Pfizer Inc RX
FDA Approved Drugs
Pfizer Inc RX
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 226
- Latest Approval Date Mar 07, 2024
- Data Source FDA
- First Approval Date Jan 01, 1982
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FDA Approved Drug Records ( 226 records )
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
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
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
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
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 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
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 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
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
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
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
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 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
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
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
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 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/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
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 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
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
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
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
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
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
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
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-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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 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
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 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 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
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
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
226 total- 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
ALDACTAZIDE
Application Number
12616
Product Number
4
Active Ingredient
HYDROCHLOROTHIAZIDE; SPIRONOLACTONE
Dosage Form
-
Strength
25MG;25MG
FDA Approved Drug Data
Approved drug product information
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