG/ML)
Approval Date
1996-06-14
Regulatory Status
RX
Drug Name
CAMPTOSAR
Product Number
3
Dosage Form
-
Strength
300MG/15ML (20MG/ML)
Approval Date
2010-08-05
Active Ingredient
IRINOTECAN HYDROCHLORIDE
Application Number
20571
Product Number
3
Dosage Form
-
Strength
300MG/15ML (20MG/ML)
Approval Date
2010-08-05
Regulatory Status
RX
Drug Name
CARDRASE
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
1982-01-01
Active Ingredient
ETHOXZOLAMIDE
Application Number
11047
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CARDRASE
Product Number
2
Dosage Form
-
Strength
62.5MG
Approval Date
1982-01-01
Active Ingredient
ETHOXZOLAMIDE
Application Number
11047
Product Number
2
Dosage Form
-
Strength
62.5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CAVERJECT
Product Number
1
Dosage Form
-
Strength
0.01MG/VIAL
Approval Date
1995-07-06
Active Ingredient
ALPROSTADIL
Application Number
20379
Product Number
1
Dosage Form
-
Strength
0.01MG/VIAL
Approval Date
1995-07-06
Regulatory Status
RX
Drug Name
CAVERJECT
Product Number
2
Dosage Form
-
Strength
0.02MG/VIAL
Approval Date
1995-07-06
Active Ingredient
ALPROSTADIL
Application Number
20379
Product Number
2
Dosage Form
-
Strength
0.02MG/VIAL
Approval Date
1995-07-06
Regulatory Status
RX
Drug Name
CAVERJECT
Product Number
3
Dosage Form
-
Strength
0.005MG/VIAL
Approval Date
1996-06-27
Active Ingredient
ALPROSTADIL
Application Number
20379
Product Number
3
Dosage Form
-
Strength
0.005MG/VIAL
Approval Date
1996-06-27
Regulatory Status
Discontinued
Drug Name
CAVERJECT
Product Number
4
Dosage Form
-
Strength
0.04MG/VIAL
Approval Date
1997-05-19
Active Ingredient
ALPROSTADIL
Application Number
20379
Product Number
4
Dosage Form
-
Strength
0.04MG/VIAL
Approval Date
1997-05-19
Regulatory Status
RX
Drug Name
CAVERJECT
Product Number
1
Dosage Form
-
Strength
0.005MG/ML
Approval Date
1997-10-31
Active Ingredient
ALPROSTADIL
Application Number
20755
Product Number
1
Dosage Form
-
Strength
0.005MG/ML
Approval Date
1997-10-31
Regulatory Status
Discontinued
Drug Name
CAVERJECT
Product Number
2
Dosage Form
-
Strength
0.01MG/ML
Approval Date
1997-10-01
Active Ingredient
ALPROSTADIL
Application Number
20755
Product Number
2
Dosage Form
-
Strength
0.01MG/ML
Approval Date
1997-10-01
Regulatory Status
Discontinued
Drug Name
CAVERJECT
Product Number
3
Dosage Form
-
Strength
0.02MG/ML
Approval Date
1997-10-01
Active Ingredient
ALPROSTADIL
Application Number
20755
Product Number
3
Dosage Form
-
Strength
0.02MG/ML
Approval Date
1997-10-01
Regulatory Status
Discontinued
Drug Name
CAVERJECT IMPULSE
Product Number
1
Dosage Form
-
Strength
0.01MG/VIAL
Approval Date
2002-06-11
Active Ingredient
ALPROSTADIL
Application Number
21212
Product Number
1
Dosage Form
-
Strength
0.01MG/VIAL
Approval Date
2002-06-11
Regulatory Status
RX
Drug Name
CAVERJECT IMPULSE
Product Number
2
Dosage Form
-
Strength
0.02MG/VIAL
Approval Date
2002-06-11
Active Ingredient
ALPROSTADIL
Application Number
21212
Product Number
2
Dosage Form
-
Strength
0.02MG/VIAL
Approval Date
2002-06-11
Regulatory Status
RX
Drug Name
CEFOBID
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
1982-11-18
Active Ingredient
CEFOPERAZONE SODIUM
Application Number
50551
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
1982-11-18
Regulatory Status
Discontinued
Drug Name
CEFOBID
Product Number
2
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
1982-11-18
Active Ingredient
CEFOPERAZONE SODIUM
Application Number
50551
Product Number
2
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
1982-11-18
Regulatory Status
Discontinued
Drug Name
CEFOBID
Product Number
3
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
1990-03-05
Active Ingredient
CEFOPERAZONE SODIUM
Application Number
50551
Product Number
3
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
1990-03-05
Regulatory Status
Discontinued
Drug Name
CEFOBID
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
1995-03-31
Active Ingredient
CEFOPERAZONE SODIUM
Application Number
63333
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
1995-03-31
Regulatory Status
Discontinued
Drug Name
CEFOBID
Product Number
2
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
1995-03-31
Active Ingredient
CEFOPERAZONE SODIUM
Application Number
63333
Product Number
2
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
1995-03-31
Regulatory Status
Discontinued
Drug Name
CEFOBID IN PLASTIC CONTAINER
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/ML
Approval Date
1986-07-23
Active Ingredient
CEFOPERAZONE SODIUM
Application Number
50613
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/ML
Approval Date
1986-07-23
Regulatory Status
Discontinued
Drug Name
CEFOBID IN PLASTIC CONTAINER
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE/ML
Approval Date
1987-07-31
Active Ingredient
CEFOPERAZONE SODIUM
Application Number
50613
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE/ML
Approval Date
1987-07-31
Regulatory Status
Discontinued
Drug Name
CELONTIN
Product Number
7
Dosage Form
-
Strength
150MG
Approval Date
1982-01-01
Active Ingredient
METHSUXIMIDE
Application Number
10596
Product Number
7
Dosage Form
-
Strength
150MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CELONTIN
Product Number
8
Dosage Form
-
Strength
300MG
Approval Date
1982-01-01
Active Ingredient
METHSUXIMIDE
Application Number
10596
Product Number
8
Dosage Form
-
Strength
300MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
CENTRAX
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
PRAZEPAM
Application Number
17415
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CENTRAX
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Active Ingredient
PRAZEPAM
Application Number
18144
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CENTRAX
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
PRAZEPAM
Application Number
18144
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CENTRAX
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
1982-05-10
Active Ingredient
PRAZEPAM
Application Number
18144
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
1982-05-10
Regulatory Status
Discontinued
Drug Name
CEREBYX
Product Number
1
Dosage Form
-
Strength
EQ 50MG PHENYTOIN NA/ML
Approval Date
1996-08-05
Active Ingredient
FOSPHENYTOIN SODIUM
Application Number
20450
Product Number
1
Dosage Form
-
Strength
EQ 50MG PHENYTOIN NA/ML
Approval Date
1996-08-05
Regulatory Status
RX
Drug Name
CHANTIX
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2006-05-10
Active Ingredient
VARENICLINE TARTRATE
Application Number
21928
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2006-05-10
Regulatory Status
RX
Drug Name
CHANTIX
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2006-05-10
Active Ingredient
VARENICLINE TARTRATE
Application Number
21928
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2006-05-10
Regulatory Status
RX
Drug Name
CHLORDIAZEPOXIDE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
CHLORDIAZEPOXIDE HYDROCHLORIDE
Application Number
84598
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CHLORDIAZEPOXIDE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Active Ingredient
CHLORDIAZEPOXIDE HYDROCHLORIDE
Application Number
85163
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CHLORDIAZEPOXIDE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Active Ingredient
CHLORDIAZEPOXIDE HYDROCHLORIDE
Application Number
85164
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CHLOROMYCETIN
Product Number
1
Dosage Form
-
Strength
250MG/ML
Approval Date
1982-01-01
Active Ingredient
CHLORAMPHENICOL
Application Number
50153
Product Number
1
Dosage Form
-
Strength
250MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CHLOROMYCETIN
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1982-01-01
Active Ingredient
CHLORAMPHENICOL
Application Number
50183
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CHLOROMYXIN
Product Number
2
Dosage Form
-
Strength
1%;10,000 UNITS/GM
Approval Date
1982-01-01
Active Ingredient
CHLORAMPHENICOL; POLYMYXIN B SULFATE
Application Number
50203
Product Number
2
Dosage Form
-
Strength
1%;10,000 UNITS/GM
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CHOLEDYL
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Active Ingredient
OXTRIPHYLLINE
Application Number
9268
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CHOLEDYL
Product Number
7
Dosage Form
-
Strength
200MG
Approval Date
1982-01-01
Active Ingredient
OXTRIPHYLLINE
Application Number
9268
Product Number
7
Dosage Form
-
Strength
200MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CHOLEDYL
Product Number
11
Dosage Form
-
Strength
50MG/5ML
Approval Date
1982-01-01
Active Ingredient
OXTRIPHYLLINE
Application Number
9268
Product Number
11
Dosage Form
-
Strength
50MG/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CHOLEDYL
Product Number
12
Dosage Form
-
Strength
100MG/5ML
Approval Date
1984-11-27
Active Ingredient
OXTRIPHYLLINE
Application Number
9268
Product Number
12
Dosage Form
-
Strength
100MG/5ML
Approval Date
1984-11-27
Regulatory Status
Discontinued
Drug Name
CHOLYBAR
Product Number
1
Dosage Form
-
Strength
EQ 4GM RESIN/BAR
Approval Date
1988-05-26
Active Ingredient
CHOLESTYRAMINE
Application Number
71621
Product Number
1
Dosage Form
-
Strength
EQ 4GM RESIN/BAR
Approval Date
1988-05-26
Regulatory Status
Discontinued
Drug Name
CHOLYBAR
Product Number
1
Dosage Form
-
Strength
EQ 4GM RESIN/BAR
Approval Date
1988-05-26
Active Ingredient
CHOLESTYRAMINE
Application Number
71739
Product Number
1
Dosage Form
-
Strength
EQ 4GM RESIN/BAR
Approval Date
1988-05-26
Regulatory Status
Discontinued
Drug Name
CIBINQO
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2022-01-14
Active Ingredient
ABROCITINIB
Application Number
213871
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2022-01-14
Regulatory Status
RX
Drug Name
CIBINQO
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2022-01-14
Active Ingredient
ABROCITINIB
Application Number
213871
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2022-01-14
Regulatory Status
RX
Drug Name
CIBINQO
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2022-01-14
Active Ingredient
ABROCITINIB
Application Number
213871
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2022-01-14
Regulatory Status
RX
Drug Name
CLEOCIN
Product Number
2
Dosage Form
-
Strength
EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1994-02-22
Active Ingredient
CLINDAMYCIN PHOSPHATE
Application Number
50537
Product Number
2
Dosage Form
-
Strength
EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1994-02-22
Regulatory Status
Discontinued
Drug Name
CLEOCIN
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE
Approval Date
1992-08-11
Active Ingredient
CLINDAMYCIN PHOSPHATE
Application Number
50680
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE
Approval Date
1992-08-11
Regulatory Status
Discontinued
Drug Name
CLEOCIN
Product Number
2
Dosage Form
-
Strength
EQ 2% BASE
Approval Date
1998-03-02
Active Ingredient
CLINDAMYCIN PHOSPHATE
Application Number
50680
Product Number
2
Dosage Form
-
Strength
EQ 2% BASE
Approval Date
1998-03-02
Regulatory Status
RX
Drug Name
CLEOCIN
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1999-08-13
Active Ingredient
CLINDAMYCIN PHOSPHATE
Application Number
50767
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1999-08-13
Regulatory Status
RX
Drug Name
CLEOCIN
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
1982-01-01
Active Ingredient
CLINDAMYCIN HYDROCHLORIDE
Application Number
61809
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CLEOCIN
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
1982-01-01
Active Ingredient
CLINDAMYCIN HYDROCHLORIDE
Application Number
61809
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CLEOCIN
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
CLINDAMYCIN PALMITATE HYDROCHLORIDE
Application Number
61827
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CLEOCIN
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE/5ML
Approval Date
1986-04-07
Active Ingredient
CLINDAMYCIN PALMITATE HYDROCHLORIDE
Application Number
62644
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE/5ML
Approval Date
1986-04-07
Regulatory Status
RX
Drug Name
CLEOCIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
1982-01-01
Active Ingredient
CLINDAMYCIN HYDROCHLORIDE
Application Number
50162
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
CLEOCIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
1982-01-01
Active Ingredient
CLINDAMYCIN HYDROCHLORIDE
Application Number
50162
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
CLEOCIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
1988-04-14
Active Ingredient
CLINDAMYCIN HYDROCHLORIDE
Application Number
50162
Product Number
3
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
1988-04-14
Regulatory Status
RX
Drug Name
CLEOCIN PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE/ML
Approval Date
1982-01-01
Active Ingredient
CLINDAMYCIN PHOSPHATE
Application Number
50441
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
CLEOCIN PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE/ML
Approval Date
1982-01-01
Active Ingredient
CLINDAMYCIN PHOSPHATE
Application Number
61839
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CLEOCIN PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE/ML
Approval Date
1987-10-16
Active Ingredient
CLINDAMYCIN PHOSPHATE
Application Number
62803
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE/ML
Approval Date
1987-10-16
Regulatory Status
RX
Drug Name
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Product Number
1
Dosage Form
-
Strength
EQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1989-08-30
Active Ingredient
CLINDAMYCIN PHOSPHATE
Application Number
50639
Product Number
1
Dosage Form
-
Strength
EQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1989-08-30
Regulatory Status
Discontinued
Drug Name
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Product Number
2
Dosage Form
-
Strength
EQ 12MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1989-08-30
Active Ingredient
CLINDAMYCIN PHOSPHATE
Application Number
50639
Product Number
2
Dosage Form
-
Strength
EQ 12MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1989-08-30
Regulatory Status
Discontinued
Drug Name
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Product Number
3
Dosage Form
-
Strength
EQ 18MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1991-04-10
Active Ingredient
CLINDAMYCIN PHOSPHATE
Application Number
50639
Product Number
3
Dosage Form
-
Strength
EQ 18MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1991-04-10
Regulatory Status
Discontinued
Drug Name
CLEOCIN T
Product Number
1
Dosage Form
-
Strength
EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
CLINDAMYCIN PHOSPHATE
Application Number
50537
Product Number
1
Dosage Form
-
Strength
EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CLEOCIN T
Product Number
1
Dosage Form
-
Strength
EQ 1% BASE
Approval Date
1989-05-31
Active Ingredient
CLINDAMYCIN PHOSPHATE
Application Number
50600
Product Number
1
Dosage Form
-
Strength
EQ 1% BASE
Approval Date
1989-05-31
Regulatory Status
RX
Drug Name
CLEOCIN T
Product Number
1
Dosage Form
-
Strength
EQ 1% BASE
Approval Date
1987-01-07
Active Ingredient
CLINDAMYCIN PHOSPHATE
Application Number
50615
Product Number
1
Dosage Form
-
Strength
EQ 1% BASE
Approval Date
1987-01-07
Regulatory Status
RX
Drug Name
CLEOCIN T
Product Number
1
Dosage Form
-
Strength
EQ 1% BASE
Approval Date
1982-02-08
Active Ingredient
CLINDAMYCIN PHOSPHATE
Application Number
62363
Product Number
1
Dosage Form
-
Strength
EQ 1% BASE
Approval Date
1982-02-08
Regulatory Status
Discontinued
Drug Name
COLESTID
Product Number
3
Dosage Form
-
Strength
5GM/SCOOPFUL
Approval Date
1995-09-22
Active Ingredient
COLESTIPOL HYDROCHLORIDE
Application Number
17563
Product Number
3
Dosage Form
-
Strength
5GM/SCOOPFUL
Approval Date
1995-09-22
Regulatory Status
RX
Drug Name
COLESTID
Product Number
4
Dosage Form
-
Strength
5GM/PACKET
Approval Date
1995-09-22
Active Ingredient
COLESTIPOL HYDROCHLORIDE
Application Number
17563
Product Number
4
Dosage Form
-
Strength
5GM/PACKET
Approval Date
1995-09-22
Regulatory Status
RX
Drug Name
COLESTID
Product Number
1
Dosage Form
-
Strength
1GM
Approval Date
1994-07-19
Active Ingredient
COLESTIPOL HYDROCHLORIDE
Application Number
20222
Product Number
1
Dosage Form
-
Strength
1GM
Approval Date
1994-07-19
Regulatory Status
RX
Drug Name
COLY-MYCIN S
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE/5ML
Approval Date
1982-01-01
Active Ingredient
COLISTIN SULFATE
Application Number
50355
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CORTEF
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE
Application Number
8697
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
CORTEF
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE
Application Number
8697
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
CORTEF
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE
Application Number
8697
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
CORTEF
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE
Application Number
9864
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CORTEF
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/5ML
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE CYPIONATE
Application Number
9900
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CORTEF ACETATE
Product Number
1
Dosage Form
-
Strength
2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE ACETATE
Application Number
8917
Product Number
1
Dosage Form
-
Strength
2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CORTEF ACETATE
Product Number
2
Dosage Form
-
Strength
1%
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE ACETATE
Application Number
8917
Product Number
2
Dosage Form
-
Strength
1%
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CORTEF ACETATE
Product Number
2
Dosage Form
-
Strength
50MG/ML
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE ACETATE
Application Number
9378
Product Number
2
Dosage Form
-
Strength
50MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CORTISONE ACETATE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Active Ingredient
CORTISONE ACETATE
Application Number
8126
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CORTISONE ACETATE
Product Number
2
Dosage Form
-
Strength
25MG/ML
Approval Date
1982-01-01
Active Ingredient
CORTISONE ACETATE
Application Number
8126
Product Number
2
Dosage Form
-
Strength
25MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CORTISONE ACETATE
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Active Ingredient
CORTISONE ACETATE
Application Number
8126
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CORTISONE ACETATE
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
CORTISONE ACETATE
Application Number
8126
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CORTISPORIN
Product Number
2
Dosage Form
-
Strength
400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1984-05-04
Active Ingredient
BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Application Number
50168
Product Number
2
Dosage Form
-
Strength
400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1984-05-04
Regulatory Status
Discontinued
Drug Name
CORTISPORIN
Product Number
1
Dosage Form
-
Strength
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Application Number
50169
Product Number
1
Dosage Form
-
Strength
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CORTISPORIN
Product Number
1
Dosage Form
-
Strength
0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1985-08-09
Active Ingredient
HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Application Number
50218
Product Number
1
Dosage Form
-
Strength
0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1985-08-09
Regulatory Status
Discontinued
Drug Name
CORTISPORIN
Product Number
1
Dosage Form
-
Strength
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Application Number
50479
Product Number
1
Dosage Form
-
Strength
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CORTRIL
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE
Application Number
9127
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CORTRIL
Product Number
5
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE
Application Number
9127
Product Number
5
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CORTRIL
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE ACETATE
Application Number
9164
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CORTRIL
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE
Application Number
9796
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CORVERT
Product Number
1
Dosage Form
-
Strength
0.1MG/ML
Approval Date
1995-12-28
Active Ingredient
IBUTILIDE FUMARATE
Application Number
20491
Product Number
1
Dosage Form
-
Strength
0.1MG/ML
Approval Date
1995-12-28
Regulatory Status
RX
Drug Name
CORZIDE
Product Number
1
Dosage Form
-
Strength
5MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1983-05-25
Active Ingredient
BENDROFLUMETHIAZIDE; NADOLOL
Application Number
18647
Product Number
1
Dosage Form
-
Strength
5MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1983-05-25
Regulatory Status
Discontinued
Drug Name
CORZIDE
Product Number
2
Dosage Form
-
Strength
5MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1983-05-25
Active Ingredient
BENDROFLUMETHIAZIDE; NADOLOL
Application Number
18647
Product Number
2
Dosage Form
-
Strength
5MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1983-05-25
Regulatory Status
Discontinued
Drug Name
COVERA-HS
Product Number
1
Dosage Form
-
Strength
180MG
Approval Date
1996-02-26
Active Ingredient
VERAPAMIL HYDROCHLORIDE
Application Number
20552
Product Number
1
Dosage Form
-
Strength
180MG
Approval Date
1996-02-26
Regulatory Status
Discontinued
Drug Name
COVERA-HS
Product Number
2
Dosage Form
-
Strength
240MG
Approval Date
1996-02-26
Active Ingredient
VERAPAMIL HYDROCHLORIDE
Application Number
20552
Product Number
2
Dosage Form
-
Strength
240MG
Approval Date
1996-02-26
Regulatory Status
Discontinued
Drug Name
CROMOPTIC
Product Number
1
Dosage Form
-
Strength
4%
Approval Date
1999-04-27
Active Ingredient
CROMOLYN SODIUM
Application Number
75088
Product Number
1
Dosage Form
-
Strength
4%
Approval Date
1999-04-27
Regulatory Status
Discontinued
Drug Name
CYKLOKAPRON
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1986-12-30
Active Ingredient
TRANEXAMIC ACID
Application Number
19280
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1986-12-30
Regulatory Status
Discontinued
Drug Name
CYKLOKAPRON
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
1986-12-30
Active Ingredient
TRANEXAMIC ACID
Application Number
19281
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
1986-12-30
Regulatory Status
RX
Drug Name
CYTOMEL
Product Number
1
Dosage Form
-
Strength
EQ 0.005MG BASE
Approval Date
1982-01-01
Active Ingredient
LIOTHYRONINE SODIUM
Application Number
10379
Product Number
1
Dosage Form
-
Strength
EQ 0.005MG BASE
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
CYTOMEL
Product Number
2
Dosage Form
-
Strength
EQ 0.025MG BASE
Approval Date
1982-01-01
Active Ingredient
LIOTHYRONINE SODIUM
Application Number
10379
Product Number
2
Dosage Form
-
Strength
EQ 0.025MG BASE
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
CYTOMEL
Product Number
3
Dosage Form
-
Strength
EQ 0.05MG BASE
Approval Date
1982-01-01
Active Ingredient
LIOTHYRONINE SODIUM
Application Number
10379
Product Number
3
Dosage Form
-
Strength
EQ 0.05MG BASE
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
CYTOTEC
Product Number
1
Dosage Form
-
Strength
0.2MG
Approval Date
1988-12-27
Active Ingredient
MISOPROSTOL
Application Number
19268
Product Number
1
Dosage Form
-
Strength
0.2MG
Approval Date
1988-12-27
Regulatory Status
RX
Drug Name
CYTOTEC
Product Number
3
Dosage Form
-
Strength
0.1MG
Approval Date
1990-09-21
Active Ingredient
MISOPROSTOL
Application Number
19268
Product Number
3
Dosage Form
-
Strength
0.1MG
Approval Date
1990-09-21
Regulatory Status
RX
Drug Name
DARICON
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
OXYPHENCYCLIMINE HYDROCHLORIDE
Application Number
11612
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DAURISMO
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2018-11-21
Active Ingredient
GLASDEGIB MALEATE
Application Number
210656
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2018-11-21
Regulatory Status
RX
Drug Name
DAURISMO
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2018-11-21
Active Ingredient
GLASDEGIB MALEATE
Application Number
210656
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2018-11-21
Regulatory Status
RX
Drug Name
DAYPRO
Product Number
4
Dosage Form
-
Strength
600MG
Approval Date
1992-10-29
Active Ingredient
OXAPROZIN
Application Number
18841
Product Number
4
Dosage Form
-
Strength
600MG
Approval Date
1992-10-29
Regulatory Status
Discontinued
Drug Name
DAYPRO ALTA
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2002-10-17
Active Ingredient
OXAPROZIN POTASSIUM
Application Number
20776
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2002-10-17
Regulatory Status
Discontinued
Drug Name
DELTA-CORTEF
Product Number
4
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Active Ingredient
PREDNISOLONE
Application Number
9987
Product Number
4
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DELTASONE
Product Number
2
Dosage Form
-
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
PREDNISONE
Application Number
9986
Product Number
2
Dosage Form
-
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DELTASONE
Product Number
5
Dosage Form
-
Strength
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
PREDNISONE
Application Number
9986
Product Number
5
Dosage Form
-
Strength
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DELTASONE
Product Number
6
Dosage Form
-
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
PREDNISONE
Application Number
9986
Product Number
6
Dosage Form
-
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DELTASONE
Product Number
7
Dosage Form
-
Strength
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
PREDNISONE
Application Number
9986
Product Number
7
Dosage Form
-
Strength
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DELTASONE
Product Number
8
Dosage Form
-
Strength
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
PREDNISONE
Application Number
9986
Product Number
8
Dosage Form
-
Strength
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DEPO-ESTRADIOL
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
1982-01-01
Active Ingredient
ESTRADIOL CYPIONATE
Application Number
85470
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DEPO-ESTRADIOL
Product Number
2
Dosage Form
-
Strength
3MG/ML
Approval Date
1982-01-01
Active Ingredient
ESTRADIOL CYPIONATE
Application Number
85470
Product Number
2
Dosage Form
-
Strength
3MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DEPO-ESTRADIOL
Product Number
3
Dosage Form
-
Strength
5MG/ML
Approval Date
1982-01-01
Active Ingredient
ESTRADIOL CYPIONATE
Application Number
85470
Product Number
3
Dosage Form
-
Strength
5MG/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
DEPO-MEDROL
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
1982-01-01
Active Ingredient
METHYLPREDNISOLONE ACETATE
Application Number
11757
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
DEPO-MEDROL
Product Number
2
Dosage Form
-
Strength
20MG/ML
Approval Date
1982-01-01
Active Ingredient
METHYLPREDNISOLONE ACETATE
Application Number
11757
Product Number
2
Dosage Form
-
Strength
20MG/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
DEPO-MEDROL
Product Number
4
Dosage Form
-
Strength
80MG/ML
Approval Date
1982-01-01
Active Ingredient
METHYLPREDNISOLONE ACETATE
Application Number
11757
Product Number
4
Dosage Form
-
Strength
80MG/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
DEPO-PROVERA
Product Number
2
Dosage Form
-
Strength
100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
MEDROXYPROGESTERONE ACETATE
Application Number
12541
Product Number
2
Dosage Form
-
Strength
100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DEPO-PROVERA
Product Number
3
Dosage Form
-
Strength
400MG/ML
Approval Date
1982-01-01
Active Ingredient
MEDROXYPROGESTERONE ACETATE
Application Number
12541
Product Number
3
Dosage Form
-
Strength
400MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DEPO-PROVERA
Product Number
1
Dosage Form
-
Strength
150MG/ML
Approval Date
1992-10-29
Active Ingredient
MEDROXYPROGESTERONE ACETATE
Application Number
20246
Product Number
1
Dosage Form
-
Strength
150MG/ML
Approval Date
1992-10-29
Regulatory Status
RX
Drug Name
DEPO-SUBQ PROVERA 104
Product Number
1
Dosage Form
-
Strength
104MG/0.65ML
Approval Date
2004-12-17
Active Ingredient
MEDROXYPROGESTERONE ACETATE
Application Number
21583
Product Number
1
Dosage Form
-
Strength
104MG/0.65ML
Approval Date
2004-12-17
Regulatory Status
RX
Drug Name
DEPO-TESTADIOL
Product Number
1
Dosage Form
-
Strength
2MG/ML;50MG/ML
Approval Date
1982-01-01
Active Ingredient
ESTRADIOL CYPIONATE; TESTOSTERONE CYPIONATE
Application Number
17968
Product Number
1
Dosage Form
-
Strength
2MG/ML;50MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DEPO-TESTOSTERONE
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
1982-01-01
Active Ingredient
TESTOSTERONE CYPIONATE
Application Number
85635
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DEPO-TESTOSTERONE
Product Number
2
Dosage Form
-
Strength
100MG/ML
Approval Date
1982-01-01
Active Ingredient
TESTOSTERONE CYPIONATE
Application Number
85635
Product Number
2
Dosage Form
-
Strength
100MG/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
DEPO-TESTOSTERONE
Product Number
3
Dosage Form
-
Strength
200MG/ML
Approval Date
1982-01-01
Active Ingredient
TESTOSTERONE CYPIONATE
Application Number
85635
Product Number
3
Dosage Form
-
Strength
200MG/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
DERMACORT
Product Number
2
Dosage Form
-
Strength
1%
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE
Application Number
83011
Product Number
2
Dosage Form
-
Strength
1%
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DESLORATADINE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2010-10-25
Active Ingredient
DESLORATADINE
Application Number
78352
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2010-10-25
Regulatory Status
RX
Drug Name
DIABINESE
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Active Ingredient
CHLORPROPAMIDE
Application Number
11641
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DIABINESE
Product Number
6
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Active Ingredient
CHLORPROPAMIDE
Application Number
11641
Product Number
6
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DICLOFENAC SODIUM
Product Number
1
Dosage Form
-
Strength
2%
Approval Date
2022-09-20
Active Ingredient
DICLOFENAC SODIUM
Application Number
208021
Product Number
1
Dosage Form
-
Strength
2%
Approval Date
2022-09-20
Regulatory Status
RX
Drug Name
DIDREX
Product Number
2
Dosage Form
-
Strength
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
BENZPHETAMINE HYDROCHLORIDE
Application Number
12427
Product Number
2
Dosage Form
-
Strength
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DIDREX
Product Number
3
Dosage Form
-
Strength
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
BENZPHETAMINE HYDROCHLORIDE
Application Number
12427
Product Number
3
Dosage Form
-
Strength
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DIFLUCAN
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1990-01-29
Active Ingredient
FLUCONAZOLE
Application Number
19949
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1990-01-29
Regulatory Status
RX
Drug Name
DIFLUCAN
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
1990-01-29
Active Ingredient
FLUCONAZOLE
Application Number
19949
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
1990-01-29
Regulatory Status
RX
Drug Name
DIFLUCAN
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
1990-01-29
Active Ingredient
FLUCONAZOLE
Application Number
19949
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
1990-01-29
Regulatory Status
RX
Drug Name
DIFLUCAN
Product Number
4
Dosage Form
-
Strength
150MG
Approval Date
1994-06-30
Active Ingredient
FLUCONAZOLE
Application Number
19949
Product Number
4
Dosage Form
-
Strength
150MG
Approval Date
1994-06-30
Regulatory Status
RX
Drug Name
DIFLUCAN
Product Number
1
Dosage Form
-
Strength
50MG/5ML
Approval Date
1993-12-23
Active Ingredient
FLUCONAZOLE
Application Number
20090
Product Number
1
Dosage Form
-
Strength
50MG/5ML
Approval Date
1993-12-23
Regulatory Status
RX
Drug Name
DIFLUCAN
Product Number
2
Dosage Form
-
Strength
200MG/5ML
Approval Date
1993-12-23
Active Ingredient
FLUCONAZOLE
Application Number
20090
Product Number
2
Dosage Form
-
Strength
200MG/5ML
Approval Date
1993-12-23
Regulatory Status
RX
Drug Name
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
Product Number
3
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
1992-09-29
Active Ingredient
FLUCONAZOLE
Application Number
19950
Product Number
3
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
1992-09-29
Regulatory Status
Discontinued
Drug Name
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
Product Number
5
Dosage Form
-
Strength
400MG/200ML (2MG/ML)
Approval Date
1994-07-08
Active Ingredient
FLUCONAZOLE
Application Number
19950
Product Number
5
Dosage Form
-
Strength
400MG/200ML (2MG/ML)
Approval Date
1994-07-08
Regulatory Status
Discontinued
Drug Name
DIFLUCAN IN SODIUM CHLORIDE 0.9%
Product Number
1
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
1990-01-29
Active Ingredient
FLUCONAZOLE
Application Number
19950
Product Number
1
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
1990-01-29
Regulatory Status
Discontinued
Drug Name
DIFLUCAN IN SODIUM CHLORIDE 0.9%
Product Number
6
Dosage Form
-
Strength
400MG/200ML (2MG/ML)
Approval Date
1990-01-29
Active Ingredient
FLUCONAZOLE
Application Number
19950
Product Number
6
Dosage Form
-
Strength
400MG/200ML (2MG/ML)
Approval Date
1990-01-29
Regulatory Status
Discontinued
Drug Name
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Product Number
2
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
1990-01-29
Active Ingredient
FLUCONAZOLE
Application Number
19950
Product Number
2
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
1990-01-29
Regulatory Status
Discontinued
Drug Name
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Product Number
4
Dosage Form
-
Strength
400MG/200ML (2MG/ML)
Approval Date
1990-01-29
Active Ingredient
FLUCONAZOLE
Application Number
19950
Product Number
4
Dosage Form
-
Strength
400MG/200ML (2MG/ML)
Approval Date
1990-01-29
Regulatory Status
Discontinued
Drug Name
DILANTIN
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
1982-01-01
Active Ingredient
PHENYTOIN SODIUM
Application Number
10151
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Product Number
1
Dosage Form
-
Strength
0.025MG;2.5MG
Approval Date
1982-01-01
Active Ingredient
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Application Number
87131
Product Number
1
Dosage Form
-
Strength
0.025MG;2.5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DIZAC
Product Number
1
Dosage Form
-
Strength
5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1993-06-18
Active Ingredient
DIAZEPAM
Application Number
19287
Product Number
1
Dosage Form
-
Strength
5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1993-06-18
Regulatory Status
Discontinued
Drug Name
DOCETAXEL
Product Number
1
Dosage Form
-
Strength
20MG/2ML (10MG/ML)
Approval Date
2014-03-13
Active Ingredient
DOCETAXEL
Application Number
202356
Product Number
1
Dosage Form
-
Strength
20MG/2ML (10MG/ML)
Approval Date
2014-03-13
Regulatory Status
Discontinued
Drug Name
DOCETAXEL
Product Number
2
Dosage Form
-
Strength
80MG/8ML (10MG/ML)
Approval Date
2014-03-13
Active Ingredient
DOCETAXEL
Application Number
202356
Product Number
2
Dosage Form
-
Strength
80MG/8ML (10MG/ML)
Approval Date
2014-03-13
Regulatory Status
Discontinued
Drug Name
DOCETAXEL
Product Number
3
Dosage Form
-
Strength
130MG/13ML (10MG/ML)
Approval Date
2014-03-13
Active Ingredient
DOCETAXEL
Application Number
202356
Product Number
3
Dosage Form
-
Strength
130MG/13ML (10MG/ML)
Approval Date
2014-03-13
Regulatory Status
Discontinued
Drug Name
DOCETAXEL
Product Number
4
Dosage Form
-
Strength
200MG/20ML (10MG/ML)
Approval Date
2014-03-13
Active Ingredient
DOCETAXEL
Application Number
202356
Product Number
4
Dosage Form
-
Strength
200MG/20ML (10MG/ML)
Approval Date
2014-03-13
Regulatory Status
Discontinued
Drug Name
DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
Product Number
1
Dosage Form
-
Strength
50MG/300MG/300MG
Approval Date
-
Active Ingredient
DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Application Number
212303
Product Number
1
Dosage Form
-
Strength
50MG/300MG/300MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR ALAFENAMIDE
Product Number
1
Dosage Form
-
Strength
50MG;300MG;25MG
Approval Date
-
Active Ingredient
DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR ALAFENAMIDE
Application Number
215187
Product Number
1
Dosage Form
-
Strength
50MG;300MG;25MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DOSTINEX
Product Number
1
Dosage Form
-
Strength
0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1996-12-23
Active Ingredient
CABERGOLINE
Application Number
20664
Product Number
1
Dosage Form
-
Strength
0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1996-12-23
Regulatory Status
Discontinued
Drug Name
DOXORUBICIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG/VIAL
Approval Date
1982-01-01
Active Ingredient
DOXORUBICIN HYDROCHLORIDE
Application Number
50467
Product Number
1
Dosage Form
-
Strength
10MG/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DOXORUBICIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
50MG/VIAL
Approval Date
1982-01-01
Active Ingredient
DOXORUBICIN HYDROCHLORIDE
Application Number
50467
Product Number
2
Dosage Form
-
Strength
50MG/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DOXORUBICIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
20MG/VIAL
Approval Date
1985-05-20
Active Ingredient
DOXORUBICIN HYDROCHLORIDE
Application Number
50467
Product Number
3
Dosage Form
-
Strength
20MG/VIAL
Approval Date
1985-05-20
Regulatory Status
Discontinued
Drug Name
DOXORUBICIN HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
150MG/VIAL
Approval Date
1987-07-22
Active Ingredient
DOXORUBICIN HYDROCHLORIDE
Application Number
50467
Product Number
4
Dosage Form
-
Strength
150MG/VIAL
Approval Date
1987-07-22
Regulatory Status
Discontinued
Drug Name
DOXORUBICIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
1987-12-23
Active Ingredient
DOXORUBICIN HYDROCHLORIDE
Application Number
50629
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
1987-12-23
Regulatory Status
RX
Drug Name
DOXORUBICIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
200MG/100ML
Approval Date
1988-05-03
Active Ingredient
DOXORUBICIN HYDROCHLORIDE
Application Number
50629
Product Number
2
Dosage Form
-
Strength
200MG/100ML
Approval Date
1988-05-03
Regulatory Status
RX
Drug Name
DOXORUBICIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
150MG/75ML
Approval Date
2011-03-28
Active Ingredient
DOXORUBICIN HYDROCHLORIDE
Application Number
50629
Product Number
3
Dosage Form
-
Strength
150MG/75ML
Approval Date
2011-03-28
Regulatory Status
Discontinued
Drug Name
DROXIDOPA
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2021-02-18
Active Ingredient
DROXIDOPA
Application Number
211652
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2021-02-18
Regulatory Status
Discontinued
Drug Name
DROXIDOPA
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2021-02-18
Active Ingredient
DROXIDOPA
Application Number
211652
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2021-02-18
Regulatory Status
Discontinued
Drug Name
DROXIDOPA
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2021-02-18
Active Ingredient
DROXIDOPA
Application Number
211652
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2021-02-18
Regulatory Status
Discontinued
Drug Name
E-MYCIN E
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE/5ML
Approval Date
1982-01-01
Active Ingredient
ERYTHROMYCIN ETHYLSUCCINATE
Application Number
62198
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
E-MYCIN E
Product Number
2
Dosage Form
-
Strength
EQ 400MG BASE/5ML
Approval Date
1982-01-01
Active Ingredient
ERYTHROMYCIN ETHYLSUCCINATE
Application Number
62198
Product Number
2
Dosage Form
-
Strength
EQ 400MG BASE/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ELASE-CHLOROMYCETIN
Product Number
1
Dosage Form
-
Strength
10MG/GM;666 UNITS/GM;1 UNITS/GM
Approval Date
-
Active Ingredient
CHLORAMPHENICOL; DESOXYRIBONUCLEASE; FIBRINOLYSIN
Application Number
50294
Product Number
1
Dosage Form
-
Strength
10MG/GM;666 UNITS/GM;1 UNITS/GM
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ELELYSO
Product Number
1
Dosage Form
-
Strength
200 UNITS/VIAL
Approval Date
-
Active Ingredient
TALIGLUCERASE ALFA
Application Number
22458
Product Number
1
Dosage Form
-
Strength
200 UNITS/VIAL
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ELLENCE
Product Number
1
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
1999-09-15
Active Ingredient
EPIRUBICIN HYDROCHLORIDE
Application Number
50778
Product Number
1
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
1999-09-15
Regulatory Status
RX
Drug Name
ELLENCE
Product Number
2
Dosage Form
-
Strength
50MG/25ML (2MG/ML)
Approval Date
1999-09-15
Active Ingredient
EPIRUBICIN HYDROCHLORIDE
Application Number
50778
Product Number
2
Dosage Form
-
Strength
50MG/25ML (2MG/ML)
Approval Date
1999-09-15
Regulatory Status
RX
Drug Name
ELREXFIO
Product Number
1
Dosage Form
-
Strength
12MG
Approval Date
-
Active Ingredient
ELRANATAMAB
Application Number
761345
Product Number
1
Dosage Form
-
Strength
12MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
EMCYT
Product Number
1
Dosage Form
-
Strength
EQ 140MG PHOSPHATE
Approval Date
1982-01-01
Active Ingredient
ESTRAMUSTINE PHOSPHATE SODIUM
Application Number
18045
Product Number
1
Dosage Form
-
Strength
EQ 140MG PHOSPHATE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
EMETE-CON
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/VIAL
Approval Date
1982-01-01
Active Ingredient
BENZQUINAMIDE HYDROCHLORIDE
Application Number
16820
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ERAXIS
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
-
Active Ingredient
ANIDULAFUNGIN
Application Number
21948
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ERYC
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1985-07-25
Active Ingredient
ERYTHROMYCIN
Application Number
62546
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1985-07-25
Regulatory Status
Discontinued
Drug Name
ERYC
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1985-09-25
Active Ingredient
ERYTHROMYCIN
Application Number
62618
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1985-09-25
Regulatory Status
Discontinued
Drug Name
ERYC 125
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
1985-10-24
Active Ingredient
ERYTHROMYCIN
Application Number
62648
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
1985-10-24
Regulatory Status
Discontinued
Drug Name
ERYPAR
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1982-01-01
Active Ingredient
ERYTHROMYCIN STEARATE
Application Number
62032
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ERYPAR
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1982-01-01
Active Ingredient
ERYTHROMYCIN STEARATE
Application Number
62032
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ERYTHROMYCIN ETHYLSUCCINATE
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE/5ML
Approval Date
1982-01-01
Active Ingredient
ERYTHROMYCIN ETHYLSUCCINATE
Application Number
62231
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ERYTHROMYCIN ETHYLSUCCINATE
Product Number
2
Dosage Form
-
Strength
EQ 400MG BASE/5ML
Approval Date
1982-01-01
Active Ingredient
ERYTHROMYCIN ETHYLSUCCINATE
Application Number
62231
Product Number
2
Dosage Form
-
Strength
EQ 400MG BASE/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ESTRING
Product Number
1
Dosage Form
-
Strength
0.0075MG/24HR
Approval Date
1996-04-26
Active Ingredient
ESTRADIOL
Application Number
20472
Product Number
1
Dosage Form
-
Strength
0.0075MG/24HR
Approval Date
1996-04-26
Regulatory Status
RX
Drug Name
ESTROVIS
Product Number
2
Dosage Form
-
Strength
0.1MG
Approval Date
1982-01-01
Active Ingredient
QUINESTROL
Application Number
16768
Product Number
2
Dosage Form
-
Strength
0.1MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ESTROVIS
Product Number
3
Dosage Form
-
Strength
0.2MG
Approval Date
1982-01-01
Active Ingredient
QUINESTROL
Application Number
16768
Product Number
3
Dosage Form
-
Strength
0.2MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
EUTHROID-0.5
Product Number
1
Dosage Form
-
Strength
0.03MG;0.0075MG
Approval Date
1982-01-01
Active Ingredient
LIOTRIX (T4;T3)
Application Number
16680
Product Number
1
Dosage Form
-
Strength
0.03MG;0.0075MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
EUTHROID-1
Product Number
2
Dosage Form
-
Strength
0.06MG;0.015MG
Approval Date
1982-01-01
Active Ingredient
LIOTRIX (T4;T3)
Application Number
16680
Product Number
2
Dosage Form
-
Strength
0.06MG;0.015MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
EUTHROID-2
Product Number
3
Dosage Form
-
Strength
0.12MG;0.03MG
Approval Date
1982-01-01
Active Ingredient
LIOTRIX (T4;T3)
Application Number
16680
Product Number
3
Dosage Form
-
Strength
0.12MG;0.03MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
EUTHROID-3
Product Number
4
Dosage Form
-
Strength
0.18MG;0.045MG
Approval Date
1982-01-01
Active Ingredient
LIOTRIX (T4;T3)
Application Number
16680
Product Number
4
Dosage Form
-
Strength
0.18MG;0.045MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
EVANS BLUE
Product Number
1
Dosage Form
-
Strength
0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
EVANS BLUE
Application Number
8041
Product Number
1
Dosage Form
-
Strength
0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
FELDENE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
1982-04-06
Active Ingredient
PIROXICAM
Application Number
18147
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
1982-04-06
Regulatory Status
RX
Drug Name
FELDENE
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
1982-04-06
Active Ingredient
PIROXICAM
Application Number
18147
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
1982-04-06
Regulatory Status
RX
Drug Name
FEMINONE
Product Number
1
Dosage Form
-
Strength
0.05MG
Approval Date
1982-01-01
Active Ingredient
ETHINYL ESTRADIOL
Application Number
16649
Product Number
1
Dosage Form
-
Strength
0.05MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
FEMPATCH
Product Number
1
Dosage Form
-
Strength
0.025MG/24HR
Approval Date
1996-12-03
Active Ingredient
ESTRADIOL
Application Number
20417
Product Number
1
Dosage Form
-
Strength
0.025MG/24HR
Approval Date
1996-12-03
Regulatory Status
Discontinued
Drug Name
FLAGYL
Product Number
1
Dosage Form
-
Strength
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
METRONIDAZOLE
Application Number
12623
Product Number
1
Dosage Form
-
Strength
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
FLAGYL
Product Number
3
Dosage Form
-
Strength
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
METRONIDAZOLE
Application Number
12623
Product Number
3
Dosage Form
-
Strength
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
FLAGYL
Product Number
1
Dosage Form
-
Strength
375MG
Approval Date
1995-05-03
Active Ingredient
METRONIDAZOLE
Application Number
20334
Product Number
1
Dosage Form
-
Strength
375MG
Approval Date
1995-05-03
Regulatory Status
RX
Drug Name
FLAGYL ER
Product Number
1
Dosage Form
-
Strength
750MG
Approval Date
1997-11-26
Active Ingredient
METRONIDAZOLE
Application Number
20868
Product Number
1
Dosage Form
-
Strength
750MG
Approval Date
1997-11-26
Regulatory Status
Discontinued
Drug Name
FLAGYL I.V.
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
METRONIDAZOLE HYDROCHLORIDE
Application Number
18353
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
FLAGYL I.V. RTU IN PLASTIC CONTAINER
Product Number
2
Dosage Form
-
Strength
500MG/100ML
Approval Date
1982-01-01
Active Ingredient
METRONIDAZOLE
Application Number
18353
Product Number
2
Dosage Form
-
Strength
500MG/100ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
FLAVORED COLESTID
Product Number
1
Dosage Form
-
Strength
5GM/PACKET
Approval Date
1982-01-01
Active Ingredient
COLESTIPOL HYDROCHLORIDE
Application Number
17563
Product Number
1
Dosage Form
-
Strength
5GM/PACKET
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
FLAVORED COLESTID
Product Number
2
Dosage Form
-
Strength
5GM/SCOOPFUL
Approval Date
1982-01-01
Active Ingredient
COLESTIPOL HYDROCHLORIDE
Application Number
17563
Product Number
2
Dosage Form
-
Strength
5GM/SCOOPFUL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
FLORONE
Product Number
1
Dosage Form
-
Strength
0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
DIFLORASONE DIACETATE
Application Number
17741
Product Number
1
Dosage Form
-
Strength
0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
FLORONE E
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
1985-08-28
Active Ingredient
DIFLORASONE DIACETATE
Application Number
19259
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
1985-08-28
Regulatory Status
Discontinued
Drug Name
FLUIDIL
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
1982-01-01
Active Ingredient
CYCLOTHIAZIDE
Application Number
18173
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
FOLEX
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE/VIAL
Approval Date
1983-04-08
Active Ingredient
METHOTREXATE SODIUM
Application Number
87695
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE/VIAL
Approval Date
1983-04-08
Regulatory Status
Discontinued
Drug Name
FOLEX
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE/VIAL
Approval Date
1983-04-08
Active Ingredient
METHOTREXATE SODIUM
Application Number
87695
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE/VIAL
Approval Date
1983-04-08
Regulatory Status
Discontinued
Drug Name
FOLEX
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE/VIAL
Approval Date
1983-04-08
Active Ingredient
METHOTREXATE SODIUM
Application Number
87695
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE/VIAL
Approval Date
1983-04-08
Regulatory Status
Discontinued
Drug Name
FOLEX
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/VIAL
Approval Date
1985-10-24
Active Ingredient
METHOTREXATE SODIUM
Application Number
88954
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/VIAL
Approval Date
1985-10-24
Regulatory Status
Discontinued
Drug Name
FOLEX PFS
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE/ML
Approval Date
1991-08-23
Active Ingredient
METHOTREXATE SODIUM
Application Number
81242
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE/ML
Approval Date
1991-08-23
Regulatory Status
Discontinued
Drug Name
FOLEX PFS
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE/ML
Approval Date
1986-01-03
Active Ingredient
METHOTREXATE SODIUM
Application Number
89180
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE/ML
Approval Date
1986-01-03
Regulatory Status
Discontinued
Drug Name
FOVANE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Active Ingredient
BENZTHIAZIDE
Application Number
12128
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
FRAGMIN
Product Number
1
Dosage Form
-
Strength
2,500IU/0.2ML (12,500IU/ML)
Approval Date
1994-12-22
Active Ingredient
DALTEPARIN SODIUM
Application Number
20287
Product Number
1
Dosage Form
-
Strength
2,500IU/0.2ML (12,500IU/ML)
Approval Date
1994-12-22
Regulatory Status
RX
Drug Name
FRAGMIN
Product Number
2
Dosage Form
-
Strength
10,000IU/0.4ML (25,000IU/ML)
Approval Date
2007-05-01
Active Ingredient
DALTEPARIN SODIUM
Application Number
20287
Product Number
2
Dosage Form
-
Strength
10,000IU/0.4ML (25,000IU/ML)
Approval Date
2007-05-01
Regulatory Status
Discontinued
Drug Name
FRAGMIN
Product Number
3
Dosage Form
-
Strength
5,000IU/0.2ML (25,000IU/ML)
Approval Date
1996-03-18
Active Ingredient
DALTEPARIN SODIUM
Application Number
20287
Product Number
3
Dosage Form
-
Strength
5,000IU/0.2ML (25,000IU/ML)
Approval Date
1996-03-18
Regulatory Status
RX
Drug Name
FRAGMIN
Product Number
4
Dosage Form
-
Strength
10,000IU/ML (10,000IU/ML)
Approval Date
1998-01-30
Active Ingredient
DALTEPARIN SODIUM
Application Number
20287
Product Number
4
Dosage Form
-
Strength
10,000IU/ML (10,000IU/ML)
Approval Date
1998-01-30
Regulatory Status
RX
Drug Name
FRAGMIN
Product Number
5
Dosage Form
-
Strength
7,500IU/0.3ML (25,000IU/ML)
Approval Date
2002-04-04
Active Ingredient
DALTEPARIN SODIUM
Application Number
20287
Product Number
5
Dosage Form
-
Strength
7,500IU/0.3ML (25,000IU/ML)
Approval Date
2002-04-04
Regulatory Status
RX
Drug Name
FRAGMIN
Product Number
6
Dosage Form
-
Strength
95,000IU/3.8ML (25,000IU/ML)
Approval Date
2002-04-04
Active Ingredient
DALTEPARIN SODIUM
Application Number
20287
Product Number
6
Dosage Form
-
Strength
95,000IU/3.8ML (25,000IU/ML)
Approval Date
2002-04-04
Regulatory Status
RX
Drug Name
FRAGMIN
Product Number
7
Dosage Form
-
Strength
95,000IU/9.5ML (10,000IU/ML)
Approval Date
2002-04-04
Active Ingredient
DALTEPARIN SODIUM
Application Number
20287
Product Number
7
Dosage Form
-
Strength
95,000IU/9.5ML (10,000IU/ML)
Approval Date
2002-04-04
Regulatory Status
Discontinued
Drug Name
FRAGMIN
Product Number
8
Dosage Form
-
Strength
7,500 IU/0.75ML
Approval Date
2002-04-04
Active Ingredient
DALTEPARIN SODIUM
Application Number
20287
Product Number
8
Dosage Form
-
Strength
7,500 IU/0.75ML
Approval Date
2002-04-04
Regulatory Status
Discontinued
Drug Name
FRAGMIN
Product Number
9
Dosage Form
-
Strength
12,500IU/0.5ML (25,000IU/ML)
Approval Date
2007-05-01
Active Ingredient
DALTEPARIN SODIUM
Application Number
20287
Product Number
9
Dosage Form
-
Strength
12,500IU/0.5ML (25,000IU/ML)
Approval Date
2007-05-01
Regulatory Status
RX
Drug Name
FRAGMIN
Product Number
10
Dosage Form
-
Strength
15,000IU/0.6ML (25,000IU/ML)
Approval Date
2007-05-01
Active Ingredient
DALTEPARIN SODIUM
Application Number
20287
Product Number
10
Dosage Form
-
Strength
15,000IU/0.6ML (25,000IU/ML)
Approval Date
2007-05-01
Regulatory Status
RX
Drug Name
FRAGMIN
Product Number
11
Dosage Form
-
Strength
18,000IU/0.72ML (25,000IU/ML)
Approval Date
2007-05-01
Active Ingredient
DALTEPARIN SODIUM
Application Number
20287
Product Number
11
Dosage Form
-
Strength
18,000IU/0.72ML (25,000IU/ML)
Approval Date
2007-05-01
Regulatory Status
RX
Drug Name
FRAGMIN
Product Number
12
Dosage Form
-
Strength
10,000IU/4ML (2,500IU/ML)
Approval Date
2022-03-15
Active Ingredient
DALTEPARIN SODIUM
Application Number
20287
Product Number
12
Dosage Form
-
Strength
10,000IU/4ML (2,500IU/ML)
Approval Date
2022-03-15
Regulatory Status
RX
Drug Name
GEOCILLIN
Product Number
1
Dosage Form
-
Strength
EQ 382MG BASE
Approval Date
1982-01-01
Active Ingredient
CARBENICILLIN INDANYL SODIUM
Application Number
50435
Product Number
1
Dosage Form
-
Strength
EQ 382MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
GEODON
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
2006-03-29
Active Ingredient
ZIPRASIDONE HYDROCHLORIDE
Application Number
21483
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
2006-03-29
Regulatory Status
Discontinued
Drug Name
GLUCOTROL
Product Number
1
Dosage Form
-
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1984-05-08
Active Ingredient
GLIPIZIDE
Application Number
17783
Product Number
1
Dosage Form
-
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1984-05-08
Regulatory Status
Discontinued
Drug Name
GLUCOTROL
Product Number
2
Dosage Form
-
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1984-05-08
Active Ingredient
GLIPIZIDE
Application Number
17783
Product Number
2
Dosage Form
-
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1984-05-08
Regulatory Status
Discontinued
Drug Name
GLUCOTROL
Product Number
3
Dosage Form
-
Strength
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1993-05-11
Active Ingredient
GLIPIZIDE
Application Number
17783
Product Number
3
Dosage Form
-
Strength
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1993-05-11
Regulatory Status
Discontinued
Drug Name
GLUCOTROL XL
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
1994-04-26
Active Ingredient
GLIPIZIDE
Application Number
20329
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
1994-04-26
Regulatory Status
RX
Drug Name
GLUCOTROL XL
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
1994-04-26
Active Ingredient
GLIPIZIDE
Application Number
20329
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
1994-04-26
Regulatory Status
RX
Drug Name
GLUCOTROL XL
Product Number
3
Dosage Form
-
Strength
2.5MG
Approval Date
1999-08-10
Active Ingredient
GLIPIZIDE
Application Number
20329
Product Number
3
Dosage Form
-
Strength
2.5MG
Approval Date
1999-08-10
Regulatory Status
Discontinued
Drug Name
GLYNASE
Product Number
1
Dosage Form
-
Strength
1.5MG
Approval Date
1992-03-04
Active Ingredient
GLYBURIDE
Application Number
20051
Product Number
1
Dosage Form
-
Strength
1.5MG
Approval Date
1992-03-04
Regulatory Status
Discontinued
Drug Name
GLYNASE
Product Number
2
Dosage Form
-
Strength
3MG
Approval Date
1992-03-04
Active Ingredient
GLYBURIDE
Application Number
20051
Product Number
2
Dosage Form
-
Strength
3MG
Approval Date
1992-03-04
Regulatory Status
Discontinued
Drug Name
GLYNASE
Product Number
3
Dosage Form
-
Strength
4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1993-09-24
Active Ingredient
GLYBURIDE
Application Number
20051
Product Number
3
Dosage Form
-
Strength
4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1993-09-24
Regulatory Status
Discontinued
Drug Name
GLYNASE
Product Number
4
Dosage Form
-
Strength
6MG
Approval Date
1993-09-24
Active Ingredient
GLYBURIDE
Application Number
20051
Product Number
4
Dosage Form
-
Strength
6MG
Approval Date
1993-09-24
Regulatory Status
Discontinued
Drug Name
GLYSET
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1996-12-18
Active Ingredient
MIGLITOL
Application Number
20682
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1996-12-18
Regulatory Status
Discontinued
Drug Name
GLYSET
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
1996-12-18
Active Ingredient
MIGLITOL
Application Number
20682
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
1996-12-18
Regulatory Status
Discontinued
Drug Name
GLYSET
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
1996-12-18
Active Ingredient
MIGLITOL
Application Number
20682
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
1996-12-18
Regulatory Status
Discontinued
Drug Name
HALCION
Product Number
1
Dosage Form
-
Strength
0.25MG
Approval Date
1982-11-15
Active Ingredient
TRIAZOLAM
Application Number
17892
Product Number
1
Dosage Form
-
Strength
0.25MG
Approval Date
1982-11-15
Regulatory Status
RX
Drug Name
HALCION
Product Number
2
Dosage Form
-
Strength
0.5MG
Approval Date
1982-11-15
Active Ingredient
TRIAZOLAM
Application Number
17892
Product Number
2
Dosage Form
-
Strength
0.5MG
Approval Date
1982-11-15
Regulatory Status
Discontinued
Drug Name
HALCION
Product Number
3
Dosage Form
-
Strength
0.125MG
Approval Date
1985-04-26
Active Ingredient
TRIAZOLAM
Application Number
17892
Product Number
3
Dosage Form
-
Strength
0.125MG
Approval Date
1985-04-26
Regulatory Status
RX
Drug Name
HALOTESTIN
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
1982-01-01
Active Ingredient
FLUOXYMESTERONE
Application Number
10611
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HALOTESTIN
Product Number
6
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Active Ingredient
FLUOXYMESTERONE
Application Number
10611
Product Number
6
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HALOTESTIN
Product Number
10
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
FLUOXYMESTERONE
Application Number
10611
Product Number
10
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HEMABATE
Product Number
1
Dosage Form
-
Strength
EQ 0.25MG BASE/ML
Approval Date
1982-01-01
Active Ingredient
CARBOPROST TROMETHAMINE
Application Number
17989
Product Number
1
Dosage Form
-
Strength
EQ 0.25MG BASE/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
HEPARIN LOCK FLUSH
Product Number
6
Dosage Form
-
Strength
10 UNITS/ML
Approval Date
1982-01-01
Active Ingredient
HEPARIN SODIUM
Application Number
17346
Product Number
6
Dosage Form
-
Strength
10 UNITS/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HEPARIN SODIUM
Product Number
1
Dosage Form
-
Strength
1,000 UNITS/ML
Approval Date
1982-01-01
Active Ingredient
HEPARIN SODIUM
Application Number
4570
Product Number
1
Dosage Form
-
Strength
1,000 UNITS/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HEPARIN SODIUM
Product Number
2
Dosage Form
-
Strength
5,000 UNITS/ML
Approval Date
1982-01-01
Active Ingredient
HEPARIN SODIUM
Application Number
4570
Product Number
2
Dosage Form
-
Strength
5,000 UNITS/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HEPARIN SODIUM
Product Number
3
Dosage Form
-
Strength
10,000 UNITS/ML
Approval Date
1982-01-01
Active Ingredient
HEPARIN SODIUM
Application Number
4570
Product Number
3
Dosage Form
-
Strength
10,000 UNITS/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HEPARIN SODIUM
Product Number
1
Dosage Form
-
Strength
1,000 UNITS/ML
Approval Date
1982-01-01
Active Ingredient
HEPARIN SODIUM
Application Number
17346
Product Number
1
Dosage Form
-
Strength
1,000 UNITS/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HEPARIN SODIUM
Product Number
2
Dosage Form
-
Strength
5,000 UNITS/ML
Approval Date
1982-01-01
Active Ingredient
HEPARIN SODIUM
Application Number
17346
Product Number
2
Dosage Form
-
Strength
5,000 UNITS/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HEPARIN SODIUM
Product Number
3
Dosage Form
-
Strength
7,500 UNITS/ML
Approval Date
1982-01-01
Active Ingredient
HEPARIN SODIUM
Application Number
17346
Product Number
3
Dosage Form
-
Strength
7,500 UNITS/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HEPARIN SODIUM
Product Number
4
Dosage Form
-
Strength
10,000 UNITS/ML
Approval Date
1982-01-01
Active Ingredient
HEPARIN SODIUM
Application Number
17346
Product Number
4
Dosage Form
-
Strength
10,000 UNITS/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HEPARIN SODIUM
Product Number
5
Dosage Form
-
Strength
20,000 UNITS/ML
Approval Date
1982-01-01
Active Ingredient
HEPARIN SODIUM
Application Number
17346
Product Number
5
Dosage Form
-
Strength
20,000 UNITS/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HEPARIN SODIUM
Product Number
1
Dosage Form
-
Strength
1,000 UNITS/ML
Approval Date
2011-07-21
Active Ingredient
HEPARIN SODIUM
Application Number
201370
Product Number
1
Dosage Form
-
Strength
1,000 UNITS/ML
Approval Date
2011-07-21
Regulatory Status
Discontinued
Drug Name
HEPARIN SODIUM
Product Number
2
Dosage Form
-
Strength
5,000 UNITS/ML
Approval Date
2011-07-21
Active Ingredient
HEPARIN SODIUM
Application Number
201370
Product Number
2
Dosage Form
-
Strength
5,000 UNITS/ML
Approval Date
2011-07-21
Regulatory Status
Discontinued
Drug Name
HEPARIN SODIUM
Product Number
3
Dosage Form
-
Strength
10,000 UNITS/ML
Approval Date
2011-07-21
Active Ingredient
HEPARIN SODIUM
Application Number
201370
Product Number
3
Dosage Form
-
Strength
10,000 UNITS/ML
Approval Date
2011-07-21
Regulatory Status
Discontinued
Drug Name
HEPARIN SODIUM PRESERVATIVE FREE
Product Number
4
Dosage Form
-
Strength
1,000 UNITS/ML
Approval Date
2011-07-21
Active Ingredient
HEPARIN SODIUM
Application Number
201370
Product Number
4
Dosage Form
-
Strength
1,000 UNITS/ML
Approval Date
2011-07-21
Regulatory Status
RX
Drug Name
HUMATIN
Product Number
1
Dosage Form
-
Strength
EQ 125MG BASE/5ML
Approval Date
1982-01-01
Active Ingredient
PAROMOMYCIN SULFATE
Application Number
60522
Product Number
1
Dosage Form
-
Strength
EQ 125MG BASE/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HUMATIN
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1982-01-01
Active Ingredient
PAROMOMYCIN SULFATE
Application Number
62310
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HYDROCORTISONE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE
Application Number
84243
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HYDROCORTISONE ACETATE
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1989-01-03
Active Ingredient
HYDROCORTISONE ACETATE
Application Number
89914
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1989-01-03
Regulatory Status
Discontinued
Drug Name
HYLOREL
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-12-29
Active Ingredient
GUANADREL SULFATE
Application Number
18104
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-12-29
Regulatory Status
Discontinued
Drug Name
HYLOREL
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
1982-12-29
Active Ingredient
GUANADREL SULFATE
Application Number
18104
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
1982-12-29
Regulatory Status
Discontinued
Drug Name
HYMPAVZI
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
-
Active Ingredient
MARSTACIMAB-HNCQ
Application Number
761369
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
IBRANCE
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2015-02-03
Active Ingredient
PALBOCICLIB
Application Number
207103
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2015-02-03
Regulatory Status
RX
Drug Name
IBRANCE
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2015-02-03
Active Ingredient
PALBOCICLIB
Application Number
207103
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2015-02-03
Regulatory Status
RX
Drug Name
IBRANCE
Product Number
3
Dosage Form
-
Strength
125MG
Approval Date
2015-02-03
Active Ingredient
PALBOCICLIB
Application Number
207103
Product Number
3
Dosage Form
-
Strength
125MG
Approval Date
2015-02-03
Regulatory Status
RX
Drug Name
IBRANCE
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2019-11-01
Active Ingredient
PALBOCICLIB
Application Number
212436
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2019-11-01
Regulatory Status
RX
Drug Name
IBRANCE
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2019-11-01
Active Ingredient
PALBOCICLIB
Application Number
212436
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2019-11-01
Regulatory Status
RX
Drug Name
IBRANCE
Product Number
3
Dosage Form
-
Strength
125MG
Approval Date
2019-11-01
Active Ingredient
PALBOCICLIB
Application Number
212436
Product Number
3
Dosage Form
-
Strength
125MG
Approval Date
2019-11-01
Regulatory Status
RX
Drug Name
IDAMYCIN
Product Number
1
Dosage Form
-
Strength
10MG/VIAL
Approval Date
1990-09-27
Active Ingredient
IDARUBICIN HYDROCHLORIDE
Application Number
50661
Product Number
1
Dosage Form
-
Strength
10MG/VIAL
Approval Date
1990-09-27
Regulatory Status
Discontinued
Drug Name
IDAMYCIN
Product Number
2
Dosage Form
-
Strength
5MG/VIAL
Approval Date
1990-09-27
Active Ingredient
IDARUBICIN HYDROCHLORIDE
Application Number
50661
Product Number
2
Dosage Form
-
Strength
5MG/VIAL
Approval Date
1990-09-27
Regulatory Status
Discontinued
Drug Name
IDAMYCIN
Product Number
3
Dosage Form
-
Strength
20MG/VIAL
Approval Date
1995-04-25
Active Ingredient
IDARUBICIN HYDROCHLORIDE
Application Number
50661
Product Number
3
Dosage Form
-
Strength
20MG/VIAL
Approval Date
1995-04-25
Regulatory Status
Discontinued
Drug Name
IDAMYCIN PFS
Product Number
1
Dosage Form
-
Strength
5MG/5ML (1MG/ML)
Approval Date
1997-02-17
Active Ingredient
IDARUBICIN HYDROCHLORIDE
Application Number
50734
Product Number
1
Dosage Form
-
Strength
5MG/5ML (1MG/ML)
Approval Date
1997-02-17
Regulatory Status
RX
Drug Name
IDARUBICIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
10MG/10ML (1MG/ML)
Approval Date
1997-02-17
Active Ingredient
IDARUBICIN HYDROCHLORIDE
Application Number
50734
Product Number
2
Dosage Form
-
Strength
10MG/10ML (1MG/ML)
Approval Date
1997-02-17
Regulatory Status
RX
Drug Name
IDARUBICIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
20MG/20ML (1MG/ML)
Approval Date
1997-02-17
Active Ingredient
IDARUBICIN HYDROCHLORIDE
Application Number
50734
Product Number
3
Dosage Form
-
Strength
20MG/20ML (1MG/ML)
Approval Date
1997-02-17
Regulatory Status
RX
Drug Name
INDOMETHACIN
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1984-11-23
Active Ingredient
INDOMETHACIN
Application Number
18806
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1984-11-23
Regulatory Status
Discontinued
Drug Name
INDOMETHACIN
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
1984-11-23
Active Ingredient
INDOMETHACIN
Application Number
18806
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
1984-11-23
Regulatory Status
Discontinued
Drug Name
INLYTA
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2012-01-27
Active Ingredient
AXITINIB
Application Number
202324
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2012-01-27
Regulatory Status
RX
Drug Name
INLYTA
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2012-01-27
Active Ingredient
AXITINIB
Application Number
202324
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2012-01-27
Regulatory Status
RX
Drug Name
INTAL
Product Number
1
Dosage Form
-
Strength
10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-05-28
Active Ingredient
CROMOLYN SODIUM
Application Number
18596
Product Number
1
Dosage Form
-
Strength
10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-05-28
Regulatory Status
Discontinued
Drug Name
INTAL
Product Number
1
Dosage Form
-
Strength
0.8MG/INH
Approval Date
1985-12-05
Active Ingredient
CROMOLYN SODIUM
Application Number
18887
Product Number
1
Dosage Form
-
Strength
0.8MG/INH
Approval Date
1985-12-05
Regulatory Status
Discontinued
Drug Name
ISOETHARINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1982-01-01
Active Ingredient
ISOETHARINE HYDROCHLORIDE
Application Number
85889
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ISOETHARINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.5%
Approval Date
1982-01-01
Active Ingredient
ISOETHARINE HYDROCHLORIDE
Application Number
85997
Product Number
1
Dosage Form
-
Strength
0.5%
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ISOPROTERENOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.5%
Approval Date
1982-01-01
Active Ingredient
ISOPROTERENOL HYDROCHLORIDE
Application Number
85540
Product Number
1
Dosage Form
-
Strength
0.5%
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ISOPROTERENOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.25%
Approval Date
1982-01-01
Active Ingredient
ISOPROTERENOL HYDROCHLORIDE
Application Number
85994
Product Number
1
Dosage Form
-
Strength
0.25%
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
IXIFI
Product Number
1
Dosage Form
-
Strength
100MG/VIAL
Approval Date
-
Active Ingredient
INFLIXIMAB-QBTX
Application Number
761072
Product Number
1
Dosage Form
-
Strength
100MG/VIAL
Approval Date
-
Regulatory Status
Unclassified
Drug Name
KEMADRIN
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Active Ingredient
PROCYCLIDINE HYDROCHLORIDE
Application Number
9818
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
KEMADRIN
Product Number
5
Dosage Form
-
Strength
2MG
Approval Date
1982-01-01
Active Ingredient
PROCYCLIDINE HYDROCHLORIDE
Application Number
9818
Product Number
5
Dosage Form
-
Strength
2MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
KLEBCIL
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE/2ML
Approval Date
1982-01-01
Active Ingredient
KANAMYCIN SULFATE
Application Number
62170
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE/2ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
KLEBCIL
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/2ML
Approval Date
1982-01-01
Active Ingredient
KANAMYCIN SULFATE
Application Number
62170
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/2ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
KLEBCIL
Product Number
3
Dosage Form
-
Strength
EQ 1GM BASE/3ML
Approval Date
1982-01-01
Active Ingredient
KANAMYCIN SULFATE
Application Number
62170
Product Number
3
Dosage Form
-
Strength
EQ 1GM BASE/3ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
LEVOXYL
Product Number
1
Dosage Form
-
Strength
0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2001-05-25
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
21301
Product Number
1
Dosage Form
-
Strength
0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2001-05-25
Regulatory Status
RX
Drug Name
LEVOXYL
Product Number
2
Dosage Form
-
Strength
0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2001-05-25
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
21301
Product Number
2
Dosage Form
-
Strength
0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2001-05-25
Regulatory Status
RX
Drug Name
LEVOXYL
Product Number
3
Dosage Form
-
Strength
0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2001-05-25
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
21301
Product Number
3
Dosage Form
-
Strength
0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2001-05-25
Regulatory Status
RX
Drug Name
LEVOXYL
Product Number
4
Dosage Form
-
Strength
0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2001-05-25
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
21301
Product Number
4
Dosage Form
-
Strength
0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2001-05-25
Regulatory Status
RX
Drug Name
LEVOXYL
Product Number
5
Dosage Form
-
Strength
0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2001-05-25
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
21301
Product Number
5
Dosage Form
-
Strength
0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2001-05-25
Regulatory Status
RX
Drug Name
LEVOXYL
Product Number
6
Dosage Form
-
Strength
0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2001-05-25
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
21301
Product Number
6
Dosage Form
-
Strength
0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2001-05-25
Regulatory Status
RX
Drug Name
LEVOXYL
Product Number
7
Dosage Form
-
Strength
0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2001-05-25
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
21301
Product Number
7
Dosage Form
-
Strength
0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2001-05-25
Regulatory Status
RX
Drug Name
LEVOXYL
Product Number
8
Dosage Form
-
Strength
0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2001-05-25
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
21301
Product Number
8
Dosage Form
-
Strength
0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2001-05-25
Regulatory Status
RX
Drug Name
LEVOXYL
Product Number
9
Dosage Form
-
Strength
0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2001-05-25
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
21301
Product Number
9
Dosage Form
-
Strength
0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2001-05-25
Regulatory Status
RX
Drug Name
LEVOXYL
Product Number
10
Dosage Form
-
Strength
0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2001-05-25
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
21301
Product Number
10
Dosage Form
-
Strength
0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2001-05-25
Regulatory Status
RX
Drug Name
LEVOXYL
Product Number
11
Dosage Form
-
Strength
0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2001-05-25
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
21301
Product Number
11
Dosage Form
-
Strength
0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2001-05-25
Regulatory Status
RX
Drug Name
LEVOXYL
Product Number
12
Dosage Form
-
Strength
0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2001-05-25
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
21301
Product Number
12
Dosage Form
-
Strength
0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2001-05-25
Regulatory Status
Discontinued
Drug Name
LIDOPEN
Product Number
1
Dosage Form
-
Strength
10%
Approval Date
1982-01-01
Active Ingredient
LIDOCAINE HYDROCHLORIDE
Application Number
17549
Product Number
1
Dosage Form
-
Strength
10%
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
LINCOCIN
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1982-01-01
Active Ingredient
LINCOMYCIN HYDROCHLORIDE
Application Number
50316
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
LINCOCIN
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1982-01-01
Active Ingredient
LINCOMYCIN HYDROCHLORIDE
Application Number
50316
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
LINCOCIN
Product Number
1
Dosage Form
-
Strength
EQ 300MG BASE/ML
Approval Date
1982-01-01
Active Ingredient
LINCOMYCIN HYDROCHLORIDE
Application Number
50317
Product Number
1
Dosage Form
-
Strength
EQ 300MG BASE/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
LITFULO
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2023-06-23
Active Ingredient
RITLECITINIB TOSYLATE
Application Number
215830
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2023-06-23
Regulatory Status
RX
Drug Name
LITHIUM CARBONATE
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
1982-01-01
Active Ingredient
LITHIUM CARBONATE
Application Number
16834
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
LOMOTIL
Product Number
1
Dosage Form
-
Strength
0.025MG;2.5MG
Approval Date
1982-01-01
Active Ingredient
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Application Number
12462
Product Number
1
Dosage Form
-
Strength
0.025MG;2.5MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
LONITEN
Product Number
1
Dosage Form
-
Strength
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
MINOXIDIL
Application Number
18154
Product Number
1
Dosage Form
-
Strength
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
LONITEN
Product Number
3
Dosage Form
-
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
MINOXIDIL
Application Number
18154
Product Number
3
Dosage Form
-
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
LOPID
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1982-01-01
Active Ingredient
GEMFIBROZIL
Application Number
18422
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
LOPID
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
1982-01-01
Active Ingredient
GEMFIBROZIL
Application Number
18422
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
LOPID
Product Number
3
Dosage Form
-
Strength
600MG
Approval Date
1986-11-20
Active Ingredient
GEMFIBROZIL
Application Number
18422
Product Number
3
Dosage Form
-
Strength
600MG
Approval Date
1986-11-20
Regulatory Status
RX
Drug Name
LORABID
Product Number
1
Dosage Form
-
Strength
100MG/5ML
Approval Date
1991-12-31
Active Ingredient
LORACARBEF
Application Number
50667
Product Number
1
Dosage Form
-
Strength
100MG/5ML
Approval Date
1991-12-31
Regulatory Status
Discontinued
Drug Name
LORABID
Product Number
2
Dosage Form
-
Strength
200MG/5ML
Approval Date
1991-12-31
Active Ingredient
LORACARBEF
Application Number
50667
Product Number
2
Dosage Form
-
Strength
200MG/5ML
Approval Date
1991-12-31
Regulatory Status
Discontinued
Drug Name
LORABID
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1991-12-31
Active Ingredient
LORACARBEF
Application Number
50668
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1991-12-31
Regulatory Status
Discontinued
Drug Name
LORABID
Product Number
2
Dosage Form
-
Strength
400MG
Approval Date
1996-04-05
Active Ingredient
LORACARBEF
Application Number
50668
Product Number
2
Dosage Form
-
Strength
400MG
Approval Date
1996-04-05
Regulatory Status
Discontinued
Drug Name
LORBRENA
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2018-11-02
Active Ingredient
LORLATINIB
Application Number
210868
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2018-11-02
Regulatory Status
RX
Drug Name
LORBRENA
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2018-11-02
Active Ingredient
LORLATINIB
Application Number
210868
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2018-11-02
Regulatory Status
RX
Drug Name
LUNELLE
Product Number
1
Dosage Form
-
Strength
5MG/0.5ML;25MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2000-10-05
Active Ingredient
ESTRADIOL CYPIONATE; MEDROXYPROGESTERONE ACETATE
Application Number
20874
Product Number
1
Dosage Form
-
Strength
5MG/0.5ML;25MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2000-10-05
Regulatory Status
Discontinued
Drug Name
MAGNACORT
Product Number
1
Dosage Form
-
Strength
0.5%
Approval Date
1982-01-01
Active Ingredient
HYDROCORTAMATE HYDROCHLORIDE
Application Number
10554
Product Number
1
Dosage Form
-
Strength
0.5%
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MAXOLON
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1986-03-04
Active Ingredient
METOCLOPRAMIDE HYDROCHLORIDE
Application Number
70106
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1986-03-04
Regulatory Status
Discontinued
Drug Name
MECLOMEN
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1982-01-01
Active Ingredient
MECLOFENAMATE SODIUM
Application Number
18006
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MECLOMEN
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1982-01-01
Active Ingredient
MECLOFENAMATE SODIUM
Application Number
18006
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MEDROL
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
1982-01-01
Active Ingredient
METHYLPREDNISOLONE
Application Number
11153
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
MEDROL
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
1982-01-01
Active Ingredient
METHYLPREDNISOLONE
Application Number
11153
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
MEDROL
Product Number
3
Dosage Form
-
Strength
16MG
Approval Date
1982-01-01
Active Ingredient
METHYLPREDNISOLONE
Application Number
11153
Product Number
3
Dosage Form
-
Strength
16MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
MEDROL
Product Number
4
Dosage Form
-
Strength
8MG
Approval Date
1982-01-01
Active Ingredient
METHYLPREDNISOLONE
Application Number
11153
Product Number
4
Dosage Form
-
Strength
8MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
MEDROL
Product Number
5
Dosage Form
-
Strength
24MG
Approval Date
1982-01-01
Active Ingredient
METHYLPREDNISOLONE
Application Number
11153
Product Number
5
Dosage Form
-
Strength
24MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MEDROL
Product Number
6
Dosage Form
-
Strength
32MG
Approval Date
1982-01-01
Active Ingredient
METHYLPREDNISOLONE
Application Number
11153
Product Number
6
Dosage Form
-
Strength
32MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
MEDROL
Product Number
1
Dosage Form
-
Strength
40MG/BOT
Approval Date
1982-01-01
Active Ingredient
METHYLPREDNISOLONE ACETATE
Application Number
18102
Product Number
1
Dosage Form
-
Strength
40MG/BOT
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MEDROL ACETATE
Product Number
1
Dosage Form
-
Strength
0.25%
Approval Date
1982-01-01
Active Ingredient
METHYLPREDNISOLONE ACETATE
Application Number
12421
Product Number
1
Dosage Form
-
Strength
0.25%
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MEDROL ACETATE
Product Number
2
Dosage Form
-
Strength
1%
Approval Date
1982-01-01
Active Ingredient
METHYLPREDNISOLONE ACETATE
Application Number
12421
Product Number
2
Dosage Form
-
Strength
1%
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MELOXICAM
Product Number
1
Dosage Form
-
Strength
7.5MG
Approval Date
2006-07-19
Active Ingredient
MELOXICAM
Application Number
77944
Product Number
1
Dosage Form
-
Strength
7.5MG
Approval Date
2006-07-19
Regulatory Status
Discontinued
Drug Name
MELOXICAM
Product Number
2
Dosage Form
-
Strength
15MG
Approval Date
2006-07-19
Active Ingredient
MELOXICAM
Application Number
77944
Product Number
2
Dosage Form
-
Strength
15MG
Approval Date
2006-07-19
Regulatory Status
Discontinued
Drug Name
MENEST
Product Number
1
Dosage Form
-
Strength
0.625MG
Approval Date
1982-01-01
Active Ingredient
ESTROGENS, ESTERIFIED
Application Number
84948
Product Number
1
Dosage Form
-
Strength
0.625MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MENEST
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
1982-01-01
Active Ingredient
ESTROGENS, ESTERIFIED
Application Number
84949
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MENEST
Product Number
1
Dosage Form
-
Strength
1.25MG
Approval Date
1982-01-01
Active Ingredient
ESTROGENS, ESTERIFIED
Application Number
84950
Product Number
1
Dosage Form
-
Strength
1.25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MENEST
Product Number
1
Dosage Form
-
Strength
0.3MG
Approval Date
1982-01-01
Active Ingredient
ESTROGENS, ESTERIFIED
Application Number
84951
Product Number
1
Dosage Form
-
Strength
0.3MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MEPERIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
1982-01-01
Active Ingredient
MEPERIDINE HYDROCHLORIDE
Application Number
80364
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MEPERIDINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
50MG/ML
Approval Date
1982-01-01
Active Ingredient
MEPERIDINE HYDROCHLORIDE
Application Number
80364
Product Number
2
Dosage Form
-
Strength
50MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MEPERIDINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
75MG/ML
Approval Date
1982-01-01
Active Ingredient
MEPERIDINE HYDROCHLORIDE
Application Number
80364
Product Number
3
Dosage Form
-
Strength
75MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MEPROBAMATE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1982-01-01
Active Ingredient
MEPROBAMATE
Application Number
84744
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MEPROBAMATE
Product Number
2
Dosage Form
-
Strength
400MG
Approval Date
1982-01-01
Active Ingredient
MEPROBAMATE
Application Number
84744
Product Number
2
Dosage Form
-
Strength
400MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MERREM IV
Product Number
1
Dosage Form
-
Strength
1GM/VIAL
Approval Date
1996-06-21
Active Ingredient
MEROPENEM
Application Number
50706
Product Number
1
Dosage Form
-
Strength
1GM/VIAL
Approval Date
1996-06-21
Regulatory Status
Discontinued
Drug Name
MERREM IV
Product Number
3
Dosage Form
-
Strength
500MG/VIAL
Approval Date
1996-06-21
Active Ingredient
MEROPENEM
Application Number
50706
Product Number
3
Dosage Form
-
Strength
500MG/VIAL
Approval Date
1996-06-21
Regulatory Status
Discontinued
Drug Name
METHYLDOPA
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
1986-04-15
Active Ingredient
METHYLDOPA
Application Number
70331
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
1986-04-15
Regulatory Status
Discontinued
Drug Name
METHYLDOPA
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1986-04-15
Active Ingredient
METHYLDOPA
Application Number
70332
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1986-04-15
Regulatory Status
Discontinued
Drug Name
METHYLDOPA
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1986-04-15
Active Ingredient
METHYLDOPA
Application Number
70333
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1986-04-15
Regulatory Status
Discontinued
Drug Name
METHYLDOPA AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
15MG;250MG
Approval Date
1987-11-23
Active Ingredient
HYDROCHLOROTHIAZIDE; METHYLDOPA
Application Number
71897
Product Number
1
Dosage Form
-
Strength
15MG;250MG
Approval Date
1987-11-23
Regulatory Status
Discontinued
Drug Name
METHYLDOPA AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
25MG;250MG
Approval Date
1987-11-23
Active Ingredient
HYDROCHLOROTHIAZIDE; METHYLDOPA
Application Number
71898
Product Number
1
Dosage Form
-
Strength
25MG;250MG
Approval Date
1987-11-23
Regulatory Status
Discontinued
Drug Name
METHYLDOPA AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
30MG;500MG
Approval Date
1987-11-23
Active Ingredient
HYDROCHLOROTHIAZIDE; METHYLDOPA
Application Number
71899
Product Number
1
Dosage Form
-
Strength
30MG;500MG
Approval Date
1987-11-23
Regulatory Status
Discontinued
Drug Name
METHYLDOPA AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
50MG;500MG
Approval Date
1987-11-23
Active Ingredient
HYDROCHLOROTHIAZIDE; METHYLDOPA
Application Number
71900
Product Number
1
Dosage Form
-
Strength
50MG;500MG
Approval Date
1987-11-23
Regulatory Status
Discontinued
Drug Name
METHYLTESTOSTERONE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Active Ingredient
METHYLTESTOSTERONE
Application Number
84241
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
METHYLTESTOSTERONE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
METHYLTESTOSTERONE
Application Number
84244
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MICRONASE
Product Number
1
Dosage Form
-
Strength
1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1984-05-01
Active Ingredient
GLYBURIDE
Application Number
17498
Product Number
1
Dosage Form
-
Strength
1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1984-05-01
Regulatory Status
Discontinued
Drug Name
MICRONASE
Product Number
2
Dosage Form
-
Strength
2.5MG
Approval Date
1984-05-01
Active Ingredient
GLYBURIDE
Application Number
17498
Product Number
2
Dosage Form
-
Strength
2.5MG
Approval Date
1984-05-01
Regulatory Status
Discontinued
Drug Name
MICRONASE
Product Number
3
Dosage Form
-
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1984-05-01
Active Ingredient
GLYBURIDE
Application Number
17498
Product Number
3
Dosage Form
-
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1984-05-01
Regulatory Status
Discontinued
Drug Name
MILONTIN
Product Number
4
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Active Ingredient
PHENSUXIMIDE
Application Number
8855
Product Number
4
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MINIPRESS
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
1982-01-01
Active Ingredient
PRAZOSIN HYDROCHLORIDE
Application Number
17442
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
MINIPRESS
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
1982-01-01
Active Ingredient
PRAZOSIN HYDROCHLORIDE
Application Number
17442
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
MINIPRESS
Product Number
3
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
1982-01-01
Active Ingredient
PRAZOSIN HYDROCHLORIDE
Application Number
17442
Product Number
3
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
MINIPRESS XL
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
1992-01-29
Active Ingredient
PRAZOSIN HYDROCHLORIDE
Application Number
19775
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
1992-01-29
Regulatory Status
Discontinued
Drug Name
MINIPRESS XL
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
1992-01-29
Active Ingredient
PRAZOSIN HYDROCHLORIDE
Application Number
19775
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
1992-01-29
Regulatory Status
Discontinued
Drug Name
MINIZIDE
Product Number
1
Dosage Form
-
Strength
0.5MG;EQ 1MG BASE
Approval Date
1982-01-01
Active Ingredient
POLYTHIAZIDE; PRAZOSIN HYDROCHLORIDE
Application Number
17986
Product Number
1
Dosage Form
-
Strength
0.5MG;EQ 1MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MINIZIDE
Product Number
2
Dosage Form
-
Strength
0.5MG;EQ 2MG BASE
Approval Date
1982-01-01
Active Ingredient
POLYTHIAZIDE; PRAZOSIN HYDROCHLORIDE
Application Number
17986
Product Number
2
Dosage Form
-
Strength
0.5MG;EQ 2MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MINIZIDE
Product Number
3
Dosage Form
-
Strength
0.5MG;EQ 5MG BASE
Approval Date
1982-01-01
Active Ingredient
POLYTHIAZIDE; PRAZOSIN HYDROCHLORIDE
Application Number
17986
Product Number
3
Dosage Form
-
Strength
0.5MG;EQ 5MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MITHRACIN
Product Number
1
Dosage Form
-
Strength
2.5MG/VIAL
Approval Date
1982-01-01
Active Ingredient
PLICAMYCIN
Application Number
50109
Product Number
1
Dosage Form
-
Strength
2.5MG/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MODERIL
Product Number
3
Dosage Form
-
Strength
0.25MG
Approval Date
1982-01-01
Active Ingredient
RESCINNAMINE
Application Number
10686
Product Number
3
Dosage Form
-
Strength
0.25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MODERIL
Product Number
6
Dosage Form
-
Strength
0.5MG
Approval Date
1982-01-01
Active Ingredient
RESCINNAMINE
Application Number
10686
Product Number
6
Dosage Form
-
Strength
0.5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MORPHINE SULFATE (AUTOINJECTOR)
Product Number
1
Dosage Form
-
Strength
10MG/0.7ML (10MG/0.7ML)
Approval Date
1990-07-12
Active Ingredient
MORPHINE SULFATE
Application Number
19999
Product Number
1
Dosage Form
-
Strength
10MG/0.7ML (10MG/0.7ML)
Approval Date
1990-07-12
Regulatory Status
Discontinued
Drug Name
MYCIFRADIN
Product Number
1
Dosage Form
-
Strength
EQ 87.5MG BASE/5ML
Approval Date
1982-01-01
Active Ingredient
NEOMYCIN SULFATE
Application Number
50285
Product Number
1
Dosage Form
-
Strength
EQ 87.5MG BASE/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MYCIFRADIN
Product Number
1
Dosage Form
-
Strength
EQ 350MG BASE
Approval Date
1982-01-01
Active Ingredient
NEOMYCIN SULFATE
Application Number
60520
Product Number
1
Dosage Form
-
Strength
EQ 350MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MYCITRACIN
Product Number
1
Dosage Form
-
Strength
500 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM
Approval Date
1982-01-01
Active Ingredient
BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Application Number
61048
Product Number
1
Dosage Form
-
Strength
500 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MYCOBUTIN
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
1992-12-23
Active Ingredient
RIFABUTIN
Application Number
50689
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
1992-12-23
Regulatory Status
RX
Drug Name
NARDIL
Product Number
2
Dosage Form
-
Strength
EQ 15MG BASE
Approval Date
1982-01-01
Active Ingredient
PHENELZINE SULFATE
Application Number
11909
Product Number
2
Dosage Form
-
Strength
EQ 15MG BASE
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
NAVANE
Product Number
1
Dosage Form
-
Strength
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
THIOTHIXENE
Application Number
16584
Product Number
1
Dosage Form
-
Strength
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NAVANE
Product Number
2
Dosage Form
-
Strength
2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
THIOTHIXENE
Application Number
16584
Product Number
2
Dosage Form
-
Strength
2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NAVANE
Product Number
3
Dosage Form
-
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
THIOTHIXENE
Application Number
16584
Product Number
3
Dosage Form
-
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NAVANE
Product Number
4
Dosage Form
-
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
THIOTHIXENE
Application Number
16584
Product Number
4
Dosage Form
-
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NAVANE
Product Number
5
Dosage Form
-
Strength
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
THIOTHIXENE
Application Number
16584
Product Number
5
Dosage Form
-
Strength
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NAVANE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
THIOTHIXENE HYDROCHLORIDE
Application Number
16758
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NAVANE
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
1982-01-01
Active Ingredient
THIOTHIXENE HYDROCHLORIDE
Application Number
16904
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NAVANE
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE/VIAL
Approval Date
1982-01-01
Active Ingredient
THIOTHIXENE HYDROCHLORIDE
Application Number
16904
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NEO-CORTEF
Product Number
1
Dosage Form
-
Strength
0.5%;EQ 3.5MG BASE/GM
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE ACETATE; NEOMYCIN SULFATE
Application Number
60610
Product Number
1
Dosage Form
-
Strength
0.5%;EQ 3.5MG BASE/GM
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NEO-CORTEF
Product Number
2
Dosage Form
-
Strength
1.5%;EQ 3.5MG BASE/GM
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE ACETATE; NEOMYCIN SULFATE
Application Number
60610
Product Number
2
Dosage Form
-
Strength
1.5%;EQ 3.5MG BASE/GM
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NEO-CORTEF
Product Number
1
Dosage Form
-
Strength
1.5%;EQ 3.5MG BASE/ML
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE ACETATE; NEOMYCIN SULFATE
Application Number
60612
Product Number
1
Dosage Form
-
Strength
1.5%;EQ 3.5MG BASE/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NEO-CORTEF
Product Number
2
Dosage Form
-
Strength
0.5%;EQ 3.5MG BASE/ML
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE ACETATE; NEOMYCIN SULFATE
Application Number
60612
Product Number
2
Dosage Form
-
Strength
0.5%;EQ 3.5MG BASE/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NEO-CORTEF
Product Number
1
Dosage Form
-
Strength
0.5%;EQ 3.5MG BASE/GM
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE ACETATE; NEOMYCIN SULFATE
Application Number
60751
Product Number
1
Dosage Form
-
Strength
0.5%;EQ 3.5MG BASE/GM
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NEO-CORTEF
Product Number
2
Dosage Form
-
Strength
1%;EQ 3.5MG BASE/GM
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE ACETATE; NEOMYCIN SULFATE
Application Number
60751
Product Number
2
Dosage Form
-
Strength
1%;EQ 3.5MG BASE/GM
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NEO-CORTEF
Product Number
3
Dosage Form
-
Strength
2.5%;EQ 3.5MG BASE/GM
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE ACETATE; NEOMYCIN SULFATE
Application Number
60751
Product Number
3
Dosage Form
-
Strength
2.5%;EQ 3.5MG BASE/GM
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NEO-CORTEF
Product Number
1
Dosage Form
-
Strength
1%;EQ 3.5MG BASE/GM
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE ACETATE; NEOMYCIN SULFATE
Application Number
61049
Product Number
1
Dosage Form
-
Strength
1%;EQ 3.5MG BASE/GM
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NEO-CORTEF
Product Number
2
Dosage Form
-
Strength
2.5%;EQ 3.5MG BASE/GM
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE ACETATE; NEOMYCIN SULFATE
Application Number
61049
Product Number
2
Dosage Form
-
Strength
2.5%;EQ 3.5MG BASE/GM
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NEO-DELTA-CORTEF
Product Number
1
Dosage Form
-
Strength
EQ 3.5MG BASE/ML;0.25%
Approval Date
1982-01-01
Active Ingredient
NEOMYCIN SULFATE; PREDNISOLONE ACETATE
Application Number
61037
Product Number
1
Dosage Form
-
Strength
EQ 3.5MG BASE/ML;0.25%
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NEO-DELTA-CORTEF
Product Number
1
Dosage Form
-
Strength
EQ 3.5MG BASE/GM;0.5%
Approval Date
1982-01-01
Active Ingredient
NEOMYCIN SULFATE; PREDNISOLONE ACETATE
Application Number
61039
Product Number
1
Dosage Form
-
Strength
EQ 3.5MG BASE/GM;0.5%
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NEO-DELTA-CORTEF
Product Number
2
Dosage Form
-
Strength
EQ 3.5MG BASE/GM;0.25%
Approval Date
1982-01-01
Active Ingredient
NEOMYCIN SULFATE; PREDNISOLONE ACETATE
Application Number
61039
Product Number
2
Dosage Form
-
Strength
EQ 3.5MG BASE/GM;0.25%
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NEO-MEDROL
Product Number
1
Dosage Form
-
Strength
0.1%;EQ 3.5MG BASE/GM
Approval Date
1982-01-01
Active Ingredient
METHYLPREDNISOLONE; NEOMYCIN SULFATE
Application Number
60645
Product Number
1
Dosage Form
-
Strength
0.1%;EQ 3.5MG BASE/GM
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NEO-MEDROL ACETATE
Product Number
1
Dosage Form
-
Strength
1%;EQ 3.5MG BASE/GM
Approval Date
1982-01-01
Active Ingredient
METHYLPREDNISOLONE ACETATE; NEOMYCIN SULFATE
Application Number
60611
Product Number
1
Dosage Form
-
Strength
1%;EQ 3.5MG BASE/GM
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NEO-MEDROL ACETATE
Product Number
2
Dosage Form
-
Strength
0.25%;EQ 3.5MG BASE/GM
Approval Date
1982-01-01
Active Ingredient
METHYLPREDNISOLONE ACETATE; NEOMYCIN SULFATE
Application Number
60611
Product Number
2
Dosage Form
-
Strength
0.25%;EQ 3.5MG BASE/GM
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NEOBIOTIC
Product Number
1
Dosage Form
-
Strength
EQ 350MG BASE
Approval Date
1982-01-01
Active Ingredient
NEOMYCIN SULFATE
Application Number
60475
Product Number
1
Dosage Form
-
Strength
EQ 350MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NEOSPORIN
Product Number
1
Dosage Form
-
Strength
0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML
Approval Date
1982-01-01
Active Ingredient
GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Application Number
60582
Product Number
1
Dosage Form
-
Strength
0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NEOSPORIN G.U. IRRIGANT
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/ML;200,000 UNITS/ML
Approval Date
1982-01-01
Active Ingredient
NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Application Number
60707
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/ML;200,000 UNITS/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NEOSPORIN G.U. IRRIGANT
Product Number
2
Dosage Form
-
Strength
EQ 800MG BASE/20ML;4,000,000 UNITS/20ML (EQ 40MG BASE/ML;200,000 UNITS/ML)
Approval Date
-
Active Ingredient
NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Application Number
60707
Product Number
2
Dosage Form
-
Strength
EQ 800MG BASE/20ML;4,000,000 UNITS/20ML (EQ 40MG BASE/ML;200,000 UNITS/ML)
Approval Date
-
Regulatory Status
Unclassified
Drug Name
NEURONTIN
Product Number
1
Dosage Form
-
Strength
250MG/5ML
Approval Date
-
Active Ingredient
GABAPENTIN
Application Number
21216
Product Number
1
Dosage Form
-
Strength
250MG/5ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
NEURONTIN
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
-
Active Ingredient
GABAPENTIN
Application Number
21397
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
NEURONTIN
Product Number
1
Dosage Form
-
Strength
800MG
Approval Date
-
Active Ingredient
GABAPENTIN
Application Number
21423
Product Number
1
Dosage Form
-
Strength
800MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
NEURONTIN
Product Number
1
Dosage Form
-
Strength
250MG/5ML
Approval Date
-
Active Ingredient
GABAPENTIN
Application Number
21424
Product Number
1
Dosage Form
-
Strength
250MG/5ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
NGENLA
Product Number
1
Dosage Form
-
Strength
24MG
Approval Date
-
Active Ingredient
SOMATROGON-GHLA
Application Number
761184
Product Number
1
Dosage Form
-
Strength
24MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
NGENLA
Product Number
2
Dosage Form
-
Strength
60MG
Approval Date
-
Active Ingredient
SOMATROGON-GHLA
Application Number
761184
Product Number
2
Dosage Form
-
Strength
60MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
NICOTROL
Product Number
1
Dosage Form
-
Strength
0.5MG/SPRAY
Approval Date
1996-03-22
Active Ingredient
NICOTINE
Application Number
20385
Product Number
1
Dosage Form
-
Strength
0.5MG/SPRAY
Approval Date
1996-03-22
Regulatory Status
RX
Drug Name
NICOTROL
Product Number
1
Dosage Form
-
Strength
4MG/CARTRIDGE
Approval Date
1997-05-02
Active Ingredient
NICOTINE
Application Number
20714
Product Number
1
Dosage Form
-
Strength
4MG/CARTRIDGE
Approval Date
1997-05-02
Regulatory Status
Discontinued
Drug Name
NITROSTAT
Product Number
1
Dosage Form
-
Strength
0.8MG/ML
Approval Date
1982-01-01
Active Ingredient
NITROGLYCERIN
Application Number
18588
Product Number
1
Dosage Form
-
Strength
0.8MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NITROSTAT
Product Number
2
Dosage Form
-
Strength
5MG/ML
Approval Date
1983-12-23
Active Ingredient
NITROGLYCERIN
Application Number
18588
Product Number
2
Dosage Form
-
Strength
5MG/ML
Approval Date
1983-12-23
Regulatory Status
Discontinued
Drug Name
NITROSTAT
Product Number
1
Dosage Form
-
Strength
5MG/ML
Approval Date
1987-01-08
Active Ingredient
NITROGLYCERIN
Application Number
70863
Product Number
1
Dosage Form
-
Strength
5MG/ML
Approval Date
1987-01-08
Regulatory Status
Discontinued
Drug Name
NITROSTAT
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
1987-01-08
Active Ingredient
NITROGLYCERIN
Application Number
70871
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
1987-01-08
Regulatory Status
Discontinued
Drug Name
NITROSTAT
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
1987-01-08
Active Ingredient
NITROGLYCERIN
Application Number
70872
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
1987-01-08
Regulatory Status
Discontinued
Drug Name
NORGESTIMATE AND ETHINYL ESTRADIOL
Product Number
1
Dosage Form
-
Strength
0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG
Approval Date
2012-06-25
Active Ingredient
ETHINYL ESTRADIOL; NORGESTIMATE
Application Number
200541
Product Number
1
Dosage Form
-
Strength
0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG
Approval Date
2012-06-25
Regulatory Status
RX
Drug Name
NORLESTRIN 21 1/50
Product Number
1
Dosage Form
-
Strength
0.05MG;1MG
Approval Date
1982-01-01
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Application Number
16749
Product Number
1
Dosage Form
-
Strength
0.05MG;1MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NORLESTRIN 21 2.5/50
Product Number
1
Dosage Form
-
Strength
0.05MG;2.5MG
Approval Date
1982-01-01
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Application Number
16852
Product Number
1
Dosage Form
-
Strength
0.05MG;2.5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NORLESTRIN 28 1/50
Product Number
1
Dosage Form
-
Strength
0.05MG;1MG
Approval Date
1982-01-01
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Application Number
16723
Product Number
1
Dosage Form
-
Strength
0.05MG;1MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NORLESTRIN FE 1/50
Product Number
1
Dosage Form
-
Strength
0.05MG;75MG;1MG
Approval Date
1982-01-01
Active Ingredient
ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE ACETATE
Application Number
16766
Product Number
1
Dosage Form
-
Strength
0.05MG;75MG;1MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NORLESTRIN FE 2.5/50
Product Number
1
Dosage Form
-
Strength
0.05MG;75MG;2.5MG
Approval Date
1982-01-01
Active Ingredient
ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE ACETATE
Application Number
16854
Product Number
1
Dosage Form
-
Strength
0.05MG;75MG;2.5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NORLUTATE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Active Ingredient
NORETHINDRONE ACETATE
Application Number
12184
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NORLUTIN
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Active Ingredient
NORETHINDRONE
Application Number
10895
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NORMIFLO
Product Number
1
Dosage Form
-
Strength
10,000 UNITS/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-05-23
Active Ingredient
ARDEPARIN SODIUM
Application Number
20227
Product Number
1
Dosage Form
-
Strength
10,000 UNITS/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-05-23
Regulatory Status
Discontinued
Drug Name
NORMIFLO
Product Number
2
Dosage Form
-
Strength
5,000 UNITS/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-05-23
Active Ingredient
ARDEPARIN SODIUM
Application Number
20227
Product Number
2
Dosage Form
-
Strength
5,000 UNITS/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-05-23
Regulatory Status
Discontinued
Drug Name
NORPACE
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1982-01-01
Active Ingredient
DISOPYRAMIDE PHOSPHATE
Application Number
17447
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
NORPACE
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
1982-01-01
Active Ingredient
DISOPYRAMIDE PHOSPHATE
Application Number
17447
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
NORPACE CR
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1982-07-20
Active Ingredient
DISOPYRAMIDE PHOSPHATE
Application Number
18655
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1982-07-20
Regulatory Status
RX
Drug Name
NORPACE CR
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
1982-07-20
Active Ingredient
DISOPYRAMIDE PHOSPHATE
Application Number
18655
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
1982-07-20
Regulatory Status
RX
Drug Name
NORQUEST FE
Product Number
1
Dosage Form
-
Strength
0.035MG;75MG;1MG
Approval Date
1986-07-18
Active Ingredient
ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE
Application Number
18926
Product Number
1
Dosage Form
-
Strength
0.035MG;75MG;1MG
Approval Date
1986-07-18
Regulatory Status
Discontinued
Drug Name
NURTEC ODT
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2020-02-27
Active Ingredient
RIMEGEPANT SULFATE
Application Number
212728
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2020-02-27
Regulatory Status
RX
Drug Name
OGEN
Product Number
1
Dosage Form
-
Strength
1.5MG/GM
Approval Date
1982-01-01
Active Ingredient
ESTROPIPATE
Application Number
84710
Product Number
1
Dosage Form
-
Strength
1.5MG/GM
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
OGEN .625
Product Number
1
Dosage Form
-
Strength
0.75MG
Approval Date
1982-01-01
Active Ingredient
ESTROPIPATE
Application Number
83220
Product Number
1
Dosage Form
-
Strength
0.75MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
OGEN 1.25
Product Number
2
Dosage Form
-
Strength
1.5MG
Approval Date
1982-01-01
Active Ingredient
ESTROPIPATE
Application Number
83220
Product Number
2
Dosage Form
-
Strength
1.5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
OGEN 2.5
Product Number
3
Dosage Form
-
Strength
3MG
Approval Date
1982-01-01
Active Ingredient
ESTROPIPATE
Application Number
83220
Product Number
3
Dosage Form
-
Strength
3MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
OGEN 5
Product Number
4
Dosage Form
-
Strength
6MG
Approval Date
1982-01-01
Active Ingredient
ESTROPIPATE
Application Number
83220
Product Number
4
Dosage Form
-
Strength
6MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
ORINASE
Product Number
1
Dosage Form
-
Strength
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
TOLBUTAMIDE
Application Number
10670
Product Number
1
Dosage Form
-
Strength
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ORINASE
Product Number
2
Dosage Form
-
Strength
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
TOLBUTAMIDE
Application Number
10670
Product Number
2
Dosage Form
-
Strength
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ORINASE DIAGNOSTIC
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
1982-01-01
Active Ingredient
TOLBUTAMIDE SODIUM
Application Number
12095
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
OXAZEPAM
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
1987-02-02
Active Ingredient
OXAZEPAM
Application Number
71508
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
1987-02-02
Regulatory Status
Discontinued
Drug Name
OXYLONE
Product Number
1
Dosage Form
-
Strength
0.025%
Approval Date
1982-01-01
Active Ingredient
FLUOROMETHOLONE
Application Number
11748
Product Number
1
Dosage Form
-
Strength
0.025%
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PANMYCIN
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Active Ingredient
TETRACYCLINE HYDROCHLORIDE
Application Number
60347
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PANMYCIN
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Active Ingredient
TETRACYCLINE HYDROCHLORIDE
Application Number
61705
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PANMYCIN
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Active Ingredient
TETRACYCLINE HYDROCHLORIDE
Application Number
61705
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PARACORT
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Active Ingredient
PREDNISONE
Application Number
10962
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PARSIDOL
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
ETHOPROPAZINE HYDROCHLORIDE
Application Number
9078
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PARSIDOL
Product Number
6
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Active Ingredient
ETHOPROPAZINE HYDROCHLORIDE
Application Number
9078
Product Number
6
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PARSIDOL
Product Number
8
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Active Ingredient
ETHOPROPAZINE HYDROCHLORIDE
Application Number
9078
Product Number
8
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PAXLOVID (COPACKAGED)
Product Number
1
Dosage Form
-
Strength
150MG;100MG
Approval Date
2023-05-25
Active Ingredient
NIRMATRELVIR; RITONAVIR
Application Number
217188
Product Number
1
Dosage Form
-
Strength
150MG;100MG
Approval Date
2023-05-25
Regulatory Status
RX
Drug Name
PAXLOVID (COPACKAGED)
Product Number
2
Dosage Form
-
Strength
300MG;100MG
Approval Date
-
Active Ingredient
NIRMATRELVIR; RITONAVIR
Application Number
217188
Product Number
2
Dosage Form
-
Strength
300MG;100MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PEDIOTIC
Product Number
1
Dosage Form
-
Strength
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Approval Date
1987-09-29
Active Ingredient
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Application Number
62822
Product Number
1
Dosage Form
-
Strength
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Approval Date
1987-09-29
Regulatory Status
Discontinued
Drug Name
PENAPAR-VK
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1982-01-01
Active Ingredient
PENICILLIN V POTASSIUM
Application Number
62001
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PENAPAR-VK
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1982-01-01
Active Ingredient
PENICILLIN V POTASSIUM
Application Number
62001
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PENAPAR-VK
Product Number
1
Dosage Form
-
Strength
EQ 125MG BASE/5ML
Approval Date
1982-01-01
Active Ingredient
PENICILLIN V POTASSIUM
Application Number
62002
Product Number
1
Dosage Form
-
Strength
EQ 125MG BASE/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PENAPAR-VK
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE/5ML
Approval Date
1982-01-01
Active Ingredient
PENICILLIN V POTASSIUM
Application Number
62002
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PENICILLIN G POTASSIUM
Product Number
3
Dosage Form
-
Strength
20,000,000 UNITS/VIAL
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G POTASSIUM
Application Number
60074
Product Number
3
Dosage Form
-
Strength
20,000,000 UNITS/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PENICILLIN G POTASSIUM
Product Number
1
Dosage Form
-
Strength
1,000,000 UNITS/VIAL
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G POTASSIUM
Application Number
62003
Product Number
1
Dosage Form
-
Strength
1,000,000 UNITS/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PENICILLIN G POTASSIUM
Product Number
2
Dosage Form
-
Strength
5,000,000 UNITS/VIAL
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G POTASSIUM
Application Number
62003
Product Number
2
Dosage Form
-
Strength
5,000,000 UNITS/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PENICILLIN G PROCAINE
Product Number
1
Dosage Form
-
Strength
300,000 UNITS/VIAL
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G PROCAINE
Application Number
60099
Product Number
1
Dosage Form
-
Strength
300,000 UNITS/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PENICILLIN G PROCAINE
Product Number
2
Dosage Form
-
Strength
1,500,000 UNITS/VIAL
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G PROCAINE
Application Number
60099
Product Number
2
Dosage Form
-
Strength
1,500,000 UNITS/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PENICILLIN G PROCAINE
Product Number
1
Dosage Form
-
Strength
600,000 UNITS/ML
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G PROCAINE
Application Number
60101
Product Number
1
Dosage Form
-
Strength
600,000 UNITS/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
PENICILLIN G PROCAINE
Product Number
2
Dosage Form
-
Strength
300,000 UNITS/ML
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G PROCAINE
Application Number
60101
Product Number
2
Dosage Form
-
Strength
300,000 UNITS/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
PENICILLIN G PROCAINE
Product Number
1
Dosage Form
-
Strength
300,000 UNITS/ML
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G PROCAINE
Application Number
62029
Product Number
1
Dosage Form
-
Strength
300,000 UNITS/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PENICILLIN G SODIUM
Product Number
1
Dosage Form
-
Strength
1,000,000 UNITS/VIAL
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G SODIUM
Application Number
61046
Product Number
1
Dosage Form
-
Strength
1,000,000 UNITS/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PFIZER-E
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1982-01-01
Active Ingredient
ERYTHROMYCIN STEARATE
Application Number
61791
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PFIZER-E
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1982-01-01
Active Ingredient
ERYTHROMYCIN STEARATE
Application Number
61791
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PFIZERPEN
Product Number
1
Dosage Form
-
Strength
1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G POTASSIUM
Application Number
60657
Product Number
1
Dosage Form
-
Strength
1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PFIZERPEN
Product Number
2
Dosage Form
-
Strength
5,000,000 UNITS/VIAL
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G POTASSIUM
Application Number
60657
Product Number
2
Dosage Form
-
Strength
5,000,000 UNITS/VIAL
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
PFIZERPEN
Product Number
3
Dosage Form
-
Strength
20,000,000 UNITS/VIAL
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G POTASSIUM
Application Number
60657
Product Number
3
Dosage Form
-
Strength
20,000,000 UNITS/VIAL
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
PFIZERPEN G
Product Number
1
Dosage Form
-
Strength
50,000 UNITS
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G POTASSIUM
Application Number
60075
Product Number
1
Dosage Form
-
Strength
50,000 UNITS
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PFIZERPEN G
Product Number
2
Dosage Form
-
Strength
100,000 UNITS
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G POTASSIUM
Application Number
60075
Product Number
2
Dosage Form
-
Strength
100,000 UNITS
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PFIZERPEN G
Product Number
3
Dosage Form
-
Strength
200,000 UNITS
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G POTASSIUM
Application Number
60075
Product Number
3
Dosage Form
-
Strength
200,000 UNITS
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PFIZERPEN G
Product Number
4
Dosage Form
-
Strength
250,000 UNITS
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G POTASSIUM
Application Number
60075
Product Number
4
Dosage Form
-
Strength
250,000 UNITS
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PFIZERPEN G
Product Number
5
Dosage Form
-
Strength
400,000 UNITS
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G POTASSIUM
Application Number
60075
Product Number
5
Dosage Form
-
Strength
400,000 UNITS
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PFIZERPEN G
Product Number
6
Dosage Form
-
Strength
800,000 UNITS
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G POTASSIUM
Application Number
60075
Product Number
6
Dosage Form
-
Strength
800,000 UNITS
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PFIZERPEN G
Product Number
1
Dosage Form
-
Strength
400,000 UNITS/5ML
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G POTASSIUM
Application Number
60587
Product Number
1
Dosage Form
-
Strength
400,000 UNITS/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PFIZERPEN VK
Product Number
1
Dosage Form
-
Strength
EQ 125MG BASE/5ML
Approval Date
1982-01-01
Active Ingredient
PENICILLIN V POTASSIUM
Application Number
61815
Product Number
1
Dosage Form
-
Strength
EQ 125MG BASE/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PFIZERPEN VK
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE/5ML
Approval Date
1982-01-01
Active Ingredient
PENICILLIN V POTASSIUM
Application Number
61815
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PFIZERPEN VK
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1982-01-01
Active Ingredient
PENICILLIN V POTASSIUM
Application Number
61836
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PFIZERPEN VK
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1982-01-01
Active Ingredient
PENICILLIN V POTASSIUM
Application Number
61836
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PFIZERPEN-A
Product Number
1
Dosage Form
-
Strength
EQ 125MG BASE/5ML
Approval Date
1982-01-01
Active Ingredient
AMPICILLIN/AMPICILLIN TRIHYDRATE
Application Number
62049
Product Number
1
Dosage Form
-
Strength
EQ 125MG BASE/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PFIZERPEN-A
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE/5ML
Approval Date
1982-01-01
Active Ingredient
AMPICILLIN/AMPICILLIN TRIHYDRATE
Application Number
62049
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PFIZERPEN-A
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1982-01-01
Active Ingredient
AMPICILLIN/AMPICILLIN TRIHYDRATE
Application Number
62050
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PFIZERPEN-A
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1982-01-01
Active Ingredient
AMPICILLIN/AMPICILLIN TRIHYDRATE
Application Number
62050
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PFIZERPEN-AS
Product Number
1
Dosage Form
-
Strength
300,000 UNITS/ML
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G PROCAINE
Application Number
60286
Product Number
1
Dosage Form
-
Strength
300,000 UNITS/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PFIZERPEN-AS
Product Number
2
Dosage Form
-
Strength
600,000 UNITS/ML
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G PROCAINE
Application Number
60286
Product Number
2
Dosage Form
-
Strength
600,000 UNITS/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PITRESSIN TANNATE
Product Number
1
Dosage Form
-
Strength
5PRESSOR UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
VASOPRESSIN TANNATE
Application Number
3402
Product Number
1
Dosage Form
-
Strength
5PRESSOR UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
POLYSPORIN
Product Number
1
Dosage Form
-
Strength
500 UNITS/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**
Approval Date
1982-01-01
Active Ingredient
BACITRACIN ZINC; POLYMYXIN B SULFATE
Application Number
61229
Product Number
1
Dosage Form
-
Strength
500 UNITS/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
POVAN
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/5ML
Approval Date
1982-01-01
Active Ingredient
PYRVINIUM PAMOATE
Application Number
11964
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
POVAN
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1982-01-01
Active Ingredient
PYRVINIUM PAMOATE
Application Number
12485
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PRALIDOXIME CHLORIDE (AUTOINJECTOR)
Product Number
1
Dosage Form
-
Strength
600MG/2ML (300MG/ML)
Approval Date
1983-04-26
Active Ingredient
PRALIDOXIME CHLORIDE
Application Number
18986
Product Number
1
Dosage Form
-
Strength
600MG/2ML (300MG/ML)
Approval Date
1983-04-26
Regulatory Status
Discontinued
Drug Name
PRE-SATE
Product Number
1
Dosage Form
-
Strength
EQ 65MG BASE
Approval Date
1982-01-01
Active Ingredient
CHLORPHENTERMINE HYDROCHLORIDE
Application Number
14696
Product Number
1
Dosage Form
-
Strength
EQ 65MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PREPIDIL
Product Number
1
Dosage Form
-
Strength
0.5MG/3GM
Approval Date
1992-12-09
Active Ingredient
DINOPROSTONE
Application Number
19617
Product Number
1
Dosage Form
-
Strength
0.5MG/3GM
Approval Date
1992-12-09
Regulatory Status
RX
Drug Name
PRISTIQ
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2008-02-29
Active Ingredient
DESVENLAFAXINE SUCCINATE
Application Number
21992
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2008-02-29
Regulatory Status
RX
Drug Name
PRISTIQ
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2008-02-29
Active Ingredient
DESVENLAFAXINE SUCCINATE
Application Number
21992
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2008-02-29
Regulatory Status
RX
Drug Name
PRISTIQ
Product Number
3
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2014-08-20
Active Ingredient
DESVENLAFAXINE SUCCINATE
Application Number
21992
Product Number
3
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2014-08-20
Regulatory Status
RX
Drug Name
PROCAN
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Active Ingredient
PROCAINAMIDE HYDROCHLORIDE
Application Number
85079
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PROCAN
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Active Ingredient
PROCAINAMIDE HYDROCHLORIDE
Application Number
85804
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PROCAN
Product Number
1
Dosage Form
-
Strength
375MG
Approval Date
1982-01-01
Active Ingredient
PROCAINAMIDE HYDROCHLORIDE
Application Number
87502
Product Number
1
Dosage Form
-
Strength
375MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PROCAN SR
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Active Ingredient
PROCAINAMIDE HYDROCHLORIDE
Application Number
86468
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PROCANBID
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1996-01-31
Active Ingredient
PROCAINAMIDE HYDROCHLORIDE
Application Number
20545
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1996-01-31
Regulatory Status
Discontinued
Drug Name
PROCANBID
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
1996-01-31
Active Ingredient
PROCAINAMIDE HYDROCHLORIDE
Application Number
20545
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
1996-01-31
Regulatory Status
Discontinued
Drug Name
PROCARDIA
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
NIFEDIPINE
Application Number
18482
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PROCARDIA
Product Number
2
Dosage Form
-
Strength
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1986-07-24
Active Ingredient
NIFEDIPINE
Application Number
18482
Product Number
2
Dosage Form
-
Strength
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1986-07-24
Regulatory Status
Discontinued
Drug Name
PROCARDIA XL
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
1989-09-06
Active Ingredient
NIFEDIPINE
Application Number
19684
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
1989-09-06
Regulatory Status
RX
Drug Name
PROCARDIA XL
Product Number
2
Dosage Form
-
Strength
60MG
Approval Date
1989-09-06
Active Ingredient
NIFEDIPINE
Application Number
19684
Product Number
2
Dosage Form
-
Strength
60MG
Approval Date
1989-09-06
Regulatory Status
RX
Drug Name
PROCARDIA XL
Product Number
3
Dosage Form
-
Strength
90MG
Approval Date
1989-09-06
Active Ingredient
NIFEDIPINE
Application Number
19684
Product Number
3
Dosage Form
-
Strength
90MG
Approval Date
1989-09-06
Regulatory Status
Discontinued
Drug Name
PROCTOCORT
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE
Application Number
83011
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PROLOPRIM
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Active Ingredient
TRIMETHOPRIM
Application Number
17943
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PROLOPRIM
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
1982-07-14
Active Ingredient
TRIMETHOPRIM
Application Number
17943
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
1982-07-14
Regulatory Status
Discontinued
Drug Name
PROMAPAR
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Active Ingredient
CHLORPROMAZINE HYDROCHLORIDE
Application Number
84423
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PROMAPAR
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1982-01-01
Active Ingredient
CHLORPROMAZINE HYDROCHLORIDE
Application Number
86885
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PROMAPAR
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
CHLORPROMAZINE HYDROCHLORIDE
Application Number
86886
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PROMAPAR
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Active Ingredient
CHLORPROMAZINE HYDROCHLORIDE
Application Number
86887
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PROMAPAR
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Active Ingredient
CHLORPROMAZINE HYDROCHLORIDE
Application Number
86888
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PROSTIN E2
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
1982-01-01
Active Ingredient
DINOPROSTONE
Application Number
17810
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PROSTIN F2 ALPHA
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
1982-01-01
Active Ingredient
DINOPROST TROMETHAMINE
Application Number
17434
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PROSTIN VR PEDIATRIC
Product Number
1
Dosage Form
-
Strength
0.5MG/ML
Approval Date
1982-01-01
Active Ingredient
ALPROSTADIL
Application Number
18484
Product Number
1
Dosage Form
-
Strength
0.5MG/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
PROTAMINE SULFATE
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
1982-01-01
Active Ingredient
PROTAMINE SULFATE
Application Number
7413
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PROTAMINE SULFATE
Product Number
2
Dosage Form
-
Strength
250MG/VIAL
Approval Date
1984-08-02
Active Ingredient
PROTAMINE SULFATE
Application Number
7413
Product Number
2
Dosage Form
-
Strength
250MG/VIAL
Approval Date
1984-08-02
Regulatory Status
Discontinued
Drug Name
PROVERA
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
1982-01-01
Active Ingredient
MEDROXYPROGESTERONE ACETATE
Application Number
11839
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
PROVERA
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Active Ingredient
MEDROXYPROGESTERONE ACETATE
Application Number
11839
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
PROVERA
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
MEDROXYPROGESTERONE ACETATE
Application Number
11839
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
PSORCON
Product Number
1
Dosage Form
-
Strength
0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1985-08-28
Active Ingredient
DIFLORASONE DIACETATE
Application Number
19260
Product Number
1
Dosage Form
-
Strength
0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1985-08-28
Regulatory Status
Discontinued
Drug Name
PSORCON E
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
1982-01-01
Active Ingredient
DIFLORASONE DIACETATE
Application Number
17994
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
QUIBRON-T
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
1985-08-22
Active Ingredient
THEOPHYLLINE
Application Number
88656
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
1985-08-22
Regulatory Status
Discontinued
Drug Name
QUIBRON-T/SR
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
1983-06-21
Active Ingredient
THEOPHYLLINE
Application Number
87563
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
1983-06-21
Regulatory Status
Discontinued
Drug Name
QUINIDINE SULFATE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1982-01-01
Active Ingredient
QUINIDINE SULFATE
Application Number
85175
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
R-GENE 10
Product Number
1
Dosage Form
-
Strength
10GM/100ML
Approval Date
1982-01-01
Active Ingredient
ARGININE HYDROCHLORIDE
Application Number
16931
Product Number
1
Dosage Form
-
Strength
10GM/100ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
RAPAMUNE
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
1999-09-15
Active Ingredient
SIROLIMUS
Application Number
21083
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
1999-09-15
Regulatory Status
RX
Drug Name
RAPAMUNE
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2000-08-25
Active Ingredient
SIROLIMUS
Application Number
21110
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2000-08-25
Regulatory Status
RX
Drug Name
RAPAMUNE
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2002-08-22
Active Ingredient
SIROLIMUS
Application Number
21110
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2002-08-22
Regulatory Status
RX
Drug Name
RAPAMUNE
Product Number
3
Dosage Form
-
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2004-02-23
Active Ingredient
SIROLIMUS
Application Number
21110
Product Number
3
Dosage Form
-
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2004-02-23
Regulatory Status
Discontinued
Drug Name
RAPAMUNE
Product Number
4
Dosage Form
-
Strength
0.5MG
Approval Date
2010-01-25
Active Ingredient
SIROLIMUS
Application Number
21110
Product Number
4
Dosage Form
-
Strength
0.5MG
Approval Date
2010-01-25
Regulatory Status
RX
Drug Name
RENESE
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
1982-01-01
Active Ingredient
POLYTHIAZIDE
Application Number
12845
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
RENESE
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
1982-01-01
Active Ingredient
POLYTHIAZIDE
Application Number
12845
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
RENESE
Product Number
3
Dosage Form
-
Strength
4MG
Approval Date
1982-01-01
Active Ingredient
POLYTHIAZIDE
Application Number
12845
Product Number
3
Dosage Form
-
Strength
4MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
RENESE-R
Product Number
1
Dosage Form
-
Strength
2MG;0.25MG
Approval Date
1982-01-01
Active Ingredient
POLYTHIAZIDE; RESERPINE
Application Number
13636
Product Number
1
Dosage Form
-
Strength
2MG;0.25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
REZULIN
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1997-01-29
Active Ingredient
TROGLITAZONE
Application Number
20720
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1997-01-29
Regulatory Status
Discontinued
Drug Name
REZULIN
Product Number
2
Dosage Form
-
Strength
400MG
Approval Date
1997-01-29
Active Ingredient
TROGLITAZONE
Application Number
20720
Product Number
2
Dosage Form
-
Strength
400MG
Approval Date
1997-01-29
Regulatory Status
Discontinued
Drug Name
REZULIN
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
1997-08-04
Active Ingredient
TROGLITAZONE
Application Number
20720
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
1997-08-04
Regulatory Status
Discontinued
Drug Name
RIFAMPIN
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2013-08-21
Active Ingredient
RIFAMPIN
Application Number
90034
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2013-08-21
Regulatory Status
RX
Drug Name
RIFAMPIN
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2013-08-21
Active Ingredient
RIFAMPIN
Application Number
90034
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2013-08-21
Regulatory Status
RX
Drug Name
RUXIENCE
Product Number
1
Dosage Form
-
Strength
100MG/10ML(10MG/ML)
Approval Date
-
Active Ingredient
RITUXIMAB-PVVR
Application Number
761103
Product Number
1
Dosage Form
-
Strength
100MG/10ML(10MG/ML)
Approval Date
-
Regulatory Status
Unclassified
Drug Name
RUXIENCE
Product Number
2
Dosage Form
-
Strength
500MG/50ML(10MG/ML)
Approval Date
-
Active Ingredient
RITUXIMAB-PVVR
Application Number
761103
Product Number
2
Dosage Form
-
Strength
500MG/50ML(10MG/ML)
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SECOBARBITAL SODIUM
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Active Ingredient
SECOBARBITAL SODIUM
Application Number
84762
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
SEPTRA
Product Number
1
Dosage Form
-
Strength
400MG;80MG
Approval Date
1982-01-01
Active Ingredient
SULFAMETHOXAZOLE; TRIMETHOPRIM
Application Number
17376
Product Number
1
Dosage Form
-
Strength
400MG;80MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
SEPTRA
Product Number
1
Dosage Form
-
Strength
200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
SULFAMETHOXAZOLE; TRIMETHOPRIM
Application Number
17598
Product Number
1
Dosage Form
-
Strength
200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
SEPTRA
Product Number
1
Dosage Form
-
Strength
80MG/ML;16MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
SULFAMETHOXAZOLE; TRIMETHOPRIM
Application Number
18452
Product Number
1
Dosage Form
-
Strength
80MG/ML;16MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
SEPTRA DS
Product Number
2
Dosage Form
-
Strength
800MG;160MG
Approval Date
1982-01-01
Active Ingredient
SULFAMETHOXAZOLE; TRIMETHOPRIM
Application Number
17376
Product Number
2
Dosage Form
-
Strength
800MG;160MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
SEPTRA GRAPE
Product Number
2
Dosage Form
-
Strength
200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1986-02-12
Active Ingredient
SULFAMETHOXAZOLE; TRIMETHOPRIM
Application Number
17598
Product Number
2
Dosage Form
-
Strength
200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1986-02-12
Regulatory Status
Discontinued
Drug Name
SILVADENE
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1982-01-01
Active Ingredient
SILVER SULFADIAZINE
Application Number
17381
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
SINEQUAN
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
16798
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
SINEQUAN
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
16798
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
SINEQUAN
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
16798
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
SINEQUAN
Product Number
5
Dosage Form
-
Strength
EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
16798
Product Number
5
Dosage Form
-
Strength
EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
SINEQUAN
Product Number
6
Dosage Form
-
Strength
EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
16798
Product Number
6
Dosage Form
-
Strength
EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
SINEQUAN
Product Number
7
Dosage Form
-
Strength
EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
16798
Product Number
7
Dosage Form
-
Strength
EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
SINEQUAN
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
17516
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
SKELAXIN
Product Number
1
Dosage Form
-
Strength
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
METAXALONE
Application Number
13217
Product Number
1
Dosage Form
-
Strength
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
SKELAXIN
Product Number
3
Dosage Form
-
Strength
800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2002-08-30
Active Ingredient
METAXALONE
Application Number
13217
Product Number
3
Dosage Form
-
Strength
800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2002-08-30
Regulatory Status
Discontinued
Drug Name
SODIUM PENTOBARBITAL
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Active Ingredient
PENTOBARBITAL SODIUM
Application Number
84156
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
SOLU-CORTEF
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/VIAL
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE SODIUM SUCCINATE
Application Number
9866
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/VIAL
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
SOLU-CORTEF
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE/VIAL
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE SODIUM SUCCINATE
Application Number
9866
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE/VIAL
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
SOLU-CORTEF
Product Number
3
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE SODIUM SUCCINATE
Application Number
9866
Product Number
3
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
SOLU-CORTEF
Product Number
4
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE SODIUM SUCCINATE
Application Number
9866
Product Number
4
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
SOLU-MEDROL
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE/VIAL
Approval Date
1982-01-01
Active Ingredient
METHYLPREDNISOLONE SODIUM SUCCINATE
Application Number
11856
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE/VIAL
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
SOLU-MEDROL
Product Number
4
Dosage Form
-
Strength
EQ 125MG BASE/VIAL
Approval Date
1982-01-01
Active Ingredient
METHYLPREDNISOLONE SODIUM SUCCINATE
Application Number
11856
Product Number
4
Dosage Form
-
Strength
EQ 125MG BASE/VIAL
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
SOLU-MEDROL
Product Number
5
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
1982-01-01
Active Ingredient
METHYLPREDNISOLONE SODIUM SUCCINATE
Application Number
11856
Product Number
5
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
SOLU-MEDROL
Product Number
6
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
1982-01-01
Active Ingredient
METHYLPREDNISOLONE SODIUM SUCCINATE
Application Number
11856
Product Number
6
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
SOLU-MEDROL
Product Number
7
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
1985-02-27
Active Ingredient
METHYLPREDNISOLONE SODIUM SUCCINATE
Application Number
11856
Product Number
7
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
1985-02-27
Regulatory Status
RX
Drug Name
SONATA
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
1999-08-13
Active Ingredient
ZALEPLON
Application Number
20859
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
1999-08-13
Regulatory Status
Discontinued
Drug Name
SONATA
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
1999-08-13
Active Ingredient
ZALEPLON
Application Number
20859
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
1999-08-13
Regulatory Status
Discontinued
Drug Name
SPECTROBID
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
1982-01-01
Active Ingredient
BACAMPICILLIN HYDROCHLORIDE
Application Number
50520
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
SPECTROBID
Product Number
2
Dosage Form
-
Strength
800MG
Approval Date
1983-09-12
Active Ingredient
BACAMPICILLIN HYDROCHLORIDE
Application Number
50520
Product Number
2
Dosage Form
-
Strength
800MG
Approval Date
1983-09-12
Regulatory Status
Discontinued
Drug Name
SPECTROBID
Product Number
1
Dosage Form
-
Strength
125MG/5ML
Approval Date
1982-03-23
Active Ingredient
BACAMPICILLIN HYDROCHLORIDE
Application Number
50556
Product Number
1
Dosage Form
-
Strength
125MG/5ML
Approval Date
1982-03-23
Regulatory Status
Discontinued
Drug Name
SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
25MG;25MG
Approval Date
1983-02-22
Active Ingredient
HYDROCHLOROTHIAZIDE; SPIRONOLACTONE
Application Number
87948
Product Number
1
Dosage Form
-
Strength
25MG;25MG
Approval Date
1983-02-22
Regulatory Status
Discontinued
Drug Name
STERANE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Active Ingredient
PREDNISOLONE
Application Number
9996
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
STERANE
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
1982-01-01
Active Ingredient
PREDNISOLONE ACETATE
Application Number
11446
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
STREPTOMYCIN SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
STREPTOMYCIN SULFATE
Application Number
60076
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
STREPTOMYCIN SULFATE
Product Number
2
Dosage Form
-
Strength
EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
STREPTOMYCIN SULFATE
Application Number
60076
Product Number
2
Dosage Form
-
Strength
EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
STREPTOMYCIN SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/2.5ML
Approval Date
1982-01-01
Active Ingredient
STREPTOMYCIN SULFATE
Application Number
60111
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/2.5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
SULFALAR
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Active Ingredient
SULFISOXAZOLE
Application Number
84955
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
SUPRAX
Product Number
1
Dosage Form
-
Strength
100MG/5ML
Approval Date
2004-02-23
Active Ingredient
CEFIXIME
Application Number
65129
Product Number
1
Dosage Form
-
Strength
100MG/5ML
Approval Date
2004-02-23
Regulatory Status
Discontinued
Drug Name
SUPRAX
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2004-02-12
Active Ingredient
CEFIXIME
Application Number
65130
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2004-02-12
Regulatory Status
Discontinued
Drug Name
SUPRAX
Product Number
1
Dosage Form
-
Strength
200MG/5ML
Approval Date
2007-04-10
Active Ingredient
CEFIXIME
Application Number
65355
Product Number
1
Dosage Form
-
Strength
200MG/5ML
Approval Date
2007-04-10
Regulatory Status
RX
Drug Name
SYNAREL
Product Number
1
Dosage Form
-
Strength
EQ 0.2MG BASE/SPRAY
Approval Date
1990-02-13
Active Ingredient
NAFARELIN ACETATE
Application Number
19886
Product Number
1
Dosage Form
-
Strength
EQ 0.2MG BASE/SPRAY
Approval Date
1990-02-13
Regulatory Status
RX
Drug Name
SYNERCID
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
-
Active Ingredient
QUINUPRISTIN; DALFOPRISTIN
Application Number
50747
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SYNERCID
Product Number
1
Dosage Form
-
Strength
350MG/VIAL;150MG/VIAL
Approval Date
1999-09-21
Active Ingredient
DALFOPRISTIN; QUINUPRISTIN
Application Number
50748
Product Number
1
Dosage Form
-
Strength
350MG/VIAL;150MG/VIAL
Approval Date
1999-09-21
Regulatory Status
Discontinued
Drug Name
SYNERCID
Product Number
2
Dosage Form
-
Strength
420MG/VIAL;180MG/VIAL
Approval Date
2000-08-24
Active Ingredient
DALFOPRISTIN; QUINUPRISTIN
Application Number
50748
Product Number
2
Dosage Form
-
Strength
420MG/VIAL;180MG/VIAL
Approval Date
2000-08-24
Regulatory Status
Discontinued
Drug Name
TALZENNA
Product Number
1
Dosage Form
-
Strength
EQ 0.25MG BASE
Approval Date
2018-10-16
Active Ingredient
TALAZOPARIB TOSYLATE
Application Number
211651
Product Number
1
Dosage Form
-
Strength
EQ 0.25MG BASE
Approval Date
2018-10-16
Regulatory Status
Discontinued
Drug Name
TALZENNA
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2018-10-16
Active Ingredient
TALAZOPARIB TOSYLATE
Application Number
211651
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2018-10-16
Regulatory Status
Discontinued
Drug Name
TALZENNA
Product Number
3
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2021-09-20
Active Ingredient
TALAZOPARIB TOSYLATE
Application Number
211651
Product Number
3
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2021-09-20
Regulatory Status
Discontinued
Drug Name
TALZENNA
Product Number
4
Dosage Form
-
Strength
EQ 0.75MG BASE
Approval Date
2021-09-20
Active Ingredient
TALAZOPARIB TOSYLATE
Application Number
211651
Product Number
4
Dosage Form
-
Strength
EQ 0.75MG BASE
Approval Date
2021-09-20
Regulatory Status
Discontinued
Drug Name
TALZENNA
Product Number
5
Dosage Form
-
Strength
EQ 0.1MG BASE
Approval Date
2023-06-20
Active Ingredient
TALAZOPARIB TOSYLATE
Application Number
211651
Product Number
5
Dosage Form
-
Strength
EQ 0.1MG BASE
Approval Date
2023-06-20
Regulatory Status
Discontinued
Drug Name
TALZENNA
Product Number
6
Dosage Form
-
Strength
EQ 0.35MG BASE
Approval Date
2023-06-20
Active Ingredient
TALAZOPARIB TOSYLATE
Application Number
211651
Product Number
6
Dosage Form
-
Strength
EQ 0.35MG BASE
Approval Date
2023-06-20
Regulatory Status
Discontinued
Drug Name
TALZENNA
Product Number
1
Dosage Form
-
Strength
EQ 0.1MG BASE
Approval Date
2024-03-07
Active Ingredient
TALAZOPARIB TOSYLATE
Application Number
217439
Product Number
1
Dosage Form
-
Strength
EQ 0.1MG BASE
Approval Date
2024-03-07
Regulatory Status
RX
Drug Name
TALZENNA
Product Number
2
Dosage Form
-
Strength
EQ 0.25MG BASE
Approval Date
2024-03-07
Active Ingredient
TALAZOPARIB TOSYLATE
Application Number
217439
Product Number
2
Dosage Form
-
Strength
EQ 0.25MG BASE
Approval Date
2024-03-07
Regulatory Status
RX
Drug Name
TALZENNA
Product Number
3
Dosage Form
-
Strength
EQ 0.35MG BASE
Approval Date
2024-03-07
Active Ingredient
TALAZOPARIB TOSYLATE
Application Number
217439
Product Number
3
Dosage Form
-
Strength
EQ 0.35MG BASE
Approval Date
2024-03-07
Regulatory Status
RX
Drug Name
TALZENNA
Product Number
4
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2024-03-07
Active Ingredient
TALAZOPARIB TOSYLATE
Application Number
217439
Product Number
4
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2024-03-07
Regulatory Status
RX
Drug Name
TALZENNA
Product Number
5
Dosage Form
-
Strength
EQ 0.75MG BASE
Approval Date
2024-03-07
Active Ingredient
TALAZOPARIB TOSYLATE
Application Number
217439
Product Number
5
Dosage Form
-
Strength
EQ 0.75MG BASE
Approval Date
2024-03-07
Regulatory Status
RX
Drug Name
TALZENNA
Product Number
6
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2024-03-07
Active Ingredient
TALAZOPARIB TOSYLATE
Application Number
217439
Product Number
6
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2024-03-07
Regulatory Status
RX
Drug Name
TAO
Product Number
1
Dosage Form
-
Strength
EQ 125MG BASE/5ML
Approval Date
1982-01-01
Active Ingredient
TROLEANDOMYCIN
Application Number
50332
Product Number
1
Dosage Form
-
Strength
EQ 125MG BASE/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TAO
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1982-01-01
Active Ingredient
TROLEANDOMYCIN
Application Number
50336
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TAPAZOLE
Product Number
2
Dosage Form
-
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
METHIMAZOLE
Application Number
7517
Product Number
2
Dosage Form
-
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TAPAZOLE
Product Number
4
Dosage Form
-
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
METHIMAZOLE
Application Number
7517
Product Number
4
Dosage Form
-
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TAPAZOLE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2000-03-31
Active Ingredient
METHIMAZOLE
Application Number
40320
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2000-03-31
Regulatory Status
Discontinued
Drug Name
TAPAZOLE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2000-03-31
Active Ingredient
METHIMAZOLE
Application Number
40320
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2000-03-31
Regulatory Status
Discontinued
Drug Name
TERRA-CORTRIL
Product Number
1
Dosage Form
-
Strength
1.5%;EQ 5MG BASE/ML
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE ACETATE; OXYTETRACYCLINE HYDROCHLORIDE
Application Number
61016
Product Number
1
Dosage Form
-
Strength
1.5%;EQ 5MG BASE/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TERRAMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 125MG BASE
Approval Date
1982-01-01
Active Ingredient
OXYTETRACYCLINE HYDROCHLORIDE
Application Number
50286
Product Number
1
Dosage Form
-
Strength
EQ 125MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TERRAMYCIN
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1982-01-01
Active Ingredient
OXYTETRACYCLINE HYDROCHLORIDE
Application Number
50286
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TERRAMYCIN
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Active Ingredient
OXYTETRACYCLINE
Application Number
50287
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TERRAMYCIN
Product Number
1
Dosage Form
-
Strength
2%;50MG/ML
Approval Date
1982-01-01
Active Ingredient
LIDOCAINE HYDROCHLORIDE; OXYTETRACYCLINE
Application Number
60567
Product Number
1
Dosage Form
-
Strength
2%;50MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TERRAMYCIN
Product Number
2
Dosage Form
-
Strength
2%;125MG/ML
Approval Date
1982-01-01
Active Ingredient
LIDOCAINE HYDROCHLORIDE; OXYTETRACYCLINE
Application Number
60567
Product Number
2
Dosage Form
-
Strength
2%;125MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TERRAMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/VIAL
Approval Date
1982-01-01
Active Ingredient
OXYTETRACYCLINE HYDROCHLORIDE
Application Number
60586
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TERRAMYCIN
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
1982-01-01
Active Ingredient
OXYTETRACYCLINE HYDROCHLORIDE
Application Number
60586
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TERRAMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 125MG BASE/5ML
Approval Date
1982-01-01
Active Ingredient
OXYTETRACYCLINE CALCIUM
Application Number
60595
Product Number
1
Dosage Form
-
Strength
EQ 125MG BASE/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TERRAMYCIN W/ POLYMYXIN
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/GM;10,000 UNITS/GM
Approval Date
1982-01-01
Active Ingredient
OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE
Application Number
61841
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/GM;10,000 UNITS/GM
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TERRAMYCIN-POLYMYXIN
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE;100,000 UNITS
Approval Date
1982-01-01
Active Ingredient
OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE
Application Number
61009
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE;100,000 UNITS
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TESSALON
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Active Ingredient
BENZONATATE
Application Number
11210
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
TESSALON
Product Number
3
Dosage Form
-
Strength
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-06-25
Active Ingredient
BENZONATATE
Application Number
11210
Product Number
3
Dosage Form
-
Strength
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-06-25
Regulatory Status
Discontinued
Drug Name
TETRACYN
Product Number
3
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Active Ingredient
TETRACYCLINE HYDROCHLORIDE
Application Number
60082
Product Number
3
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TETRACYN
Product Number
4
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Active Ingredient
TETRACYCLINE HYDROCHLORIDE
Application Number
60082
Product Number
4
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TETRACYN
Product Number
1
Dosage Form
-
Strength
125MG/5ML
Approval Date
1982-01-01
Active Ingredient
TETRACYCLINE HYDROCHLORIDE
Application Number
60095
Product Number
1
Dosage Form
-
Strength
125MG/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TETRACYN
Product Number
1
Dosage Form
-
Strength
250MG/VIAL
Approval Date
1982-01-01
Active Ingredient
TETRACYCLINE HYDROCHLORIDE
Application Number
60096
Product Number
1
Dosage Form
-
Strength
250MG/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TETRACYN
Product Number
2
Dosage Form
-
Strength
500MG/VIAL
Approval Date
1982-01-01
Active Ingredient
TETRACYCLINE HYDROCHLORIDE
Application Number
60096
Product Number
2
Dosage Form
-
Strength
500MG/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TETRACYN
Product Number
2
Dosage Form
-
Strength
40MG/VIAL;100MG/VIAL
Approval Date
1982-01-01
Active Ingredient
PROCAINE HYDROCHLORIDE; TETRACYCLINE HYDROCHLORIDE
Application Number
60285
Product Number
2
Dosage Form
-
Strength
40MG/VIAL;100MG/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TETRACYN
Product Number
3
Dosage Form
-
Strength
40MG/VIAL;250MG/VIAL
Approval Date
1982-01-01
Active Ingredient
PROCAINE HYDROCHLORIDE; TETRACYCLINE HYDROCHLORIDE
Application Number
60285
Product Number
3
Dosage Form
-
Strength
40MG/VIAL;250MG/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
THALITONE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-11-12
Active Ingredient
CHLORTHALIDONE
Application Number
88051
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-11-12
Regulatory Status
Discontinued
Drug Name
THIAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
1982-01-01
Active Ingredient
THIAMINE HYDROCHLORIDE
Application Number
80770
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TIGAN
Product Number
6
Dosage Form
-
Strength
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2001-12-13
Active Ingredient
TRIMETHOBENZAMIDE HYDROCHLORIDE
Application Number
17531
Product Number
6
Dosage Form
-
Strength
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2001-12-13
Regulatory Status
Discontinued
Drug Name
TIKOSYN
Product Number
1
Dosage Form
-
Strength
0.125MG
Approval Date
1999-10-01
Active Ingredient
DOFETILIDE
Application Number
20931
Product Number
1
Dosage Form
-
Strength
0.125MG
Approval Date
1999-10-01
Regulatory Status
RX
Drug Name
TIKOSYN
Product Number
2
Dosage Form
-
Strength
0.25MG
Approval Date
1999-10-01
Active Ingredient
DOFETILIDE
Application Number
20931
Product Number
2
Dosage Form
-
Strength
0.25MG
Approval Date
1999-10-01
Regulatory Status
RX
Drug Name
TIKOSYN
Product Number
3
Dosage Form
-
Strength
0.5MG
Approval Date
1999-10-01
Active Ingredient
DOFETILIDE
Application Number
20931
Product Number
3
Dosage Form
-
Strength
0.5MG
Approval Date
1999-10-01
Regulatory Status
RX
Drug Name
TILADE
Product Number
1
Dosage Form
-
Strength
1.75MG/INH
Approval Date
1992-12-30
Active Ingredient
NEDOCROMIL SODIUM
Application Number
19660
Product Number
1
Dosage Form
-
Strength
1.75MG/INH
Approval Date
1992-12-30
Regulatory Status
Discontinued
Drug Name
TOLBUTAMIDE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Active Ingredient
TOLBUTAMIDE
Application Number
86047
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TOLINASE
Product Number
2
Dosage Form
-
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
TOLAZAMIDE
Application Number
15500
Product Number
2
Dosage Form
-
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TOLINASE
Product Number
4
Dosage Form
-
Strength
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
TOLAZAMIDE
Application Number
15500
Product Number
4
Dosage Form
-
Strength
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TOLINASE
Product Number
5
Dosage Form
-
Strength
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
TOLAZAMIDE
Application Number
15500
Product Number
5
Dosage Form
-
Strength
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TORISEL
Product Number
1
Dosage Form
-
Strength
25MG/ML (25MG/ML)
Approval Date
2007-05-30
Active Ingredient
TEMSIROLIMUS
Application Number
22088
Product Number
1
Dosage Form
-
Strength
25MG/ML (25MG/ML)
Approval Date
2007-05-30
Regulatory Status
RX
Drug Name
TOVIAZ
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2008-10-31
Active Ingredient
FESOTERODINE FUMARATE
Application Number
22030
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2008-10-31
Regulatory Status
RX
Drug Name
TOVIAZ
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2008-10-31
Active Ingredient
FESOTERODINE FUMARATE
Application Number
22030
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2008-10-31
Regulatory Status
RX
Drug Name
TRAZIMERA
Product Number
1
Dosage Form
-
Strength
420MG
Approval Date
-
Active Ingredient
TRASTUZUMAB-QYYP
Application Number
761081
Product Number
1
Dosage Form
-
Strength
420MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
TRIPELENNAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Active Ingredient
TRIPELENNAMINE HYDROCHLORIDE
Application Number
83625
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TRIPELENNAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Active Ingredient
TRIPELENNAMINE HYDROCHLORIDE
Application Number
83626
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TROBICIN
Product Number
1
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
1982-01-01
Active Ingredient
SPECTINOMYCIN HYDROCHLORIDE
Application Number
50347
Product Number
1
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TROBICIN
Product Number
2
Dosage Form
-
Strength
EQ 4GM BASE/VIAL
Approval Date
1982-01-01
Active Ingredient
SPECTINOMYCIN HYDROCHLORIDE
Application Number
50347
Product Number
2
Dosage Form
-
Strength
EQ 4GM BASE/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TROVAN
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1997-12-18
Active Ingredient
TROVAFLOXACIN MESYLATE
Application Number
20759
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1997-12-18
Regulatory Status
Discontinued
Drug Name
TROVAN
Product Number
2
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
1997-12-18
Active Ingredient
TROVAFLOXACIN MESYLATE
Application Number
20759
Product Number
2
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
1997-12-18
Regulatory Status
Discontinued
Drug Name
TROVAN PRESERVATIVE FREE
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE/VIAL
Approval Date
1997-12-18
Active Ingredient
ALATROFLOXACIN MESYLATE
Application Number
20760
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE/VIAL
Approval Date
1997-12-18
Regulatory Status
Discontinued
Drug Name
TROVAN PRESERVATIVE FREE
Product Number
2
Dosage Form
-
Strength
EQ 300MG BASE/VIAL
Approval Date
1997-12-18
Active Ingredient
ALATROFLOXACIN MESYLATE
Application Number
20760
Product Number
2
Dosage Form
-
Strength
EQ 300MG BASE/VIAL
Approval Date
1997-12-18
Regulatory Status
Discontinued
Drug Name
TROVAN/ZITHROMAX COMPLIANCE PAK
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE,N/A;N/A,EQ 100MG BASE
Approval Date
1998-12-18
Active Ingredient
AZITHROMYCIN DIHYDRATE; TROVAFLOXACIN MESYLATE
Application Number
50762
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE,N/A;N/A,EQ 100MG BASE
Approval Date
1998-12-18
Regulatory Status
Discontinued
Drug Name
TROXYCA ER
Product Number
1
Dosage Form
-
Strength
1.2MG;10MG
Approval Date
2016-08-19
Active Ingredient
NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Application Number
207621
Product Number
1
Dosage Form
-
Strength
1.2MG;10MG
Approval Date
2016-08-19
Regulatory Status
Discontinued
Drug Name
TROXYCA ER
Product Number
2
Dosage Form
-
Strength
2.4MG;20MG
Approval Date
2016-08-19
Active Ingredient
NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Application Number
207621
Product Number
2
Dosage Form
-
Strength
2.4MG;20MG
Approval Date
2016-08-19
Regulatory Status
Discontinued
Drug Name
TROXYCA ER
Product Number
3
Dosage Form
-
Strength
3.6MG;30MG
Approval Date
2016-08-19
Active Ingredient
NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Application Number
207621
Product Number
3
Dosage Form
-
Strength
3.6MG;30MG
Approval Date
2016-08-19
Regulatory Status
Discontinued
Drug Name
TROXYCA ER
Product Number
4
Dosage Form
-
Strength
4.8MG;40MG
Approval Date
2016-08-19
Active Ingredient
NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Application Number
207621
Product Number
4
Dosage Form
-
Strength
4.8MG;40MG
Approval Date
2016-08-19
Regulatory Status
Discontinued
Drug Name
TROXYCA ER
Product Number
5
Dosage Form
-
Strength
7.2MG;60MG
Approval Date
2016-08-19
Active Ingredient
NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Application Number
207621
Product Number
5
Dosage Form
-
Strength
7.2MG;60MG
Approval Date
2016-08-19
Regulatory Status
Discontinued
Drug Name
TROXYCA ER
Product Number
6
Dosage Form
-
Strength
9.6MG;80MG
Approval Date
2016-08-19
Active Ingredient
NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Application Number
207621
Product Number
6
Dosage Form
-
Strength
9.6MG;80MG
Approval Date
2016-08-19
Regulatory Status
Discontinued
Drug Name
TUSSIGON
Product Number
1
Dosage Form
-
Strength
1.5MG;5MG
Approval Date
1985-07-30
Active Ingredient
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
Application Number
88508
Product Number
1
Dosage Form
-
Strength
1.5MG;5MG
Approval Date
1985-07-30
Regulatory Status
Discontinued
Drug Name
TYGACIL
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2005-06-15
Active Ingredient
TIGECYCLINE
Application Number
21821
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2005-06-15
Regulatory Status
RX
Drug Name
TYMTRAN
Product Number
1
Dosage Form
-
Strength
0.02MG/ML
Approval Date
1982-01-01
Active Ingredient
CERULETIDE DIETHYLAMINE
Application Number
18296
Product Number
1
Dosage Form
-
Strength
0.02MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TZ-3
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1983-02-18
Active Ingredient
TIOCONAZOLE
Application Number
18682
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1983-02-18
Regulatory Status
Discontinued
Drug Name
U-GENCIN
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
1982-01-01
Active Ingredient
GENTAMICIN SULFATE
Application Number
62248
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
U-GENCIN
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE/ML
Approval Date
1982-01-01
Active Ingredient
GENTAMICIN SULFATE
Application Number
62248
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
UNASYN
Product Number
1
Dosage Form
-
Strength
EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
Approval Date
1986-12-31
Active Ingredient
AMPICILLIN SODIUM; SULBACTAM SODIUM
Application Number
50608
Product Number
1
Dosage Form
-
Strength
EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
Approval Date
1986-12-31
Regulatory Status
RX
Drug Name
UNASYN
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date
1986-12-31
Active Ingredient
AMPICILLIN SODIUM; SULBACTAM SODIUM
Application Number
50608
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date
1986-12-31
Regulatory Status
RX
Drug Name
UNASYN
Product Number
3
Dosage Form
-
Strength
EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL
Approval Date
1986-12-31
Active Ingredient
AMPICILLIN SODIUM; SULBACTAM SODIUM
Application Number
50608
Product Number
3
Dosage Form
-
Strength
EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL
Approval Date
1986-12-31
Regulatory Status
Discontinued
Drug Name
UNASYN
Product Number
5
Dosage Form
-
Strength
EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
Approval Date
1993-12-10
Active Ingredient
AMPICILLIN SODIUM; SULBACTAM SODIUM
Application Number
50608
Product Number
5
Dosage Form
-
Strength
EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
Approval Date
1993-12-10
Regulatory Status
RX
Drug Name
UNASYN
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date
1988-11-23
Active Ingredient
AMPICILLIN SODIUM; SULBACTAM SODIUM
Application Number
62901
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date
1988-11-23
Regulatory Status
Discontinued
Drug Name
UNASYN
Product Number
2
Dosage Form
-
Strength
EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
Approval Date
1992-02-27
Active Ingredient
AMPICILLIN SODIUM; SULBACTAM SODIUM
Application Number
62901
Product Number
2
Dosage Form
-
Strength
EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
Approval Date
1992-02-27
Regulatory Status
Discontinued
Drug Name
UNISOM
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1986-02-05
Active Ingredient
DOXYLAMINE SUCCINATE
Application Number
19440
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1986-02-05
Regulatory Status
Discontinued
Drug Name
URESE
Product Number
3
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Active Ingredient
BENZTHIAZIDE
Application Number
12128
Product Number
3
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
UTICILLIN VK
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1982-01-01
Active Ingredient
PENICILLIN V POTASSIUM
Application Number
61651
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
UTICILLIN VK
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1982-01-01
Active Ingredient
PENICILLIN V POTASSIUM
Application Number
61651
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
UTICORT
Product Number
2
Dosage Form
-
Strength
0.025%
Approval Date
1982-01-01
Active Ingredient
BETAMETHASONE BENZOATE
Application Number
16998
Product Number
2
Dosage Form
-
Strength
0.025%
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
UTICORT
Product Number
1
Dosage Form
-
Strength
0.025%
Approval Date
1982-01-01
Active Ingredient
BETAMETHASONE BENZOATE
Application Number
17244
Product Number
1
Dosage Form
-
Strength
0.025%
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
UTICORT
Product Number
1
Dosage Form
-
Strength
0.025%
Approval Date
1982-01-01
Active Ingredient
BETAMETHASONE BENZOATE
Application Number
17528
Product Number
1
Dosage Form
-
Strength
0.025%
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
UTICORT
Product Number
1
Dosage Form
-
Strength
0.025%
Approval Date
1982-01-01
Active Ingredient
BETAMETHASONE BENZOATE
Application Number
18089
Product Number
1
Dosage Form
-
Strength
0.025%
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
UTIMOX
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Active Ingredient
AMOXICILLIN
Application Number
62107
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
UTIMOX
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Active Ingredient
AMOXICILLIN
Application Number
62107
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
UTIMOX
Product Number
1
Dosage Form
-
Strength
125MG/5ML
Approval Date
1982-01-01
Active Ingredient
AMOXICILLIN
Application Number
62127
Product Number
1
Dosage Form
-
Strength
125MG/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
UTIMOX
Product Number
2
Dosage Form
-
Strength
250MG/5ML
Approval Date
1982-01-01
Active Ingredient
AMOXICILLIN
Application Number
62127
Product Number
2
Dosage Form
-
Strength
250MG/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
VANCOR
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
1988-08-01
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
62956
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
1988-08-01
Regulatory Status
Discontinued
Drug Name
VANCOR
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
1988-08-01
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
62956
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
1988-08-01
Regulatory Status
Discontinued
Drug Name
VANSIL
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Active Ingredient
OXAMNIQUINE
Application Number
18069
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
VANTIN
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1992-08-07
Active Ingredient
CEFPODOXIME PROXETIL
Application Number
50674
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1992-08-07
Regulatory Status
Discontinued
Drug Name
VANTIN
Product Number
2
Dosage Form
-
Strength
EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1992-08-07
Active Ingredient
CEFPODOXIME PROXETIL
Application Number
50674
Product Number
2
Dosage Form
-
Strength
EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1992-08-07
Regulatory Status
Discontinued
Drug Name
VANTIN
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1992-08-07
Active Ingredient
CEFPODOXIME PROXETIL
Application Number
50675
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1992-08-07
Regulatory Status
Discontinued
Drug Name
VANTIN
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1992-08-07
Active Ingredient
CEFPODOXIME PROXETIL
Application Number
50675
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1992-08-07
Regulatory Status
Discontinued
Drug Name
VELSIPITY
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2023-10-12
Active Ingredient
ETRASIMOD ARGININE
Application Number
216956
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2023-10-12
Regulatory Status
RX
Drug Name
VFEND
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2002-05-24
Active Ingredient
VORICONAZOLE
Application Number
21266
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2002-05-24
Regulatory Status
RX
Drug Name
VFEND
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2002-05-24
Active Ingredient
VORICONAZOLE
Application Number
21266
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2002-05-24
Regulatory Status
RX
Drug Name
VFEND
Product Number
1
Dosage Form
-
Strength
200MG/VIAL
Approval Date
2002-05-24
Active Ingredient
VORICONAZOLE
Application Number
21267
Product Number
1
Dosage Form
-
Strength
200MG/VIAL
Approval Date
2002-05-24
Regulatory Status
RX
Drug Name
VFEND
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
-
Active Ingredient
VORICONAZOLE
Application Number
21464
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
VFEND
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
-
Active Ingredient
VORICONAZOLE
Application Number
21464
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
VFEND
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
-
Active Ingredient
VORICONAZOLE
Application Number
21464
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
VFEND
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
-
Active Ingredient
VORICONAZOLE
Application Number
21466
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
VFEND
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
-
Active Ingredient
VORICONAZOLE
Application Number
21466
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
VFEND
Product Number
3
Dosage Form
-
Strength
200MG/VIAL
Approval Date
-
Active Ingredient
VORICONAZOLE
Application Number
21466
Product Number
3
Dosage Form
-
Strength
200MG/VIAL
Approval Date
-
Regulatory Status
Unclassified
Drug Name
VFEND
Product Number
1
Dosage Form
-
Strength
200MG/5ML
Approval Date
2003-12-19
Active Ingredient
VORICONAZOLE
Application Number
21630
Product Number
1
Dosage Form
-
Strength
200MG/5ML
Approval Date
2003-12-19
Regulatory Status
RX
Drug Name
VIBRA-TABS
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
50533
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
VIBRAMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
DOXYCYCLINE
Application Number
50006
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
VIBRAMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
50007
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
VIBRAMYCIN
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
50007
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
VIBRAMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
50442
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
VIBRAMYCIN
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
50442
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
VIBRAMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/5ML
Approval Date
1982-01-01
Active Ingredient
DOXYCYCLINE CALCIUM
Application Number
50480
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
VIOCIN SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
1982-01-01
Active Ingredient
VIOMYCIN SULFATE
Application Number
61086
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
VIOCIN SULFATE
Product Number
2
Dosage Form
-
Strength
EQ 5GM BASE/VIAL
Approval Date
1982-01-01
Active Ingredient
VIOMYCIN SULFATE
Application Number
61086
Product Number
2
Dosage Form
-
Strength
EQ 5GM BASE/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
VIROPTIC
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1982-01-01
Active Ingredient
TRIFLURIDINE
Application Number
18299
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
VISTARIL
Product Number
1
Dosage Form
-
Strength
25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
HYDROXYZINE HYDROCHLORIDE
Application Number
11111
Product Number
1
Dosage Form
-
Strength
25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
VISTARIL
Product Number
2
Dosage Form
-
Strength
50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
HYDROXYZINE HYDROCHLORIDE
Application Number
11111
Product Number
2
Dosage Form
-
Strength
50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
VISTARIL
Product Number
2
Dosage Form
-
Strength
EQ 25MG HYDROCHLORIDE
Approval Date
1982-01-01
Active Ingredient
HYDROXYZINE PAMOATE
Application Number
11459
Product Number
2
Dosage Form
-
Strength
EQ 25MG HYDROCHLORIDE
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
VISTARIL
Product Number
4
Dosage Form
-
Strength
EQ 50MG HYDROCHLORIDE
Approval Date
1982-01-01
Active Ingredient
HYDROXYZINE PAMOATE
Application Number
11459
Product Number
4
Dosage Form
-
Strength
EQ 50MG HYDROCHLORIDE
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
VISTARIL
Product Number
6
Dosage Form
-
Strength
EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
HYDROXYZINE PAMOATE
Application Number
11459
Product Number
6
Dosage Form
-
Strength
EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
VISTARIL
Product Number
1
Dosage Form
-
Strength
EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
HYDROXYZINE PAMOATE
Application Number
11795
Product Number
1
Dosage Form
-
Strength
EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
VIZIMPRO
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2018-09-27
Active Ingredient
DACOMITINIB
Application Number
211288
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2018-09-27
Regulatory Status
Discontinued
Drug Name
VIZIMPRO
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2018-09-27
Active Ingredient
DACOMITINIB
Application Number
211288
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2018-09-27
Regulatory Status
Discontinued
Drug Name
VIZIMPRO
Product Number
3
Dosage Form
-
Strength
45MG
Approval Date
2018-09-27
Active Ingredient
DACOMITINIB
Application Number
211288
Product Number
3
Dosage Form
-
Strength
45MG
Approval Date
2018-09-27
Regulatory Status
Discontinued
Drug Name
XALKORI
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2011-08-26
Active Ingredient
CRIZOTINIB
Application Number
202570
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2011-08-26
Regulatory Status
RX
Drug Name
XALKORI
Product Number
2
Dosage Form
-
Strength
250MG
Approval Date
2011-08-26
Active Ingredient
CRIZOTINIB
Application Number
202570
Product Number
2
Dosage Form
-
Strength
250MG
Approval Date
2011-08-26
Regulatory Status
RX
Drug Name
XALKORI
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2023-09-07
Active Ingredient
CRIZOTINIB
Application Number
217581
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2023-09-07
Regulatory Status
RX
Drug Name
XALKORI
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2023-09-07
Active Ingredient
CRIZOTINIB
Application Number
217581
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2023-09-07
Regulatory Status
RX
Drug Name
XALKORI
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2023-09-07
Active Ingredient
CRIZOTINIB
Application Number
217581
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2023-09-07
Regulatory Status
RX
Drug Name
XELJANZ
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2012-11-06
Active Ingredient
TOFACITINIB CITRATE
Application Number
203214
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2012-11-06
Regulatory Status
RX
Drug Name
XELJANZ
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2018-05-30
Active Ingredient
TOFACITINIB CITRATE
Application Number
203214
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2018-05-30
Regulatory Status
RX
Drug Name
XELJANZ
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2020-09-25
Active Ingredient
TOFACITINIB CITRATE
Application Number
213082
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2020-09-25
Regulatory Status
RX
Drug Name
XELJANZ XR
Product Number
1
Dosage Form
-
Strength
EQ 11MG BASE
Approval Date
2016-02-23
Active Ingredient
TOFACITINIB CITRATE
Application Number
208246
Product Number
1
Dosage Form
-
Strength
EQ 11MG BASE
Approval Date
2016-02-23
Regulatory Status
RX
Drug Name
XELJANZ XR
Product Number
2
Dosage Form
-
Strength
EQ 22MG BASE
Approval Date
2019-12-12
Active Ingredient
TOFACITINIB CITRATE
Application Number
208246
Product Number
2
Dosage Form
-
Strength
EQ 22MG BASE
Approval Date
2019-12-12
Regulatory Status
RX
Drug Name
ZARONTIN
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Active Ingredient
ETHOSUXIMIDE
Application Number
12380
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
ZAVZPRET
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/SPRAY
Approval Date
2023-03-09
Active Ingredient
ZAVEGEPANT HYDROCHLORIDE
Application Number
216386
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/SPRAY
Approval Date
2023-03-09
Regulatory Status
RX
Drug Name
ZEFAZONE
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1989-12-11
Active Ingredient
CEFMETAZOLE SODIUM
Application Number
50637
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1989-12-11
Regulatory Status
Discontinued
Drug Name
ZEFAZONE
Product Number
2
Dosage Form
-
Strength
EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1989-12-11
Active Ingredient
CEFMETAZOLE SODIUM
Application Number
50637
Product Number
2
Dosage Form
-
Strength
EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1989-12-11
Regulatory Status
Discontinued
Drug Name
ZEFAZONE IN PLASTIC CONTAINER
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1992-12-29
Active Ingredient
CEFMETAZOLE SODIUM
Application Number
50683
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1992-12-29
Regulatory Status
Discontinued
Drug Name
ZEFAZONE IN PLASTIC CONTAINER
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1992-12-29
Active Ingredient
CEFMETAZOLE SODIUM
Application Number
50683
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1992-12-29
Regulatory Status
Discontinued
Drug Name
ZINECARD
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1995-05-26
Active Ingredient
DEXRAZOXANE HYDROCHLORIDE
Application Number
20212
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1995-05-26
Regulatory Status
Discontinued
Drug Name
ZINECARD
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1995-05-26
Active Ingredient
DEXRAZOXANE HYDROCHLORIDE
Application Number
20212
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1995-05-26
Regulatory Status
Discontinued
Drug Name
ZIPRASIDONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2012-03-02
Active Ingredient
ZIPRASIDONE HYDROCHLORIDE
Application Number
77560
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2012-03-02
Regulatory Status
Discontinued
Drug Name
ZIPRASIDONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2012-03-02
Active Ingredient
ZIPRASIDONE HYDROCHLORIDE
Application Number
77560
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2012-03-02
Regulatory Status
Discontinued
Drug Name
ZIPRASIDONE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2012-03-02
Active Ingredient
ZIPRASIDONE HYDROCHLORIDE
Application Number
77560
Product Number
3
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2012-03-02
Regulatory Status
Discontinued
Drug Name
ZIPRASIDONE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2012-03-02
Active Ingredient
ZIPRASIDONE HYDROCHLORIDE
Application Number
77560
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2012-03-02
Regulatory Status
Discontinued
Drug Name
ZIRABEV
Product Number
1
Dosage Form
-
Strength
100MG/4ML
Approval Date
-
Active Ingredient
BEVACIZUMAB-BVZR
Application Number
761099
Product Number
1
Dosage Form
-
Strength
100MG/4ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ZIRABEV
Product Number
2
Dosage Form
-
Strength
400MG/16ML
Approval Date
-
Active Ingredient
BEVACIZUMAB-BVZR
Application Number
761099
Product Number
2
Dosage Form
-
Strength
400MG/16ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ZITHROMAX
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1991-11-01
Active Ingredient
AZITHROMYCIN
Application Number
50670
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1991-11-01
Regulatory Status
Discontinued
Drug Name
ZITHROMAX
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/PACKET
Approval Date
1994-09-28
Active Ingredient
AZITHROMYCIN
Application Number
50693
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/PACKET
Approval Date
1994-09-28
Regulatory Status
Discontinued
Drug Name
ZITHROMAX
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/5ML
Approval Date
1995-10-19
Active Ingredient
AZITHROMYCIN
Application Number
50710
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/5ML
Approval Date
1995-10-19
Regulatory Status
RX
Drug Name
ZITHROMAX
Product Number
2
Dosage Form
-
Strength
EQ 200MG BASE/5ML
Approval Date
1995-10-19
Active Ingredient
AZITHROMYCIN
Application Number
50710
Product Number
2
Dosage Form
-
Strength
EQ 200MG BASE/5ML
Approval Date
1995-10-19
Regulatory Status
RX
Drug Name
ZITHROMAX
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1996-07-18
Active Ingredient
AZITHROMYCIN
Application Number
50711
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1996-07-18
Regulatory Status
RX
Drug Name
ZITHROMAX
Product Number
1
Dosage Form
-
Strength
EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1996-06-12
Active Ingredient
AZITHROMYCIN
Application Number
50730
Product Number
1
Dosage Form
-
Strength
EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1996-06-12
Regulatory Status
Discontinued
Drug Name
ZITHROMAX
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
1997-01-30
Active Ingredient
AZITHROMYCIN
Application Number
50733
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
1997-01-30
Regulatory Status
Discontinued
Drug Name
ZITHROMAX
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2002-05-24
Active Ingredient
AZITHROMYCIN
Application Number
50784
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2002-05-24
Regulatory Status
RX
Drug Name
ZMAX
Product Number
1
Dosage Form
-
Strength
EQ 2GM BASE/BOT
Approval Date
2005-06-10
Active Ingredient
AZITHROMYCIN
Application Number
50797
Product Number
1
Dosage Form
-
Strength
EQ 2GM BASE/BOT
Approval Date
2005-06-10
Regulatory Status
Discontinued
Drug Name
ZOLEDRONIC ACID
Product Number
1
Dosage Form
-
Strength
4MG/5ML
Approval Date
-
Active Ingredient
ZOLEDRONIC ACID
Application Number
203344
Product Number
1
Dosage Form
-
Strength
4MG/5ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ZYVOX
Product Number
1
Dosage Form
-
Strength
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2000-04-18
Active Ingredient
LINEZOLID
Application Number
21130
Product Number
1
Dosage Form
-
Strength
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2000-04-18
Regulatory Status
Discontinued
Drug Name
ZYVOX
Product Number
2
Dosage Form
-
Strength
600MG
Approval Date
2000-04-18
Active Ingredient
LINEZOLID
Application Number
21130
Product Number
2
Dosage Form
-
Strength
600MG
Approval Date
2000-04-18
Regulatory Status
Discontinued
Drug Name
ZYVOX
Product Number
1
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2000-04-18
Active Ingredient
LINEZOLID
Application Number
21131
Product Number
1
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2000-04-18
Regulatory Status
RX
Drug Name
ZYVOX
Product Number
2
Dosage Form
-
Strength
400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2000-04-18
Active Ingredient
LINEZOLID
Application Number
21131
Product Number
2
Dosage Form
-
Strength
400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2000-04-18
Regulatory Status
Discontinued
Drug Name
ZYVOX
Product Number
3
Dosage Form
-
Strength
600MG/300ML (2MG/ML)
Approval Date
2000-04-18
Active Ingredient
LINEZOLID
Application Number
21131
Product Number
3
Dosage Form
-
Strength
600MG/300ML (2MG/ML)
Approval Date
2000-04-18
Regulatory Status
RX
Drug Name
ZYVOX
Product Number
1
Dosage Form
-
Strength
100MG/5ML
Approval Date
2000-04-18
Active Ingredient
LINEZOLID
Application Number
21132
Product Number
1
Dosage Form
-
Strength
100MG/5ML
Approval Date
2000-04-18
Regulatory Status
RX
Drug Status Breakdown
856 total- Unclassified
- Discontinued
- RX
Official Source
FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.
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Drug Name
ABRILADA
Application Number
761118
Product Number
1
Active Ingredient
ADALIMUMAB-AFZB
Dosage Form
-
Strength
40MG/0.8ML
FDA Approved Drug Data
Approved drug product information
Regular Updates
Data maintained from official sources
Structured Database
Searchable pharmaceutical data
Reliable Data
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