Bayer AG
FDA Approved Drugs
Bayer AG
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 277
- Latest Approval Date Jun 12, 2026
- Data Source FDA
- First Approval Date Jan 01, 1982
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Bayer AG
Mullerstr. 178, 13353 Berlin
Germany
pharma.bayer.com/ pharmachemicals@bayer.com View on MapFDA Approved Drug Records ( 277 records )
Drug Name
8-HOUR BAYER
Product Number
1
Dosage Form
-
Strength
650MG
Approval Date
1982-01-01
Active Ingredient
ASPIRIN
Application Number
16030
Product Number
1
Dosage Form
-
Strength
650MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ACTRON
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
1995-10-06
Active Ingredient
KETOPROFEN
Application Number
20499
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
1995-10-06
Regulatory Status
Discontinued
Drug Name
ADEMPAS
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
2013-10-08
Active Ingredient
RIOCIGUAT
Application Number
204819
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
2013-10-08
Regulatory Status
RX
Drug Name
ADEMPAS
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
2013-10-08
Active Ingredient
RIOCIGUAT
Application Number
204819
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
2013-10-08
Regulatory Status
RX
Drug Name
ADEMPAS
Product Number
3
Dosage Form
-
Strength
1.5MG
Approval Date
2013-10-08
Active Ingredient
RIOCIGUAT
Application Number
204819
Product Number
3
Dosage Form
-
Strength
1.5MG
Approval Date
2013-10-08
Regulatory Status
RX
Drug Name
ADEMPAS
Product Number
4
Dosage Form
-
Strength
2MG
Approval Date
2013-10-08
Active Ingredient
RIOCIGUAT
Application Number
204819
Product Number
4
Dosage Form
-
Strength
2MG
Approval Date
2013-10-08
Regulatory Status
RX
Drug Name
ADEMPAS
Product Number
5
Dosage Form
-
Strength
2.5MG
Approval Date
2013-10-08
Active Ingredient
RIOCIGUAT
Application Number
204819
Product Number
5
Dosage Form
-
Strength
2.5MG
Approval Date
2013-10-08
Regulatory Status
RX
Drug Name
AKRINOL
Product Number
1
Dosage Form
-
Strength
2MG/GM
Approval Date
1982-01-01
Active Ingredient
ACRISORCIN
Application Number
12470
Product Number
1
Dosage Form
-
Strength
2MG/GM
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ALEVE
Product Number
2
Dosage Form
-
Strength
220MG
Approval Date
1994-01-11
Active Ingredient
NAPROXEN SODIUM
Application Number
20204
Product Number
2
Dosage Form
-
Strength
220MG
Approval Date
1994-01-11
Regulatory Status
OTC
Drug Name
ALEVE PM
Product Number
1
Dosage Form
-
Strength
25MG;220MG
Approval Date
2014-01-17
Active Ingredient
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
Application Number
205352
Product Number
1
Dosage Form
-
Strength
25MG;220MG
Approval Date
2014-01-17
Regulatory Status
OTC
Drug Name
ALEVE-D SINUS & COLD
Product Number
1
Dosage Form
-
Strength
220MG;120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-11-29
Active Ingredient
NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
Application Number
21076
Product Number
1
Dosage Form
-
Strength
220MG;120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-11-29
Regulatory Status
Discontinued
Drug Name
ALIQOPA
Product Number
1
Dosage Form
-
Strength
60MG/VIAL
Approval Date
2017-09-14
Active Ingredient
COPANLISIB DIHYDROCHLORIDE
Application Number
209936
Product Number
1
Dosage Form
-
Strength
60MG/VIAL
Approval Date
2017-09-14
Regulatory Status
Discontinued
Drug Name
AMBELVIST
Product Number
1
Dosage Form
-
Strength
0.5158GM/2ML (257.9MG/ML)
Approval Date
2026-06-12
Active Ingredient
GADOQUATRANE
Application Number
219627
Product Number
1
Dosage Form
-
Strength
0.5158GM/2ML (257.9MG/ML)
Approval Date
2026-06-12
Regulatory Status
RX
Drug Name
AMBELVIST
Product Number
2
Dosage Form
-
Strength
1.93425GM/7.5ML (257.9MG/ML)
Approval Date
2026-06-12
Active Ingredient
GADOQUATRANE
Application Number
219627
Product Number
2
Dosage Form
-
Strength
1.93425GM/7.5ML (257.9MG/ML)
Approval Date
2026-06-12
Regulatory Status
RX
Drug Name
AMBELVIST
Product Number
3
Dosage Form
-
Strength
2.579GM/10ML (257.9MG/ML)
Approval Date
2026-06-12
Active Ingredient
GADOQUATRANE
Application Number
219627
Product Number
3
Dosage Form
-
Strength
2.579GM/10ML (257.9MG/ML)
Approval Date
2026-06-12
Regulatory Status
RX
Drug Name
AMBELVIST
Product Number
4
Dosage Form
-
Strength
3.8685GM/15ML (257.9MG/ML)
Approval Date
2026-06-12
Active Ingredient
GADOQUATRANE
Application Number
219627
Product Number
4
Dosage Form
-
Strength
3.8685GM/15ML (257.9MG/ML)
Approval Date
2026-06-12
Regulatory Status
RX
Drug Name
AMBELVIST
Product Number
5
Dosage Form
-
Strength
7.737GM/30ML (257.9MG/ML)
Approval Date
2026-06-12
Active Ingredient
GADOQUATRANE
Application Number
219627
Product Number
5
Dosage Form
-
Strength
7.737GM/30ML (257.9MG/ML)
Approval Date
2026-06-12
Regulatory Status
RX
Drug Name
AMBELVIST
Product Number
6
Dosage Form
-
Strength
16.7635GM/65ML (257.9MG/ML)
Approval Date
2026-06-12
Active Ingredient
GADOQUATRANE
Application Number
219627
Product Number
6
Dosage Form
-
Strength
16.7635GM/65ML (257.9MG/ML)
Approval Date
2026-06-12
Regulatory Status
RX
Drug Name
ANGELIQ
Product Number
1
Dosage Form
-
Strength
0.25MG;0.5MG
Approval Date
2012-02-29
Active Ingredient
DROSPIRENONE; ESTRADIOL
Application Number
21355
Product Number
1
Dosage Form
-
Strength
0.25MG;0.5MG
Approval Date
2012-02-29
Regulatory Status
RX
Drug Name
ANGELIQ
Product Number
2
Dosage Form
-
Strength
0.5MG;1MG
Approval Date
2005-09-28
Active Ingredient
DROSPIRENONE; ESTRADIOL
Application Number
21355
Product Number
2
Dosage Form
-
Strength
0.5MG;1MG
Approval Date
2005-09-28
Regulatory Status
RX
Drug Name
ANGIOVIST 282
Product Number
1
Dosage Form
-
Strength
60%
Approval Date
1982-09-23
Active Ingredient
DIATRIZOATE MEGLUMINE
Application Number
87726
Product Number
1
Dosage Form
-
Strength
60%
Approval Date
1982-09-23
Regulatory Status
Discontinued
Drug Name
ANGIOVIST 292
Product Number
1
Dosage Form
-
Strength
52%;8%
Approval Date
1982-09-23
Active Ingredient
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM
Application Number
87724
Product Number
1
Dosage Form
-
Strength
52%;8%
Approval Date
1982-09-23
Regulatory Status
Discontinued
Drug Name
ANGIOVIST 370
Product Number
1
Dosage Form
-
Strength
66%;10%
Approval Date
1982-09-23
Active Ingredient
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM
Application Number
87723
Product Number
1
Dosage Form
-
Strength
66%;10%
Approval Date
1982-09-23
Regulatory Status
Discontinued
Drug Name
ASTEPRO ALLERGY
Product Number
1
Dosage Form
-
Strength
0.2055MG/SPRAY
Approval Date
2021-06-17
Active Ingredient
AZELASTINE HYDROCHLORIDE
Application Number
213872
Product Number
1
Dosage Form
-
Strength
0.2055MG/SPRAY
Approval Date
2021-06-17
Regulatory Status
OTC
Drug Name
AVELOX
Product Number
1
Dosage Form
-
Strength
EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-12-10
Active Ingredient
MOXIFLOXACIN HYDROCHLORIDE
Application Number
21085
Product Number
1
Dosage Form
-
Strength
EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-12-10
Regulatory Status
Discontinued
Drug Name
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Product Number
1
Dosage Form
-
Strength
400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2001-11-30
Active Ingredient
MOXIFLOXACIN HYDROCHLORIDE
Application Number
21277
Product Number
1
Dosage Form
-
Strength
400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2001-11-30
Regulatory Status
Discontinued
Drug Name
BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2001-10-18
Active Ingredient
ASPIRIN
Application Number
21317
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2001-10-18
Regulatory Status
Discontinued
Drug Name
BETAPAR
Product Number
2
Dosage Form
-
Strength
4MG
Approval Date
1982-01-01
Active Ingredient
MEPREDNISONE
Application Number
16053
Product Number
2
Dosage Form
-
Strength
4MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
BEYAZ
Product Number
1
Dosage Form
-
Strength
3MG,N/A;0.02MG,N/A;0.451MG,0.451MG
Approval Date
2010-09-24
Active Ingredient
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
Application Number
22532
Product Number
1
Dosage Form
-
Strength
3MG,N/A;0.02MG,N/A;0.451MG,0.451MG
Approval Date
2010-09-24
Regulatory Status
RX
Drug Name
BILIVIST
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1982-08-11
Active Ingredient
IPODATE SODIUM
Application Number
87768
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1982-08-11
Regulatory Status
Discontinued
Drug Name
BILTRICIDE
Product Number
1
Dosage Form
-
Strength
600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-12-29
Active Ingredient
PRAZIQUANTEL
Application Number
18714
Product Number
1
Dosage Form
-
Strength
600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-12-29
Regulatory Status
Discontinued
Drug Name
CELESTONE
Product Number
3
Dosage Form
-
Strength
0.6MG
Approval Date
1982-01-01
Active Ingredient
BETAMETHASONE
Application Number
12657
Product Number
3
Dosage Form
-
Strength
0.6MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CELESTONE
Product Number
1
Dosage Form
-
Strength
0.2%
Approval Date
1982-01-01
Active Ingredient
BETAMETHASONE
Application Number
14762
Product Number
1
Dosage Form
-
Strength
0.2%
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CELESTONE
Product Number
1
Dosage Form
-
Strength
EQ 3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
BETAMETHASONE SODIUM PHOSPHATE
Application Number
17561
Product Number
1
Dosage Form
-
Strength
EQ 3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CHILDRENS ASTEPRO ALLERGY
Product Number
2
Dosage Form
-
Strength
0.2055MG/SPRAY
Approval Date
2021-06-17
Active Ingredient
AZELASTINE HYDROCHLORIDE
Application Number
213872
Product Number
2
Dosage Form
-
Strength
0.2055MG/SPRAY
Approval Date
2021-06-17
Regulatory Status
OTC
Drug Name
CHLOR-TRIMETON
Product Number
2
Dosage Form
-
Strength
4MG
Approval Date
1982-01-01
Active Ingredient
CHLORPHENIRAMINE MALEATE
Application Number
6921
Product Number
2
Dosage Form
-
Strength
4MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CHLOR-TRIMETON
Product Number
6
Dosage Form
-
Strength
2MG/5ML
Approval Date
1982-01-01
Active Ingredient
CHLORPHENIRAMINE MALEATE
Application Number
6921
Product Number
6
Dosage Form
-
Strength
2MG/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CIPRO
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1987-10-22
Active Ingredient
CIPROFLOXACIN HYDROCHLORIDE
Application Number
19537
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1987-10-22
Regulatory Status
RX
Drug Name
CIPRO
Product Number
3
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1987-10-22
Active Ingredient
CIPROFLOXACIN HYDROCHLORIDE
Application Number
19537
Product Number
3
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1987-10-22
Regulatory Status
RX
Drug Name
CIPRO
Product Number
4
Dosage Form
-
Strength
EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1987-10-22
Active Ingredient
CIPROFLOXACIN HYDROCHLORIDE
Application Number
19537
Product Number
4
Dosage Form
-
Strength
EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1987-10-22
Regulatory Status
Discontinued
Drug Name
CIPRO
Product Number
1
Dosage Form
-
Strength
400MG/40ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1990-12-26
Active Ingredient
CIPROFLOXACIN
Application Number
19847
Product Number
1
Dosage Form
-
Strength
400MG/40ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1990-12-26
Regulatory Status
Discontinued
Drug Name
CIPRO
Product Number
2
Dosage Form
-
Strength
200MG/20ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1990-12-26
Active Ingredient
CIPROFLOXACIN
Application Number
19847
Product Number
2
Dosage Form
-
Strength
200MG/20ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1990-12-26
Regulatory Status
Discontinued
Drug Name
CIPRO
Product Number
3
Dosage Form
-
Strength
1200MG/120ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1990-12-26
Active Ingredient
CIPROFLOXACIN
Application Number
19847
Product Number
3
Dosage Form
-
Strength
1200MG/120ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1990-12-26
Regulatory Status
Discontinued
Drug Name
CIPRO
Product Number
1
Dosage Form
-
Strength
250MG/5ML
Approval Date
1997-09-26
Active Ingredient
CIPROFLOXACIN
Application Number
20780
Product Number
1
Dosage Form
-
Strength
250MG/5ML
Approval Date
1997-09-26
Regulatory Status
RX
Drug Name
CIPRO
Product Number
2
Dosage Form
-
Strength
500MG/5ML
Approval Date
1997-09-26
Active Ingredient
CIPROFLOXACIN
Application Number
20780
Product Number
2
Dosage Form
-
Strength
500MG/5ML
Approval Date
1997-09-26
Regulatory Status
RX
Drug Name
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
Product Number
1
Dosage Form
-
Strength
200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1990-12-26
Active Ingredient
CIPROFLOXACIN
Application Number
19857
Product Number
1
Dosage Form
-
Strength
200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1990-12-26
Regulatory Status
Discontinued
Drug Name
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
Product Number
2
Dosage Form
-
Strength
400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1990-12-26
Active Ingredient
CIPROFLOXACIN
Application Number
19857
Product Number
2
Dosage Form
-
Strength
400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1990-12-26
Regulatory Status
Discontinued
Drug Name
CIPRO XR
Product Number
1
Dosage Form
-
Strength
212.6MG;EQ 287.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2002-12-13
Active Ingredient
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE
Application Number
21473
Product Number
1
Dosage Form
-
Strength
212.6MG;EQ 287.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2002-12-13
Regulatory Status
Discontinued
Drug Name
CIPRO XR
Product Number
2
Dosage Form
-
Strength
425.2MG;EQ 574.9MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2003-08-28
Active Ingredient
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE
Application Number
21473
Product Number
2
Dosage Form
-
Strength
425.2MG;EQ 574.9MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2003-08-28
Regulatory Status
Discontinued
Drug Name
CLARINEX
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
-
Active Ingredient
DESLORATADINE
Application Number
21297
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
CLARINEX
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
-
Active Ingredient
DESLORATADINE
Application Number
21363
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
CLARINEX
Product Number
1
Dosage Form
-
Strength
0.5MG/ML
Approval Date
-
Active Ingredient
DESLORATADINE
Application Number
21563
Product Number
1
Dosage Form
-
Strength
0.5MG/ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
CLIMARA
Product Number
1
Dosage Form
-
Strength
0.05MG/24HR
Approval Date
1994-12-22
Active Ingredient
ESTRADIOL
Application Number
20375
Product Number
1
Dosage Form
-
Strength
0.05MG/24HR
Approval Date
1994-12-22
Regulatory Status
RX
Drug Name
CLIMARA
Product Number
2
Dosage Form
-
Strength
0.1MG/24HR
Approval Date
1994-12-22
Active Ingredient
ESTRADIOL
Application Number
20375
Product Number
2
Dosage Form
-
Strength
0.1MG/24HR
Approval Date
1994-12-22
Regulatory Status
RX
Drug Name
CLIMARA
Product Number
3
Dosage Form
-
Strength
0.075MG/24HR
Approval Date
1998-03-23
Active Ingredient
ESTRADIOL
Application Number
20375
Product Number
3
Dosage Form
-
Strength
0.075MG/24HR
Approval Date
1998-03-23
Regulatory Status
RX
Drug Name
CLIMARA
Product Number
4
Dosage Form
-
Strength
0.025MG/24HR
Approval Date
1999-03-05
Active Ingredient
ESTRADIOL
Application Number
20375
Product Number
4
Dosage Form
-
Strength
0.025MG/24HR
Approval Date
1999-03-05
Regulatory Status
RX
Drug Name
CLIMARA
Product Number
5
Dosage Form
-
Strength
0.0375MG/24HR
Approval Date
2003-05-27
Active Ingredient
ESTRADIOL
Application Number
20375
Product Number
5
Dosage Form
-
Strength
0.0375MG/24HR
Approval Date
2003-05-27
Regulatory Status
RX
Drug Name
CLIMARA
Product Number
6
Dosage Form
-
Strength
0.06MG/24HR
Approval Date
2003-05-27
Active Ingredient
ESTRADIOL
Application Number
20375
Product Number
6
Dosage Form
-
Strength
0.06MG/24HR
Approval Date
2003-05-27
Regulatory Status
RX
Drug Name
CLIMARA PRO
Product Number
1
Dosage Form
-
Strength
0.045MG/24HR;0.015MG/24HR
Approval Date
2003-11-21
Active Ingredient
ESTRADIOL; LEVONORGESTREL
Application Number
21258
Product Number
1
Dosage Form
-
Strength
0.045MG/24HR;0.015MG/24HR
Approval Date
2003-11-21
Regulatory Status
RX
Drug Name
DIPROLENE
Product Number
1
Dosage Form
-
Strength
EQ 0.05% BASE
Approval Date
1986-01-31
Active Ingredient
BETAMETHASONE DIPROPIONATE
Application Number
19408
Product Number
1
Dosage Form
-
Strength
EQ 0.05% BASE
Approval Date
1986-01-31
Regulatory Status
Discontinued
Drug Name
DIPROLENE
Product Number
2
Dosage Form
-
Strength
EQ 0.05% BASE
Approval Date
1991-11-22
Active Ingredient
BETAMETHASONE DIPROPIONATE
Application Number
19408
Product Number
2
Dosage Form
-
Strength
EQ 0.05% BASE
Approval Date
1991-11-22
Regulatory Status
Discontinued
Drug Name
DIPROSONE
Product Number
1
Dosage Form
-
Strength
EQ 0.05% BASE
Approval Date
1982-01-01
Active Ingredient
BETAMETHASONE DIPROPIONATE
Application Number
17536
Product Number
1
Dosage Form
-
Strength
EQ 0.05% BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DIPROSONE
Product Number
1
Dosage Form
-
Strength
EQ 0.05% BASE
Approval Date
1982-01-01
Active Ingredient
BETAMETHASONE DIPROPIONATE
Application Number
17691
Product Number
1
Dosage Form
-
Strength
EQ 0.05% BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DIPROSONE
Product Number
1
Dosage Form
-
Strength
EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
BETAMETHASONE DIPROPIONATE
Application Number
17781
Product Number
1
Dosage Form
-
Strength
EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DIPROSONE
Product Number
1
Dosage Form
-
Strength
EQ 0.1% BASE
Approval Date
1982-01-01
Active Ingredient
BETAMETHASONE DIPROPIONATE
Application Number
17829
Product Number
1
Dosage Form
-
Strength
EQ 0.1% BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DISOMER
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
1982-01-01
Active Ingredient
DEXBROMPHENIRAMINE MALEATE
Application Number
11814
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DISOMER
Product Number
2
Dosage Form
-
Strength
2MG/5ML
Approval Date
1982-01-01
Active Ingredient
DEXBROMPHENIRAMINE MALEATE
Application Number
11814
Product Number
2
Dosage Form
-
Strength
2MG/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DISOPHROL
Product Number
2
Dosage Form
-
Strength
2MG;60MG
Approval Date
1982-01-01
Active Ingredient
DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
Application Number
12394
Product Number
2
Dosage Form
-
Strength
2MG;60MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DTIC-DOME
Product Number
1
Dosage Form
-
Strength
100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
DACARBAZINE
Application Number
17575
Product Number
1
Dosage Form
-
Strength
100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DTIC-DOME
Product Number
2
Dosage Form
-
Strength
200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
DACARBAZINE
Application Number
17575
Product Number
2
Dosage Form
-
Strength
200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
EOVIST
Product Number
1
Dosage Form
-
Strength
1.8143GM/10ML (181.43MG/ML)
Approval Date
2008-07-03
Active Ingredient
GADOXETATE DISODIUM
Application Number
22090
Product Number
1
Dosage Form
-
Strength
1.8143GM/10ML (181.43MG/ML)
Approval Date
2008-07-03
Regulatory Status
RX
Drug Name
EOVIST
Product Number
2
Dosage Form
-
Strength
2.72145GM/15ML (181.43MG/ML)
Approval Date
2013-02-04
Active Ingredient
GADOXETATE DISODIUM
Application Number
22090
Product Number
2
Dosage Form
-
Strength
2.72145GM/15ML (181.43MG/ML)
Approval Date
2013-02-04
Regulatory Status
RX
Drug Name
ESTINYL
Product Number
1
Dosage Form
-
Strength
0.02MG
Approval Date
1982-01-01
Active Ingredient
ETHINYL ESTRADIOL
Application Number
5292
Product Number
1
Dosage Form
-
Strength
0.02MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ESTINYL
Product Number
2
Dosage Form
-
Strength
0.05MG
Approval Date
1982-01-01
Active Ingredient
ETHINYL ESTRADIOL
Application Number
5292
Product Number
2
Dosage Form
-
Strength
0.05MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ESTINYL
Product Number
3
Dosage Form
-
Strength
0.5MG
Approval Date
1982-01-01
Active Ingredient
ETHINYL ESTRADIOL
Application Number
5292
Product Number
3
Dosage Form
-
Strength
0.5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ETRAFON 2-10
Product Number
7
Dosage Form
-
Strength
10MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Application Number
14713
Product Number
7
Dosage Form
-
Strength
10MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ETRAFON 2-25
Product Number
4
Dosage Form
-
Strength
25MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Application Number
14713
Product Number
4
Dosage Form
-
Strength
25MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ETRAFON-A
Product Number
2
Dosage Form
-
Strength
10MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Application Number
14713
Product Number
2
Dosage Form
-
Strength
10MG;4MG **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
ETRAFON-FORTE
Product Number
6
Dosage Form
-
Strength
25MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Application Number
14713
Product Number
6
Dosage Form
-
Strength
25MG;4MG **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
EULEXIN
Product Number
1
Dosage Form
-
Strength
125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1989-01-27
Active Ingredient
FLUTAMIDE
Application Number
18554
Product Number
1
Dosage Form
-
Strength
125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1989-01-27
Regulatory Status
Discontinued
Drug Name
FEMSTAT 3
Product Number
1
Dosage Form
-
Strength
2%
Approval Date
1995-12-21
Active Ingredient
BUTOCONAZOLE NITRATE
Application Number
20421
Product Number
1
Dosage Form
-
Strength
2%
Approval Date
1995-12-21
Regulatory Status
Discontinued
Drug Name
GADAVIST
Product Number
1
Dosage Form
-
Strength
4.5354GM/7.5ML (604.72MG/ML)
Approval Date
2011-03-14
Active Ingredient
GADOBUTROL
Application Number
201277
Product Number
1
Dosage Form
-
Strength
4.5354GM/7.5ML (604.72MG/ML)
Approval Date
2011-03-14
Regulatory Status
RX
Drug Name
GADAVIST
Product Number
2
Dosage Form
-
Strength
6.0472GM/10ML (604.72MG/ML)
Approval Date
2011-03-14
Active Ingredient
GADOBUTROL
Application Number
201277
Product Number
2
Dosage Form
-
Strength
6.0472GM/10ML (604.72MG/ML)
Approval Date
2011-03-14
Regulatory Status
RX
Drug Name
GADAVIST
Product Number
3
Dosage Form
-
Strength
9.0708GM/15ML (604.72MG/ML)
Approval Date
2011-03-14
Active Ingredient
GADOBUTROL
Application Number
201277
Product Number
3
Dosage Form
-
Strength
9.0708GM/15ML (604.72MG/ML)
Approval Date
2011-03-14
Regulatory Status
RX
Drug Name
GADAVIST
Product Number
4
Dosage Form
-
Strength
18.1416GM/30ML (604.72MG/ML)
Approval Date
2011-03-14
Active Ingredient
GADOBUTROL
Application Number
201277
Product Number
4
Dosage Form
-
Strength
18.1416GM/30ML (604.72MG/ML)
Approval Date
2011-03-14
Regulatory Status
RX
Drug Name
GADAVIST
Product Number
5
Dosage Form
-
Strength
39.3068GM/65ML (604.72MG/ML)
Approval Date
2011-03-14
Active Ingredient
GADOBUTROL
Application Number
201277
Product Number
5
Dosage Form
-
Strength
39.3068GM/65ML (604.72MG/ML)
Approval Date
2011-03-14
Regulatory Status
RX
Drug Name
GADAVIST
Product Number
6
Dosage Form
-
Strength
1.20944GM/2ML (604.72MG/ML)
Approval Date
2013-12-18
Active Ingredient
GADOBUTROL
Application Number
201277
Product Number
6
Dosage Form
-
Strength
1.20944GM/2ML (604.72MG/ML)
Approval Date
2013-12-18
Regulatory Status
RX
Drug Name
GARAMYCIN
Product Number
2
Dosage Form
-
Strength
EQ 0.3% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
GENTAMICIN SULFATE
Application Number
50039
Product Number
2
Dosage Form
-
Strength
EQ 0.3% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
GARAMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 0.3% BASE
Approval Date
1982-01-01
Active Ingredient
GENTAMICIN SULFATE
Application Number
50425
Product Number
1
Dosage Form
-
Strength
EQ 0.3% BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
GARAMYCIN
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
1982-01-01
Active Ingredient
GENTAMICIN SULFATE
Application Number
50505
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
1982-01-01
Regulatory Status
Discontinued
Drug Name
GARAMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 0.1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
GENTAMICIN SULFATE
Application Number
60462
Product Number
1
Dosage Form
-
Strength
EQ 0.1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
GARAMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 0.1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
GENTAMICIN SULFATE
Application Number
60463
Product Number
1
Dosage Form
-
Strength
EQ 0.1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
GARAMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
GENTAMICIN SULFATE
Application Number
61716
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
GARAMYCIN
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
GENTAMICIN SULFATE
Application Number
61716
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
GARAMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
GENTAMICIN SULFATE
Application Number
61739
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
GASTROVIST
Product Number
1
Dosage Form
-
Strength
66%;10%
Approval Date
1982-09-23
Active Ingredient
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM
Application Number
87728
Product Number
1
Dosage Form
-
Strength
66%;10%
Approval Date
1982-09-23
Regulatory Status
Discontinued
Drug Name
HYPERSTAT
Product Number
1
Dosage Form
-
Strength
15MG/ML
Approval Date
1982-01-01
Active Ingredient
DIAZOXIDE
Application Number
16996
Product Number
1
Dosage Form
-
Strength
15MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HYRNUO
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2025-11-19
Active Ingredient
SEVABERTINIB
Application Number
219972
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2025-11-19
Regulatory Status
RX
Drug Name
INTRON A
Product Number
1
Dosage Form
-
Strength
10MIU/VIAL
Approval Date
-
Active Ingredient
INTERFERON ALFA-2B
Application Number
103132
Product Number
1
Dosage Form
-
Strength
10MIU/VIAL
Approval Date
-
Regulatory Status
Unclassified
Drug Name
INTRON A
Product Number
2
Dosage Form
-
Strength
18MIU/VIAL
Approval Date
-
Active Ingredient
INTERFERON ALFA-2B
Application Number
103132
Product Number
2
Dosage Form
-
Strength
18MIU/VIAL
Approval Date
-
Regulatory Status
Unclassified
Drug Name
INTRON A
Product Number
3
Dosage Form
-
Strength
25MIU/VIAL
Approval Date
-
Active Ingredient
INTERFERON ALFA-2B
Application Number
103132
Product Number
3
Dosage Form
-
Strength
25MIU/VIAL
Approval Date
-
Regulatory Status
Unclassified
Drug Name
KERENDIA
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2021-07-09
Active Ingredient
FINERENONE
Application Number
215341
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2021-07-09
Regulatory Status
RX
Drug Name
KERENDIA
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2021-07-09
Active Ingredient
FINERENONE
Application Number
215341
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2021-07-09
Regulatory Status
RX
Drug Name
KERENDIA
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2025-07-11
Active Ingredient
FINERENONE
Application Number
215341
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2025-07-11
Regulatory Status
RX
Drug Name
KYLEENA
Product Number
1
Dosage Form
-
Strength
19.5MG
Approval Date
2016-09-16
Active Ingredient
LEVONORGESTREL
Application Number
208224
Product Number
1
Dosage Form
-
Strength
19.5MG
Approval Date
2016-09-16
Regulatory Status
RX
Drug Name
LAMPIT
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2020-08-06
Active Ingredient
NIFURTIMOX
Application Number
213464
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2020-08-06
Regulatory Status
RX
Drug Name
LAMPIT
Product Number
2
Dosage Form
-
Strength
120MG
Approval Date
2020-08-06
Active Ingredient
NIFURTIMOX
Application Number
213464
Product Number
2
Dosage Form
-
Strength
120MG
Approval Date
2020-08-06
Regulatory Status
RX
Drug Name
LEVITRA
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2003-08-19
Active Ingredient
VARDENAFIL HYDROCHLORIDE
Application Number
21400
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2003-08-19
Regulatory Status
Discontinued
Drug Name
LEVITRA
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2003-08-19
Active Ingredient
VARDENAFIL HYDROCHLORIDE
Application Number
21400
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2003-08-19
Regulatory Status
Discontinued
Drug Name
LEVITRA
Product Number
3
Dosage Form
-
Strength
EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2003-08-19
Active Ingredient
VARDENAFIL HYDROCHLORIDE
Application Number
21400
Product Number
3
Dosage Form
-
Strength
EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2003-08-19
Regulatory Status
Discontinued
Drug Name
LEVITRA
Product Number
4
Dosage Form
-
Strength
EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2003-08-19
Active Ingredient
VARDENAFIL HYDROCHLORIDE
Application Number
21400
Product Number
4
Dosage Form
-
Strength
EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2003-08-19
Regulatory Status
Discontinued
Drug Name
LEVLITE
Product Number
1
Dosage Form
-
Strength
0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1998-07-13
Active Ingredient
ETHINYL ESTRADIOL; LEVONORGESTREL
Application Number
20860
Product Number
1
Dosage Form
-
Strength
0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1998-07-13
Regulatory Status
Discontinued
Drug Name
LEVLITE
Product Number
2
Dosage Form
-
Strength
0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1998-07-13
Active Ingredient
ETHINYL ESTRADIOL; LEVONORGESTREL
Application Number
20860
Product Number
2
Dosage Form
-
Strength
0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1998-07-13
Regulatory Status
Discontinued
Drug Name
LOTRIMIN
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1984-02-17
Active Ingredient
CLOTRIMAZOLE
Application Number
18813
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1984-02-17
Regulatory Status
Discontinued
Drug Name
LYNKUET
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
2025-10-24
Active Ingredient
ELINZANETANT
Application Number
219469
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
2025-10-24
Regulatory Status
RX
Drug Name
MAGNEVIST
Product Number
1
Dosage Form
-
Strength
469.01MG/ML
Approval Date
1988-06-02
Active Ingredient
GADOPENTETATE DIMEGLUMINE
Application Number
19596
Product Number
1
Dosage Form
-
Strength
469.01MG/ML
Approval Date
1988-06-02
Regulatory Status
Discontinued
Drug Name
MAGNEVIST
Product Number
1
Dosage Form
-
Strength
469.01MG/ML
Approval Date
2000-03-10
Active Ingredient
GADOPENTETATE DIMEGLUMINE
Application Number
21037
Product Number
1
Dosage Form
-
Strength
469.01MG/ML
Approval Date
2000-03-10
Regulatory Status
Discontinued
Drug Name
MEASURIN
Product Number
2
Dosage Form
-
Strength
650MG
Approval Date
1982-01-01
Active Ingredient
ASPIRIN
Application Number
16030
Product Number
2
Dosage Form
-
Strength
650MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MENOSTAR
Product Number
7
Dosage Form
-
Strength
0.014MG/24HR
Approval Date
-
Active Ingredient
ESTRADIOL
Application Number
20375
Product Number
7
Dosage Form
-
Strength
0.014MG/24HR
Approval Date
-
Regulatory Status
Unclassified
Drug Name
MENOSTAR
Product Number
1
Dosage Form
-
Strength
0.014MG/24HR
Approval Date
2004-06-08
Active Ingredient
ESTRADIOL
Application Number
21674
Product Number
1
Dosage Form
-
Strength
0.014MG/24HR
Approval Date
2004-06-08
Regulatory Status
RX
Drug Name
METI-DERM
Product Number
2
Dosage Form
-
Strength
0.5%
Approval Date
1982-01-01
Active Ingredient
PREDNISOLONE
Application Number
10209
Product Number
2
Dosage Form
-
Strength
0.5%
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
METICORTELONE
Product Number
2
Dosage Form
-
Strength
25MG/ML
Approval Date
1982-01-01
Active Ingredient
PREDNISOLONE ACETATE
Application Number
10255
Product Number
2
Dosage Form
-
Strength
25MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
METICORTEN
Product Number
1
Dosage Form
-
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
PREDNISONE
Application Number
9766
Product Number
1
Dosage Form
-
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
METICORTEN
Product Number
2
Dosage Form
-
Strength
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
PREDNISONE
Application Number
9766
Product Number
2
Dosage Form
-
Strength
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
METIMYD
Product Number
1
Dosage Form
-
Strength
0.5%;10%
Approval Date
1982-01-01
Active Ingredient
PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM
Application Number
10210
Product Number
1
Dosage Form
-
Strength
0.5%;10%
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
METIMYD
Product Number
2
Dosage Form
-
Strength
0.5%;10%
Approval Date
1984-09-09
Active Ingredient
PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM
Application Number
10210
Product Number
2
Dosage Form
-
Strength
0.5%;10%
Approval Date
1984-09-09
Regulatory Status
Discontinued
Drug Name
METOCLOPRAMIDE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1987-02-02
Active Ingredient
METOCLOPRAMIDE HYDROCHLORIDE
Application Number
70598
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1987-02-02
Regulatory Status
Discontinued
Drug Name
METRETON
Product Number
1
Dosage Form
-
Strength
EQ 0.5% PHOSPHATE
Approval Date
1982-01-01
Active Ingredient
PREDNISOLONE SODIUM PHOSPHATE
Application Number
83834
Product Number
1
Dosage Form
-
Strength
EQ 0.5% PHOSPHATE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MIDOL
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1987-09-02
Active Ingredient
IBUPROFEN
Application Number
70591
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1987-09-02
Regulatory Status
Discontinued
Drug Name
MIDOL
Product Number
1
Dosage Form
-
Strength
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1987-09-02
Active Ingredient
IBUPROFEN
Application Number
70626
Product Number
1
Dosage Form
-
Strength
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1987-09-02
Regulatory Status
Discontinued
Drug Name
MIDOL
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1987-09-02
Active Ingredient
IBUPROFEN
Application Number
71001
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1987-09-02
Regulatory Status
Discontinued
Drug Name
MIDOL
Product Number
1
Dosage Form
-
Strength
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1987-09-02
Active Ingredient
IBUPROFEN
Application Number
71002
Product Number
1
Dosage Form
-
Strength
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1987-09-02
Regulatory Status
Discontinued
Drug Name
MIRADON
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Active Ingredient
ANISINDIONE
Application Number
10909
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MIRENA
Product Number
1
Dosage Form
-
Strength
52MG
Approval Date
2000-12-06
Active Ingredient
LEVONORGESTREL
Application Number
21225
Product Number
1
Dosage Form
-
Strength
52MG
Approval Date
2000-12-06
Regulatory Status
RX
Drug Name
MYCELEX
Product Number
1
Dosage Form
-
Strength
1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
CLOTRIMAZOLE
Application Number
18181
Product Number
1
Dosage Form
-
Strength
1% **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
MYCELEX
Product Number
2
Dosage Form
-
Strength
1%
Approval Date
-
Active Ingredient
CLOTRIMAZOLE
Application Number
18181
Product Number
2
Dosage Form
-
Strength
1%
Approval Date
-
Regulatory Status
Unclassified
Drug Name
MYCELEX
Product Number
1
Dosage Form
-
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1983-06-17
Active Ingredient
CLOTRIMAZOLE
Application Number
18713
Product Number
1
Dosage Form
-
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1983-06-17
Regulatory Status
Discontinued
Drug Name
NAQUA
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
1982-01-01
Active Ingredient
TRICHLORMETHIAZIDE
Application Number
12265
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NAQUA
Product Number
2
Dosage Form
-
Strength
4MG
Approval Date
1982-01-01
Active Ingredient
TRICHLORMETHIAZIDE
Application Number
12265
Product Number
2
Dosage Form
-
Strength
4MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NAQUIVAL
Product Number
3
Dosage Form
-
Strength
0.1MG;4MG
Approval Date
1982-01-01
Active Ingredient
RESERPINE; TRICHLORMETHIAZIDE
Application Number
12265
Product Number
3
Dosage Form
-
Strength
0.1MG;4MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NATAZIA
Product Number
1
Dosage Form
-
Strength
N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A
Approval Date
2010-05-06
Active Ingredient
DIENOGEST; ESTRADIOL VALERATE
Application Number
22252
Product Number
1
Dosage Form
-
Strength
N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A
Approval Date
2010-05-06
Regulatory Status
RX
Drug Name
NETROMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
1983-02-28
Active Ingredient
NETILMICIN SULFATE
Application Number
50544
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
1983-02-28
Regulatory Status
Discontinued
Drug Name
NETROMYCIN
Product Number
2
Dosage Form
-
Strength
EQ 25MG BASE/ML
Approval Date
1983-02-28
Active Ingredient
NETILMICIN SULFATE
Application Number
50544
Product Number
2
Dosage Form
-
Strength
EQ 25MG BASE/ML
Approval Date
1983-02-28
Regulatory Status
Discontinued
Drug Name
NETROMYCIN
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE/ML
Approval Date
1983-02-28
Active Ingredient
NETILMICIN SULFATE
Application Number
50544
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE/ML
Approval Date
1983-02-28
Regulatory Status
Discontinued
Drug Name
NEXAVAR
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2005-12-20
Active Ingredient
SORAFENIB TOSYLATE
Application Number
21923
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2005-12-20
Regulatory Status
RX
Drug Name
NORMODYNE
Product Number
1
Dosage Form
-
Strength
5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1984-08-01
Active Ingredient
LABETALOL HYDROCHLORIDE
Application Number
18686
Product Number
1
Dosage Form
-
Strength
5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1984-08-01
Regulatory Status
Discontinued
Drug Name
NORMODYNE
Product Number
1
Dosage Form
-
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1987-08-31
Active Ingredient
LABETALOL HYDROCHLORIDE
Application Number
18687
Product Number
1
Dosage Form
-
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1987-08-31
Regulatory Status
Discontinued
Drug Name
NORMODYNE
Product Number
2
Dosage Form
-
Strength
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1984-08-01
Active Ingredient
LABETALOL HYDROCHLORIDE
Application Number
18687
Product Number
2
Dosage Form
-
Strength
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1984-08-01
Regulatory Status
Discontinued
Drug Name
NORMODYNE
Product Number
3
Dosage Form
-
Strength
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1984-08-01
Active Ingredient
LABETALOL HYDROCHLORIDE
Application Number
18687
Product Number
3
Dosage Form
-
Strength
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1984-08-01
Regulatory Status
Discontinued
Drug Name
NORMODYNE
Product Number
4
Dosage Form
-
Strength
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1984-08-01
Active Ingredient
LABETALOL HYDROCHLORIDE
Application Number
18687
Product Number
4
Dosage Form
-
Strength
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1984-08-01
Regulatory Status
Discontinued
Drug Name
NORMOZIDE
Product Number
1
Dosage Form
-
Strength
25MG;100MG
Approval Date
1987-04-06
Active Ingredient
HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE
Application Number
19046
Product Number
1
Dosage Form
-
Strength
25MG;100MG
Approval Date
1987-04-06
Regulatory Status
Discontinued
Drug Name
NORMOZIDE
Product Number
2
Dosage Form
-
Strength
25MG;200MG
Approval Date
1987-04-06
Active Ingredient
HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE
Application Number
19046
Product Number
2
Dosage Form
-
Strength
25MG;200MG
Approval Date
1987-04-06
Regulatory Status
Discontinued
Drug Name
NORMOZIDE
Product Number
3
Dosage Form
-
Strength
25MG;300MG
Approval Date
1987-04-06
Active Ingredient
HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE
Application Number
19046
Product Number
3
Dosage Form
-
Strength
25MG;300MG
Approval Date
1987-04-06
Regulatory Status
Discontinued
Drug Name
NORMOZIDE
Product Number
4
Dosage Form
-
Strength
25MG;400MG
Approval Date
1987-04-06
Active Ingredient
HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE
Application Number
19046
Product Number
4
Dosage Form
-
Strength
25MG;400MG
Approval Date
1987-04-06
Regulatory Status
Discontinued
Drug Name
NOXAFIL
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2006-09-15
Active Ingredient
POSACONAZOLE
Application Number
22003
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2006-09-15
Regulatory Status
RX
Drug Name
NOXAFIL
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
-
Active Ingredient
POSACONAZOLE
Application Number
22027
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
NUBEQA
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
2019-07-30
Active Ingredient
DAROLUTAMIDE
Application Number
212099
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
2019-07-30
Regulatory Status
RX
Drug Name
OPTIMINE
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
1982-01-01
Active Ingredient
AZATADINE MALEATE
Application Number
17601
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ORETON
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
METHYLTESTOSTERONE
Application Number
80281
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ORETON METHYL
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
METHYLTESTOSTERONE
Application Number
3158
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ORETON METHYL
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Active Ingredient
METHYLTESTOSTERONE
Application Number
3158
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
OSMOVIST 190
Product Number
1
Dosage Form
-
Strength
40.6%
Approval Date
1989-12-07
Active Ingredient
IOTROLAN
Application Number
19580
Product Number
1
Dosage Form
-
Strength
40.6%
Approval Date
1989-12-07
Regulatory Status
Discontinued
Drug Name
OSMOVIST 240
Product Number
2
Dosage Form
-
Strength
51.3%
Approval Date
1989-12-07
Active Ingredient
IOTROLAN
Application Number
19580
Product Number
2
Dosage Form
-
Strength
51.3%
Approval Date
1989-12-07
Regulatory Status
Discontinued
Drug Name
OTOBIONE
Product Number
1
Dosage Form
-
Strength
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Application Number
61816
Product Number
1
Dosage Form
-
Strength
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
OTOBIOTIC
Product Number
1
Dosage Form
-
Strength
5MG/ML;EQ 10,000 UNITS BASE/ML
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE; POLYMYXIN B SULFATE
Application Number
62302
Product Number
1
Dosage Form
-
Strength
5MG/ML;EQ 10,000 UNITS BASE/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PAXIPAM
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
1982-01-01
Active Ingredient
HALAZEPAM
Application Number
17736
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PAXIPAM
Product Number
4
Dosage Form
-
Strength
40MG
Approval Date
1982-01-01
Active Ingredient
HALAZEPAM
Application Number
17736
Product Number
4
Dosage Form
-
Strength
40MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PEGINTRON
Product Number
1
Dosage Form
-
Strength
50UG/0.5ML
Approval Date
-
Active Ingredient
PEGINTERFERON ALFA-2B
Application Number
103949
Product Number
1
Dosage Form
-
Strength
50UG/0.5ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PEGINTRON
Product Number
2
Dosage Form
-
Strength
80UG/0.5ML
Approval Date
-
Active Ingredient
PEGINTERFERON ALFA-2B
Application Number
103949
Product Number
2
Dosage Form
-
Strength
80UG/0.5ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PEGINTRON
Product Number
3
Dosage Form
-
Strength
120UG/0.5ML
Approval Date
-
Active Ingredient
PEGINTERFERON ALFA-2B
Application Number
103949
Product Number
3
Dosage Form
-
Strength
120UG/0.5ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PEGINTRON
Product Number
4
Dosage Form
-
Strength
150UG/0.5ML
Approval Date
-
Active Ingredient
PEGINTERFERON ALFA-2B
Application Number
103949
Product Number
4
Dosage Form
-
Strength
150UG/0.5ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PEGINTRON
Product Number
5
Dosage Form
-
Strength
50UG/0.5ML
Approval Date
-
Active Ingredient
PEGINTERFERON ALFA-2B
Application Number
103949
Product Number
5
Dosage Form
-
Strength
50UG/0.5ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PEGINTRON
Product Number
6
Dosage Form
-
Strength
80UG/0.5ML
Approval Date
-
Active Ingredient
PEGINTERFERON ALFA-2B
Application Number
103949
Product Number
6
Dosage Form
-
Strength
80UG/0.5ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PEGINTRON
Product Number
7
Dosage Form
-
Strength
150UG/0.5ML
Approval Date
-
Active Ingredient
PEGINTERFERON ALFA-2B
Application Number
103949
Product Number
7
Dosage Form
-
Strength
150UG/0.5ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PEGINTRON
Product Number
8
Dosage Form
-
Strength
120UG/0.5ML
Approval Date
-
Active Ingredient
PEGINTERFERON ALFA-2B
Application Number
103949
Product Number
8
Dosage Form
-
Strength
120UG/0.5ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PERMITIL
Product Number
1
Dosage Form
-
Strength
0.25MG
Approval Date
1982-01-01
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
12034
Product Number
1
Dosage Form
-
Strength
0.25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PERMITIL
Product Number
4
Dosage Form
-
Strength
2.5MG
Approval Date
1982-01-01
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
12034
Product Number
4
Dosage Form
-
Strength
2.5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PERMITIL
Product Number
5
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
12034
Product Number
5
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PERMITIL
Product Number
6
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
12034
Product Number
6
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PERMITIL
Product Number
4
Dosage Form
-
Strength
1MG
Approval Date
1982-01-01
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
12419
Product Number
4
Dosage Form
-
Strength
1MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PERMITIL
Product Number
1
Dosage Form
-
Strength
5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
16008
Product Number
1
Dosage Form
-
Strength
5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
POLARAMINE
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
1982-01-01
Active Ingredient
DEXCHLORPHENIRAMINE MALEATE
Application Number
86835
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
POLARAMINE
Product Number
1
Dosage Form
-
Strength
2MG/5ML
Approval Date
1982-07-19
Active Ingredient
DEXCHLORPHENIRAMINE MALEATE
Application Number
86837
Product Number
1
Dosage Form
-
Strength
2MG/5ML
Approval Date
1982-07-19
Regulatory Status
Discontinued
Drug Name
POTASSIUM CHLORIDE
Product Number
1
Dosage Form
-
Strength
20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1986-06-13
Active Ingredient
POTASSIUM CHLORIDE
Application Number
19439
Product Number
1
Dosage Form
-
Strength
20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1986-06-13
Regulatory Status
Discontinued
Drug Name
POTASSIUM CHLORIDE
Product Number
2
Dosage Form
-
Strength
10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1986-06-13
Active Ingredient
POTASSIUM CHLORIDE
Application Number
19439
Product Number
2
Dosage Form
-
Strength
10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1986-06-13
Regulatory Status
Discontinued
Drug Name
PRANTAL
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Active Ingredient
DIPHEMANIL METHYLSULFATE
Application Number
8114
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PRECOSE
Product Number
1
Dosage Form
-
Strength
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1995-09-06
Active Ingredient
ACARBOSE
Application Number
20482
Product Number
1
Dosage Form
-
Strength
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1995-09-06
Regulatory Status
Discontinued
Drug Name
PRECOSE
Product Number
2
Dosage Form
-
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1995-09-06
Active Ingredient
ACARBOSE
Application Number
20482
Product Number
2
Dosage Form
-
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1995-09-06
Regulatory Status
Discontinued
Drug Name
PRECOSE
Product Number
4
Dosage Form
-
Strength
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-05-29
Active Ingredient
ACARBOSE
Application Number
20482
Product Number
4
Dosage Form
-
Strength
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-05-29
Regulatory Status
Discontinued
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1985-08-06
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
70120
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1985-08-06
Regulatory Status
Discontinued
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
1985-08-06
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
70121
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
1985-08-06
Regulatory Status
Discontinued
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
1985-08-06
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
70122
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
1985-08-06
Regulatory Status
Discontinued
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
1986-10-29
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
70123
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
1986-10-29
Regulatory Status
Discontinued
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
80MG
Approval Date
1985-08-06
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
70124
Product Number
1
Dosage Form
-
Strength
80MG
Approval Date
1985-08-06
Regulatory Status
Discontinued
Drug Name
PROVENTIL
Product Number
1
Dosage Form
-
Strength
0.09MG/INH
Approval Date
1982-01-01
Active Ingredient
ALBUTEROL
Application Number
17559
Product Number
1
Dosage Form
-
Strength
0.09MG/INH
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PROVENTIL
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-05-07
Active Ingredient
ALBUTEROL SULFATE
Application Number
17853
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-05-07
Regulatory Status
Discontinued
Drug Name
PROVENTIL
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-05-07
Active Ingredient
ALBUTEROL SULFATE
Application Number
17853
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-05-07
Regulatory Status
Discontinued
Drug Name
PROVENTIL
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1983-01-19
Active Ingredient
ALBUTEROL SULFATE
Application Number
18062
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1983-01-19
Regulatory Status
Discontinued
Drug Name
PROVENTIL
Product Number
1
Dosage Form
-
Strength
EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1987-01-14
Active Ingredient
ALBUTEROL SULFATE
Application Number
19243
Product Number
1
Dosage Form
-
Strength
EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1987-01-14
Regulatory Status
Discontinued
Drug Name
PROVENTIL
Product Number
2
Dosage Form
-
Strength
EQ 0.083% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1987-01-14
Active Ingredient
ALBUTEROL SULFATE
Application Number
19243
Product Number
2
Dosage Form
-
Strength
EQ 0.083% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1987-01-14
Regulatory Status
Discontinued
Drug Name
PROVENTIL
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
1987-07-13
Active Ingredient
ALBUTEROL SULFATE
Application Number
19383
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
1987-07-13
Regulatory Status
Discontinued
Drug Name
QUINACT
Product Number
1
Dosage Form
-
Strength
266MG
Approval Date
1982-01-01
Active Ingredient
QUINIDINE GLUCONATE
Application Number
85978
Product Number
1
Dosage Form
-
Strength
266MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
QUINACT
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
1982-01-01
Active Ingredient
QUINIDINE GLUCONATE
Application Number
86099
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
QUINAGLUTE
Product Number
1
Dosage Form
-
Strength
324MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
QUINIDINE GLUCONATE
Application Number
16647
Product Number
1
Dosage Form
-
Strength
324MG **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
QUINORA
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
1982-01-01
Active Ingredient
QUINIDINE SULFATE
Application Number
85222
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
REBETOL
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2003-07-29
Active Ingredient
RIBAVIRIN
Application Number
21546
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2003-07-29
Regulatory Status
Discontinued
Drug Name
RELA
Product Number
1
Dosage Form
-
Strength
350MG
Approval Date
1982-01-01
Active Ingredient
CARISOPRODOL
Application Number
12155
Product Number
1
Dosage Form
-
Strength
350MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
RENORMAX
Product Number
1
Dosage Form
-
Strength
3MG
Approval Date
1994-12-29
Active Ingredient
SPIRAPRIL HYDROCHLORIDE
Application Number
20240
Product Number
1
Dosage Form
-
Strength
3MG
Approval Date
1994-12-29
Regulatory Status
Discontinued
Drug Name
RENORMAX
Product Number
2
Dosage Form
-
Strength
6MG
Approval Date
1994-12-29
Active Ingredient
SPIRAPRIL HYDROCHLORIDE
Application Number
20240
Product Number
2
Dosage Form
-
Strength
6MG
Approval Date
1994-12-29
Regulatory Status
Discontinued
Drug Name
RENORMAX
Product Number
3
Dosage Form
-
Strength
12MG
Approval Date
1994-12-29
Active Ingredient
SPIRAPRIL HYDROCHLORIDE
Application Number
20240
Product Number
3
Dosage Form
-
Strength
12MG
Approval Date
1994-12-29
Regulatory Status
Discontinued
Drug Name
RENORMAX
Product Number
4
Dosage Form
-
Strength
24MG
Approval Date
1994-12-29
Active Ingredient
SPIRAPRIL HYDROCHLORIDE
Application Number
20240
Product Number
4
Dosage Form
-
Strength
24MG
Approval Date
1994-12-29
Regulatory Status
Discontinued
Drug Name
SAFYRAL
Product Number
1
Dosage Form
-
Strength
3MG,N/A;0.03MG,N/A;0.451MG,0.451MG
Approval Date
2010-12-16
Active Ingredient
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
Application Number
22574
Product Number
1
Dosage Form
-
Strength
3MG,N/A;0.03MG,N/A;0.451MG,0.451MG
Approval Date
2010-12-16
Regulatory Status
RX
Drug Name
SKYLA
Product Number
1
Dosage Form
-
Strength
13.5MG
Approval Date
2013-01-09
Active Ingredient
LEVONORGESTREL
Application Number
203159
Product Number
1
Dosage Form
-
Strength
13.5MG
Approval Date
2013-01-09
Regulatory Status
RX
Drug Name
SODIUM SULAMYD
Product Number
1
Dosage Form
-
Strength
10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
SULFACETAMIDE SODIUM
Application Number
5963
Product Number
1
Dosage Form
-
Strength
10% **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
SODIUM SULAMYD
Product Number
2
Dosage Form
-
Strength
10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
SULFACETAMIDE SODIUM
Application Number
5963
Product Number
2
Dosage Form
-
Strength
10% **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
SODIUM SULAMYD
Product Number
3
Dosage Form
-
Strength
30% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
SULFACETAMIDE SODIUM
Application Number
5963
Product Number
3
Dosage Form
-
Strength
30% **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
STAXYN
Product Number
1
Dosage Form
-
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2010-06-17
Active Ingredient
VARDENAFIL HYDROCHLORIDE
Application Number
200179
Product Number
1
Dosage Form
-
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2010-06-17
Regulatory Status
Discontinued
Drug Name
STIVARGA
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2012-09-27
Active Ingredient
REGORAFENIB
Application Number
203085
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2012-09-27
Regulatory Status
RX
Drug Name
SULLA
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Active Ingredient
SULFAMETER
Application Number
16000
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
SYLATRON
Product Number
9
Dosage Form
-
Strength
296 MCG LYOPHILIZED POWDER PER SINGLE-USE VIAL
Approval Date
-
Active Ingredient
PEGINTERFERON ALFA-2B
Application Number
103949
Product Number
9
Dosage Form
-
Strength
296 MCG LYOPHILIZED POWDER PER SINGLE-USE VIAL
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SYLATRON
Product Number
10
Dosage Form
-
Strength
444 MCG LYOPHILIZED POWDER PER SINGLE-USE VIAL
Approval Date
-
Active Ingredient
PEGINTERFERON ALFA-2B
Application Number
103949
Product Number
10
Dosage Form
-
Strength
444 MCG LYOPHILIZED POWDER PER SINGLE-USE VIAL
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SYLATRON
Product Number
11
Dosage Form
-
Strength
888 MCG LYOPHILIZED POWDER PER SINGLE-USE VIAL
Approval Date
-
Active Ingredient
PEGINTERFERON ALFA-2B
Application Number
103949
Product Number
11
Dosage Form
-
Strength
888 MCG LYOPHILIZED POWDER PER SINGLE-USE VIAL
Approval Date
-
Regulatory Status
Unclassified
Drug Name
THEO-DUR
Product Number
1
Dosage Form
-
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
THEOPHYLLINE
Application Number
85328
Product Number
1
Dosage Form
-
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
THEO-DUR
Product Number
2
Dosage Form
-
Strength
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
THEOPHYLLINE
Application Number
85328
Product Number
2
Dosage Form
-
Strength
300MG **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
THEO-DUR
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1982-01-01
Active Ingredient
THEOPHYLLINE
Application Number
86998
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
THEO-DUR
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1985-09-10
Active Ingredient
THEOPHYLLINE
Application Number
87995
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1985-09-10
Regulatory Status
Discontinued
Drug Name
THEO-DUR
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
1985-09-10
Active Ingredient
THEOPHYLLINE
Application Number
88015
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
1985-09-10
Regulatory Status
Discontinued
Drug Name
THEO-DUR
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
1985-09-10
Active Ingredient
THEOPHYLLINE
Application Number
88016
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
1985-09-10
Regulatory Status
Discontinued
Drug Name
THEO-DUR
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1985-09-10
Active Ingredient
THEOPHYLLINE
Application Number
88022
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1985-09-10
Regulatory Status
Discontinued
Drug Name
THEO-DUR
Product Number
1
Dosage Form
-
Strength
450MG
Approval Date
1986-06-25
Active Ingredient
THEOPHYLLINE
Application Number
89131
Product Number
1
Dosage Form
-
Strength
450MG
Approval Date
1986-06-25
Regulatory Status
Discontinued
Drug Name
THEOVENT
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
1985-01-31
Active Ingredient
THEOPHYLLINE
Application Number
87010
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
1985-01-31
Regulatory Status
Discontinued
Drug Name
THEOVENT
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1985-01-31
Active Ingredient
THEOPHYLLINE
Application Number
87910
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1985-01-31
Regulatory Status
Discontinued
Drug Name
TINDAL
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
1982-01-01
Active Ingredient
ACETOPHENAZINE MALEATE
Application Number
12254
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TRASYLOL
Product Number
1
Dosage Form
-
Strength
10,000KIU/ML
Approval Date
-
Active Ingredient
APROTININ
Application Number
20304
Product Number
1
Dosage Form
-
Strength
10,000KIU/ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
TREMIN
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
1982-01-01
Active Ingredient
TRIHEXYPHENIDYL HYDROCHLORIDE
Application Number
80381
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TREMIN
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Active Ingredient
TRIHEXYPHENIDYL HYDROCHLORIDE
Application Number
80381
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TRILAFON
Product Number
1
Dosage Form
-
Strength
2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
PERPHENAZINE
Application Number
10775
Product Number
1
Dosage Form
-
Strength
2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TRILAFON
Product Number
2
Dosage Form
-
Strength
4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
PERPHENAZINE
Application Number
10775
Product Number
2
Dosage Form
-
Strength
4MG **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
TRILAFON
Product Number
3
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
PERPHENAZINE
Application Number
10775
Product Number
3
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
TRILAFON
Product Number
4
Dosage Form
-
Strength
16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
PERPHENAZINE
Application Number
10775
Product Number
4
Dosage Form
-
Strength
16MG **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
TRILAFON
Product Number
2
Dosage Form
-
Strength
5MG/ML
Approval Date
1982-01-01
Active Ingredient
PERPHENAZINE
Application Number
11213
Product Number
2
Dosage Form
-
Strength
5MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TRILAFON
Product Number
2
Dosage Form
-
Strength
2MG/5ML
Approval Date
1982-01-01
Active Ingredient
PERPHENAZINE
Application Number
11294
Product Number
2
Dosage Form
-
Strength
2MG/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TRILAFON
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
1982-01-01
Active Ingredient
PERPHENAZINE
Application Number
11361
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TRILAFON
Product Number
1
Dosage Form
-
Strength
16MG/5ML
Approval Date
1982-01-01
Active Ingredient
PERPHENAZINE
Application Number
11557
Product Number
1
Dosage Form
-
Strength
16MG/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TRINALIN
Product Number
1
Dosage Form
-
Strength
1MG;120MG
Approval Date
1982-03-23
Active Ingredient
AZATADINE MALEATE; PSEUDOEPHEDRINE SULFATE
Application Number
18506
Product Number
1
Dosage Form
-
Strength
1MG;120MG
Approval Date
1982-03-23
Regulatory Status
Discontinued
Drug Name
ULTRAVIST (PHARMACY BULK)
Product Number
1
Dosage Form
-
Strength
62.3%
Approval Date
2002-09-20
Active Ingredient
IOPROMIDE
Application Number
21425
Product Number
1
Dosage Form
-
Strength
62.3%
Approval Date
2002-09-20
Regulatory Status
RX
Drug Name
ULTRAVIST (PHARMACY BULK)
Product Number
2
Dosage Form
-
Strength
76.9%
Approval Date
2002-09-20
Active Ingredient
IOPROMIDE
Application Number
21425
Product Number
2
Dosage Form
-
Strength
76.9%
Approval Date
2002-09-20
Regulatory Status
RX
Drug Name
ULTRAVIST (PHARMACY BULK)
Product Number
3
Dosage Form
-
Strength
49.9%
Approval Date
2004-03-12
Active Ingredient
IOPROMIDE
Application Number
21425
Product Number
3
Dosage Form
-
Strength
49.9%
Approval Date
2004-03-12
Regulatory Status
Discontinued
Drug Name
ULTRAVIST 150
Product Number
4
Dosage Form
-
Strength
31.2%
Approval Date
1995-05-10
Active Ingredient
IOPROMIDE
Application Number
20220
Product Number
4
Dosage Form
-
Strength
31.2%
Approval Date
1995-05-10
Regulatory Status
Discontinued
Drug Name
ULTRAVIST 240
Product Number
3
Dosage Form
-
Strength
49.9%
Approval Date
1995-05-10
Active Ingredient
IOPROMIDE
Application Number
20220
Product Number
3
Dosage Form
-
Strength
49.9%
Approval Date
1995-05-10
Regulatory Status
Discontinued
Drug Name
ULTRAVIST 300
Product Number
2
Dosage Form
-
Strength
62.3%
Approval Date
1995-05-10
Active Ingredient
IOPROMIDE
Application Number
20220
Product Number
2
Dosage Form
-
Strength
62.3%
Approval Date
1995-05-10
Regulatory Status
RX
Drug Name
ULTRAVIST 300 IN PLASTIC CONTAINER
Product Number
5
Dosage Form
-
Strength
62.3%
Approval Date
2008-11-18
Active Ingredient
IOPROMIDE
Application Number
20220
Product Number
5
Dosage Form
-
Strength
62.3%
Approval Date
2008-11-18
Regulatory Status
Discontinued
Drug Name
ULTRAVIST 370
Product Number
1
Dosage Form
-
Strength
76.9%
Approval Date
1995-05-10
Active Ingredient
IOPROMIDE
Application Number
20220
Product Number
1
Dosage Form
-
Strength
76.9%
Approval Date
1995-05-10
Regulatory Status
RX
Drug Name
UNI-DUR
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
1995-01-04
Active Ingredient
THEOPHYLLINE
Application Number
89822
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
1995-01-04
Regulatory Status
Discontinued
Drug Name
UNI-DUR
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
1995-01-04
Active Ingredient
THEOPHYLLINE
Application Number
89823
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
1995-01-04
Regulatory Status
Discontinued
Drug Name
UROVIST CYSTO
Product Number
1
Dosage Form
-
Strength
30%
Approval Date
1982-09-23
Active Ingredient
DIATRIZOATE MEGLUMINE
Application Number
87729
Product Number
1
Dosage Form
-
Strength
30%
Approval Date
1982-09-23
Regulatory Status
Discontinued
Drug Name
UROVIST CYSTO PEDIATRIC
Product Number
1
Dosage Form
-
Strength
30%
Approval Date
1982-09-23
Active Ingredient
DIATRIZOATE MEGLUMINE
Application Number
87731
Product Number
1
Dosage Form
-
Strength
30%
Approval Date
1982-09-23
Regulatory Status
Discontinued
Drug Name
UROVIST MEGLUMINE DIU/CT
Product Number
1
Dosage Form
-
Strength
30%
Approval Date
1982-09-23
Active Ingredient
DIATRIZOATE MEGLUMINE
Application Number
87739
Product Number
1
Dosage Form
-
Strength
30%
Approval Date
1982-09-23
Regulatory Status
Discontinued
Drug Name
UROVIST SODIUM 300
Product Number
1
Dosage Form
-
Strength
50%
Approval Date
1982-09-23
Active Ingredient
DIATRIZOATE SODIUM
Application Number
87725
Product Number
1
Dosage Form
-
Strength
50%
Approval Date
1982-09-23
Regulatory Status
Discontinued
Drug Name
VALISONE
Product Number
1
Dosage Form
-
Strength
EQ 0.1% BASE
Approval Date
1982-01-01
Active Ingredient
BETAMETHASONE VALERATE
Application Number
16322
Product Number
1
Dosage Form
-
Strength
EQ 0.1% BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
VALISONE
Product Number
2
Dosage Form
-
Strength
EQ 0.01% BASE
Approval Date
1982-01-01
Active Ingredient
BETAMETHASONE VALERATE
Application Number
16322
Product Number
2
Dosage Form
-
Strength
EQ 0.01% BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
VALISONE
Product Number
1
Dosage Form
-
Strength
EQ 0.1% BASE
Approval Date
1982-01-01
Active Ingredient
BETAMETHASONE VALERATE
Application Number
16740
Product Number
1
Dosage Form
-
Strength
EQ 0.1% BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
VALISONE
Product Number
1
Dosage Form
-
Strength
EQ 0.1% BASE
Approval Date
1982-01-01
Active Ingredient
BETAMETHASONE VALERATE
Application Number
16932
Product Number
1
Dosage Form
-
Strength
EQ 0.1% BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
VANCENASE
Product Number
1
Dosage Form
-
Strength
0.042MG/INH
Approval Date
1982-01-01
Active Ingredient
BECLOMETHASONE DIPROPIONATE
Application Number
18521
Product Number
1
Dosage Form
-
Strength
0.042MG/INH
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
VANCENASE AQ
Product Number
1
Dosage Form
-
Strength
EQ 0.042MG DIPROP/SPRAY
Approval Date
1987-12-23
Active Ingredient
BECLOMETHASONE DIPROPIONATE MONOHYDRATE
Application Number
19589
Product Number
1
Dosage Form
-
Strength
EQ 0.042MG DIPROP/SPRAY
Approval Date
1987-12-23
Regulatory Status
Discontinued
Drug Name
VANCENASE AQ
Product Number
1
Dosage Form
-
Strength
EQ 0.084MG DIPROP/SPRAY
Approval Date
1996-06-26
Active Ingredient
BECLOMETHASONE DIPROPIONATE MONOHYDRATE
Application Number
20469
Product Number
1
Dosage Form
-
Strength
EQ 0.084MG DIPROP/SPRAY
Approval Date
1996-06-26
Regulatory Status
Discontinued
Drug Name
VANCERIL
Product Number
1
Dosage Form
-
Strength
0.042MG/INH
Approval Date
1982-01-01
Active Ingredient
BECLOMETHASONE DIPROPIONATE
Application Number
17573
Product Number
1
Dosage Form
-
Strength
0.042MG/INH
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
VANCERIL DOUBLE STRENGTH
Product Number
1
Dosage Form
-
Strength
0.084MG/INH
Approval Date
1996-12-24
Active Ingredient
BECLOMETHASONE DIPROPIONATE
Application Number
20486
Product Number
1
Dosage Form
-
Strength
0.084MG/INH
Approval Date
1996-12-24
Regulatory Status
Discontinued
Drug Name
VI-TWEL
Product Number
2
Dosage Form
-
Strength
1MG/ML
Approval Date
1982-01-01
Active Ingredient
CYANOCOBALAMIN
Application Number
7012
Product Number
2
Dosage Form
-
Strength
1MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
VITRAKVI
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2018-11-26
Active Ingredient
LAROTRECTINIB SULFATE
Application Number
210861
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2018-11-26
Regulatory Status
RX
Drug Name
VITRAKVI
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2018-11-26
Active Ingredient
LAROTRECTINIB SULFATE
Application Number
210861
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2018-11-26
Regulatory Status
RX
Drug Name
VITRAKVI
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/ML
Approval Date
2018-11-26
Active Ingredient
LAROTRECTINIB SULFATE
Application Number
211710
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/ML
Approval Date
2018-11-26
Regulatory Status
RX
Drug Name
XOFIGO
Product Number
1
Dosage Form
-
Strength
162mCi/6ML (27mCi/ML)
Approval Date
2013-05-15
Active Ingredient
RADIUM RA-223 DICHLORIDE
Application Number
203971
Product Number
1
Dosage Form
-
Strength
162mCi/6ML (27mCi/ML)
Approval Date
2013-05-15
Regulatory Status
RX
Drug Name
YASMIN
Product Number
1
Dosage Form
-
Strength
3MG;0.03MG
Approval Date
2001-05-11
Active Ingredient
DROSPIRENONE; ETHINYL ESTRADIOL
Application Number
21098
Product Number
1
Dosage Form
-
Strength
3MG;0.03MG
Approval Date
2001-05-11
Regulatory Status
RX
Drug Name
YAZ
Product Number
1
Dosage Form
-
Strength
3MG;0.02MG
Approval Date
2006-03-16
Active Ingredient
DROSPIRENONE; ETHINYL ESTRADIOL
Application Number
21676
Product Number
1
Dosage Form
-
Strength
3MG;0.02MG
Approval Date
2006-03-16
Regulatory Status
RX
Drug Name
YAZ
Product Number
1
Dosage Form
-
Strength
3MG; 0.02MG
Approval Date
-
Active Ingredient
DROSPIRENONE; ETHINYL ESTRADIOL
Application Number
21873
Product Number
1
Dosage Form
-
Strength
3MG; 0.02MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
YAZ
Product Number
1
Dosage Form
-
Strength
3MG; 0.02MG
Approval Date
-
Active Ingredient
DROSPIRENONE; ETHINYL ESTRADIOL
Application Number
22045
Product Number
1
Dosage Form
-
Strength
3MG; 0.02MG
Approval Date
-
Regulatory Status
Unclassified
Drug Status Breakdown
277 total- Discontinued
- RX
- OTC
- Unclassified
Official Source
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Drug Name
8-HOUR BAYER
Application Number
16030
Product Number
1
Active Ingredient
ASPIRIN
Dosage Form
-
Strength
650MG
FDA Approved Drug Data
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