Sandoz B2B
FDA Approved Drugs
Sandoz B2B
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 751
- Latest Approval Date Aug 13, 2026
- Data Source FDA
- First Approval Date Jan 01, 1982
Company Overview
Social Profiles
Company Snapshot
Sandoz B2B
Forum 1, Novartis Campus, CH-4056 Basel
Switzerland
www.sandoz.com/ sandoz.b2b@sandoz.com View on MapFDA Approved Drug Records ( 751 records )
Drug Name
ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2016-03-22
Active Ingredient
ACETAMINOPHEN
Application Number
204052
Product Number
1
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2016-03-22
Regulatory Status
RX
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
2
Dosage Form
-
Strength
300MG;30MG
Approval Date
1982-01-01
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Application Number
85291
Product Number
2
Dosage Form
-
Strength
300MG;30MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
300MG;30MG
Approval Date
1982-01-01
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Application Number
85917
Product Number
1
Dosage Form
-
Strength
300MG;30MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
300MG;60MG
Approval Date
1982-01-01
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Application Number
85964
Product Number
1
Dosage Form
-
Strength
300MG;60MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
300MG;60MG
Approval Date
1982-01-01
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Application Number
87423
Product Number
1
Dosage Form
-
Strength
300MG;60MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
300MG;15MG
Approval Date
1982-01-01
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Application Number
87433
Product Number
1
Dosage Form
-
Strength
300MG;15MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ALBUTEROL SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 0.09MG BASE/INH
Approval Date
2021-06-01
Active Ingredient
ALBUTEROL SULFATE
Application Number
207085
Product Number
1
Dosage Form
-
Strength
EQ 0.09MG BASE/INH
Approval Date
2021-06-01
Regulatory Status
RX
Drug Name
ALKERGOT
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
1982-01-01
Active Ingredient
ERGOLOID MESYLATES
Application Number
85153
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ALKERGOT
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
1982-01-01
Active Ingredient
ERGOLOID MESYLATES
Application Number
87417
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ALLOPURINOL
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
1985-12-31
Active Ingredient
ALLOPURINOL
Application Number
70269
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
1985-12-31
Regulatory Status
Discontinued
Drug Name
ALPHAZINE
Product Number
1
Dosage Form
-
Strength
35MG
Approval Date
1982-01-01
Active Ingredient
PHENDIMETRAZINE TARTRATE
Application Number
85034
Product Number
1
Dosage Form
-
Strength
35MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ALPRAZOLAM
Product Number
1
Dosage Form
-
Strength
0.25MG
Approval Date
1995-12-29
Active Ingredient
ALPRAZOLAM
Application Number
74112
Product Number
1
Dosage Form
-
Strength
0.25MG
Approval Date
1995-12-29
Regulatory Status
RX
Drug Name
ALPRAZOLAM
Product Number
2
Dosage Form
-
Strength
0.5MG
Approval Date
1995-12-29
Active Ingredient
ALPRAZOLAM
Application Number
74112
Product Number
2
Dosage Form
-
Strength
0.5MG
Approval Date
1995-12-29
Regulatory Status
RX
Drug Name
ALPRAZOLAM
Product Number
3
Dosage Form
-
Strength
1MG
Approval Date
1995-12-29
Active Ingredient
ALPRAZOLAM
Application Number
74112
Product Number
3
Dosage Form
-
Strength
1MG
Approval Date
1995-12-29
Regulatory Status
RX
Drug Name
ALPRAZOLAM
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
1998-03-25
Active Ingredient
ALPRAZOLAM
Application Number
74909
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
1998-03-25
Regulatory Status
RX
Drug Name
AMANTADINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1987-02-18
Active Ingredient
AMANTADINE HYDROCHLORIDE
Application Number
71293
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1987-02-18
Regulatory Status
RX
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
85968
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
85968
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
85968
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
85968
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
150MG
Approval Date
1982-01-01
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
85968
Product Number
5
Dosage Form
-
Strength
150MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
6
Dosage Form
-
Strength
75MG
Approval Date
1982-01-01
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
85968
Product Number
6
Dosage Form
-
Strength
75MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
-
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
85970
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
AMOXICILLIN
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1994-09-30
Active Ingredient
AMOXICILLIN
Application Number
64076
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1994-09-30
Regulatory Status
RX
Drug Name
AMOXICILLIN
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
1994-09-30
Active Ingredient
AMOXICILLIN
Application Number
64076
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
1994-09-30
Regulatory Status
RX
Drug Name
AMOXICILLIN
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2005-07-13
Active Ingredient
AMOXICILLIN
Application Number
65228
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2005-07-13
Regulatory Status
RX
Drug Name
AMOXICILLIN
Product Number
2
Dosage Form
-
Strength
875MG
Approval Date
2005-07-13
Active Ingredient
AMOXICILLIN
Application Number
65228
Product Number
2
Dosage Form
-
Strength
875MG
Approval Date
2005-07-13
Regulatory Status
RX
Drug Name
AMOXICILLIN
Product Number
1
Dosage Form
-
Strength
200MG/5ML
Approval Date
2007-03-26
Active Ingredient
AMOXICILLIN
Application Number
65378
Product Number
1
Dosage Form
-
Strength
200MG/5ML
Approval Date
2007-03-26
Regulatory Status
RX
Drug Name
AMOXICILLIN
Product Number
2
Dosage Form
-
Strength
400MG/5ML
Approval Date
2007-03-26
Active Ingredient
AMOXICILLIN
Application Number
65378
Product Number
2
Dosage Form
-
Strength
400MG/5ML
Approval Date
2007-03-26
Regulatory Status
RX
Drug Name
AMOXICILLIN
Product Number
1
Dosage Form
-
Strength
125MG/5ML
Approval Date
2007-03-26
Active Ingredient
AMOXICILLIN
Application Number
65387
Product Number
1
Dosage Form
-
Strength
125MG/5ML
Approval Date
2007-03-26
Regulatory Status
RX
Drug Name
AMOXICILLIN
Product Number
2
Dosage Form
-
Strength
250MG/5ML
Approval Date
2007-03-26
Active Ingredient
AMOXICILLIN
Application Number
65387
Product Number
2
Dosage Form
-
Strength
250MG/5ML
Approval Date
2007-03-26
Regulatory Status
RX
Drug Name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Product Number
1
Dosage Form
-
Strength
875MG;EQ 125MG BASE
Approval Date
2002-03-14
Active Ingredient
AMOXICILLIN; CLAVULANATE POTASSIUM
Application Number
65063
Product Number
1
Dosage Form
-
Strength
875MG;EQ 125MG BASE
Approval Date
2002-03-14
Regulatory Status
RX
Drug Name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Product Number
1
Dosage Form
-
Strength
500MG;EQ 125MG BASE
Approval Date
2002-03-15
Active Ingredient
AMOXICILLIN; CLAVULANATE POTASSIUM
Application Number
65064
Product Number
1
Dosage Form
-
Strength
500MG;EQ 125MG BASE
Approval Date
2002-03-15
Regulatory Status
RX
Drug Name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Product Number
1
Dosage Form
-
Strength
200MG/5ML;EQ 28.5MG BASE/5ML
Approval Date
2002-06-05
Active Ingredient
AMOXICILLIN; CLAVULANATE POTASSIUM
Application Number
65066
Product Number
1
Dosage Form
-
Strength
200MG/5ML;EQ 28.5MG BASE/5ML
Approval Date
2002-06-05
Regulatory Status
RX
Drug Name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Product Number
2
Dosage Form
-
Strength
400MG/5ML;EQ 57MG BASE/5ML
Approval Date
2002-06-05
Active Ingredient
AMOXICILLIN; CLAVULANATE POTASSIUM
Application Number
65066
Product Number
2
Dosage Form
-
Strength
400MG/5ML;EQ 57MG BASE/5ML
Approval Date
2002-06-05
Regulatory Status
RX
Drug Name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Product Number
1
Dosage Form
-
Strength
250MG;EQ 125MG BASE
Approval Date
2005-08-23
Active Ingredient
AMOXICILLIN; CLAVULANATE POTASSIUM
Application Number
65189
Product Number
1
Dosage Form
-
Strength
250MG;EQ 125MG BASE
Approval Date
2005-08-23
Regulatory Status
RX
Drug Name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Product Number
1
Dosage Form
-
Strength
1GM;EQ 62.5MG BASE
Approval Date
2010-04-21
Active Ingredient
AMOXICILLIN; CLAVULANATE POTASSIUM
Application Number
90227
Product Number
1
Dosage Form
-
Strength
1GM;EQ 62.5MG BASE
Approval Date
2010-04-21
Regulatory Status
RX
Drug Name
AMPICILLIN AND SULBACTAM
Product Number
1
Dosage Form
-
Strength
EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
Approval Date
2006-07-25
Active Ingredient
AMPICILLIN SODIUM; SULBACTAM SODIUM
Application Number
65240
Product Number
1
Dosage Form
-
Strength
EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
Approval Date
2006-07-25
Regulatory Status
RX
Drug Name
AMPICILLIN AND SULBACTAM
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date
2006-07-25
Active Ingredient
AMPICILLIN SODIUM; SULBACTAM SODIUM
Application Number
65241
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date
2006-07-25
Regulatory Status
RX
Drug Name
AMPICILLIN AND SULBACTAM
Product Number
2
Dosage Form
-
Strength
EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
Approval Date
2006-07-25
Active Ingredient
AMPICILLIN SODIUM; SULBACTAM SODIUM
Application Number
65241
Product Number
2
Dosage Form
-
Strength
EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
Approval Date
2006-07-25
Regulatory Status
RX
Drug Name
AMPICILLIN AND SULBACTAM
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date
2006-07-25
Active Ingredient
AMPICILLIN SODIUM; SULBACTAM SODIUM
Application Number
65310
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date
2006-07-25
Regulatory Status
Discontinued
Drug Name
AMPICILLIN AND SULBACTAM
Product Number
2
Dosage Form
-
Strength
EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
Approval Date
2006-07-25
Active Ingredient
AMPICILLIN SODIUM; SULBACTAM SODIUM
Application Number
65310
Product Number
2
Dosage Form
-
Strength
EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
Approval Date
2006-07-25
Regulatory Status
Discontinued
Drug Name
AMPICILLIN SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 125MG BASE/VIAL
Approval Date
1982-01-01
Active Ingredient
AMPICILLIN SODIUM
Application Number
61395
Product Number
1
Dosage Form
-
Strength
EQ 125MG BASE/VIAL
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
AMPICILLIN SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE/VIAL
Approval Date
1982-01-01
Active Ingredient
AMPICILLIN SODIUM
Application Number
61395
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE/VIAL
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
AMPICILLIN SODIUM
Product Number
3
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
1982-01-01
Active Ingredient
AMPICILLIN SODIUM
Application Number
61395
Product Number
3
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
AMPICILLIN SODIUM
Product Number
4
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
1982-01-01
Active Ingredient
AMPICILLIN SODIUM
Application Number
61395
Product Number
4
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
AMPICILLIN SODIUM
Product Number
5
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
1982-01-01
Active Ingredient
AMPICILLIN SODIUM
Application Number
61395
Product Number
5
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
AMPICILLIN SODIUM
Product Number
6
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
1982-01-01
Active Ingredient
AMPICILLIN SODIUM
Application Number
61395
Product Number
6
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
AMPICILLIN SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
1987-02-19
Active Ingredient
AMPICILLIN SODIUM
Application Number
62738
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
1987-02-19
Regulatory Status
Discontinued
Drug Name
AMPICILLIN SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
1987-02-19
Active Ingredient
AMPICILLIN SODIUM
Application Number
62738
Product Number
2
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
1987-02-19
Regulatory Status
Discontinued
Drug Name
AMPICILLIN TRIHYDRATE
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1995-08-29
Active Ingredient
AMPICILLIN/AMPICILLIN TRIHYDRATE
Application Number
64082
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1995-08-29
Regulatory Status
Discontinued
Drug Name
AMPICILLIN TRIHYDRATE
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1995-08-29
Active Ingredient
AMPICILLIN/AMPICILLIN TRIHYDRATE
Application Number
64082
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1995-08-29
Regulatory Status
RX
Drug Name
ANASTROZOLE
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2010-06-28
Active Ingredient
ANASTROZOLE
Application Number
79007
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2010-06-28
Regulatory Status
Discontinued
Drug Name
ANECTINE
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
1982-01-01
Active Ingredient
SUCCINYLCHOLINE CHLORIDE
Application Number
8453
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ANECTINE
Product Number
2
Dosage Form
-
Strength
20MG/ML
Approval Date
1982-01-01
Active Ingredient
SUCCINYLCHOLINE CHLORIDE
Application Number
8453
Product Number
2
Dosage Form
-
Strength
20MG/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
ANECTINE
Product Number
3
Dosage Form
-
Strength
50MG/ML
Approval Date
1982-01-01
Active Ingredient
SUCCINYLCHOLINE CHLORIDE
Application Number
8453
Product Number
3
Dosage Form
-
Strength
50MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ANECTINE
Product Number
4
Dosage Form
-
Strength
1GM/VIAL
Approval Date
1982-01-01
Active Ingredient
SUCCINYLCHOLINE CHLORIDE
Application Number
8453
Product Number
4
Dosage Form
-
Strength
1GM/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ANGIOMAX
Product Number
1
Dosage Form
-
Strength
250MG/VIAL
Approval Date
2000-12-15
Active Ingredient
BIVALIRUDIN
Application Number
20873
Product Number
1
Dosage Form
-
Strength
250MG/VIAL
Approval Date
2000-12-15
Regulatory Status
RX
Drug Name
APREPITANT
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2012-09-24
Active Ingredient
APREPITANT
Application Number
90999
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2012-09-24
Regulatory Status
RX
Drug Name
APREPITANT
Product Number
2
Dosage Form
-
Strength
80MG
Approval Date
2012-09-24
Active Ingredient
APREPITANT
Application Number
90999
Product Number
2
Dosage Form
-
Strength
80MG
Approval Date
2012-09-24
Regulatory Status
RX
Drug Name
APREPITANT
Product Number
3
Dosage Form
-
Strength
125MG
Approval Date
2012-09-24
Active Ingredient
APREPITANT
Application Number
90999
Product Number
3
Dosage Form
-
Strength
125MG
Approval Date
2012-09-24
Regulatory Status
RX
Drug Name
ARGATROBAN
Product Number
1
Dosage Form
-
Strength
250MG/2.5ML (100MG/ML)
Approval Date
2000-06-30
Active Ingredient
ARGATROBAN
Application Number
20883
Product Number
1
Dosage Form
-
Strength
250MG/2.5ML (100MG/ML)
Approval Date
2000-06-30
Regulatory Status
Discontinued
Drug Name
ARGATROBAN IN DEXTROSE
Product Number
1
Dosage Form
-
Strength
125MG/125ML (1MG/ML)
Approval Date
2011-05-09
Active Ingredient
ARGATROBAN
Application Number
201743
Product Number
1
Dosage Form
-
Strength
125MG/125ML (1MG/ML)
Approval Date
2011-05-09
Regulatory Status
Discontinued
Drug Name
ARRANON
Product Number
1
Dosage Form
-
Strength
250MG/50ML (5MG/ML)
Approval Date
2005-10-28
Active Ingredient
NELARABINE
Application Number
21877
Product Number
1
Dosage Form
-
Strength
250MG/50ML (5MG/ML)
Approval Date
2005-10-28
Regulatory Status
RX
Drug Name
ARSENIC TRIOXIDE
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2021-12-02
Active Ingredient
ARSENIC TRIOXIDE
Application Number
215359
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2021-12-02
Regulatory Status
RX
Drug Name
ASPIRIN AND DIPYRIDAMOLE
Product Number
1
Dosage Form
-
Strength
25MG;200MG
Approval Date
2017-01-18
Active Ingredient
ASPIRIN; DIPYRIDAMOLE
Application Number
206739
Product Number
1
Dosage Form
-
Strength
25MG;200MG
Approval Date
2017-01-18
Regulatory Status
RX
Drug Name
AZELASTINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2012-05-31
Active Ingredient
AZELASTINE HYDROCHLORIDE
Application Number
202305
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2012-05-31
Regulatory Status
RX
Drug Name
AZITHROMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 600MG BASE
Approval Date
2005-11-14
Active Ingredient
AZITHROMYCIN
Application Number
65209
Product Number
1
Dosage Form
-
Strength
EQ 600MG BASE
Approval Date
2005-11-14
Regulatory Status
RX
Drug Name
AZITHROMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2005-11-14
Active Ingredient
AZITHROMYCIN
Application Number
65211
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2005-11-14
Regulatory Status
RX
Drug Name
AZITHROMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2005-11-14
Active Ingredient
AZITHROMYCIN
Application Number
65212
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2005-11-14
Regulatory Status
RX
Drug Name
AZITHROMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/5ML
Approval Date
2006-09-18
Active Ingredient
AZITHROMYCIN
Application Number
65297
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/5ML
Approval Date
2006-09-18
Regulatory Status
Discontinued
Drug Name
AZITHROMYCIN
Product Number
2
Dosage Form
-
Strength
EQ 200MG BASE/5ML
Approval Date
2006-09-18
Active Ingredient
AZITHROMYCIN
Application Number
65297
Product Number
2
Dosage Form
-
Strength
EQ 200MG BASE/5ML
Approval Date
2006-09-18
Regulatory Status
Discontinued
Drug Name
AZOPT
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1998-04-01
Active Ingredient
BRINZOLAMIDE
Application Number
20816
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1998-04-01
Regulatory Status
RX
Drug Name
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
5MG;6.25MG
Approval Date
2004-02-11
Active Ingredient
BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Application Number
76631
Product Number
1
Dosage Form
-
Strength
5MG;6.25MG
Approval Date
2004-02-11
Regulatory Status
RX
Drug Name
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
10MG;12.5MG
Approval Date
2004-02-11
Active Ingredient
BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Application Number
76631
Product Number
2
Dosage Form
-
Strength
10MG;12.5MG
Approval Date
2004-02-11
Regulatory Status
RX
Drug Name
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
20MG;12.5MG
Approval Date
2004-02-11
Active Ingredient
BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Application Number
76631
Product Number
3
Dosage Form
-
Strength
20MG;12.5MG
Approval Date
2004-02-11
Regulatory Status
RX
Drug Name
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Product Number
4
Dosage Form
-
Strength
20MG;25MG
Approval Date
2004-02-11
Active Ingredient
BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Application Number
76631
Product Number
4
Dosage Form
-
Strength
20MG;25MG
Approval Date
2004-02-11
Regulatory Status
RX
Drug Name
BETHANECHOL CHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Active Ingredient
BETHANECHOL CHLORIDE
Application Number
84353
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
BETHANECHOL CHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
BETHANECHOL CHLORIDE
Application Number
84378
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
BETHANECHOL CHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
BETHANECHOL CHLORIDE
Application Number
84379
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
BETHANECHOL CHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Active Ingredient
BETHANECHOL CHLORIDE
Application Number
84383
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
BETHANECHOL CHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Active Ingredient
BETHANECHOL CHLORIDE
Application Number
84384
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
BETOPTIC
Product Number
1
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
1985-08-30
Active Ingredient
BETAXOLOL HYDROCHLORIDE
Application Number
19270
Product Number
1
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
1985-08-30
Regulatory Status
RX
Drug Name
BICALUTAMIDE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2009-07-06
Active Ingredient
BICALUTAMIDE
Application Number
78575
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2009-07-06
Regulatory Status
RX
Drug Name
BIMATOPROST
Product Number
1
Dosage Form
-
Strength
0.03
Approval Date
-
Active Ingredient
BIMATOPROST
Application Number
200487
Product Number
1
Dosage Form
-
Strength
0.03
Approval Date
-
Regulatory Status
Unclassified
Drug Name
BIMATOPROST
Product Number
1
Dosage Form
-
Strength
0.03%
Approval Date
2015-05-05
Active Ingredient
BIMATOPROST
Application Number
202565
Product Number
1
Dosage Form
-
Strength
0.03%
Approval Date
2015-05-05
Regulatory Status
RX
Drug Name
BIMATOPROST
Product Number
1
Dosage Form
-
Strength
0.03%
Approval Date
2016-04-19
Active Ingredient
BIMATOPROST
Application Number
202719
Product Number
1
Dosage Form
-
Strength
0.03%
Approval Date
2016-04-19
Regulatory Status
RX
Drug Name
BREXPIPRAZOLE
Product Number
1
Dosage Form
-
Strength
0.25MG
Approval Date
2022-09-26
Active Ingredient
BREXPIPRAZOLE
Application Number
213570
Product Number
1
Dosage Form
-
Strength
0.25MG
Approval Date
2022-09-26
Regulatory Status
Discontinued
Drug Name
BREXPIPRAZOLE
Product Number
2
Dosage Form
-
Strength
0.5MG
Approval Date
2022-09-26
Active Ingredient
BREXPIPRAZOLE
Application Number
213570
Product Number
2
Dosage Form
-
Strength
0.5MG
Approval Date
2022-09-26
Regulatory Status
Discontinued
Drug Name
BREXPIPRAZOLE
Product Number
3
Dosage Form
-
Strength
1MG
Approval Date
2022-09-26
Active Ingredient
BREXPIPRAZOLE
Application Number
213570
Product Number
3
Dosage Form
-
Strength
1MG
Approval Date
2022-09-26
Regulatory Status
Discontinued
Drug Name
BREXPIPRAZOLE
Product Number
4
Dosage Form
-
Strength
2MG
Approval Date
2022-09-26
Active Ingredient
BREXPIPRAZOLE
Application Number
213570
Product Number
4
Dosage Form
-
Strength
2MG
Approval Date
2022-09-26
Regulatory Status
Discontinued
Drug Name
BREXPIPRAZOLE
Product Number
5
Dosage Form
-
Strength
3MG
Approval Date
2022-09-26
Active Ingredient
BREXPIPRAZOLE
Application Number
213570
Product Number
5
Dosage Form
-
Strength
3MG
Approval Date
2022-09-26
Regulatory Status
Discontinued
Drug Name
BREXPIPRAZOLE
Product Number
6
Dosage Form
-
Strength
4MG
Approval Date
2022-09-26
Active Ingredient
BREXPIPRAZOLE
Application Number
213570
Product Number
6
Dosage Form
-
Strength
4MG
Approval Date
2022-09-26
Regulatory Status
Discontinued
Drug Name
BRIMONIDINE TARTRATE
Product Number
1
Dosage Form
-
Strength
0.2%
Approval Date
2003-09-16
Active Ingredient
BRIMONIDINE TARTRATE
Application Number
76254
Product Number
1
Dosage Form
-
Strength
0.2%
Approval Date
2003-09-16
Regulatory Status
RX
Drug Name
BRIMONIDINE TARTRATE
Product Number
1
Dosage Form
-
Strength
0.2%
Approval Date
2008-01-30
Active Ingredient
BRIMONIDINE TARTRATE
Application Number
78075
Product Number
1
Dosage Form
-
Strength
0.2%
Approval Date
2008-01-30
Regulatory Status
RX
Drug Name
BRIMONIDINE TARTRATE
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2024-03-04
Active Ingredient
BRIMONIDINE TARTRATE
Application Number
203172
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2024-03-04
Regulatory Status
RX
Drug Name
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
Product Number
1
Dosage Form
-
Strength
0.2%;EQ 0.5% BASE
Approval Date
2022-04-04
Active Ingredient
BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Application Number
91087
Product Number
1
Dosage Form
-
Strength
0.2%;EQ 0.5% BASE
Approval Date
2022-04-04
Regulatory Status
RX
Drug Name
BROMOCRIPTINE MESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
1998-01-13
Active Ingredient
BROMOCRIPTINE MESYLATE
Application Number
74631
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
1998-01-13
Regulatory Status
RX
Drug Name
BUDESONIDE
Product Number
1
Dosage Form
-
Strength
1MG/2ML
Approval Date
2013-09-27
Active Ingredient
BUDESONIDE
Application Number
201966
Product Number
1
Dosage Form
-
Strength
1MG/2ML
Approval Date
2013-09-27
Regulatory Status
Discontinued
Drug Name
BUDESONIDE
Product Number
2
Dosage Form
-
Strength
0.5MG/2ML
Approval Date
2013-09-27
Active Ingredient
BUDESONIDE
Application Number
201966
Product Number
2
Dosage Form
-
Strength
0.5MG/2ML
Approval Date
2013-09-27
Regulatory Status
Discontinued
Drug Name
BUDESONIDE
Product Number
3
Dosage Form
-
Strength
0.25MG/2ML
Approval Date
2013-09-27
Active Ingredient
BUDESONIDE
Application Number
201966
Product Number
3
Dosage Form
-
Strength
0.25MG/2ML
Approval Date
2013-09-27
Regulatory Status
Discontinued
Drug Name
BUMETANIDE
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
1996-11-21
Active Ingredient
BUMETANIDE
Application Number
74700
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
1996-11-21
Regulatory Status
RX
Drug Name
BUMETANIDE
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
1996-11-21
Active Ingredient
BUMETANIDE
Application Number
74700
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
1996-11-21
Regulatory Status
RX
Drug Name
BUMETANIDE
Product Number
3
Dosage Form
-
Strength
2MG
Approval Date
1996-11-21
Active Ingredient
BUMETANIDE
Application Number
74700
Product Number
3
Dosage Form
-
Strength
2MG
Approval Date
1996-11-21
Regulatory Status
RX
Drug Name
BUPROPION HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2005-07-14
Active Ingredient
BUPROPION HYDROCHLORIDE
Application Number
76845
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2005-07-14
Regulatory Status
Discontinued
Drug Name
BUPROPION HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2005-07-14
Active Ingredient
BUPROPION HYDROCHLORIDE
Application Number
76845
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2005-07-14
Regulatory Status
Discontinued
Drug Name
BUPROPION HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2008-03-12
Active Ingredient
BUPROPION HYDROCHLORIDE
Application Number
77475
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2008-03-12
Regulatory Status
RX
Drug Name
BUTABARBITAL SODIUM
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
1982-01-01
Active Ingredient
BUTABARBITAL SODIUM
Application Number
84272
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
BUTABARBITAL SODIUM
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
1982-02-09
Active Ingredient
BUTABARBITAL SODIUM
Application Number
84292
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
1982-02-09
Regulatory Status
Discontinued
Drug Name
BUTABARBITAL SODIUM
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
1982-01-01
Active Ingredient
BUTABARBITAL SODIUM
Application Number
85934
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
BUTABARBITAL SODIUM
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
1982-01-01
Active Ingredient
BUTABARBITAL SODIUM
Application Number
85938
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CABAZITAXEL
Product Number
1
Dosage Form
-
Strength
45MG/4.5ML (10MG/ML)
Approval Date
-
Active Ingredient
CABAZITAXEL
Application Number
208715
Product Number
1
Dosage Form
-
Strength
45MG/4.5ML (10MG/ML)
Approval Date
-
Regulatory Status
Unclassified
Drug Name
CABAZITAXEL
Product Number
2
Dosage Form
-
Strength
60MG/6ML (10MG/ML)
Approval Date
-
Active Ingredient
CABAZITAXEL
Application Number
208715
Product Number
2
Dosage Form
-
Strength
60MG/6ML (10MG/ML)
Approval Date
-
Regulatory Status
Unclassified
Drug Name
CAPTOPRIL
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
1996-02-13
Active Ingredient
CAPTOPRIL
Application Number
74481
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
1996-02-13
Regulatory Status
Discontinued
Drug Name
CAPTOPRIL
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
1996-02-13
Active Ingredient
CAPTOPRIL
Application Number
74481
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
1996-02-13
Regulatory Status
Discontinued
Drug Name
CAPTOPRIL
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
1996-02-13
Active Ingredient
CAPTOPRIL
Application Number
74481
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
1996-02-13
Regulatory Status
Discontinued
Drug Name
CAPTOPRIL
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
1996-02-13
Active Ingredient
CAPTOPRIL
Application Number
74481
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
1996-02-13
Regulatory Status
Discontinued
Drug Name
CARBOPLATIN
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2005-03-18
Active Ingredient
CARBOPLATIN
Application Number
76959
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2005-03-18
Regulatory Status
Discontinued
Drug Name
CARBOPLATIN
Product Number
2
Dosage Form
-
Strength
150MG/VIAL
Approval Date
2005-03-18
Active Ingredient
CARBOPLATIN
Application Number
76959
Product Number
2
Dosage Form
-
Strength
150MG/VIAL
Approval Date
2005-03-18
Regulatory Status
Discontinued
Drug Name
CARBOPLATIN
Product Number
3
Dosage Form
-
Strength
450MG/VIAL
Approval Date
2005-03-18
Active Ingredient
CARBOPLATIN
Application Number
76959
Product Number
3
Dosage Form
-
Strength
450MG/VIAL
Approval Date
2005-03-18
Regulatory Status
Discontinued
Drug Name
CARBOPLATIN
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2008-05-08
Active Ingredient
CARBOPLATIN
Application Number
78280
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2008-05-08
Regulatory Status
RX
Drug Name
CARBOPLATIN
Product Number
2
Dosage Form
-
Strength
150MG/15ML (10MG/ML)
Approval Date
2008-05-08
Active Ingredient
CARBOPLATIN
Application Number
78280
Product Number
2
Dosage Form
-
Strength
150MG/15ML (10MG/ML)
Approval Date
2008-05-08
Regulatory Status
RX
Drug Name
CARBOPLATIN
Product Number
3
Dosage Form
-
Strength
450MG/45ML (10MG/ML)
Approval Date
2008-05-08
Active Ingredient
CARBOPLATIN
Application Number
78280
Product Number
3
Dosage Form
-
Strength
450MG/45ML (10MG/ML)
Approval Date
2008-05-08
Regulatory Status
RX
Drug Name
CARISOPRODOL
Product Number
1
Dosage Form
-
Strength
350MG
Approval Date
1988-08-30
Active Ingredient
CARISOPRODOL
Application Number
89566
Product Number
1
Dosage Form
-
Strength
350MG
Approval Date
1988-08-30
Regulatory Status
Discontinued
Drug Name
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
325MG;200MG;16MG
Approval Date
1996-04-16
Active Ingredient
ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE
Application Number
40118
Product Number
1
Dosage Form
-
Strength
325MG;200MG;16MG
Approval Date
1996-04-16
Regulatory Status
Discontinued
Drug Name
CARTEOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
2000-01-03
Active Ingredient
CARTEOLOL HYDROCHLORIDE
Application Number
75476
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
2000-01-03
Regulatory Status
RX
Drug Name
CARVEDILOL
Product Number
1
Dosage Form
-
Strength
3.125MG
Approval Date
2007-09-05
Active Ingredient
CARVEDILOL
Application Number
78227
Product Number
1
Dosage Form
-
Strength
3.125MG
Approval Date
2007-09-05
Regulatory Status
RX
Drug Name
CARVEDILOL
Product Number
2
Dosage Form
-
Strength
6.25MG
Approval Date
2007-09-05
Active Ingredient
CARVEDILOL
Application Number
78227
Product Number
2
Dosage Form
-
Strength
6.25MG
Approval Date
2007-09-05
Regulatory Status
RX
Drug Name
CARVEDILOL
Product Number
3
Dosage Form
-
Strength
12.5MG
Approval Date
2007-09-05
Active Ingredient
CARVEDILOL
Application Number
78227
Product Number
3
Dosage Form
-
Strength
12.5MG
Approval Date
2007-09-05
Regulatory Status
RX
Drug Name
CARVEDILOL
Product Number
4
Dosage Form
-
Strength
25MG
Approval Date
2007-09-05
Active Ingredient
CARVEDILOL
Application Number
78227
Product Number
4
Dosage Form
-
Strength
25MG
Approval Date
2007-09-05
Regulatory Status
RX
Drug Name
CEFADROXIL
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1982-01-01
Active Ingredient
CEFADROXIL/CEFADROXIL HEMIHYDRATE
Application Number
62291
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CEFAZOLIN SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
1988-12-09
Active Ingredient
CEFAZOLIN SODIUM
Application Number
62831
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
1988-12-09
Regulatory Status
RX
Drug Name
CEFAZOLIN SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
1988-12-09
Active Ingredient
CEFAZOLIN SODIUM
Application Number
62831
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
1988-12-09
Regulatory Status
RX
Drug Name
CEFAZOLIN SODIUM
Product Number
3
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
1992-09-25
Active Ingredient
CEFAZOLIN SODIUM
Application Number
62831
Product Number
3
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
1992-09-25
Regulatory Status
RX
Drug Name
CEFAZOLIN SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2007-05-09
Active Ingredient
CEFAZOLIN SODIUM
Application Number
65345
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2007-05-09
Regulatory Status
Discontinued
Drug Name
CEFPODOXIME PROXETIL
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2008-05-28
Active Ingredient
CEFPODOXIME PROXETIL
Application Number
65462
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2008-05-28
Regulatory Status
RX
Drug Name
CEFPODOXIME PROXETIL
Product Number
2
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2008-05-28
Active Ingredient
CEFPODOXIME PROXETIL
Application Number
65462
Product Number
2
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2008-05-28
Regulatory Status
RX
Drug Name
CEFPROZIL
Product Number
1
Dosage Form
-
Strength
125MG/5ML
Approval Date
2005-12-08
Active Ingredient
CEFPROZIL
Application Number
65257
Product Number
1
Dosage Form
-
Strength
125MG/5ML
Approval Date
2005-12-08
Regulatory Status
Discontinued
Drug Name
CEFPROZIL
Product Number
2
Dosage Form
-
Strength
250MG/5ML
Approval Date
2005-12-08
Active Ingredient
CEFPROZIL
Application Number
65257
Product Number
2
Dosage Form
-
Strength
250MG/5ML
Approval Date
2005-12-08
Regulatory Status
Discontinued
Drug Name
CEFTRIAXONE
Product Number
1
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
2005-05-17
Active Ingredient
CEFTRIAXONE SODIUM
Application Number
65168
Product Number
1
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
2005-05-17
Regulatory Status
RX
Drug Name
CEFTRIAXONE
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/VIAL
Approval Date
2005-05-09
Active Ingredient
CEFTRIAXONE SODIUM
Application Number
65169
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/VIAL
Approval Date
2005-05-09
Regulatory Status
RX
Drug Name
CEFTRIAXONE
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2005-05-09
Active Ingredient
CEFTRIAXONE SODIUM
Application Number
65169
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2005-05-09
Regulatory Status
RX
Drug Name
CEFTRIAXONE
Product Number
3
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2005-05-09
Active Ingredient
CEFTRIAXONE SODIUM
Application Number
65169
Product Number
3
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2005-05-09
Regulatory Status
RX
Drug Name
CEFTRIAXONE
Product Number
4
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
2005-05-09
Active Ingredient
CEFTRIAXONE SODIUM
Application Number
65169
Product Number
4
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
2005-05-09
Regulatory Status
RX
Drug Name
CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2008-02-14
Active Ingredient
CETIRIZINE HYDROCHLORIDE
Application Number
78692
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2008-02-14
Regulatory Status
OTC
Drug Name
CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2008-02-14
Active Ingredient
CETIRIZINE HYDROCHLORIDE
Application Number
78692
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2008-02-14
Regulatory Status
OTC
Drug Name
CHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Active Ingredient
CHLOROTHIAZIDE
Application Number
85485
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CHLORPROPAMIDE
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Active Ingredient
CHLORPROPAMIDE
Application Number
84669
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CHLORTHALIDONE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Active Ingredient
CHLORTHALIDONE
Application Number
87118
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CILOXAN
Product Number
1
Dosage Form
-
Strength
EQ 0.3% BASE
Approval Date
1990-12-31
Active Ingredient
CIPROFLOXACIN HYDROCHLORIDE
Application Number
19992
Product Number
1
Dosage Form
-
Strength
EQ 0.3% BASE
Approval Date
1990-12-31
Regulatory Status
RX
Drug Name
CILOXAN
Product Number
1
Dosage Form
-
Strength
EQ 0.3% BASE
Approval Date
1998-03-30
Active Ingredient
CIPROFLOXACIN HYDROCHLORIDE
Application Number
20369
Product Number
1
Dosage Form
-
Strength
EQ 0.3% BASE
Approval Date
1998-03-30
Regulatory Status
RX
Drug Name
CIMETIDINE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1995-06-29
Active Ingredient
CIMETIDINE
Application Number
74250
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1995-06-29
Regulatory Status
Discontinued
Drug Name
CIMETIDINE
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
1995-06-29
Active Ingredient
CIMETIDINE
Application Number
74250
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
1995-06-29
Regulatory Status
Discontinued
Drug Name
CIMETIDINE
Product Number
3
Dosage Form
-
Strength
400MG
Approval Date
1995-06-29
Active Ingredient
CIMETIDINE
Application Number
74250
Product Number
3
Dosage Form
-
Strength
400MG
Approval Date
1995-06-29
Regulatory Status
Discontinued
Drug Name
CIMETIDINE
Product Number
4
Dosage Form
-
Strength
800MG
Approval Date
1995-06-29
Active Ingredient
CIMETIDINE
Application Number
74250
Product Number
4
Dosage Form
-
Strength
800MG
Approval Date
1995-06-29
Regulatory Status
Discontinued
Drug Name
CIMETIDINE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1998-06-19
Active Ingredient
CIMETIDINE
Application Number
75122
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1998-06-19
Regulatory Status
Discontinued
Drug Name
CIMETIDINE
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
1998-06-19
Active Ingredient
CIMETIDINE
Application Number
75122
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
1998-06-19
Regulatory Status
Discontinued
Drug Name
CIPRO HC
Product Number
1
Dosage Form
-
Strength
EQ 0.2% BASE;1%
Approval Date
1998-02-10
Active Ingredient
CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE
Application Number
20805
Product Number
1
Dosage Form
-
Strength
EQ 0.2% BASE;1%
Approval Date
1998-02-10
Regulatory Status
RX
Drug Name
CIPRODEX
Product Number
1
Dosage Form
-
Strength
0.3%;0.1%
Approval Date
2003-07-18
Active Ingredient
CIPROFLOXACIN; DEXAMETHASONE
Application Number
21537
Product Number
1
Dosage Form
-
Strength
0.3%;0.1%
Approval Date
2003-07-18
Regulatory Status
RX
Drug Name
CLARITHROMYCIN
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2005-08-25
Active Ingredient
CLARITHROMYCIN
Application Number
65136
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2005-08-25
Regulatory Status
RX
Drug Name
CLARITHROMYCIN
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2005-10-18
Active Ingredient
CLARITHROMYCIN
Application Number
65144
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2005-10-18
Regulatory Status
RX
Drug Name
CLARITHROMYCIN
Product Number
2
Dosage Form
-
Strength
125MG/5ML
Approval Date
2007-09-04
Active Ingredient
CLARITHROMYCIN
Application Number
65283
Product Number
2
Dosage Form
-
Strength
125MG/5ML
Approval Date
2007-09-04
Regulatory Status
RX
Drug Name
CLARITHROMYCIN
Product Number
3
Dosage Form
-
Strength
250MG/5ML
Approval Date
2007-09-04
Active Ingredient
CLARITHROMYCIN
Application Number
65283
Product Number
3
Dosage Form
-
Strength
250MG/5ML
Approval Date
2007-09-04
Regulatory Status
RX
Drug Name
CLOFIBRATE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1988-05-02
Active Ingredient
CLOFIBRATE
Application Number
72191
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1988-05-02
Regulatory Status
Discontinued
Drug Name
CLOMIPRAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1997-06-25
Active Ingredient
CLOMIPRAMINE HYDROCHLORIDE
Application Number
74953
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1997-06-25
Regulatory Status
RX
Drug Name
CLOMIPRAMINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
1997-06-25
Active Ingredient
CLOMIPRAMINE HYDROCHLORIDE
Application Number
74953
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
1997-06-25
Regulatory Status
RX
Drug Name
CLOMIPRAMINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
75MG
Approval Date
1997-06-25
Active Ingredient
CLOMIPRAMINE HYDROCHLORIDE
Application Number
74953
Product Number
3
Dosage Form
-
Strength
75MG
Approval Date
1997-06-25
Regulatory Status
RX
Drug Name
CLONAZEPAM
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
1997-08-29
Active Ingredient
CLONAZEPAM
Application Number
74979
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
1997-08-29
Regulatory Status
RX
Drug Name
CLONAZEPAM
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
1997-08-29
Active Ingredient
CLONAZEPAM
Application Number
74979
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
1997-08-29
Regulatory Status
RX
Drug Name
CLONAZEPAM
Product Number
3
Dosage Form
-
Strength
2MG
Approval Date
1997-08-29
Active Ingredient
CLONAZEPAM
Application Number
74979
Product Number
3
Dosage Form
-
Strength
2MG
Approval Date
1997-08-29
Regulatory Status
RX
Drug Name
CLOZAPINE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1996-08-30
Active Ingredient
CLOZAPINE
Application Number
74546
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1996-08-30
Regulatory Status
Discontinued
Drug Name
CLOZAPINE
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
1996-08-30
Active Ingredient
CLOZAPINE
Application Number
74546
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
1996-08-30
Regulatory Status
Discontinued
Drug Name
COSYNTROPIN
Product Number
1
Dosage Form
-
Strength
0.25MG/ML (0.25MG/ML)
Approval Date
2008-02-21
Active Ingredient
COSYNTROPIN
Application Number
22028
Product Number
1
Dosage Form
-
Strength
0.25MG/ML (0.25MG/ML)
Approval Date
2008-02-21
Regulatory Status
Discontinued
Drug Name
COSYNTROPIN
Product Number
1
Dosage Form
-
Strength
0.25MG/VIAL
Approval Date
2012-06-29
Active Ingredient
COSYNTROPIN
Application Number
202147
Product Number
1
Dosage Form
-
Strength
0.25MG/VIAL
Approval Date
2012-06-29
Regulatory Status
RX
Drug Name
CROMOLYN SODIUM
Product Number
1
Dosage Form
-
Strength
4%
Approval Date
1999-06-16
Active Ingredient
CROMOLYN SODIUM
Application Number
75282
Product Number
1
Dosage Form
-
Strength
4%
Approval Date
1999-06-16
Regulatory Status
RX
Drug Name
CYANOCOBALAMIN
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2021-01-04
Active Ingredient
CYANOCOBALAMIN
Application Number
212915
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2021-01-04
Regulatory Status
RX
Drug Name
CYCLOBENZAPRINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1993-02-26
Active Ingredient
CYCLOBENZAPRINE HYDROCHLORIDE
Application Number
73683
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1993-02-26
Regulatory Status
Discontinued
Drug Name
CYCLOPHOSPHAMIDE
Product Number
1
Dosage Form
-
Strength
500MG/5ML (100MG/ML)
Approval Date
2023-09-12
Active Ingredient
CYCLOPHOSPHAMIDE
Application Number
217150
Product Number
1
Dosage Form
-
Strength
500MG/5ML (100MG/ML)
Approval Date
2023-09-12
Regulatory Status
RX
Drug Name
CYCLOPHOSPHAMIDE
Product Number
2
Dosage Form
-
Strength
1GM/10ML (100MG/ML)
Approval Date
2023-09-12
Active Ingredient
CYCLOPHOSPHAMIDE
Application Number
217150
Product Number
2
Dosage Form
-
Strength
1GM/10ML (100MG/ML)
Approval Date
2023-09-12
Regulatory Status
RX
Drug Name
CYCLOPHOSPHAMIDE
Product Number
3
Dosage Form
-
Strength
2GM/20ML (100MG/ML)
Approval Date
2023-09-12
Active Ingredient
CYCLOPHOSPHAMIDE
Application Number
217150
Product Number
3
Dosage Form
-
Strength
2GM/20ML (100MG/ML)
Approval Date
2023-09-12
Regulatory Status
RX
Drug Name
CYCLOSPORINE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2000-01-13
Active Ingredient
CYCLOSPORINE
Application Number
65017
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2000-01-13
Regulatory Status
RX
Drug Name
CYCLOSPORINE
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2000-01-13
Active Ingredient
CYCLOSPORINE
Application Number
65017
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2000-01-13
Regulatory Status
RX
Drug Name
DAPAGLIFLOZIN
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2026-04-06
Active Ingredient
DAPAGLIFLOZIN
Application Number
211312
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2026-04-06
Regulatory Status
RX
Drug Name
DAPAGLIFLOZIN
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2026-04-06
Active Ingredient
DAPAGLIFLOZIN
Application Number
211312
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2026-04-06
Regulatory Status
RX
Drug Name
DECITABINE
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2014-08-28
Active Ingredient
DECITABINE
Application Number
202969
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2014-08-28
Regulatory Status
RX
Drug Name
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Product Number
1
Dosage Form
-
Strength
2.5MG;2.5MG;2.5MG;2.5MG
Approval Date
2002-06-14
Active Ingredient
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Application Number
40439
Product Number
1
Dosage Form
-
Strength
2.5MG;2.5MG;2.5MG;2.5MG
Approval Date
2002-06-14
Regulatory Status
RX
Drug Name
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Product Number
2
Dosage Form
-
Strength
5MG;5MG;5MG;5MG
Approval Date
2002-06-14
Active Ingredient
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Application Number
40439
Product Number
2
Dosage Form
-
Strength
5MG;5MG;5MG;5MG
Approval Date
2002-06-14
Regulatory Status
RX
Drug Name
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Product Number
3
Dosage Form
-
Strength
7.5MG;7.5MG;7.5MG;7.5MG
Approval Date
2002-06-14
Active Ingredient
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Application Number
40439
Product Number
3
Dosage Form
-
Strength
7.5MG;7.5MG;7.5MG;7.5MG
Approval Date
2002-06-14
Regulatory Status
RX
Drug Name
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Product Number
4
Dosage Form
-
Strength
1.25MG;1.25MG;1.25MG;1.25MG
Approval Date
2002-09-27
Active Ingredient
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Application Number
40439
Product Number
4
Dosage Form
-
Strength
1.25MG;1.25MG;1.25MG;1.25MG
Approval Date
2002-09-27
Regulatory Status
RX
Drug Name
DEXTROAMPHETAMINE SULFATE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
DEXTROAMPHETAMINE SULFATE
Application Number
85371
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DICLOFENAC SODIUM
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2008-02-06
Active Ingredient
DICLOFENAC SODIUM
Application Number
78031
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2008-02-06
Regulatory Status
RX
Drug Name
DICLOFENAC SODIUM AND MISOPROSTOL
Product Number
1
Dosage Form
-
Strength
50MG;0.2MG
Approval Date
2013-05-09
Active Ingredient
DICLOFENAC SODIUM; MISOPROSTOL
Application Number
200158
Product Number
1
Dosage Form
-
Strength
50MG;0.2MG
Approval Date
2013-05-09
Regulatory Status
Discontinued
Drug Name
DICLOFENAC SODIUM AND MISOPROSTOL
Product Number
2
Dosage Form
-
Strength
75MG;0.2MG
Approval Date
2013-05-09
Active Ingredient
DICLOFENAC SODIUM; MISOPROSTOL
Application Number
200158
Product Number
2
Dosage Form
-
Strength
75MG;0.2MG
Approval Date
2013-05-09
Regulatory Status
Discontinued
Drug Name
DIETHYLPROPION HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Active Ingredient
DIETHYLPROPION HYDROCHLORIDE
Application Number
85916
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DIGOXIN
Product Number
1
Dosage Form
-
Strength
0.25MG/ML
Approval Date
2003-08-21
Active Ingredient
DIGOXIN
Application Number
40481
Product Number
1
Dosage Form
-
Strength
0.25MG/ML
Approval Date
2003-08-21
Regulatory Status
RX
Drug Name
DISOBROM
Product Number
1
Dosage Form
-
Strength
6MG;120MG
Approval Date
1991-09-30
Active Ingredient
DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
Application Number
70770
Product Number
1
Dosage Form
-
Strength
6MG;120MG
Approval Date
1991-09-30
Regulatory Status
Discontinued
Drug Name
DOCETAXEL
Product Number
1
Dosage Form
-
Strength
20MG/2ML (10MG/ML)
Approval Date
2011-06-29
Active Ingredient
DOCETAXEL
Application Number
201525
Product Number
1
Dosage Form
-
Strength
20MG/2ML (10MG/ML)
Approval Date
2011-06-29
Regulatory Status
RX
Drug Name
DOCETAXEL
Product Number
2
Dosage Form
-
Strength
80MG/8ML (10MG/ML)
Approval Date
2011-06-29
Active Ingredient
DOCETAXEL
Application Number
201525
Product Number
2
Dosage Form
-
Strength
80MG/8ML (10MG/ML)
Approval Date
2011-06-29
Regulatory Status
RX
Drug Name
DOCETAXEL
Product Number
3
Dosage Form
-
Strength
160MG/16ML (10MG/ML)
Approval Date
2011-06-29
Active Ingredient
DOCETAXEL
Application Number
201525
Product Number
3
Dosage Form
-
Strength
160MG/16ML (10MG/ML)
Approval Date
2011-06-29
Regulatory Status
RX
Drug Name
DORZOLAMIDE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE
Approval Date
2008-11-06
Active Ingredient
DORZOLAMIDE HYDROCHLORIDE
Application Number
78748
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE
Approval Date
2008-11-06
Regulatory Status
RX
Drug Name
DORZOLAMIDE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE
Approval Date
2009-04-13
Active Ingredient
DORZOLAMIDE HYDROCHLORIDE
Application Number
78981
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE
Approval Date
2009-04-13
Regulatory Status
RX
Drug Name
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE;EQ 0.5% BASE
Approval Date
2008-11-06
Active Ingredient
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
Application Number
78749
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE;EQ 0.5% BASE
Approval Date
2008-11-06
Regulatory Status
RX
Drug Name
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE;EQ 0.5% BASE
Approval Date
2009-11-18
Active Ingredient
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
Application Number
90604
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE;EQ 0.5% BASE
Approval Date
2009-11-18
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
1986-05-15
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
70825
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
1986-05-15
Regulatory Status
Discontinued
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
1986-05-15
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
70827
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
1986-05-15
Regulatory Status
Discontinued
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1986-05-15
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
70828
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1986-05-15
Regulatory Status
Discontinued
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1987-03-02
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
71487
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1987-03-02
Regulatory Status
Discontinued
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1987-03-02
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
71562
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1987-03-02
Regulatory Status
Discontinued
Drug Name
DOXERCALCIFEROL
Product Number
1
Dosage Form
-
Strength
4MCG/2ML (2MCG/ML)
Approval Date
2014-05-05
Active Ingredient
DOXERCALCIFEROL
Application Number
91333
Product Number
1
Dosage Form
-
Strength
4MCG/2ML (2MCG/ML)
Approval Date
2014-05-05
Regulatory Status
RX
Drug Name
DRALSERP
Product Number
1
Dosage Form
-
Strength
25MG;0.1MG
Approval Date
1982-01-01
Active Ingredient
HYDRALAZINE HYDROCHLORIDE; RESERPINE
Application Number
84617
Product Number
1
Dosage Form
-
Strength
25MG;0.1MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DULOXETINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
-
Active Ingredient
DULOXETINE HYDROCHLORIDE
Application Number
90775
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DULOXETINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
-
Active Ingredient
DULOXETINE HYDROCHLORIDE
Application Number
90775
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DULOXETINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
60MG
Approval Date
-
Active Ingredient
DULOXETINE HYDROCHLORIDE
Application Number
90775
Product Number
3
Dosage Form
-
Strength
60MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DUREZOL
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2008-06-23
Active Ingredient
DIFLUPREDNATE
Application Number
22212
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2008-06-23
Regulatory Status
RX
Drug Name
EDARAVONE
Product Number
1
Dosage Form
-
Strength
30MG/100ML (0.3MG/ML)
Approval Date
2024-12-23
Active Ingredient
EDARAVONE
Application Number
216902
Product Number
1
Dosage Form
-
Strength
30MG/100ML (0.3MG/ML)
Approval Date
2024-12-23
Regulatory Status
RX
Drug Name
ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Product Number
1
Dosage Form
-
Strength
100MG/ML (100MG/ML)
Approval Date
2010-07-23
Active Ingredient
ENOXAPARIN SODIUM
Application Number
77857
Product Number
1
Dosage Form
-
Strength
100MG/ML (100MG/ML)
Approval Date
2010-07-23
Regulatory Status
RX
Drug Name
ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Product Number
2
Dosage Form
-
Strength
30MG/0.3ML (100MG/ML)
Approval Date
2010-07-23
Active Ingredient
ENOXAPARIN SODIUM
Application Number
77857
Product Number
2
Dosage Form
-
Strength
30MG/0.3ML (100MG/ML)
Approval Date
2010-07-23
Regulatory Status
RX
Drug Name
ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Product Number
3
Dosage Form
-
Strength
40MG/0.4ML (100MG/ML)
Approval Date
2010-07-23
Active Ingredient
ENOXAPARIN SODIUM
Application Number
77857
Product Number
3
Dosage Form
-
Strength
40MG/0.4ML (100MG/ML)
Approval Date
2010-07-23
Regulatory Status
RX
Drug Name
ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Product Number
4
Dosage Form
-
Strength
60MG/0.6ML (100MG/ML)
Approval Date
2010-07-23
Active Ingredient
ENOXAPARIN SODIUM
Application Number
77857
Product Number
4
Dosage Form
-
Strength
60MG/0.6ML (100MG/ML)
Approval Date
2010-07-23
Regulatory Status
RX
Drug Name
ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Product Number
5
Dosage Form
-
Strength
80MG/0.8ML (100MG/ML)
Approval Date
2010-07-23
Active Ingredient
ENOXAPARIN SODIUM
Application Number
77857
Product Number
5
Dosage Form
-
Strength
80MG/0.8ML (100MG/ML)
Approval Date
2010-07-23
Regulatory Status
RX
Drug Name
ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Product Number
6
Dosage Form
-
Strength
120MG/0.8ML (150MG/ML)
Approval Date
2010-07-23
Active Ingredient
ENOXAPARIN SODIUM
Application Number
77857
Product Number
6
Dosage Form
-
Strength
120MG/0.8ML (150MG/ML)
Approval Date
2010-07-23
Regulatory Status
RX
Drug Name
ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Product Number
7
Dosage Form
-
Strength
150MG/ML (150MG/ML)
Approval Date
2010-07-23
Active Ingredient
ENOXAPARIN SODIUM
Application Number
77857
Product Number
7
Dosage Form
-
Strength
150MG/ML (150MG/ML)
Approval Date
2010-07-23
Regulatory Status
RX
Drug Name
ENZALUTAMIDE
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2026-04-20
Active Ingredient
ENZALUTAMIDE
Application Number
216068
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2026-04-20
Regulatory Status
RX
Drug Name
ENZALUTAMIDE
Product Number
2
Dosage Form
-
Strength
80MG
Approval Date
2026-04-20
Active Ingredient
ENZALUTAMIDE
Application Number
216068
Product Number
2
Dosage Form
-
Strength
80MG
Approval Date
2026-04-20
Regulatory Status
RX
Drug Name
EPHEDRINE SULFATE
Product Number
1
Dosage Form
-
Strength
50MG/ML (50MG/ML)
Approval Date
2017-08-23
Active Ingredient
EPHEDRINE SULFATE
Application Number
209784
Product Number
1
Dosage Form
-
Strength
50MG/ML (50MG/ML)
Approval Date
2017-08-23
Regulatory Status
RX
Drug Name
EPINASTINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
-
Active Ingredient
EPINASTINE HYDROCHLORIDE
Application Number
90950
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
-
Regulatory Status
Unclassified
Drug Name
EPIRUBICIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG/25ML (2MG/ML)
Approval Date
2009-12-22
Active Ingredient
EPIRUBICIN HYDROCHLORIDE
Application Number
65339
Product Number
1
Dosage Form
-
Strength
50MG/25ML (2MG/ML)
Approval Date
2009-12-22
Regulatory Status
Discontinued
Drug Name
EPIRUBICIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2009-12-22
Active Ingredient
EPIRUBICIN HYDROCHLORIDE
Application Number
65339
Product Number
2
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2009-12-22
Regulatory Status
Discontinued
Drug Name
EPLERENONE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2008-08-01
Active Ingredient
EPLERENONE
Application Number
78510
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2008-08-01
Regulatory Status
RX
Drug Name
EPLERENONE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2008-08-01
Active Ingredient
EPLERENONE
Application Number
78510
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2008-08-01
Regulatory Status
RX
Drug Name
ERELZI
Product Number
1
Dosage Form
-
Strength
25MG/0.5ML
Approval Date
-
Active Ingredient
ETANERCEPT-SZZS
Application Number
761042
Product Number
1
Dosage Form
-
Strength
25MG/0.5ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ERELZI
Product Number
2
Dosage Form
-
Strength
50MG/ML
Approval Date
-
Active Ingredient
ETANERCEPT-SZZS
Application Number
761042
Product Number
2
Dosage Form
-
Strength
50MG/ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ERIBULIN MESYLATE
Product Number
1
Dosage Form
-
Strength
1MG/2ML (0.5MG/ML)
Approval Date
2025-06-09
Active Ingredient
ERIBULIN MESYLATE
Application Number
214310
Product Number
1
Dosage Form
-
Strength
1MG/2ML (0.5MG/ML)
Approval Date
2025-06-09
Regulatory Status
RX
Drug Name
ESCITALOPRAM OXALATE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
-
Active Ingredient
ESCITALOPRAM OXALATE
Application Number
78467
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ESCITALOPRAM OXALATE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
-
Active Ingredient
ESCITALOPRAM OXALATE
Application Number
78467
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ESCITALOPRAM OXALATE
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
-
Active Ingredient
ESCITALOPRAM OXALATE
Application Number
78467
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ESTERIFIED ESTROGENS
Product Number
1
Dosage Form
-
Strength
1.25MG
Approval Date
1982-01-01
Active Ingredient
ESTROGENS, ESTERIFIED
Application Number
85302
Product Number
1
Dosage Form
-
Strength
1.25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ESTRADIOL
Product Number
1
Dosage Form
-
Strength
0.0375MG/24HR
Approval Date
-
Active Ingredient
ESTRADIOL
Application Number
20538
Product Number
1
Dosage Form
-
Strength
0.0375MG/24HR
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ESTRADIOL
Product Number
2
Dosage Form
-
Strength
0.075MG/24HR
Approval Date
-
Active Ingredient
ESTRADIOL
Application Number
20538
Product Number
2
Dosage Form
-
Strength
0.075MG/24HR
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ESTRADIOL
Product Number
3
Dosage Form
-
Strength
0.05MG/24HR
Approval Date
-
Active Ingredient
ESTRADIOL
Application Number
20538
Product Number
3
Dosage Form
-
Strength
0.05MG/24HR
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ESTRADIOL
Product Number
4
Dosage Form
-
Strength
0.1MG/24HR
Approval Date
-
Active Ingredient
ESTRADIOL
Application Number
20538
Product Number
4
Dosage Form
-
Strength
0.1MG/24HR
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ETODOLAC
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1997-09-30
Active Ingredient
ETODOLAC
Application Number
74942
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1997-09-30
Regulatory Status
Discontinued
Drug Name
ETODOLAC
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
1997-09-30
Active Ingredient
ETODOLAC
Application Number
74942
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
1997-09-30
Regulatory Status
Discontinued
Drug Name
EXELON
Product Number
1
Dosage Form
-
Strength
4.6MG/24HR
Approval Date
2007-07-06
Active Ingredient
RIVASTIGMINE
Application Number
22083
Product Number
1
Dosage Form
-
Strength
4.6MG/24HR
Approval Date
2007-07-06
Regulatory Status
RX
Drug Name
EXELON
Product Number
2
Dosage Form
-
Strength
9.5MG/24HR
Approval Date
2007-07-06
Active Ingredient
RIVASTIGMINE
Application Number
22083
Product Number
2
Dosage Form
-
Strength
9.5MG/24HR
Approval Date
2007-07-06
Regulatory Status
RX
Drug Name
EXELON
Product Number
5
Dosage Form
-
Strength
13.3MG/24HR
Approval Date
2012-08-31
Active Ingredient
RIVASTIGMINE
Application Number
22083
Product Number
5
Dosage Form
-
Strength
13.3MG/24HR
Approval Date
2012-08-31
Regulatory Status
RX
Drug Name
EZETIMIBE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2017-06-12
Active Ingredient
EZETIMIBE
Application Number
203931
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2017-06-12
Regulatory Status
RX
Drug Name
FAMOTIDINE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2001-05-10
Active Ingredient
FAMOTIDINE
Application Number
75607
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2001-05-10
Regulatory Status
Discontinued
Drug Name
FAMOTIDINE
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2001-05-10
Active Ingredient
FAMOTIDINE
Application Number
75607
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2001-05-10
Regulatory Status
Discontinued
Drug Name
FAMOTIDINE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2001-04-16
Active Ingredient
FAMOTIDINE
Application Number
75793
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2001-04-16
Regulatory Status
Discontinued
Drug Name
FAMOTIDINE
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2001-04-16
Active Ingredient
FAMOTIDINE
Application Number
75793
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2001-04-16
Regulatory Status
Discontinued
Drug Name
FAMOTIDINE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2002-10-21
Active Ingredient
FAMOTIDINE
Application Number
76101
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2002-10-21
Regulatory Status
Discontinued
Drug Name
FENOLDOPAM MESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
2005-02-15
Active Ingredient
FENOLDOPAM MESYLATE
Application Number
77155
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
2005-02-15
Regulatory Status
Discontinued
Drug Name
FERUMOXYTOL
Product Number
1
Dosage Form
-
Strength
EQ 510MG IRON/17ML (EQ 30MG IRON/ML)
Approval Date
2021-01-15
Active Ingredient
FERUMOXYTOL
Application Number
206604
Product Number
1
Dosage Form
-
Strength
EQ 510MG IRON/17ML (EQ 30MG IRON/ML)
Approval Date
2021-01-15
Regulatory Status
RX
Drug Name
FEXOFENADINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
-
Active Ingredient
FEXOFENADINE HYDROCHLORIDE
Application Number
76707
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
FEXOFENADINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
60MG
Approval Date
-
Active Ingredient
FEXOFENADINE HYDROCHLORIDE
Application Number
76707
Product Number
2
Dosage Form
-
Strength
60MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
FEXOFENADINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
180MG
Approval Date
-
Active Ingredient
FEXOFENADINE HYDROCHLORIDE
Application Number
76707
Product Number
3
Dosage Form
-
Strength
180MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
FIDAXOMICIN
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2026-08-13
Active Ingredient
FIDAXOMICIN
Application Number
220465
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2026-08-13
Regulatory Status
RX
Drug Name
FLUMAZENIL
Product Number
1
Dosage Form
-
Strength
0.5MG/5ML (0.1MG/ML)
Approval Date
2005-05-03
Active Ingredient
FLUMAZENIL
Application Number
77071
Product Number
1
Dosage Form
-
Strength
0.5MG/5ML (0.1MG/ML)
Approval Date
2005-05-03
Regulatory Status
RX
Drug Name
FLUMAZENIL
Product Number
2
Dosage Form
-
Strength
1MG/10ML (0.1MG/ML)
Approval Date
2005-05-03
Active Ingredient
FLUMAZENIL
Application Number
77071
Product Number
2
Dosage Form
-
Strength
1MG/10ML (0.1MG/ML)
Approval Date
2005-05-03
Regulatory Status
RX
Drug Name
FLUOROMETHOLONE
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2026-02-12
Active Ingredient
FLUOROMETHOLONE
Application Number
218819
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2026-02-12
Regulatory Status
RX
Drug Name
FLUOROURACIL
Product Number
1
Dosage Form
-
Strength
500MG/10ML (50MG/ML)
Approval Date
2008-08-11
Active Ingredient
FLUOROURACIL
Application Number
40772
Product Number
1
Dosage Form
-
Strength
500MG/10ML (50MG/ML)
Approval Date
2008-08-11
Regulatory Status
Discontinued
Drug Name
FLUOROURACIL
Product Number
1
Dosage Form
-
Strength
2.5GM/50ML (50MG/ML)
Approval Date
2011-05-02
Active Ingredient
FLUOROURACIL
Application Number
91299
Product Number
1
Dosage Form
-
Strength
2.5GM/50ML (50MG/ML)
Approval Date
2011-05-02
Regulatory Status
Discontinued
Drug Name
FLUOROURACIL
Product Number
2
Dosage Form
-
Strength
5GM/100ML (50MG/ML)
Approval Date
2011-05-02
Active Ingredient
FLUOROURACIL
Application Number
91299
Product Number
2
Dosage Form
-
Strength
5GM/100ML (50MG/ML)
Approval Date
2011-05-02
Regulatory Status
Discontinued
Drug Name
FLUOXETINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2008-11-17
Active Ingredient
FLUOXETINE HYDROCHLORIDE
Application Number
77469
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2008-11-17
Regulatory Status
Discontinued
Drug Name
FLUOXETINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2008-11-17
Active Ingredient
FLUOXETINE HYDROCHLORIDE
Application Number
77469
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2008-11-17
Regulatory Status
Discontinued
Drug Name
FLUPHENAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
-
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
89585
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
FLUPHENAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1987-10-16
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
89586
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1987-10-16
Regulatory Status
Discontinued
Drug Name
FLUPHENAZINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
1987-10-16
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
89586
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
1987-10-16
Regulatory Status
Discontinued
Drug Name
FLUPHENAZINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
2.5MG
Approval Date
1987-10-16
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
89586
Product Number
3
Dosage Form
-
Strength
2.5MG
Approval Date
1987-10-16
Regulatory Status
Discontinued
Drug Name
FLUPHENAZINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
5MG
Approval Date
1987-10-16
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
89586
Product Number
4
Dosage Form
-
Strength
5MG
Approval Date
1987-10-16
Regulatory Status
Discontinued
Drug Name
FOCALIN
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2001-11-13
Active Ingredient
DEXMETHYLPHENIDATE HYDROCHLORIDE
Application Number
21278
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2001-11-13
Regulatory Status
RX
Drug Name
FOCALIN
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2001-11-13
Active Ingredient
DEXMETHYLPHENIDATE HYDROCHLORIDE
Application Number
21278
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2001-11-13
Regulatory Status
RX
Drug Name
FOCALIN
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2001-11-13
Active Ingredient
DEXMETHYLPHENIDATE HYDROCHLORIDE
Application Number
21278
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2001-11-13
Regulatory Status
RX
Drug Name
FOCALIN XR
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2005-05-26
Active Ingredient
DEXMETHYLPHENIDATE HYDROCHLORIDE
Application Number
21802
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2005-05-26
Regulatory Status
RX
Drug Name
FOCALIN XR
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2005-05-26
Active Ingredient
DEXMETHYLPHENIDATE HYDROCHLORIDE
Application Number
21802
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2005-05-26
Regulatory Status
RX
Drug Name
FOCALIN XR
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2005-05-26
Active Ingredient
DEXMETHYLPHENIDATE HYDROCHLORIDE
Application Number
21802
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2005-05-26
Regulatory Status
RX
Drug Name
FOCALIN XR
Product Number
4
Dosage Form
-
Strength
15MG
Approval Date
2006-08-01
Active Ingredient
DEXMETHYLPHENIDATE HYDROCHLORIDE
Application Number
21802
Product Number
4
Dosage Form
-
Strength
15MG
Approval Date
2006-08-01
Regulatory Status
RX
Drug Name
FOCALIN XR
Product Number
5
Dosage Form
-
Strength
30MG
Approval Date
2009-10-23
Active Ingredient
DEXMETHYLPHENIDATE HYDROCHLORIDE
Application Number
21802
Product Number
5
Dosage Form
-
Strength
30MG
Approval Date
2009-10-23
Regulatory Status
RX
Drug Name
FOCALIN XR
Product Number
6
Dosage Form
-
Strength
40MG
Approval Date
2010-08-11
Active Ingredient
DEXMETHYLPHENIDATE HYDROCHLORIDE
Application Number
21802
Product Number
6
Dosage Form
-
Strength
40MG
Approval Date
2010-08-11
Regulatory Status
RX
Drug Name
FOCALIN XR
Product Number
7
Dosage Form
-
Strength
35MG
Approval Date
2011-04-21
Active Ingredient
DEXMETHYLPHENIDATE HYDROCHLORIDE
Application Number
21802
Product Number
7
Dosage Form
-
Strength
35MG
Approval Date
2011-04-21
Regulatory Status
RX
Drug Name
FOCALIN XR
Product Number
8
Dosage Form
-
Strength
25MG
Approval Date
2011-04-21
Active Ingredient
DEXMETHYLPHENIDATE HYDROCHLORIDE
Application Number
21802
Product Number
8
Dosage Form
-
Strength
25MG
Approval Date
2011-04-21
Regulatory Status
RX
Drug Name
FOLIC ACID
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
1982-01-01
Active Ingredient
FOLIC ACID
Application Number
84472
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
10MG;12.5MG
Approval Date
2005-09-28
Active Ingredient
FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
Application Number
76961
Product Number
1
Dosage Form
-
Strength
10MG;12.5MG
Approval Date
2005-09-28
Regulatory Status
RX
Drug Name
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
20MG;12.5MG
Approval Date
2005-09-28
Active Ingredient
FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
Application Number
76961
Product Number
2
Dosage Form
-
Strength
20MG;12.5MG
Approval Date
2005-09-28
Regulatory Status
RX
Drug Name
FULVESTRANT
Product Number
1
Dosage Form
-
Strength
250MG/5ML (50MG/ML)
Approval Date
2019-05-14
Active Ingredient
FULVESTRANT
Application Number
205935
Product Number
1
Dosage Form
-
Strength
250MG/5ML (50MG/ML)
Approval Date
2019-05-14
Regulatory Status
RX
Drug Name
GABAPENTIN
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2006-01-24
Active Ingredient
GABAPENTIN
Application Number
75428
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2006-01-24
Regulatory Status
Discontinued
Drug Name
GABAPENTIN
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2006-01-24
Active Ingredient
GABAPENTIN
Application Number
75428
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2006-01-24
Regulatory Status
Discontinued
Drug Name
GABAPENTIN
Product Number
3
Dosage Form
-
Strength
400MG
Approval Date
2006-01-24
Active Ingredient
GABAPENTIN
Application Number
75428
Product Number
3
Dosage Form
-
Strength
400MG
Approval Date
2006-01-24
Regulatory Status
Discontinued
Drug Name
GABAPENTIN
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2005-04-06
Active Ingredient
GABAPENTIN
Application Number
75539
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2005-04-06
Regulatory Status
Discontinued
Drug Name
GABAPENTIN
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2005-04-06
Active Ingredient
GABAPENTIN
Application Number
75539
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2005-04-06
Regulatory Status
Discontinued
Drug Name
GABAPENTIN
Product Number
3
Dosage Form
-
Strength
400MG
Approval Date
2005-04-06
Active Ingredient
GABAPENTIN
Application Number
75539
Product Number
3
Dosage Form
-
Strength
400MG
Approval Date
2005-04-06
Regulatory Status
Discontinued
Drug Name
GALANTAMINE HYDROBROMIDE
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2009-06-22
Active Ingredient
GALANTAMINE HYDROBROMIDE
Application Number
77589
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2009-06-22
Regulatory Status
RX
Drug Name
GALANTAMINE HYDROBROMIDE
Product Number
2
Dosage Form
-
Strength
EQ 8MG BASE
Approval Date
2009-06-22
Active Ingredient
GALANTAMINE HYDROBROMIDE
Application Number
77589
Product Number
2
Dosage Form
-
Strength
EQ 8MG BASE
Approval Date
2009-06-22
Regulatory Status
RX
Drug Name
GALANTAMINE HYDROBROMIDE
Product Number
3
Dosage Form
-
Strength
EQ 12MG BASE
Approval Date
2009-06-22
Active Ingredient
GALANTAMINE HYDROBROMIDE
Application Number
77589
Product Number
3
Dosage Form
-
Strength
EQ 12MG BASE
Approval Date
2009-06-22
Regulatory Status
RX
Drug Name
GATIFLOXACIN
Product Number
1
Dosage Form
-
Strength
0.5%
Approval Date
2016-07-11
Active Ingredient
GATIFLOXACIN
Application Number
204227
Product Number
1
Dosage Form
-
Strength
0.5%
Approval Date
2016-07-11
Regulatory Status
RX
Drug Name
GENTAMICIN SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 0.3% BASE
Approval Date
1982-01-01
Active Ingredient
GENTAMICIN SULFATE
Application Number
62196
Product Number
1
Dosage Form
-
Strength
EQ 0.3% BASE
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
GLATOPA
Product Number
1
Dosage Form
-
Strength
20MG/ML
Approval Date
2015-04-16
Active Ingredient
GLATIRAMER ACETATE
Application Number
90218
Product Number
1
Dosage Form
-
Strength
20MG/ML
Approval Date
2015-04-16
Regulatory Status
RX
Drug Name
GLATOPA
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2018-02-12
Active Ingredient
GLATIRAMER ACETATE
Application Number
206921
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2018-02-12
Regulatory Status
RX
Drug Name
GLYCOPYRROLATE
Product Number
1
Dosage Form
-
Strength
0.2MG/ML
Approval Date
2019-05-14
Active Ingredient
GLYCOPYRROLATE
Application Number
211334
Product Number
1
Dosage Form
-
Strength
0.2MG/ML
Approval Date
2019-05-14
Regulatory Status
RX
Drug Name
GRANISETRON HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
Approval Date
2009-04-30
Active Ingredient
GRANISETRON HYDROCHLORIDE
Application Number
78531
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
Approval Date
2009-04-30
Regulatory Status
RX
Drug Name
GRANISETRON HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
Approval Date
2009-04-30
Active Ingredient
GRANISETRON HYDROCHLORIDE
Application Number
78531
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
Approval Date
2009-04-30
Regulatory Status
RX
Drug Name
GRANISETRON HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
Approval Date
2009-04-30
Active Ingredient
GRANISETRON HYDROCHLORIDE
Application Number
78534
Product Number
1
Dosage Form
-
Strength
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
Approval Date
2009-04-30
Regulatory Status
RX
Drug Name
GRANISETRON HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
Approval Date
2008-04-29
Active Ingredient
GRANISETRON HYDROCHLORIDE
Application Number
78808
Product Number
1
Dosage Form
-
Strength
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
Approval Date
2008-04-29
Regulatory Status
Discontinued
Drug Name
GRISEOFULVIN
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2013-08-07
Active Ingredient
GRISEOFULVIN, MICROSIZE
Application Number
91592
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2013-08-07
Regulatory Status
RX
Drug Name
GRISEOFULVIN
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2013-08-07
Active Ingredient
GRISEOFULVIN, MICROSIZE
Application Number
91592
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2013-08-07
Regulatory Status
RX
Drug Name
GRISEOFULVIN, ULTRAMICROSIZE
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
2018-12-26
Active Ingredient
GRISEOFULVIN, ULTRAMICROSIZE
Application Number
202805
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
2018-12-26
Regulatory Status
RX
Drug Name
GRISEOFULVIN, ULTRAMICROSIZE
Product Number
2
Dosage Form
-
Strength
250MG
Approval Date
2018-12-26
Active Ingredient
GRISEOFULVIN, ULTRAMICROSIZE
Application Number
202805
Product Number
2
Dosage Form
-
Strength
250MG
Approval Date
2018-12-26
Regulatory Status
RX
Drug Name
GUANFACINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2015-06-03
Active Ingredient
GUANFACINE HYDROCHLORIDE
Application Number
202568
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2015-06-03
Regulatory Status
RX
Drug Name
GUANFACINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2015-06-03
Active Ingredient
GUANFACINE HYDROCHLORIDE
Application Number
202568
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2015-06-03
Regulatory Status
RX
Drug Name
GUANFACINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 3MG BASE
Approval Date
2015-06-03
Active Ingredient
GUANFACINE HYDROCHLORIDE
Application Number
202568
Product Number
3
Dosage Form
-
Strength
EQ 3MG BASE
Approval Date
2015-06-03
Regulatory Status
RX
Drug Name
GUANFACINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2015-06-03
Active Ingredient
GUANFACINE HYDROCHLORIDE
Application Number
202568
Product Number
4
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2015-06-03
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
-
Active Ingredient
HALOPERIDOL
Application Number
71206
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
HALOPERIDOL
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
-
Active Ingredient
HALOPERIDOL
Application Number
71207
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
HALOPERIDOL
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
-
Active Ingredient
HALOPERIDOL
Application Number
71208
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
HALOPERIDOL DECANOATE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/ML
Approval Date
2005-06-24
Active Ingredient
HALOPERIDOL DECANOATE
Application Number
76463
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/ML
Approval Date
2005-06-24
Regulatory Status
Discontinued
Drug Name
HALOPERIDOL DECANOATE
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE/ML
Approval Date
2005-06-24
Active Ingredient
HALOPERIDOL DECANOATE
Application Number
76463
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE/ML
Approval Date
2005-06-24
Regulatory Status
Discontinued
Drug Name
HYCAMTIN
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/VIAL
Approval Date
1996-05-28
Active Ingredient
TOPOTECAN HYDROCHLORIDE
Application Number
20671
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/VIAL
Approval Date
1996-05-28
Regulatory Status
RX
Drug Name
HYCAMTIN
Product Number
1
Dosage Form
-
Strength
EQ 0.25MG BASE
Approval Date
2007-10-11
Active Ingredient
TOPOTECAN HYDROCHLORIDE
Application Number
20981
Product Number
1
Dosage Form
-
Strength
EQ 0.25MG BASE
Approval Date
2007-10-11
Regulatory Status
RX
Drug Name
HYCAMTIN
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2007-10-11
Active Ingredient
TOPOTECAN HYDROCHLORIDE
Application Number
20981
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2007-10-11
Regulatory Status
RX
Drug Name
HYDRAP-ES
Product Number
1
Dosage Form
-
Strength
25MG;15MG;0.1MG
Approval Date
1982-01-01
Active Ingredient
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE
Application Number
84876
Product Number
1
Dosage Form
-
Strength
25MG;15MG;0.1MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HYDRO-SERP "25"
Product Number
1
Dosage Form
-
Strength
25MG;0.125MG
Approval Date
1982-01-01
Active Ingredient
HYDROCHLOROTHIAZIDE; RESERPINE
Application Number
84827
Product Number
1
Dosage Form
-
Strength
25MG;0.125MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HYDRO-SERP "50"
Product Number
1
Dosage Form
-
Strength
50MG;0.125MG
Approval Date
1982-01-01
Active Ingredient
HYDROCHLOROTHIAZIDE; RESERPINE
Application Number
85213
Product Number
1
Dosage Form
-
Strength
50MG;0.125MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
500MG;5MG
Approval Date
1997-01-27
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
40149
Product Number
1
Dosage Form
-
Strength
500MG;5MG
Approval Date
1997-01-27
Regulatory Status
Discontinued
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
750MG;7.5MG
Approval Date
1997-01-27
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
40149
Product Number
2
Dosage Form
-
Strength
750MG;7.5MG
Approval Date
1997-01-27
Regulatory Status
Discontinued
Drug Name
HYDROCORTISONE
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE
Application Number
80642
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HYDROXYCHLOROQUINE SULFATE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1995-11-30
Active Ingredient
HYDROXYCHLOROQUINE SULFATE
Application Number
40104
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1995-11-30
Regulatory Status
RX
Drug Name
HYDROXYZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Active Ingredient
HYDROXYZINE HYDROCHLORIDE
Application Number
85247
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HYDROXYZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Active Ingredient
HYDROXYZINE HYDROCHLORIDE
Application Number
87245
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HYDROXYZINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
HYDROXYZINE HYDROCHLORIDE
Application Number
87246
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HYDROXYZINE PAMOATE
Product Number
1
Dosage Form
-
Strength
EQ 50MG HYDROCHLORIDE
Approval Date
1991-06-28
Active Ingredient
HYDROXYZINE PAMOATE
Application Number
81128
Product Number
1
Dosage Form
-
Strength
EQ 50MG HYDROCHLORIDE
Approval Date
1991-06-28
Regulatory Status
Discontinued
Drug Name
HYDROXYZINE PAMOATE
Product Number
1
Dosage Form
-
Strength
EQ 100MG HYDROCHLORIDE
Approval Date
1991-06-28
Active Ingredient
HYDROXYZINE PAMOATE
Application Number
81129
Product Number
1
Dosage Form
-
Strength
EQ 100MG HYDROCHLORIDE
Approval Date
1991-06-28
Regulatory Status
Discontinued
Drug Name
HYDROXYZINE PAMOATE
Product Number
1
Dosage Form
-
Strength
EQ 50MG HYDROCHLORIDE
Approval Date
1982-01-01
Active Ingredient
HYDROXYZINE PAMOATE
Application Number
86183
Product Number
1
Dosage Form
-
Strength
EQ 50MG HYDROCHLORIDE
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
HYDROXYZINE PAMOATE
Product Number
1
Dosage Form
-
Strength
EQ 25MG HYDROCHLORIDE
Approval Date
1982-01-01
Active Ingredient
HYDROXYZINE PAMOATE
Application Number
87479
Product Number
1
Dosage Form
-
Strength
EQ 25MG HYDROCHLORIDE
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
IBUPROFEN
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1988-02-25
Active Ingredient
IBUPROFEN
Application Number
71807
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1988-02-25
Regulatory Status
Discontinued
Drug Name
IBUPROFEN
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
1988-01-14
Active Ingredient
IBUPROFEN
Application Number
72064
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
1988-01-14
Regulatory Status
Discontinued
Drug Name
IBUPROFEN
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
1988-01-14
Active Ingredient
IBUPROFEN
Application Number
72065
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
1988-01-14
Regulatory Status
Discontinued
Drug Name
IBUPROFEN
Product Number
1
Dosage Form
-
Strength
800MG
Approval Date
1987-12-11
Active Ingredient
IBUPROFEN
Application Number
72169
Product Number
1
Dosage Form
-
Strength
800MG
Approval Date
1987-12-11
Regulatory Status
Discontinued
Drug Name
IBUPROFEN
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1995-12-15
Active Ingredient
IBUPROFEN
Application Number
74525
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1995-12-15
Regulatory Status
Discontinued
Drug Name
IBUPROFEN
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1995-12-15
Active Ingredient
IBUPROFEN
Application Number
74533
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1995-12-15
Regulatory Status
Discontinued
Drug Name
IDARUBICIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG/5ML (1MG/ML)
Approval Date
2011-03-29
Active Ingredient
IDARUBICIN HYDROCHLORIDE
Application Number
91293
Product Number
1
Dosage Form
-
Strength
5MG/5ML (1MG/ML)
Approval Date
2011-03-29
Regulatory Status
Discontinued
Drug Name
IDARUBICIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
10MG/10ML (1MG/ML)
Approval Date
2011-03-29
Active Ingredient
IDARUBICIN HYDROCHLORIDE
Application Number
91293
Product Number
2
Dosage Form
-
Strength
10MG/10ML (1MG/ML)
Approval Date
2011-03-29
Regulatory Status
Discontinued
Drug Name
IDARUBICIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
20MG/20ML (1MG/ML)
Approval Date
2011-03-29
Active Ingredient
IDARUBICIN HYDROCHLORIDE
Application Number
91293
Product Number
3
Dosage Form
-
Strength
20MG/20ML (1MG/ML)
Approval Date
2011-03-29
Regulatory Status
Discontinued
Drug Name
IMIPRAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Active Ingredient
IMIPRAMINE HYDROCHLORIDE
Application Number
83745
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
IMIPRAMINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Active Ingredient
IMIPRAMINE HYDROCHLORIDE
Application Number
84869
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
IMIPRAMINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
IMIPRAMINE HYDROCHLORIDE
Application Number
84936
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
IMIPRAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Active Ingredient
IMIPRAMINE HYDROCHLORIDE
Application Number
84937
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
IMIPRAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Active Ingredient
IMIPRAMINE HYDROCHLORIDE
Application Number
85133
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
IMIPRAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
IMIPRAMINE HYDROCHLORIDE
Application Number
85200
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
INDOMETHACIN
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1987-04-29
Active Ingredient
INDOMETHACIN
Application Number
70673
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1987-04-29
Regulatory Status
RX
Drug Name
INDOMETHACIN
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1987-04-29
Active Ingredient
INDOMETHACIN
Application Number
70674
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1987-04-29
Regulatory Status
RX
Drug Name
INDOMETHACIN
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
1998-05-28
Active Ingredient
INDOMETHACIN
Application Number
74464
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
1998-05-28
Regulatory Status
Discontinued
Drug Name
INFUVITE ADULT
Product Number
1
Dosage Form
-
Strength
2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML
Approval Date
2000-05-18
Active Ingredient
ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K
Application Number
21163
Product Number
1
Dosage Form
-
Strength
2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML
Approval Date
2000-05-18
Regulatory Status
RX
Drug Name
INFUVITE ADULT
Product Number
2
Dosage Form
-
Strength
2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML
Approval Date
2003-06-16
Active Ingredient
ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K
Application Number
21163
Product Number
2
Dosage Form
-
Strength
2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML
Approval Date
2003-06-16
Regulatory Status
RX
Drug Name
INFUVITE PEDIATRIC
Product Number
1
Dosage Form
-
Strength
80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL
Approval Date
2001-02-21
Active Ingredient
ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K
Application Number
21265
Product Number
1
Dosage Form
-
Strength
80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL
Approval Date
2001-02-21
Regulatory Status
RX
Drug Name
INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)
Product Number
2
Dosage Form
-
Strength
80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL
Approval Date
2004-01-29
Active Ingredient
ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K
Application Number
21265
Product Number
2
Dosage Form
-
Strength
80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL
Approval Date
2004-01-29
Regulatory Status
RX
Drug Name
IRBESARTAN
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2012-09-27
Active Ingredient
IRBESARTAN
Application Number
77466
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2012-09-27
Regulatory Status
RX
Drug Name
IRBESARTAN
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2012-09-27
Active Ingredient
IRBESARTAN
Application Number
77466
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2012-09-27
Regulatory Status
RX
Drug Name
IRBESARTAN
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2012-09-27
Active Ingredient
IRBESARTAN
Application Number
77466
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2012-09-27
Regulatory Status
RX
Drug Name
IRBESARTAN AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
12.5MG;150MG
Approval Date
2012-09-27
Active Ingredient
HYDROCHLOROTHIAZIDE; IRBESARTAN
Application Number
77446
Product Number
1
Dosage Form
-
Strength
12.5MG;150MG
Approval Date
2012-09-27
Regulatory Status
RX
Drug Name
IRBESARTAN AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
12.5MG;300MG
Approval Date
2012-09-27
Active Ingredient
HYDROCHLOROTHIAZIDE; IRBESARTAN
Application Number
77446
Product Number
2
Dosage Form
-
Strength
12.5MG;300MG
Approval Date
2012-09-27
Regulatory Status
RX
Drug Name
IRINOTECAN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
40MG/2ML (20MG/ML)
Approval Date
2008-02-27
Active Ingredient
IRINOTECAN HYDROCHLORIDE
Application Number
77994
Product Number
1
Dosage Form
-
Strength
40MG/2ML (20MG/ML)
Approval Date
2008-02-27
Regulatory Status
Discontinued
Drug Name
IRINOTECAN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
100MG/5ML (20MG/ML)
Approval Date
2008-02-27
Active Ingredient
IRINOTECAN HYDROCHLORIDE
Application Number
77994
Product Number
2
Dosage Form
-
Strength
100MG/5ML (20MG/ML)
Approval Date
2008-02-27
Regulatory Status
Discontinued
Drug Name
IRINOTECAN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
40MG/2ML (20MG/ML)
Approval Date
2009-11-12
Active Ingredient
IRINOTECAN HYDROCHLORIDE
Application Number
90137
Product Number
1
Dosage Form
-
Strength
40MG/2ML (20MG/ML)
Approval Date
2009-11-12
Regulatory Status
Discontinued
Drug Name
IRINOTECAN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
100MG/5ML (20MG/ML)
Approval Date
2009-11-12
Active Ingredient
IRINOTECAN HYDROCHLORIDE
Application Number
90137
Product Number
2
Dosage Form
-
Strength
100MG/5ML (20MG/ML)
Approval Date
2009-11-12
Regulatory Status
Discontinued
Drug Name
IRON SUCROSE
Product Number
1
Dosage Form
-
Strength
EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)
Approval Date
2025-08-08
Active Ingredient
IRON SUCROSE
Application Number
212340
Product Number
1
Dosage Form
-
Strength
EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)
Approval Date
2025-08-08
Regulatory Status
RX
Drug Name
IRON SUCROSE
Product Number
2
Dosage Form
-
Strength
EQ 100MG IRON/5ML (EQ 20MG IRON/ML)
Approval Date
2025-08-08
Active Ingredient
IRON SUCROSE
Application Number
212340
Product Number
2
Dosage Form
-
Strength
EQ 100MG IRON/5ML (EQ 20MG IRON/ML)
Approval Date
2025-08-08
Regulatory Status
RX
Drug Name
IRON SUCROSE
Product Number
3
Dosage Form
-
Strength
EQ 200MG IRON/10ML (EQ 20MG IRON/ML)
Approval Date
2025-08-08
Active Ingredient
IRON SUCROSE
Application Number
212340
Product Number
3
Dosage Form
-
Strength
EQ 200MG IRON/10ML (EQ 20MG IRON/ML)
Approval Date
2025-08-08
Regulatory Status
RX
Drug Name
ISONIAZID
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2005-07-05
Active Ingredient
ISONIAZID
Application Number
40648
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2005-07-05
Regulatory Status
RX
Drug Name
ISOPTO CARPINE
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
2010-06-22
Active Ingredient
PILOCARPINE HYDROCHLORIDE
Application Number
200890
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
2010-06-22
Regulatory Status
RX
Drug Name
ISOPTO CARPINE
Product Number
2
Dosage Form
-
Strength
2%
Approval Date
2010-06-22
Active Ingredient
PILOCARPINE HYDROCHLORIDE
Application Number
200890
Product Number
2
Dosage Form
-
Strength
2%
Approval Date
2010-06-22
Regulatory Status
RX
Drug Name
ISOPTO CARPINE
Product Number
3
Dosage Form
-
Strength
4%
Approval Date
2010-06-22
Active Ingredient
PILOCARPINE HYDROCHLORIDE
Application Number
200890
Product Number
3
Dosage Form
-
Strength
4%
Approval Date
2010-06-22
Regulatory Status
RX
Drug Name
ISOSORBIDE DINITRATE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
1988-01-07
Active Ingredient
ISOSORBIDE DINITRATE
Application Number
86221
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
1988-01-07
Regulatory Status
RX
Drug Name
ISOSORBIDE DINITRATE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
1988-02-19
Active Ingredient
ISOSORBIDE DINITRATE
Application Number
86222
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
1988-02-19
Regulatory Status
Discontinued
Drug Name
ISOSORBIDE DINITRATE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1988-01-07
Active Ingredient
ISOSORBIDE DINITRATE
Application Number
86223
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1988-01-07
Regulatory Status
RX
Drug Name
ISOSORBIDE DINITRATE
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
1988-02-19
Active Ingredient
ISOSORBIDE DINITRATE
Application Number
86225
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
1988-02-19
Regulatory Status
Discontinued
Drug Name
ISOSORBIDE DINITRATE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
1988-04-07
Active Ingredient
ISOSORBIDE DINITRATE
Application Number
89367
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
1988-04-07
Regulatory Status
RX
Drug Name
ITRACONAZOLE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2004-05-28
Active Ingredient
ITRACONAZOLE
Application Number
76104
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2004-05-28
Regulatory Status
RX
Drug Name
KETOROLAC TROMETHAMINE
Product Number
1
Dosage Form
-
Strength
15MG/ML
Approval Date
2004-10-06
Active Ingredient
KETOROLAC TROMETHAMINE
Application Number
76271
Product Number
1
Dosage Form
-
Strength
15MG/ML
Approval Date
2004-10-06
Regulatory Status
Discontinued
Drug Name
KETOROLAC TROMETHAMINE
Product Number
2
Dosage Form
-
Strength
30MG/ML
Approval Date
2004-10-06
Active Ingredient
KETOROLAC TROMETHAMINE
Application Number
76271
Product Number
2
Dosage Form
-
Strength
30MG/ML
Approval Date
2004-10-06
Regulatory Status
RX
Drug Name
KETOROLAC TROMETHAMINE
Product Number
1
Dosage Form
-
Strength
0.5%
Approval Date
2009-11-05
Active Ingredient
KETOROLAC TROMETHAMINE
Application Number
76583
Product Number
1
Dosage Form
-
Strength
0.5%
Approval Date
2009-11-05
Regulatory Status
RX
Drug Name
KETOROLAC TROMETHAMINE
Product Number
1
Dosage Form
-
Strength
0.4%
Approval Date
2009-11-05
Active Ingredient
KETOROLAC TROMETHAMINE
Application Number
78721
Product Number
1
Dosage Form
-
Strength
0.4%
Approval Date
2009-11-05
Regulatory Status
Discontinued
Drug Name
LANORINAL
Product Number
2
Dosage Form
-
Strength
325MG;50MG;40MG
Approval Date
1985-10-11
Active Ingredient
ASPIRIN; BUTALBITAL; CAFFEINE
Application Number
86996
Product Number
2
Dosage Form
-
Strength
325MG;50MG;40MG
Approval Date
1985-10-11
Regulatory Status
RX
Drug Name
LANSOPRAZOLE
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2010-04-23
Active Ingredient
LANSOPRAZOLE
Application Number
90331
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2010-04-23
Regulatory Status
Discontinued
Drug Name
LANSOPRAZOLE
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2010-04-23
Active Ingredient
LANSOPRAZOLE
Application Number
90331
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2010-04-23
Regulatory Status
Discontinued
Drug Name
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
Product Number
1
Dosage Form
-
Strength
500MG;500MG;30MG
Approval Date
2014-03-04
Active Ingredient
AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE
Application Number
202588
Product Number
1
Dosage Form
-
Strength
500MG;500MG;30MG
Approval Date
2014-03-04
Regulatory Status
RX
Drug Name
LATANOPROST
Product Number
1
Dosage Form
-
Strength
0.005%
Approval Date
2011-03-22
Active Ingredient
LATANOPROST
Application Number
91449
Product Number
1
Dosage Form
-
Strength
0.005%
Approval Date
2011-03-22
Regulatory Status
RX
Drug Name
LEFLUNOMIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2005-09-13
Active Ingredient
LEFLUNOMIDE
Application Number
77085
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2005-09-13
Regulatory Status
Discontinued
Drug Name
LEFLUNOMIDE
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2005-09-13
Active Ingredient
LEFLUNOMIDE
Application Number
77085
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2005-09-13
Regulatory Status
Discontinued
Drug Name
LESCOL XL
Product Number
1
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2000-10-06
Active Ingredient
FLUVASTATIN SODIUM
Application Number
21192
Product Number
1
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2000-10-06
Regulatory Status
RX
Drug Name
LEUPROLIDE ACETATE
Product Number
1
Dosage Form
-
Strength
14MG/2.8ML (1MG/0.2ML)
Approval Date
1998-08-04
Active Ingredient
LEUPROLIDE ACETATE
Application Number
74728
Product Number
1
Dosage Form
-
Strength
14MG/2.8ML (1MG/0.2ML)
Approval Date
1998-08-04
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2012-11-01
Active Ingredient
LEVETIRACETAM
Application Number
91668
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2012-11-01
Regulatory Status
Discontinued
Drug Name
LEVETIRACETAM
Product Number
2
Dosage Form
-
Strength
750MG
Approval Date
2012-11-01
Active Ingredient
LEVETIRACETAM
Application Number
91668
Product Number
2
Dosage Form
-
Strength
750MG
Approval Date
2012-11-01
Regulatory Status
Discontinued
Drug Name
LEVOFLOXACIN
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2011-06-20
Active Ingredient
LEVOFLOXACIN
Application Number
77438
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2011-06-20
Regulatory Status
Discontinued
Drug Name
LEVOFLOXACIN
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2011-06-20
Active Ingredient
LEVOFLOXACIN
Application Number
77438
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2011-06-20
Regulatory Status
Discontinued
Drug Name
LEVOFLOXACIN
Product Number
3
Dosage Form
-
Strength
750MG
Approval Date
2011-06-20
Active Ingredient
LEVOFLOXACIN
Application Number
77438
Product Number
3
Dosage Form
-
Strength
750MG
Approval Date
2011-06-20
Regulatory Status
Discontinued
Drug Name
LEVOLEUCOVORIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)
Approval Date
2015-03-09
Active Ingredient
LEVOLEUCOVORIN CALCIUM
Application Number
203563
Product Number
1
Dosage Form
-
Strength
EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)
Approval Date
2015-03-09
Regulatory Status
RX
Drug Name
LEVOLEUCOVORIN CALCIUM
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE/25ML (EQ 10MG BASE/ML)
Approval Date
2015-03-09
Active Ingredient
LEVOLEUCOVORIN CALCIUM
Application Number
203563
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE/25ML (EQ 10MG BASE/ML)
Approval Date
2015-03-09
Regulatory Status
Discontinued
Drug Name
LINEZOLID
Product Number
1
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2015-07-16
Active Ingredient
LINEZOLID
Application Number
200904
Product Number
1
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2015-07-16
Regulatory Status
RX
Drug Name
LINEZOLID
Product Number
2
Dosage Form
-
Strength
600MG/300ML (2MG/ML)
Approval Date
2015-07-16
Active Ingredient
LINEZOLID
Application Number
200904
Product Number
2
Dosage Form
-
Strength
600MG/300ML (2MG/ML)
Approval Date
2015-07-16
Regulatory Status
RX
Drug Name
LIRAGLUTIDE
Product Number
1
Dosage Form
-
Strength
18MG/3ML (6MG/ML)
Approval Date
2026-07-01
Active Ingredient
LIRAGLUTIDE
Application Number
212972
Product Number
1
Dosage Form
-
Strength
18MG/3ML (6MG/ML)
Approval Date
2026-07-01
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2024-07-26
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
202836
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2024-07-26
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2024-07-26
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
202836
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2024-07-26
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2024-07-26
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
202836
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2024-07-26
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
4
Dosage Form
-
Strength
50MG
Approval Date
2024-07-26
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
202836
Product Number
4
Dosage Form
-
Strength
50MG
Approval Date
2024-07-26
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
5
Dosage Form
-
Strength
60MG
Approval Date
2024-07-26
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
202836
Product Number
5
Dosage Form
-
Strength
60MG
Approval Date
2024-07-26
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
6
Dosage Form
-
Strength
70MG
Approval Date
2024-07-26
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
202836
Product Number
6
Dosage Form
-
Strength
70MG
Approval Date
2024-07-26
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
7
Dosage Form
-
Strength
10MG
Approval Date
2024-12-26
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
202836
Product Number
7
Dosage Form
-
Strength
10MG
Approval Date
2024-12-26
Regulatory Status
RX
Drug Name
LORAZEPAM
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
1987-04-21
Active Ingredient
LORAZEPAM
Application Number
71141
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
1987-04-21
Regulatory Status
RX
Drug Name
LORAZEPAM
Product Number
2
Dosage Form
-
Strength
0.5MG
Approval Date
1987-04-21
Active Ingredient
LORAZEPAM
Application Number
71141
Product Number
2
Dosage Form
-
Strength
0.5MG
Approval Date
1987-04-21
Regulatory Status
RX
Drug Name
LORAZEPAM
Product Number
3
Dosage Form
-
Strength
1MG
Approval Date
1987-04-21
Active Ingredient
LORAZEPAM
Application Number
71141
Product Number
3
Dosage Form
-
Strength
1MG
Approval Date
1987-04-21
Regulatory Status
RX
Drug Name
LORAZEPAM
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
1988-04-15
Active Ingredient
LORAZEPAM
Application Number
71193
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
1988-04-15
Regulatory Status
Discontinued
Drug Name
LORAZEPAM
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
1988-04-15
Active Ingredient
LORAZEPAM
Application Number
71194
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
1988-04-15
Regulatory Status
Discontinued
Drug Name
LORAZEPAM
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
1988-04-15
Active Ingredient
LORAZEPAM
Application Number
71195
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
1988-04-15
Regulatory Status
Discontinued
Drug Name
LORAZEPAM
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
-
Active Ingredient
LORAZEPAM
Application Number
71404
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LOTREL
Product Number
2
Dosage Form
-
Strength
EQ 2.5MG BASE;10MG
Approval Date
1995-03-03
Active Ingredient
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Application Number
20364
Product Number
2
Dosage Form
-
Strength
EQ 2.5MG BASE;10MG
Approval Date
1995-03-03
Regulatory Status
Discontinued
Drug Name
LOTREL
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;10MG
Approval Date
1995-03-03
Active Ingredient
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Application Number
20364
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;10MG
Approval Date
1995-03-03
Regulatory Status
Discontinued
Drug Name
LOTREL
Product Number
4
Dosage Form
-
Strength
EQ 5MG BASE;20MG
Approval Date
1995-03-03
Active Ingredient
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Application Number
20364
Product Number
4
Dosage Form
-
Strength
EQ 5MG BASE;20MG
Approval Date
1995-03-03
Regulatory Status
Discontinued
Drug Name
LOTREL
Product Number
5
Dosage Form
-
Strength
EQ 10MG BASE;20MG
Approval Date
2002-06-20
Active Ingredient
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Application Number
20364
Product Number
5
Dosage Form
-
Strength
EQ 10MG BASE;20MG
Approval Date
2002-06-20
Regulatory Status
Discontinued
Drug Name
LOTREL
Product Number
6
Dosage Form
-
Strength
EQ 10MG BASE;40MG
Approval Date
2006-04-11
Active Ingredient
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Application Number
20364
Product Number
6
Dosage Form
-
Strength
EQ 10MG BASE;40MG
Approval Date
2006-04-11
Regulatory Status
Discontinued
Drug Name
LOTREL
Product Number
7
Dosage Form
-
Strength
EQ 5MG BASE;40MG
Approval Date
2006-04-11
Active Ingredient
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Application Number
20364
Product Number
7
Dosage Form
-
Strength
EQ 5MG BASE;40MG
Approval Date
2006-04-11
Regulatory Status
Discontinued
Drug Name
MAXITROL
Product Number
2
Dosage Form
-
Strength
0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
Approval Date
1982-01-01
Active Ingredient
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Application Number
50065
Product Number
2
Dosage Form
-
Strength
0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
MAXITROL
Product Number
1
Dosage Form
-
Strength
0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Approval Date
1984-05-22
Active Ingredient
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Application Number
62341
Product Number
1
Dosage Form
-
Strength
0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Approval Date
1984-05-22
Regulatory Status
RX
Drug Name
MECLIZINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
12.5MG
Approval Date
1989-05-22
Active Ingredient
MECLIZINE HYDROCHLORIDE
Application Number
84843
Product Number
2
Dosage Form
-
Strength
12.5MG
Approval Date
1989-05-22
Regulatory Status
RX
Drug Name
MEDROXYPROGESTERONE ACETATE
Product Number
1
Dosage Form
-
Strength
150MG/ML
Approval Date
2009-05-20
Active Ingredient
MEDROXYPROGESTERONE ACETATE
Application Number
78711
Product Number
1
Dosage Form
-
Strength
150MG/ML
Approval Date
2009-05-20
Regulatory Status
Discontinued
Drug Name
MEPRO-ASPIRIN
Product Number
1
Dosage Form
-
Strength
325MG;200MG
Approval Date
1987-03-02
Active Ingredient
ASPIRIN; MEPROBAMATE
Application Number
89127
Product Number
1
Dosage Form
-
Strength
325MG;200MG
Approval Date
1987-03-02
Regulatory Status
Discontinued
Drug Name
MEPROBAMATE
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
1982-01-01
Active Ingredient
MEPROBAMATE
Application Number
14547
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MEPROBAMATE
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
1982-01-01
Active Ingredient
MEPROBAMATE
Application Number
14547
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MEROPENEM
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2011-03-29
Active Ingredient
MEROPENEM
Application Number
91201
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2011-03-29
Regulatory Status
Discontinued
Drug Name
MEROPENEM
Product Number
2
Dosage Form
-
Strength
1GM/VIAL
Approval Date
2011-03-29
Active Ingredient
MEROPENEM
Application Number
91201
Product Number
2
Dosage Form
-
Strength
1GM/VIAL
Approval Date
2011-03-29
Regulatory Status
Discontinued
Drug Name
MESALAMINE
Product Number
1
Dosage Form
-
Strength
1GM
Approval Date
2019-06-12
Active Ingredient
MESALAMINE
Application Number
202065
Product Number
1
Dosage Form
-
Strength
1GM
Approval Date
2019-06-12
Regulatory Status
RX
Drug Name
MESALAMINE
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2026-03-10
Active Ingredient
MESALAMINE
Application Number
219997
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2026-03-10
Regulatory Status
RX
Drug Name
MESALAMINE
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2026-03-10
Active Ingredient
MESALAMINE
Application Number
219997
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2026-03-10
Regulatory Status
RX
Drug Name
METAXALONE
Product Number
1
Dosage Form
-
Strength
800MG
Approval Date
2010-03-31
Active Ingredient
METAXALONE
Application Number
40445
Product Number
1
Dosage Form
-
Strength
800MG
Approval Date
2010-03-31
Regulatory Status
RX
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2002-01-25
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
75985
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2002-01-25
Regulatory Status
Discontinued
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
850MG
Approval Date
2002-01-25
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
75985
Product Number
2
Dosage Form
-
Strength
850MG
Approval Date
2002-01-25
Regulatory Status
Discontinued
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
1GM
Approval Date
2002-01-25
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
75985
Product Number
3
Dosage Form
-
Strength
1GM
Approval Date
2002-01-25
Regulatory Status
Discontinued
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2004-12-14
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
76223
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2004-12-14
Regulatory Status
Discontinued
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2004-12-14
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
76873
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2004-12-14
Regulatory Status
RX
Drug Name
METHOCARBAMOL
Product Number
1
Dosage Form
-
Strength
750MG
Approval Date
1982-01-01
Active Ingredient
METHOCARBAMOL
Application Number
87282
Product Number
1
Dosage Form
-
Strength
750MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
METHOCARBAMOL
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Active Ingredient
METHOCARBAMOL
Application Number
87283
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
METHYLDOPA AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
15MG;250MG
Approval Date
1987-03-09
Active Ingredient
HYDROCHLOROTHIAZIDE; METHYLDOPA
Application Number
70829
Product Number
1
Dosage Form
-
Strength
15MG;250MG
Approval Date
1987-03-09
Regulatory Status
Discontinued
Drug Name
METHYLDOPA AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
25MG;250MG
Approval Date
1987-03-09
Active Ingredient
HYDROCHLOROTHIAZIDE; METHYLDOPA
Application Number
70830
Product Number
1
Dosage Form
-
Strength
25MG;250MG
Approval Date
1987-03-09
Regulatory Status
Discontinued
Drug Name
METHYLPREDNISOLONE
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
1997-10-31
Active Ingredient
METHYLPREDNISOLONE
Application Number
40194
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
1997-10-31
Regulatory Status
RX
Drug Name
METHYLPREDNISOLONE ACETATE
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2009-01-29
Active Ingredient
METHYLPREDNISOLONE ACETATE
Application Number
40719
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2009-01-29
Regulatory Status
RX
Drug Name
METHYLPREDNISOLONE ACETATE
Product Number
2
Dosage Form
-
Strength
80MG/ML
Approval Date
2009-01-29
Active Ingredient
METHYLPREDNISOLONE ACETATE
Application Number
40719
Product Number
2
Dosage Form
-
Strength
80MG/ML
Approval Date
2009-01-29
Regulatory Status
RX
Drug Name
METHYLPREDNISOLONE ACETATE
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2009-03-05
Active Ingredient
METHYLPREDNISOLONE ACETATE
Application Number
40794
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2009-03-05
Regulatory Status
RX
Drug Name
METHYLPREDNISOLONE ACETATE
Product Number
2
Dosage Form
-
Strength
80MG/ML
Approval Date
2009-03-05
Active Ingredient
METHYLPREDNISOLONE ACETATE
Application Number
40794
Product Number
2
Dosage Form
-
Strength
80MG/ML
Approval Date
2009-03-05
Regulatory Status
RX
Drug Name
METIPRANOLOL
Product Number
1
Dosage Form
-
Strength
0.3%
Approval Date
2001-08-06
Active Ingredient
METIPRANOLOL HYDROCHLORIDE
Application Number
75720
Product Number
1
Dosage Form
-
Strength
0.3%
Approval Date
2001-08-06
Regulatory Status
Discontinued
Drug Name
METOCLOPRAMIDE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1987-02-03
Active Ingredient
METOCLOPRAMIDE HYDROCHLORIDE
Application Number
70850
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1987-02-03
Regulatory Status
Discontinued
Drug Name
METOCLOPRAMIDE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
1989-06-22
Active Ingredient
METOCLOPRAMIDE HYDROCHLORIDE
Application Number
72436
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
1989-06-22
Regulatory Status
Discontinued
Drug Name
METOLAZONE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2003-12-19
Active Ingredient
METOLAZONE
Application Number
76466
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2003-12-19
Regulatory Status
RX
Drug Name
METOLAZONE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2003-12-19
Active Ingredient
METOLAZONE
Application Number
76466
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2003-12-19
Regulatory Status
RX
Drug Name
METOLAZONE
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2003-12-19
Active Ingredient
METOLAZONE
Application Number
76732
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2003-12-19
Regulatory Status
RX
Drug Name
METOPROLOL SUCCINATE
Product Number
1
Dosage Form
-
Strength
EQ 25MG TARTRATE
Approval Date
2006-07-31
Active Ingredient
METOPROLOL SUCCINATE
Application Number
76969
Product Number
1
Dosage Form
-
Strength
EQ 25MG TARTRATE
Approval Date
2006-07-31
Regulatory Status
Discontinued
Drug Name
METOPROLOL SUCCINATE
Product Number
2
Dosage Form
-
Strength
EQ 50MG TARTRATE
Approval Date
2007-05-18
Active Ingredient
METOPROLOL SUCCINATE
Application Number
76969
Product Number
2
Dosage Form
-
Strength
EQ 50MG TARTRATE
Approval Date
2007-05-18
Regulatory Status
Discontinued
Drug Name
METOPROLOL SUCCINATE
Product Number
3
Dosage Form
-
Strength
EQ 100MG TARTRATE
Approval Date
2008-03-20
Active Ingredient
METOPROLOL SUCCINATE
Application Number
76969
Product Number
3
Dosage Form
-
Strength
EQ 100MG TARTRATE
Approval Date
2008-03-20
Regulatory Status
Discontinued
Drug Name
METOPROLOL SUCCINATE
Product Number
4
Dosage Form
-
Strength
EQ 200MG TARTRATE
Approval Date
2008-03-20
Active Ingredient
METOPROLOL SUCCINATE
Application Number
76969
Product Number
4
Dosage Form
-
Strength
EQ 200MG TARTRATE
Approval Date
2008-03-20
Regulatory Status
Discontinued
Drug Name
METOPROLOL TARTRATE
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2007-10-02
Active Ingredient
METOPROLOL TARTRATE
Application Number
77360
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2007-10-02
Regulatory Status
RX
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 45MG BASE
Approval Date
2009-08-13
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
90422
Product Number
1
Dosage Form
-
Strength
EQ 45MG BASE
Approval Date
2009-08-13
Regulatory Status
RX
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 90MG BASE
Approval Date
2009-08-13
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
90422
Product Number
2
Dosage Form
-
Strength
EQ 90MG BASE
Approval Date
2009-08-13
Regulatory Status
RX
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 135MG BASE
Approval Date
2009-08-13
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
90422
Product Number
3
Dosage Form
-
Strength
EQ 135MG BASE
Approval Date
2009-08-13
Regulatory Status
RX
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 65MG BASE
Approval Date
-
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
90422
Product Number
4
Dosage Form
-
Strength
EQ 65MG BASE
Approval Date
-
Regulatory Status
Unclassified
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
EQ 115MG BASE
Approval Date
-
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
90422
Product Number
5
Dosage Form
-
Strength
EQ 115MG BASE
Approval Date
-
Regulatory Status
Unclassified
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
6
Dosage Form
-
Strength
EQ 55MG BASE
Approval Date
-
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
90422
Product Number
6
Dosage Form
-
Strength
EQ 55MG BASE
Approval Date
-
Regulatory Status
Unclassified
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
7
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
-
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
90422
Product Number
7
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
-
Regulatory Status
Unclassified
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
8
Dosage Form
-
Strength
EQ 105MG BASE
Approval Date
-
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
90422
Product Number
8
Dosage Form
-
Strength
EQ 105MG BASE
Approval Date
-
Regulatory Status
Unclassified
Drug Name
MODAFINIL
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
-
Active Ingredient
MODAFINIL
Application Number
76935
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
MODAFINIL
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
-
Active Ingredient
MODAFINIL
Application Number
76935
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
MYCOPHENOLATE MOFETIL
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2008-10-15
Active Ingredient
MYCOPHENOLATE MOFETIL
Application Number
65379
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2008-10-15
Regulatory Status
RX
Drug Name
MYCOPHENOLATE MOFETIL
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2008-10-15
Active Ingredient
MYCOPHENOLATE MOFETIL
Application Number
65451
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2008-10-15
Regulatory Status
RX
Drug Name
MYDRIACYL
Product Number
1
Dosage Form
-
Strength
0.5%
Approval Date
1982-01-01
Active Ingredient
TROPICAMIDE
Application Number
84305
Product Number
1
Dosage Form
-
Strength
0.5%
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
NADOLOL
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
1995-11-09
Active Ingredient
NADOLOL
Application Number
74501
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
1995-11-09
Regulatory Status
RX
Drug Name
NADOLOL
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
1995-11-09
Active Ingredient
NADOLOL
Application Number
74501
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
1995-11-09
Regulatory Status
RX
Drug Name
NADOLOL
Product Number
3
Dosage Form
-
Strength
80MG
Approval Date
1995-11-09
Active Ingredient
NADOLOL
Application Number
74501
Product Number
3
Dosage Form
-
Strength
80MG
Approval Date
1995-11-09
Regulatory Status
RX
Drug Name
NAFCILLIN SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
1984-08-02
Active Ingredient
NAFCILLIN SODIUM
Application Number
62527
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
1984-08-02
Regulatory Status
Discontinued
Drug Name
NAFCILLIN SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
1984-08-02
Active Ingredient
NAFCILLIN SODIUM
Application Number
62527
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
1984-08-02
Regulatory Status
Discontinued
Drug Name
NAFCILLIN SODIUM
Product Number
3
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
1984-08-02
Active Ingredient
NAFCILLIN SODIUM
Application Number
62527
Product Number
3
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
1984-08-02
Regulatory Status
Discontinued
Drug Name
NAFCILLIN SODIUM
Product Number
4
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
1984-08-02
Active Ingredient
NAFCILLIN SODIUM
Application Number
62527
Product Number
4
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
1984-08-02
Regulatory Status
Discontinued
Drug Name
NAFCILLIN SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
1986-12-23
Active Ingredient
NAFCILLIN SODIUM
Application Number
62732
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
1986-12-23
Regulatory Status
Discontinued
Drug Name
NAFCILLIN SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
1986-12-23
Active Ingredient
NAFCILLIN SODIUM
Application Number
62732
Product Number
2
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
1986-12-23
Regulatory Status
Discontinued
Drug Name
NAPROXEN SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1993-12-21
Active Ingredient
NAPROXEN SODIUM
Application Number
74162
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1993-12-21
Regulatory Status
Discontinued
Drug Name
NAPROXEN SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1993-12-21
Active Ingredient
NAPROXEN SODIUM
Application Number
74162
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1993-12-21
Regulatory Status
Discontinued
Drug Name
NAPROXEN SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1994-12-05
Active Ingredient
NAPROXEN SODIUM
Application Number
74495
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1994-12-05
Regulatory Status
Discontinued
Drug Name
NAPROXEN SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1994-12-05
Active Ingredient
NAPROXEN SODIUM
Application Number
74495
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1994-12-05
Regulatory Status
Discontinued
Drug Name
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
Product Number
1
Dosage Form
-
Strength
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Approval Date
1983-08-25
Active Ingredient
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Application Number
62423
Product Number
1
Dosage Form
-
Strength
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Approval Date
1983-08-25
Regulatory Status
RX
Drug Name
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
Product Number
1
Dosage Form
-
Strength
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Approval Date
1985-11-06
Active Ingredient
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Application Number
62488
Product Number
1
Dosage Form
-
Strength
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Approval Date
1985-11-06
Regulatory Status
RX
Drug Name
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
Product Number
1
Dosage Form
-
Strength
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Approval Date
1988-05-11
Active Ingredient
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Application Number
62874
Product Number
1
Dosage Form
-
Strength
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Approval Date
1988-05-11
Regulatory Status
RX
Drug Name
NEOMYCIN SULFATE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Active Ingredient
NEOMYCIN SULFATE
Application Number
61586
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NEVIRAPINE
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2014-04-03
Active Ingredient
NEVIRAPINE
Application Number
203411
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2014-04-03
Regulatory Status
RX
Drug Name
NIACIN
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Active Ingredient
NIACIN
Application Number
83306
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NINTEDANIB ESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2026-04-02
Active Ingredient
NINTEDANIB ESYLATE
Application Number
216915
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2026-04-02
Regulatory Status
RX
Drug Name
NINTEDANIB ESYLATE
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2026-04-02
Active Ingredient
NINTEDANIB ESYLATE
Application Number
216915
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2026-04-02
Regulatory Status
RX
Drug Name
NITROFURANTOIN
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Active Ingredient
NITROFURANTOIN
Application Number
80043
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NITROFURANTOIN
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Active Ingredient
NITROFURANTOIN
Application Number
80043
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Product Number
1
Dosage Form
-
Strength
75MG;25MG
Approval Date
2005-04-05
Active Ingredient
NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
Application Number
77066
Product Number
1
Dosage Form
-
Strength
75MG;25MG
Approval Date
2005-04-05
Regulatory Status
RX
Drug Name
NOREPINEPHRINE BITARTRATE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2018-10-18
Active Ingredient
NOREPINEPHRINE BITARTRATE
Application Number
211359
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2018-10-18
Regulatory Status
RX
Drug Name
NYDRAZID
Product Number
1
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
ISONIAZID
Application Number
8662
Product Number
1
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
NYSTATIN
Product Number
1
Dosage Form
-
Strength
100,000 UNITS
Approval Date
1982-01-01
Active Ingredient
NYSTATIN
Application Number
61965
Product Number
1
Dosage Form
-
Strength
100,000 UNITS
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NYSTATIN
Product Number
1
Dosage Form
-
Strength
500,000 UNITS
Approval Date
1982-01-01
Active Ingredient
NYSTATIN
Application Number
62065
Product Number
1
Dosage Form
-
Strength
500,000 UNITS
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
OFLOXACIN
Product Number
1
Dosage Form
-
Strength
0.3%
Approval Date
2004-05-14
Active Ingredient
OFLOXACIN
Application Number
76231
Product Number
1
Dosage Form
-
Strength
0.3%
Approval Date
2004-05-14
Regulatory Status
Discontinued
Drug Name
OFLOXACIN
Product Number
1
Dosage Form
-
Strength
0.3%
Approval Date
2008-11-25
Active Ingredient
OFLOXACIN
Application Number
76848
Product Number
1
Dosage Form
-
Strength
0.3%
Approval Date
2008-11-25
Regulatory Status
Discontinued
Drug Name
OFLOXACIN
Product Number
1
Dosage Form
-
Strength
0.3%
Approval Date
2008-03-17
Active Ingredient
OFLOXACIN
Application Number
78222
Product Number
1
Dosage Form
-
Strength
0.3%
Approval Date
2008-03-17
Regulatory Status
Discontinued
Drug Name
OLMESARTAN MEDOXOMIL
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2020-04-13
Active Ingredient
OLMESARTAN MEDOXOMIL
Application Number
90237
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2020-04-13
Regulatory Status
Discontinued
Drug Name
OLMESARTAN MEDOXOMIL
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2020-04-13
Active Ingredient
OLMESARTAN MEDOXOMIL
Application Number
90237
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2020-04-13
Regulatory Status
Discontinued
Drug Name
OLMESARTAN MEDOXOMIL
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2020-04-13
Active Ingredient
OLMESARTAN MEDOXOMIL
Application Number
90237
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2020-04-13
Regulatory Status
Discontinued
Drug Name
OLOPATADINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
-
Active Ingredient
OLOPATADINE HYDROCHLORIDE
Application Number
90972
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
-
Regulatory Status
Unclassified
Drug Name
OMEPRAZOLE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2003-01-28
Active Ingredient
OMEPRAZOLE
Application Number
75757
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2003-01-28
Regulatory Status
RX
Drug Name
OMEPRAZOLE
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2003-01-28
Active Ingredient
OMEPRAZOLE
Application Number
75757
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2003-01-28
Regulatory Status
RX
Drug Name
OMEPRAZOLE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
-
Active Ingredient
OMEPRAZOLE
Application Number
75791
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
OMEPRAZOLE
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
-
Active Ingredient
OMEPRAZOLE
Application Number
75791
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
OMEPRAZOLE
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2009-01-21
Active Ingredient
OMEPRAZOLE
Application Number
76515
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2009-01-21
Regulatory Status
RX
Drug Name
OMNIPRED
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1982-01-01
Active Ingredient
PREDNISOLONE ACETATE
Application Number
17469
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
OMNITROPE
Product Number
1
Dosage Form
-
Strength
5.8MG/VIAL
Approval Date
-
Active Ingredient
SOMATROPIN
Application Number
21426
Product Number
1
Dosage Form
-
Strength
5.8MG/VIAL
Approval Date
-
Regulatory Status
Unclassified
Drug Name
OMNITROPE
Product Number
2
Dosage Form
-
Strength
1.5MG/VIAL
Approval Date
-
Active Ingredient
SOMATROPIN
Application Number
21426
Product Number
2
Dosage Form
-
Strength
1.5MG/VIAL
Approval Date
-
Regulatory Status
Unclassified
Drug Name
OMNITROPE
Product Number
3
Dosage Form
-
Strength
5MG/1.5ML
Approval Date
-
Active Ingredient
SOMATROPIN
Application Number
21426
Product Number
3
Dosage Form
-
Strength
5MG/1.5ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
OMNITROPE
Product Number
4
Dosage Form
-
Strength
10MG/1.5ML
Approval Date
-
Active Ingredient
SOMATROPIN
Application Number
21426
Product Number
4
Dosage Form
-
Strength
10MG/1.5ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ONDANSETRON
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2007-08-13
Active Ingredient
ONDANSETRON
Application Number
78050
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2007-08-13
Regulatory Status
RX
Drug Name
ONDANSETRON
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2007-08-13
Active Ingredient
ONDANSETRON
Application Number
78050
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2007-08-13
Regulatory Status
RX
Drug Name
ONDANSETRON HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
2007-06-27
Active Ingredient
ONDANSETRON HYDROCHLORIDE
Application Number
77430
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
2007-06-27
Regulatory Status
RX
Drug Name
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
2007-06-27
Active Ingredient
ONDANSETRON HYDROCHLORIDE
Application Number
77551
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
2007-06-27
Regulatory Status
RX
Drug Name
ORPHENADRINE CITRATE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2000-02-15
Active Ingredient
ORPHENADRINE CITRATE
Application Number
40327
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2000-02-15
Regulatory Status
RX
Drug Name
ORPHENADRINE CITRATE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Active Ingredient
ORPHENADRINE CITRATE
Application Number
85046
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE
Product Number
1
Dosage Form
-
Strength
385MG;30MG;25MG
Approval Date
1996-12-31
Active Ingredient
ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE
Application Number
74654
Product Number
1
Dosage Form
-
Strength
385MG;30MG;25MG
Approval Date
1996-12-31
Regulatory Status
Discontinued
Drug Name
ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE
Product Number
2
Dosage Form
-
Strength
770MG;60MG;50MG
Approval Date
1996-12-31
Active Ingredient
ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE
Application Number
74654
Product Number
2
Dosage Form
-
Strength
770MG;60MG;50MG
Approval Date
1996-12-31
Regulatory Status
Discontinued
Drug Name
OXACILLIN SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/VIAL
Approval Date
1982-01-01
Active Ingredient
OXACILLIN SODIUM
Application Number
61490
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
OXACILLIN SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
1982-01-01
Active Ingredient
OXACILLIN SODIUM
Application Number
61490
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
OXACILLIN SODIUM
Product Number
3
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
1982-01-01
Active Ingredient
OXACILLIN SODIUM
Application Number
61490
Product Number
3
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
OXACILLIN SODIUM
Product Number
4
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
1982-01-01
Active Ingredient
OXACILLIN SODIUM
Application Number
61490
Product Number
4
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
OXACILLIN SODIUM
Product Number
6
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
1991-05-09
Active Ingredient
OXACILLIN SODIUM
Application Number
61490
Product Number
6
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
1991-05-09
Regulatory Status
Discontinued
Drug Name
OXACILLIN SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
1986-12-23
Active Ingredient
OXACILLIN SODIUM
Application Number
62737
Product Number
1
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
1986-12-23
Regulatory Status
Discontinued
Drug Name
OXACILLIN SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
1986-12-23
Active Ingredient
OXACILLIN SODIUM
Application Number
62737
Product Number
2
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
1986-12-23
Regulatory Status
Discontinued
Drug Name
OXALIPLATIN
Product Number
1
Dosage Form
-
Strength
50MG/10ML (5MG/ML)
Approval Date
2009-08-07
Active Ingredient
OXALIPLATIN
Application Number
78812
Product Number
1
Dosage Form
-
Strength
50MG/10ML (5MG/ML)
Approval Date
2009-08-07
Regulatory Status
Discontinued
Drug Name
OXALIPLATIN
Product Number
2
Dosage Form
-
Strength
100MG/20ML (5MG/ML)
Approval Date
2009-08-07
Active Ingredient
OXALIPLATIN
Application Number
78812
Product Number
2
Dosage Form
-
Strength
100MG/20ML (5MG/ML)
Approval Date
2009-08-07
Regulatory Status
Discontinued
Drug Name
OXALIPLATIN
Product Number
1
Dosage Form
-
Strength
50MG/10ML (5MG/ML)
Approval Date
2011-01-24
Active Ingredient
OXALIPLATIN
Application Number
78817
Product Number
1
Dosage Form
-
Strength
50MG/10ML (5MG/ML)
Approval Date
2011-01-24
Regulatory Status
RX
Drug Name
OXALIPLATIN
Product Number
2
Dosage Form
-
Strength
100MG/20ML (5MG/ML)
Approval Date
2011-01-24
Active Ingredient
OXALIPLATIN
Application Number
78817
Product Number
2
Dosage Form
-
Strength
100MG/20ML (5MG/ML)
Approval Date
2011-01-24
Regulatory Status
RX
Drug Name
OXALIPLATIN
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2011-04-28
Active Ingredient
OXALIPLATIN
Application Number
90849
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2011-04-28
Regulatory Status
Discontinued
Drug Name
OXALIPLATIN
Product Number
2
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2011-04-28
Active Ingredient
OXALIPLATIN
Application Number
90849
Product Number
2
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2011-04-28
Regulatory Status
Discontinued
Drug Name
OXANDROLONE
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2006-12-01
Active Ingredient
OXANDROLONE
Application Number
76897
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2006-12-01
Regulatory Status
Discontinued
Drug Name
OXANDROLONE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2006-12-01
Active Ingredient
OXANDROLONE
Application Number
76897
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2006-12-01
Regulatory Status
Discontinued
Drug Name
OXAPROZIN
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2001-04-27
Active Ingredient
OXAPROZIN
Application Number
75850
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2001-04-27
Regulatory Status
Discontinued
Drug Name
PACLITAXEL
Product Number
1
Dosage Form
-
Strength
6MG/ML
Approval Date
2007-12-26
Active Ingredient
PACLITAXEL
Application Number
78167
Product Number
1
Dosage Form
-
Strength
6MG/ML
Approval Date
2007-12-26
Regulatory Status
Discontinued
Drug Name
PALONOSETRON HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
Approval Date
2015-10-13
Active Ingredient
PALONOSETRON HYDROCHLORIDE
Application Number
202521
Product Number
1
Dosage Form
-
Strength
EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
Approval Date
2015-10-13
Regulatory Status
RX
Drug Name
PANTOPRAZOLE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/VIAL
Approval Date
2015-07-14
Active Ingredient
PANTOPRAZOLE SODIUM
Application Number
90296
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/VIAL
Approval Date
2015-07-14
Regulatory Status
Discontinued
Drug Name
PARICALCITOL
Product Number
1
Dosage Form
-
Strength
0.002MG/ML (0.002MG/ML)
Approval Date
2011-07-27
Active Ingredient
PARICALCITOL
Application Number
91108
Product Number
1
Dosage Form
-
Strength
0.002MG/ML (0.002MG/ML)
Approval Date
2011-07-27
Regulatory Status
RX
Drug Name
PARICALCITOL
Product Number
2
Dosage Form
-
Strength
0.005MG/ML (0.005MG/ML)
Approval Date
2011-07-27
Active Ingredient
PARICALCITOL
Application Number
91108
Product Number
2
Dosage Form
-
Strength
0.005MG/ML (0.005MG/ML)
Approval Date
2011-07-27
Regulatory Status
RX
Drug Name
PARICALCITOL
Product Number
3
Dosage Form
-
Strength
0.01MG/2ML (0.005MG/ML)
Approval Date
2011-07-27
Active Ingredient
PARICALCITOL
Application Number
91108
Product Number
3
Dosage Form
-
Strength
0.01MG/2ML (0.005MG/ML)
Approval Date
2011-07-27
Regulatory Status
RX
Drug Name
PEG-LYTE
Product Number
1
Dosage Form
-
Strength
236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT
Approval Date
1993-08-31
Active Ingredient
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
Application Number
73098
Product Number
1
Dosage Form
-
Strength
236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT
Approval Date
1993-08-31
Regulatory Status
Discontinued
Drug Name
PEMETREXED DISODIUM
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/4ML (EQ 25MG BASE/ML)
Approval Date
2022-05-26
Active Ingredient
PEMETREXED DISODIUM
Application Number
214657
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/4ML (EQ 25MG BASE/ML)
Approval Date
2022-05-26
Regulatory Status
RX
Drug Name
PEMETREXED DISODIUM
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/20ML (EQ 25MG BASE/ML)
Approval Date
2022-05-26
Active Ingredient
PEMETREXED DISODIUM
Application Number
214657
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/20ML (EQ 25MG BASE/ML)
Approval Date
2022-05-26
Regulatory Status
RX
Drug Name
PEMETREXED DISODIUM
Product Number
3
Dosage Form
-
Strength
EQ 1GM BASE/40ML (EQ 25MG BASE/ML)
Approval Date
2022-05-26
Active Ingredient
PEMETREXED DISODIUM
Application Number
214657
Product Number
3
Dosage Form
-
Strength
EQ 1GM BASE/40ML (EQ 25MG BASE/ML)
Approval Date
2022-05-26
Regulatory Status
RX
Drug Name
PENICILLIN G POTASSIUM
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
2002-08-30
Active Ingredient
PENICILLIN G POTASSIUM
Application Number
65079
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
2002-08-30
Regulatory Status
Discontinued
Drug Name
PENICILLIN G POTASSIUM
Product Number
2
Dosage Form
-
Strength
5,000,000 UNITS/VIAL
Approval Date
2002-08-30
Active Ingredient
PENICILLIN G POTASSIUM
Application Number
65079
Product Number
2
Dosage Form
-
Strength
5,000,000 UNITS/VIAL
Approval Date
2002-08-30
Regulatory Status
RX
Drug Name
PENICILLIN G POTASSIUM
Product Number
3
Dosage Form
-
Strength
20,000,000 UNITS/VIAL
Approval Date
2002-08-30
Active Ingredient
PENICILLIN G POTASSIUM
Application Number
65079
Product Number
3
Dosage Form
-
Strength
20,000,000 UNITS/VIAL
Approval Date
2002-08-30
Regulatory Status
RX
Drug Name
PENICILLIN G SODIUM
Product Number
1
Dosage Form
-
Strength
5,000,000 UNITS/VIAL
Approval Date
2001-02-26
Active Ingredient
PENICILLIN G SODIUM
Application Number
65068
Product Number
1
Dosage Form
-
Strength
5,000,000 UNITS/VIAL
Approval Date
2001-02-26
Regulatory Status
RX
Drug Name
PENICILLIN V POTASSIUM
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1995-11-30
Active Ingredient
PENICILLIN V POTASSIUM
Application Number
64071
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1995-11-30
Regulatory Status
Discontinued
Drug Name
PENICILLIN V POTASSIUM
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1995-11-30
Active Ingredient
PENICILLIN V POTASSIUM
Application Number
64071
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1995-11-30
Regulatory Status
Discontinued
Drug Name
PERPHENAZINE
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
-
Active Ingredient
PERPHENAZINE
Application Number
89683
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PERPHENAZINE
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
-
Active Ingredient
PERPHENAZINE
Application Number
89684
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PERPHENAZINE
Product Number
1
Dosage Form
-
Strength
8MG
Approval Date
1988-12-08
Active Ingredient
PERPHENAZINE
Application Number
89685
Product Number
1
Dosage Form
-
Strength
8MG
Approval Date
1988-12-08
Regulatory Status
RX
Drug Name
PERPHENAZINE
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
1988-12-08
Active Ingredient
PERPHENAZINE
Application Number
89685
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
1988-12-08
Regulatory Status
RX
Drug Name
PERPHENAZINE
Product Number
3
Dosage Form
-
Strength
4MG
Approval Date
1988-12-08
Active Ingredient
PERPHENAZINE
Application Number
89685
Product Number
3
Dosage Form
-
Strength
4MG
Approval Date
1988-12-08
Regulatory Status
RX
Drug Name
PERPHENAZINE
Product Number
4
Dosage Form
-
Strength
16MG
Approval Date
1988-12-08
Active Ingredient
PERPHENAZINE
Application Number
89685
Product Number
4
Dosage Form
-
Strength
16MG
Approval Date
1988-12-08
Regulatory Status
RX
Drug Name
PERPHENAZINE
Product Number
1
Dosage Form
-
Strength
16MG
Approval Date
-
Active Ingredient
PERPHENAZINE
Application Number
89686
Product Number
1
Dosage Form
-
Strength
16MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PHENDIMETRAZINE TARTRATE
Product Number
1
Dosage Form
-
Strength
35MG
Approval Date
1982-01-01
Active Ingredient
PHENDIMETRAZINE TARTRATE
Application Number
85402
Product Number
1
Dosage Form
-
Strength
35MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PHENDIMETRAZINE TARTRATE
Product Number
1
Dosage Form
-
Strength
35MG
Approval Date
1982-01-01
Active Ingredient
PHENDIMETRAZINE TARTRATE
Application Number
85633
Product Number
1
Dosage Form
-
Strength
35MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PHENDIMETRAZINE TARTRATE
Product Number
1
Dosage Form
-
Strength
35MG
Approval Date
1982-01-01
Active Ingredient
PHENDIMETRAZINE TARTRATE
Application Number
85694
Product Number
1
Dosage Form
-
Strength
35MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PHENDIMETRAZINE TARTRATE
Product Number
1
Dosage Form
-
Strength
35MG
Approval Date
1982-01-01
Active Ingredient
PHENDIMETRAZINE TARTRATE
Application Number
85702
Product Number
1
Dosage Form
-
Strength
35MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PHENDIMETRAZINE TARTRATE
Product Number
1
Dosage Form
-
Strength
35MG
Approval Date
1982-01-01
Active Ingredient
PHENDIMETRAZINE TARTRATE
Application Number
85830
Product Number
1
Dosage Form
-
Strength
35MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PHENDIMETRAZINE TARTRATE
Product Number
1
Dosage Form
-
Strength
35MG
Approval Date
1982-01-01
Active Ingredient
PHENDIMETRAZINE TARTRATE
Application Number
86370
Product Number
1
Dosage Form
-
Strength
35MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PHENTERMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
8MG
Approval Date
1982-01-01
Active Ingredient
PHENTERMINE HYDROCHLORIDE
Application Number
85671
Product Number
1
Dosage Form
-
Strength
8MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PHENTERMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
8MG
Approval Date
1982-01-01
Active Ingredient
PHENTERMINE HYDROCHLORIDE
Application Number
85689
Product Number
1
Dosage Form
-
Strength
8MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PHENTERMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
1983-07-20
Active Ingredient
PHENTERMINE HYDROCHLORIDE
Application Number
86945
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
1983-07-20
Regulatory Status
RX
Drug Name
PHENTERMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
1982-01-01
Active Ingredient
PHENTERMINE HYDROCHLORIDE
Application Number
87190
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
PHENTERMINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
15MG
Approval Date
1982-01-01
Active Ingredient
PHENTERMINE HYDROCHLORIDE
Application Number
87190
Product Number
2
Dosage Form
-
Strength
15MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
PHENTERMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
1982-01-01
Active Ingredient
PHENTERMINE HYDROCHLORIDE
Application Number
87208
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PHENTERMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
1982-01-01
Active Ingredient
PHENTERMINE HYDROCHLORIDE
Application Number
87223
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PHENTERMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
-
Active Ingredient
PHENTERMINE HYDROCHLORIDE
Application Number
87301
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PHENTERMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
37.5MG
Approval Date
1983-10-19
Active Ingredient
PHENTERMINE HYDROCHLORIDE
Application Number
88414
Product Number
1
Dosage Form
-
Strength
37.5MG
Approval Date
1983-10-19
Regulatory Status
Discontinued
Drug Name
PHENYLEPHRINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG/ML (10MG/ML)
Approval Date
2019-01-31
Active Ingredient
PHENYLEPHRINE HYDROCHLORIDE
Application Number
208905
Product Number
1
Dosage Form
-
Strength
10MG/ML (10MG/ML)
Approval Date
2019-01-31
Regulatory Status
RX
Drug Name
PHENYLEPHRINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2019-01-31
Active Ingredient
PHENYLEPHRINE HYDROCHLORIDE
Application Number
208905
Product Number
2
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2019-01-31
Regulatory Status
RX
Drug Name
PHENYLEPHRINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
100MG/10ML (10MG/ML)
Approval Date
2019-01-31
Active Ingredient
PHENYLEPHRINE HYDROCHLORIDE
Application Number
208905
Product Number
3
Dosage Form
-
Strength
100MG/10ML (10MG/ML)
Approval Date
2019-01-31
Regulatory Status
RX
Drug Name
PIPERACILLIN AND TAZOBACTAM
Product Number
1
Dosage Form
-
Strength
EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL
Approval Date
2010-10-21
Active Ingredient
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Application Number
65362
Product Number
1
Dosage Form
-
Strength
EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL
Approval Date
2010-10-21
Regulatory Status
RX
Drug Name
PIPERACILLIN AND TAZOBACTAM
Product Number
2
Dosage Form
-
Strength
EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL
Approval Date
2010-10-21
Active Ingredient
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Application Number
65362
Product Number
2
Dosage Form
-
Strength
EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL
Approval Date
2010-10-21
Regulatory Status
RX
Drug Name
PIPERACILLIN AND TAZOBACTAM
Product Number
3
Dosage Form
-
Strength
EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date
2010-10-21
Active Ingredient
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Application Number
65362
Product Number
3
Dosage Form
-
Strength
EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date
2010-10-21
Regulatory Status
RX
Drug Name
PIPERACILLIN AND TAZOBACTAM
Product Number
1
Dosage Form
-
Strength
EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL
Approval Date
2010-10-21
Active Ingredient
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Application Number
65363
Product Number
1
Dosage Form
-
Strength
EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL
Approval Date
2010-10-21
Regulatory Status
Discontinued
Drug Name
PIPERACILLIN AND TAZOBACTAM
Product Number
2
Dosage Form
-
Strength
EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL
Approval Date
2010-10-21
Active Ingredient
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Application Number
65363
Product Number
2
Dosage Form
-
Strength
EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL
Approval Date
2010-10-21
Regulatory Status
Discontinued
Drug Name
PIPERACILLIN AND TAZOBACTAM
Product Number
3
Dosage Form
-
Strength
EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date
2010-10-21
Active Ingredient
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Application Number
65363
Product Number
3
Dosage Form
-
Strength
EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date
2010-10-21
Regulatory Status
Discontinued
Drug Name
PIPERACILLIN AND TAZOBACTAM
Product Number
1
Dosage Form
-
Strength
EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL
Approval Date
2014-10-29
Active Ingredient
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Application Number
203557
Product Number
1
Dosage Form
-
Strength
EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL
Approval Date
2014-10-29
Regulatory Status
RX
Drug Name
PIPERACILLIN AND TAZOBACTAM
Product Number
2
Dosage Form
-
Strength
EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL
Approval Date
2021-07-08
Active Ingredient
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Application Number
203557
Product Number
2
Dosage Form
-
Strength
EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL
Approval Date
2021-07-08
Regulatory Status
RX
Drug Name
PIRFENIDONE
Product Number
1
Dosage Form
-
Strength
267MG
Approval Date
2022-04-28
Active Ingredient
PIRFENIDONE
Application Number
212560
Product Number
1
Dosage Form
-
Strength
267MG
Approval Date
2022-04-28
Regulatory Status
RX
Drug Name
PIRFENIDONE
Product Number
2
Dosage Form
-
Strength
801MG
Approval Date
2022-04-28
Active Ingredient
PIRFENIDONE
Application Number
212560
Product Number
2
Dosage Form
-
Strength
801MG
Approval Date
2022-04-28
Regulatory Status
RX
Drug Name
PIRFENIDONE
Product Number
1
Dosage Form
-
Strength
267MG
Approval Date
2022-06-13
Active Ingredient
PIRFENIDONE
Application Number
212600
Product Number
1
Dosage Form
-
Strength
267MG
Approval Date
2022-06-13
Regulatory Status
RX
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.125MG
Approval Date
2010-07-06
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
90190
Product Number
1
Dosage Form
-
Strength
0.125MG
Approval Date
2010-07-06
Regulatory Status
Discontinued
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
0.25MG
Approval Date
2010-07-06
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
90190
Product Number
2
Dosage Form
-
Strength
0.25MG
Approval Date
2010-07-06
Regulatory Status
Discontinued
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
0.5MG
Approval Date
2010-07-06
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
90190
Product Number
3
Dosage Form
-
Strength
0.5MG
Approval Date
2010-07-06
Regulatory Status
Discontinued
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
1MG
Approval Date
2010-07-06
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
90190
Product Number
4
Dosage Form
-
Strength
1MG
Approval Date
2010-07-06
Regulatory Status
Discontinued
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
1.5MG
Approval Date
2010-07-06
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
90190
Product Number
5
Dosage Form
-
Strength
1.5MG
Approval Date
2010-07-06
Regulatory Status
Discontinued
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
6
Dosage Form
-
Strength
0.75MG
Approval Date
2010-10-08
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
90190
Product Number
6
Dosage Form
-
Strength
0.75MG
Approval Date
2010-10-08
Regulatory Status
Discontinued
Drug Name
PROBENECID AND COLCHICINE
Product Number
1
Dosage Form
-
Strength
0.5MG;500MG
Approval Date
1982-01-01
Active Ingredient
COLCHICINE; PROBENECID
Application Number
86130
Product Number
1
Dosage Form
-
Strength
0.5MG;500MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PROCAINAMIDE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1986-06-23
Active Ingredient
PROCAINAMIDE HYDROCHLORIDE
Application Number
89284
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1986-06-23
Regulatory Status
Discontinued
Drug Name
PROMETHAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
2006-11-08
Active Ingredient
PROMETHAZINE HYDROCHLORIDE
Application Number
40593
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
2006-11-08
Regulatory Status
Discontinued
Drug Name
PROMETHAZINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
50MG/ML
Approval Date
2006-11-08
Active Ingredient
PROMETHAZINE HYDROCHLORIDE
Application Number
40593
Product Number
2
Dosage Form
-
Strength
50MG/ML
Approval Date
2006-11-08
Regulatory Status
Discontinued
Drug Name
PROMETHAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Active Ingredient
PROMETHAZINE HYDROCHLORIDE
Application Number
84176
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
PROMETHAZINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
12.5MG
Approval Date
2009-05-22
Active Ingredient
PROMETHAZINE HYDROCHLORIDE
Application Number
84176
Product Number
2
Dosage Form
-
Strength
12.5MG
Approval Date
2009-05-22
Regulatory Status
Discontinued
Drug Name
PROMETHAZINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Active Ingredient
PROMETHAZINE HYDROCHLORIDE
Application Number
84176
Product Number
3
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
PROPANTHELINE BROMIDE
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
1982-01-01
Active Ingredient
PROPANTHELINE BROMIDE
Application Number
80928
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PROPOXYPHENE COMPOUND 65
Product Number
2
Dosage Form
-
Strength
389MG;32.4MG;65MG
Approval Date
1983-09-16
Active Ingredient
ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE
Application Number
80044
Product Number
2
Dosage Form
-
Strength
389MG;32.4MG;65MG
Approval Date
1983-09-16
Regulatory Status
Discontinued
Drug Name
PROPOXYPHENE COMPOUND-65
Product Number
2
Dosage Form
-
Strength
389MG;32.4MG;65MG
Approval Date
1985-06-24
Active Ingredient
ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE
Application Number
83101
Product Number
2
Dosage Form
-
Strength
389MG;32.4MG;65MG
Approval Date
1985-06-24
Regulatory Status
Discontinued
Drug Name
PROPOXYPHENE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
65MG
Approval Date
1982-01-01
Active Ingredient
PROPOXYPHENE HYDROCHLORIDE
Application Number
83125
Product Number
2
Dosage Form
-
Strength
65MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PROPOXYPHENE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
65MG
Approval Date
1982-01-01
Active Ingredient
PROPOXYPHENE HYDROCHLORIDE
Application Number
83688
Product Number
1
Dosage Form
-
Strength
65MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PROPOXYPHENE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
65MG
Approval Date
1982-01-01
Active Ingredient
PROPOXYPHENE HYDROCHLORIDE
Application Number
83870
Product Number
2
Dosage Form
-
Strength
65MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PROPOXYPHENE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
32MG
Approval Date
1982-01-01
Active Ingredient
PROPOXYPHENE HYDROCHLORIDE
Application Number
84014
Product Number
1
Dosage Form
-
Strength
32MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PROPOXYPHENE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
65MG
Approval Date
1982-01-01
Active Ingredient
PROPOXYPHENE HYDROCHLORIDE
Application Number
86495
Product Number
1
Dosage Form
-
Strength
65MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
650MG;65MG
Approval Date
1989-07-18
Active Ingredient
ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE
Application Number
89959
Product Number
1
Dosage Form
-
Strength
650MG;65MG
Approval Date
1989-07-18
Regulatory Status
Discontinued
Drug Name
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
650MG;100MG
Approval Date
1986-01-23
Active Ingredient
ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE
Application Number
70443
Product Number
1
Dosage Form
-
Strength
650MG;100MG
Approval Date
1986-01-23
Regulatory Status
Discontinued
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1988-07-05
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
71658
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1988-07-05
Regulatory Status
Discontinued
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
1988-07-05
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
71687
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
1988-07-05
Regulatory Status
Discontinued
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
1988-07-05
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
71688
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
1988-07-05
Regulatory Status
Discontinued
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
80MG
Approval Date
1988-07-05
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
71689
Product Number
1
Dosage Form
-
Strength
80MG
Approval Date
1988-07-05
Regulatory Status
Discontinued
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
1988-07-05
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
72197
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
1988-07-05
Regulatory Status
Discontinued
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
90MG
Approval Date
1988-07-05
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
72198
Product Number
1
Dosage Form
-
Strength
90MG
Approval Date
1988-07-05
Regulatory Status
Discontinued
Drug Name
PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
60MG;2.5MG
Approval Date
1983-05-17
Active Ingredient
PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
Application Number
88193
Product Number
1
Dosage Form
-
Strength
60MG;2.5MG
Approval Date
1983-05-17
Regulatory Status
Discontinued
Drug Name
QOLIANA
Product Number
1
Dosage Form
-
Strength
0.15%
Approval Date
2006-05-22
Active Ingredient
BRIMONIDINE TARTRATE
Application Number
21764
Product Number
1
Dosage Form
-
Strength
0.15%
Approval Date
2006-05-22
Regulatory Status
RX
Drug Name
QUINIDINE SULFATE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1982-01-01
Active Ingredient
QUINIDINE SULFATE
Application Number
84631
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1982-01-01
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
84914
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
RANITIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
1997-08-29
Active Ingredient
RANITIDINE HYDROCHLORIDE
Application Number
74467
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
1997-08-29
Regulatory Status
RX
Drug Name
RANITIDINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
1997-08-29
Active Ingredient
RANITIDINE HYDROCHLORIDE
Application Number
74467
Product Number
2
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
1997-08-29
Regulatory Status
RX
Drug Name
RANITIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
1997-10-22
Active Ingredient
RANITIDINE HYDROCHLORIDE
Application Number
74655
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
1997-10-22
Regulatory Status
RX
Drug Name
RANITIDINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
1997-10-22
Active Ingredient
RANITIDINE HYDROCHLORIDE
Application Number
74655
Product Number
2
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
1997-10-22
Regulatory Status
RX
Drug Name
RANITIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2002-09-26
Active Ingredient
RANITIDINE HYDROCHLORIDE
Application Number
75519
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2002-09-26
Regulatory Status
Discontinued
Drug Name
RECLAST
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/100ML
Approval Date
2007-04-16
Active Ingredient
ZOLEDRONIC ACID
Application Number
21817
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/100ML
Approval Date
2007-04-16
Regulatory Status
RX
Drug Name
RECLAST
Product Number
1
Dosage Form
-
Strength
5MG/100ML
Approval Date
-
Active Ingredient
ZOLEDRONIC ACID
Application Number
22080
Product Number
1
Dosage Form
-
Strength
5MG/100ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
REGONOL
Product Number
1
Dosage Form
-
Strength
5MG/ML
Approval Date
1982-01-01
Active Ingredient
PYRIDOSTIGMINE BROMIDE
Application Number
17398
Product Number
1
Dosage Form
-
Strength
5MG/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
RESERPINE
Product Number
1
Dosage Form
-
Strength
0.1MG
Approval Date
1982-01-01
Active Ingredient
RESERPINE
Application Number
9838
Product Number
1
Dosage Form
-
Strength
0.1MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
RESERPINE
Product Number
2
Dosage Form
-
Strength
0.25MG
Approval Date
1982-01-01
Active Ingredient
RESERPINE
Application Number
9838
Product Number
2
Dosage Form
-
Strength
0.25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
RESERPINE AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
50MG;0.125MG
Approval Date
1984-01-31
Active Ingredient
HYDROCHLOROTHIAZIDE; RESERPINE
Application Number
88200
Product Number
1
Dosage Form
-
Strength
50MG;0.125MG
Approval Date
1984-01-31
Regulatory Status
Discontinued
Drug Name
RIBAVIRIN
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2006-10-03
Active Ingredient
RIBAVIRIN
Application Number
77743
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2006-10-03
Regulatory Status
RX
Drug Name
RISPERIDONE
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
2009-12-22
Active Ingredient
RISPERIDONE
Application Number
78116
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
2009-12-22
Regulatory Status
RX
Drug Name
RISPERIDONE
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
2009-12-22
Active Ingredient
RISPERIDONE
Application Number
78116
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
2009-12-22
Regulatory Status
RX
Drug Name
RISPERIDONE
Product Number
3
Dosage Form
-
Strength
2MG
Approval Date
2009-12-22
Active Ingredient
RISPERIDONE
Application Number
78116
Product Number
3
Dosage Form
-
Strength
2MG
Approval Date
2009-12-22
Regulatory Status
RX
Drug Name
RISPERIDONE
Product Number
4
Dosage Form
-
Strength
3MG
Approval Date
2009-12-22
Active Ingredient
RISPERIDONE
Application Number
78116
Product Number
4
Dosage Form
-
Strength
3MG
Approval Date
2009-12-22
Regulatory Status
RX
Drug Name
RISPERIDONE
Product Number
5
Dosage Form
-
Strength
4MG
Approval Date
2009-12-22
Active Ingredient
RISPERIDONE
Application Number
78116
Product Number
5
Dosage Form
-
Strength
4MG
Approval Date
2009-12-22
Regulatory Status
RX
Drug Name
RISPERIDONE
Product Number
1
Dosage Form
-
Strength
0.25MG
Approval Date
2009-10-16
Active Ingredient
RISPERIDONE
Application Number
78528
Product Number
1
Dosage Form
-
Strength
0.25MG
Approval Date
2009-10-16
Regulatory Status
RX
Drug Name
RISPERIDONE
Product Number
2
Dosage Form
-
Strength
0.5MG
Approval Date
2009-10-16
Active Ingredient
RISPERIDONE
Application Number
78528
Product Number
2
Dosage Form
-
Strength
0.5MG
Approval Date
2009-10-16
Regulatory Status
RX
Drug Name
RISPERIDONE
Product Number
3
Dosage Form
-
Strength
1MG
Approval Date
2009-10-16
Active Ingredient
RISPERIDONE
Application Number
78528
Product Number
3
Dosage Form
-
Strength
1MG
Approval Date
2009-10-16
Regulatory Status
RX
Drug Name
RISPERIDONE
Product Number
4
Dosage Form
-
Strength
2MG
Approval Date
2009-10-16
Active Ingredient
RISPERIDONE
Application Number
78528
Product Number
4
Dosage Form
-
Strength
2MG
Approval Date
2009-10-16
Regulatory Status
RX
Drug Name
RISPERIDONE
Product Number
5
Dosage Form
-
Strength
3MG
Approval Date
2009-10-16
Active Ingredient
RISPERIDONE
Application Number
78528
Product Number
5
Dosage Form
-
Strength
3MG
Approval Date
2009-10-16
Regulatory Status
RX
Drug Name
RISPERIDONE
Product Number
6
Dosage Form
-
Strength
4MG
Approval Date
2009-10-16
Active Ingredient
RISPERIDONE
Application Number
78528
Product Number
6
Dosage Form
-
Strength
4MG
Approval Date
2009-10-16
Regulatory Status
RX
Drug Name
RITALIN
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Active Ingredient
METHYLPHENIDATE HYDROCHLORIDE
Application Number
10187
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
RITALIN
Product Number
6
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
METHYLPHENIDATE HYDROCHLORIDE
Application Number
10187
Product Number
6
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
RITALIN
Product Number
10
Dosage Form
-
Strength
20MG
Approval Date
1982-01-01
Active Ingredient
METHYLPHENIDATE HYDROCHLORIDE
Application Number
10187
Product Number
10
Dosage Form
-
Strength
20MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
RITALIN LA
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2002-06-05
Active Ingredient
METHYLPHENIDATE HYDROCHLORIDE
Application Number
21284
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2002-06-05
Regulatory Status
RX
Drug Name
RITALIN LA
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2002-06-05
Active Ingredient
METHYLPHENIDATE HYDROCHLORIDE
Application Number
21284
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2002-06-05
Regulatory Status
RX
Drug Name
RITALIN LA
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2002-06-05
Active Ingredient
METHYLPHENIDATE HYDROCHLORIDE
Application Number
21284
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2002-06-05
Regulatory Status
RX
Drug Name
RITALIN LA
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2004-04-10
Active Ingredient
METHYLPHENIDATE HYDROCHLORIDE
Application Number
21284
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2004-04-10
Regulatory Status
RX
Drug Name
RITALIN LA
Product Number
5
Dosage Form
-
Strength
60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2014-10-27
Active Ingredient
METHYLPHENIDATE HYDROCHLORIDE
Application Number
21284
Product Number
5
Dosage Form
-
Strength
60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2014-10-27
Regulatory Status
Discontinued
Drug Name
RIZATRIPTAN BENZOATE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2012-12-31
Active Ingredient
RIZATRIPTAN BENZOATE
Application Number
79230
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2012-12-31
Regulatory Status
Discontinued
Drug Name
RIZATRIPTAN BENZOATE
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2012-12-31
Active Ingredient
RIZATRIPTAN BENZOATE
Application Number
79230
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2012-12-31
Regulatory Status
Discontinued
Drug Name
ROCURONIUM BROMIDE
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2008-12-05
Active Ingredient
ROCURONIUM BROMIDE
Application Number
79195
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2008-12-05
Regulatory Status
RX
Drug Name
ROCURONIUM BROMIDE
Product Number
2
Dosage Form
-
Strength
100MG/10ML (10MG/ML)
Approval Date
2008-12-05
Active Ingredient
ROCURONIUM BROMIDE
Application Number
79195
Product Number
2
Dosage Form
-
Strength
100MG/10ML (10MG/ML)
Approval Date
2008-12-05
Regulatory Status
RX
Drug Name
ROSIGLITAZONE MALEATE
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
-
Active Ingredient
ROSIGLITAZONE MALEATE
Application Number
78674
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ROSIGLITAZONE MALEATE
Product Number
2
Dosage Form
-
Strength
4MG
Approval Date
-
Active Ingredient
ROSIGLITAZONE MALEATE
Application Number
78674
Product Number
2
Dosage Form
-
Strength
4MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ROSIGLITAZONE MALEATE
Product Number
3
Dosage Form
-
Strength
8MG
Approval Date
-
Active Ingredient
ROSIGLITAZONE MALEATE
Application Number
78674
Product Number
3
Dosage Form
-
Strength
8MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ROSUVASTATIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2016-07-19
Active Ingredient
ROSUVASTATIN CALCIUM
Application Number
79171
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2016-07-19
Regulatory Status
Discontinued
Drug Name
ROSUVASTATIN CALCIUM
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2016-07-19
Active Ingredient
ROSUVASTATIN CALCIUM
Application Number
79171
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2016-07-19
Regulatory Status
Discontinued
Drug Name
ROSUVASTATIN CALCIUM
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2016-07-19
Active Ingredient
ROSUVASTATIN CALCIUM
Application Number
79171
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2016-07-19
Regulatory Status
Discontinued
Drug Name
ROSUVASTATIN CALCIUM
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2016-07-19
Active Ingredient
ROSUVASTATIN CALCIUM
Application Number
79171
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2016-07-19
Regulatory Status
Discontinued
Drug Name
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG;EQ 50MG BASE
Approval Date
2025-12-02
Active Ingredient
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Application Number
202388
Product Number
1
Dosage Form
-
Strength
500MG;EQ 50MG BASE
Approval Date
2025-12-02
Regulatory Status
RX
Drug Name
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
1GM;EQ 50MG BASE
Approval Date
2025-12-02
Active Ingredient
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Application Number
202388
Product Number
2
Dosage Form
-
Strength
1GM;EQ 50MG BASE
Approval Date
2025-12-02
Regulatory Status
RX
Drug Name
SITAGLIPTIN PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2026-01-14
Active Ingredient
SITAGLIPTIN PHOSPHATE
Application Number
202387
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2026-01-14
Regulatory Status
RX
Drug Name
SITAGLIPTIN PHOSPHATE
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2026-01-14
Active Ingredient
SITAGLIPTIN PHOSPHATE
Application Number
202387
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2026-01-14
Regulatory Status
RX
Drug Name
SITAGLIPTIN PHOSPHATE
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2026-01-14
Active Ingredient
SITAGLIPTIN PHOSPHATE
Application Number
202387
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2026-01-14
Regulatory Status
RX
Drug Name
SUGAMMADEX SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)
Approval Date
2026-07-28
Active Ingredient
SUGAMMADEX SODIUM
Application Number
214311
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)
Approval Date
2026-07-28
Regulatory Status
RX
Drug Name
SUGAMMADEX SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Approval Date
2026-07-28
Active Ingredient
SUGAMMADEX SODIUM
Application Number
214311
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Approval Date
2026-07-28
Regulatory Status
RX
Drug Name
SUMATRIPTAN SUCCINATE
Product Number
1
Dosage Form
-
Strength
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Approval Date
2009-02-06
Active Ingredient
SUMATRIPTAN SUCCINATE
Application Number
78067
Product Number
1
Dosage Form
-
Strength
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Approval Date
2009-02-06
Regulatory Status
Discontinued
Drug Name
SUMATRIPTAN SUCCINATE
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
Approval Date
2009-02-06
Active Ingredient
SUMATRIPTAN SUCCINATE
Application Number
78067
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
Approval Date
2009-02-06
Regulatory Status
Discontinued
Drug Name
TACROLIMUS
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2009-08-10
Active Ingredient
TACROLIMUS
Application Number
65461
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2009-08-10
Regulatory Status
RX
Drug Name
TACROLIMUS
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2009-08-10
Active Ingredient
TACROLIMUS
Application Number
65461
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2009-08-10
Regulatory Status
RX
Drug Name
TACROLIMUS
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2009-08-10
Active Ingredient
TACROLIMUS
Application Number
65461
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2009-08-10
Regulatory Status
RX
Drug Name
TAFLUPROST
Product Number
1
Dosage Form
-
Strength
0.0015%
Approval Date
2022-01-28
Active Ingredient
TAFLUPROST
Application Number
209040
Product Number
1
Dosage Form
-
Strength
0.0015%
Approval Date
2022-01-28
Regulatory Status
RX
Drug Name
TAMSULOSIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.4MG
Approval Date
2010-04-27
Active Ingredient
TAMSULOSIN HYDROCHLORIDE
Application Number
78015
Product Number
1
Dosage Form
-
Strength
0.4MG
Approval Date
2010-04-27
Regulatory Status
Discontinued
Drug Name
TELMISARTAN
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2014-11-03
Active Ingredient
TELMISARTAN
Application Number
203867
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2014-11-03
Regulatory Status
RX
Drug Name
TELMISARTAN
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2014-11-03
Active Ingredient
TELMISARTAN
Application Number
203867
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2014-11-03
Regulatory Status
RX
Drug Name
TELMISARTAN
Product Number
3
Dosage Form
-
Strength
80MG
Approval Date
2014-11-03
Active Ingredient
TELMISARTAN
Application Number
203867
Product Number
3
Dosage Form
-
Strength
80MG
Approval Date
2014-11-03
Regulatory Status
RX
Drug Name
TERAZOSIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
1998-12-31
Active Ingredient
TERAZOSIN HYDROCHLORIDE
Application Number
74315
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
1998-12-31
Regulatory Status
Discontinued
Drug Name
TERAZOSIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
1998-12-31
Active Ingredient
TERAZOSIN HYDROCHLORIDE
Application Number
74315
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
1998-12-31
Regulatory Status
Discontinued
Drug Name
TERAZOSIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
1998-12-31
Active Ingredient
TERAZOSIN HYDROCHLORIDE
Application Number
74315
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
1998-12-31
Regulatory Status
Discontinued
Drug Name
TERAZOSIN HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1998-12-31
Active Ingredient
TERAZOSIN HYDROCHLORIDE
Application Number
74315
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1998-12-31
Regulatory Status
Discontinued
Drug Name
TERIFLUNOMIDE
Product Number
1
Dosage Form
-
Strength
7MG
Approval Date
2019-01-03
Active Ingredient
TERIFLUNOMIDE
Application Number
209710
Product Number
1
Dosage Form
-
Strength
7MG
Approval Date
2019-01-03
Regulatory Status
RX
Drug Name
TERIFLUNOMIDE
Product Number
2
Dosage Form
-
Strength
14MG
Approval Date
2019-01-03
Active Ingredient
TERIFLUNOMIDE
Application Number
209710
Product Number
2
Dosage Form
-
Strength
14MG
Approval Date
2019-01-03
Regulatory Status
RX
Drug Name
THEOPHYLLINE
Product Number
1
Dosage Form
-
Strength
260MG
Approval Date
1982-05-11
Active Ingredient
THEOPHYLLINE
Application Number
87462
Product Number
1
Dosage Form
-
Strength
260MG
Approval Date
1982-05-11
Regulatory Status
Discontinued
Drug Name
THIORIDAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
30MG/ML
Approval Date
1983-11-23
Active Ingredient
THIORIDAZINE HYDROCHLORIDE
Application Number
88307
Product Number
1
Dosage Form
-
Strength
30MG/ML
Approval Date
1983-11-23
Regulatory Status
Discontinued
Drug Name
THIORIDAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
1983-11-23
Active Ingredient
THIORIDAZINE HYDROCHLORIDE
Application Number
88308
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
1983-11-23
Regulatory Status
Discontinued
Drug Name
THIOTHIXENE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
-
Active Ingredient
THIOTHIXENE
Application Number
71530
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
TIGECYCLINE
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2015-05-27
Active Ingredient
TIGECYCLINE
Application Number
91620
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2015-05-27
Regulatory Status
RX
Drug Name
TIMOLOL MALEATE
Product Number
1
Dosage Form
-
Strength
EQ 0.25% BASE
Approval Date
1998-10-21
Active Ingredient
TIMOLOL MALEATE
Application Number
20963
Product Number
1
Dosage Form
-
Strength
EQ 0.25% BASE
Approval Date
1998-10-21
Regulatory Status
RX
Drug Name
TIMOLOL MALEATE
Product Number
2
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
1998-10-21
Active Ingredient
TIMOLOL MALEATE
Application Number
20963
Product Number
2
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
1998-10-21
Regulatory Status
RX
Drug Name
TIMOLOL MALEATE
Product Number
1
Dosage Form
-
Strength
EQ 0.25% BASE
Approval Date
1995-04-28
Active Ingredient
TIMOLOL MALEATE
Application Number
74261
Product Number
1
Dosage Form
-
Strength
EQ 0.25% BASE
Approval Date
1995-04-28
Regulatory Status
RX
Drug Name
TIMOLOL MALEATE
Product Number
1
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
1995-04-28
Active Ingredient
TIMOLOL MALEATE
Application Number
74262
Product Number
1
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
1995-04-28
Regulatory Status
RX
Drug Name
TOBRADEX
Product Number
1
Dosage Form
-
Strength
0.1%;0.3%
Approval Date
1988-08-18
Active Ingredient
DEXAMETHASONE; TOBRAMYCIN
Application Number
50592
Product Number
1
Dosage Form
-
Strength
0.1%;0.3%
Approval Date
1988-08-18
Regulatory Status
RX
Drug Name
TOBREX
Product Number
1
Dosage Form
-
Strength
0.3%
Approval Date
1984-12-13
Active Ingredient
TOBRAMYCIN
Application Number
62535
Product Number
1
Dosage Form
-
Strength
0.3%
Approval Date
1984-12-13
Regulatory Status
RX
Drug Name
TOLBUTAMIDE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Active Ingredient
TOLBUTAMIDE
Application Number
12678
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TOLTERODINE TARTRATE
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
-
Active Ingredient
TOLTERODINE TARTRATE
Application Number
78419
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
TOLTERODINE TARTRATE
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
-
Active Ingredient
TOLTERODINE TARTRATE
Application Number
78419
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
TRAVATAN Z
Product Number
1
Dosage Form
-
Strength
0.004%
Approval Date
2006-09-21
Active Ingredient
TRAVOPROST
Application Number
21994
Product Number
1
Dosage Form
-
Strength
0.004%
Approval Date
2006-09-21
Regulatory Status
RX
Drug Name
TREPROSTINIL
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2017-11-30
Active Ingredient
TREPROSTINIL
Application Number
203649
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2017-11-30
Regulatory Status
RX
Drug Name
TREPROSTINIL
Product Number
2
Dosage Form
-
Strength
2.5MG/ML
Approval Date
2017-11-30
Active Ingredient
TREPROSTINIL
Application Number
203649
Product Number
2
Dosage Form
-
Strength
2.5MG/ML
Approval Date
2017-11-30
Regulatory Status
RX
Drug Name
TREPROSTINIL
Product Number
3
Dosage Form
-
Strength
5MG/ML
Approval Date
2017-11-30
Active Ingredient
TREPROSTINIL
Application Number
203649
Product Number
3
Dosage Form
-
Strength
5MG/ML
Approval Date
2017-11-30
Regulatory Status
RX
Drug Name
TREPROSTINIL
Product Number
4
Dosage Form
-
Strength
10MG/ML
Approval Date
2017-11-30
Active Ingredient
TREPROSTINIL
Application Number
203649
Product Number
4
Dosage Form
-
Strength
10MG/ML
Approval Date
2017-11-30
Regulatory Status
RX
Drug Name
TRIAMCINOLONE
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
1982-01-01
Active Ingredient
TRIAMCINOLONE
Application Number
85601
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TRIAMCINOLONE ACETONIDE
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2009-06-01
Active Ingredient
TRIAMCINOLONE ACETONIDE
Application Number
90164
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2009-06-01
Regulatory Status
Discontinued
Drug Name
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
25MG;37.5MG
Approval Date
1992-04-30
Active Ingredient
HYDROCHLOROTHIAZIDE; TRIAMTERENE
Application Number
73281
Product Number
1
Dosage Form
-
Strength
25MG;37.5MG
Approval Date
1992-04-30
Regulatory Status
RX
Drug Name
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
25MG;37.5MG
Approval Date
1997-06-05
Active Ingredient
HYDROCHLOROTHIAZIDE; TRIAMTERENE
Application Number
74821
Product Number
1
Dosage Form
-
Strength
25MG;37.5MG
Approval Date
1997-06-05
Regulatory Status
RX
Drug Name
TRICHLORMETHIAZIDE
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
1982-01-01
Active Ingredient
TRICHLORMETHIAZIDE
Application Number
86171
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TRIFLUOPERAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
1982-01-01
Active Ingredient
TRIFLUOPERAZINE HYDROCHLORIDE
Application Number
85785
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
TRIFLUOPERAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
1982-01-01
Active Ingredient
TRIFLUOPERAZINE HYDROCHLORIDE
Application Number
85786
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
TRIFLUOPERAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1982-01-01
Active Ingredient
TRIFLUOPERAZINE HYDROCHLORIDE
Application Number
85788
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
TRIFLUOPERAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
1982-01-01
Active Ingredient
TRIFLUOPERAZINE HYDROCHLORIDE
Application Number
85789
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
TRIFLURIDINE
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1995-10-06
Active Ingredient
TRIFLURIDINE
Application Number
74311
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1995-10-06
Regulatory Status
RX
Drug Name
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE
Product Number
1
Dosage Form
-
Strength
10,000 UNITS/ML;EQ 1MG BASE/ML
Approval Date
1998-04-13
Active Ingredient
POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
Application Number
64211
Product Number
1
Dosage Form
-
Strength
10,000 UNITS/ML;EQ 1MG BASE/ML
Approval Date
1998-04-13
Regulatory Status
RX
Drug Name
VASOPRESSIN
Product Number
1
Dosage Form
-
Strength
20UNITS/ML (20UNITS/ML)
Approval Date
2026-05-06
Active Ingredient
VASOPRESSIN
Application Number
212068
Product Number
1
Dosage Form
-
Strength
20UNITS/ML (20UNITS/ML)
Approval Date
2026-05-06
Regulatory Status
RX
Drug Name
VASOPRESSIN
Product Number
1
Dosage Form
-
Strength
200UNITS/10ML (20UNITS/ML)
Approval Date
2026-05-06
Active Ingredient
VASOPRESSIN
Application Number
212069
Product Number
1
Dosage Form
-
Strength
200UNITS/10ML (20UNITS/ML)
Approval Date
2026-05-06
Regulatory Status
RX
Drug Name
VINORELBINE TARTRATE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
2008-02-13
Active Ingredient
VINORELBINE TARTRATE
Application Number
78408
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
2008-02-13
Regulatory Status
Discontinued
Drug Name
VIVELLE
Product Number
1
Dosage Form
-
Strength
0.0375MG/24HR
Approval Date
1994-10-28
Active Ingredient
ESTRADIOL
Application Number
20323
Product Number
1
Dosage Form
-
Strength
0.0375MG/24HR
Approval Date
1994-10-28
Regulatory Status
Discontinued
Drug Name
VIVELLE
Product Number
2
Dosage Form
-
Strength
0.05MG/24HR
Approval Date
1994-10-28
Active Ingredient
ESTRADIOL
Application Number
20323
Product Number
2
Dosage Form
-
Strength
0.05MG/24HR
Approval Date
1994-10-28
Regulatory Status
Discontinued
Drug Name
VIVELLE
Product Number
3
Dosage Form
-
Strength
0.075MG/24HR
Approval Date
1994-10-28
Active Ingredient
ESTRADIOL
Application Number
20323
Product Number
3
Dosage Form
-
Strength
0.075MG/24HR
Approval Date
1994-10-28
Regulatory Status
Discontinued
Drug Name
VIVELLE
Product Number
4
Dosage Form
-
Strength
0.1MG/24HR
Approval Date
1994-10-28
Active Ingredient
ESTRADIOL
Application Number
20323
Product Number
4
Dosage Form
-
Strength
0.1MG/24HR
Approval Date
1994-10-28
Regulatory Status
Discontinued
Drug Name
VIVELLE
Product Number
5
Dosage Form
-
Strength
0.025MG/24HR
Approval Date
2000-08-16
Active Ingredient
ESTRADIOL
Application Number
20323
Product Number
5
Dosage Form
-
Strength
0.025MG/24HR
Approval Date
2000-08-16
Regulatory Status
Discontinued
Drug Name
VIVELLE-DOT
Product Number
5
Dosage Form
-
Strength
0.0375MG/24HR
Approval Date
1999-01-08
Active Ingredient
ESTRADIOL
Application Number
20538
Product Number
5
Dosage Form
-
Strength
0.0375MG/24HR
Approval Date
1999-01-08
Regulatory Status
RX
Drug Name
VIVELLE-DOT
Product Number
6
Dosage Form
-
Strength
0.05MG/24HR
Approval Date
1999-01-08
Active Ingredient
ESTRADIOL
Application Number
20538
Product Number
6
Dosage Form
-
Strength
0.05MG/24HR
Approval Date
1999-01-08
Regulatory Status
RX
Drug Name
VIVELLE-DOT
Product Number
7
Dosage Form
-
Strength
0.075MG/24HR
Approval Date
1999-01-08
Active Ingredient
ESTRADIOL
Application Number
20538
Product Number
7
Dosage Form
-
Strength
0.075MG/24HR
Approval Date
1999-01-08
Regulatory Status
RX
Drug Name
VIVELLE-DOT
Product Number
8
Dosage Form
-
Strength
0.1MG/24HR
Approval Date
1999-01-08
Active Ingredient
ESTRADIOL
Application Number
20538
Product Number
8
Dosage Form
-
Strength
0.1MG/24HR
Approval Date
1999-01-08
Regulatory Status
RX
Drug Name
VIVELLE-DOT
Product Number
9
Dosage Form
-
Strength
0.025MG/24HR
Approval Date
2002-05-03
Active Ingredient
ESTRADIOL
Application Number
20538
Product Number
9
Dosage Form
-
Strength
0.025MG/24HR
Approval Date
2002-05-03
Regulatory Status
RX
Drug Name
WESTADONE
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
1982-01-01
Active Ingredient
METHADONE HYDROCHLORIDE
Application Number
17108
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
WESTADONE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Active Ingredient
METHADONE HYDROCHLORIDE
Application Number
17108
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
WESTADONE
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
METHADONE HYDROCHLORIDE
Application Number
17108
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
WESTADONE
Product Number
4
Dosage Form
-
Strength
40MG
Approval Date
1982-01-01
Active Ingredient
METHADONE HYDROCHLORIDE
Application Number
17108
Product Number
4
Dosage Form
-
Strength
40MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
WILPO
Product Number
1
Dosage Form
-
Strength
8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
PHENTERMINE HYDROCHLORIDE
Application Number
12737
Product Number
1
Dosage Form
-
Strength
8MG **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
ZOFRAN
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1991-01-04
Active Ingredient
ONDANSETRON HYDROCHLORIDE
Application Number
20007
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1991-01-04
Regulatory Status
Discontinued
Drug Name
ZOFRAN
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1992-12-31
Active Ingredient
ONDANSETRON HYDROCHLORIDE
Application Number
20103
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1992-12-31
Regulatory Status
Discontinued
Drug Name
ZOFRAN
Product Number
2
Dosage Form
-
Strength
EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1992-12-31
Active Ingredient
ONDANSETRON HYDROCHLORIDE
Application Number
20103
Product Number
2
Dosage Form
-
Strength
EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1992-12-31
Regulatory Status
Discontinued
Drug Name
ZOFRAN
Product Number
3
Dosage Form
-
Strength
EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-08-27
Active Ingredient
ONDANSETRON HYDROCHLORIDE
Application Number
20103
Product Number
3
Dosage Form
-
Strength
EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-08-27
Regulatory Status
Discontinued
Drug Name
ZOFRAN
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-01-24
Active Ingredient
ONDANSETRON HYDROCHLORIDE
Application Number
20605
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-01-24
Regulatory Status
Discontinued
Drug Name
ZOFRAN ODT
Product Number
1
Dosage Form
-
Strength
4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-01-27
Active Ingredient
ONDANSETRON
Application Number
20781
Product Number
1
Dosage Form
-
Strength
4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-01-27
Regulatory Status
Discontinued
Drug Name
ZOFRAN ODT
Product Number
2
Dosage Form
-
Strength
8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-01-27
Active Ingredient
ONDANSETRON
Application Number
20781
Product Number
2
Dosage Form
-
Strength
8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-01-27
Regulatory Status
Discontinued
Drug Name
ZOFRAN PRESERVATIVE FREE
Product Number
3
Dosage Form
-
Strength
EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1993-12-10
Active Ingredient
ONDANSETRON HYDROCHLORIDE
Application Number
20007
Product Number
3
Dosage Form
-
Strength
EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1993-12-10
Regulatory Status
Discontinued
Drug Name
ZOLPIDEM TARTRATE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2007-04-23
Active Ingredient
ZOLPIDEM TARTRATE
Application Number
77322
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2007-04-23
Regulatory Status
RX
Drug Name
ZOLPIDEM TARTRATE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2007-04-23
Active Ingredient
ZOLPIDEM TARTRATE
Application Number
77322
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2007-04-23
Regulatory Status
RX
Drug Name
ZOLPIDEM TARTRATE
Product Number
1
Dosage Form
-
Strength
6.25MG
Approval Date
2011-07-01
Active Ingredient
ZOLPIDEM TARTRATE
Application Number
90107
Product Number
1
Dosage Form
-
Strength
6.25MG
Approval Date
2011-07-01
Regulatory Status
RX
Drug Name
ZOLPIDEM TARTRATE
Product Number
2
Dosage Form
-
Strength
12.5MG
Approval Date
2011-07-01
Active Ingredient
ZOLPIDEM TARTRATE
Application Number
90107
Product Number
2
Dosage Form
-
Strength
12.5MG
Approval Date
2011-07-01
Regulatory Status
RX
Drug Status Breakdown
751 total- RX
- Discontinued
- Unclassified
- OTC
Official Source
FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.
Visit FDA Orange BookFDA Approved Drug Record Details Preview
Explore important FDA approved drug information available in the records above.
Drug Name
ACETAMINOPHEN
Application Number
204052
Product Number
1
Active Ingredient
ACETAMINOPHEN
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
FDA Approved Drug Data
Approved drug product information
Regular Updates
Data maintained from official sources
Structured Database
Searchable pharmaceutical data
Reliable Data
Organized FDA drug records
Create a New Buying Request
Fields marked with * are mandatory.