AbbVie Inc
FDA Approved Drugs
AbbVie Inc
FDA Approved Drugs Database
FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.
- Total Records 301
- Latest Approval Date Dec 18, 2025
- Data Source FDA
- First Approval Date Jan 01, 1982
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AbbVie Inc
1 North Waukegan Road North Chicago, IL 60064
U.S.A
www.abbvie.com/ abbviecontractmfg@abbvie.com View on MapFDA Approved Drug Records ( 301 records )
Drug Name
ACULAR
Product Number
1
Dosage Form
-
Strength
0.5%
Approval Date
1992-11-09
Active Ingredient
KETOROLAC TROMETHAMINE
Application Number
19700
Product Number
1
Dosage Form
-
Strength
0.5%
Approval Date
1992-11-09
Regulatory Status
RX
Drug Name
ACULAR LS
Product Number
1
Dosage Form
-
Strength
0.4%
Approval Date
2003-05-30
Active Ingredient
KETOROLAC TROMETHAMINE
Application Number
21528
Product Number
1
Dosage Form
-
Strength
0.4%
Approval Date
2003-05-30
Regulatory Status
RX
Drug Name
ACUVAIL
Product Number
1
Dosage Form
-
Strength
0.45%
Approval Date
2009-07-22
Active Ingredient
KETOROLAC TROMETHAMINE
Application Number
22427
Product Number
1
Dosage Form
-
Strength
0.45%
Approval Date
2009-07-22
Regulatory Status
RX
Drug Name
ACYCLOVIR
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/ML
Approval Date
1999-07-26
Active Ingredient
ACYCLOVIR SODIUM
Application Number
75114
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/ML
Approval Date
1999-07-26
Regulatory Status
Discontinued
Drug Name
AKINETON
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
1982-01-01
Active Ingredient
BIPERIDEN HYDROCHLORIDE
Application Number
12003
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
AKINETON
Product Number
2
Dosage Form
-
Strength
5MG/ML
Approval Date
1982-01-01
Active Ingredient
BIPERIDEN LACTATE
Application Number
12418
Product Number
2
Dosage Form
-
Strength
5MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ALORA
Product Number
1
Dosage Form
-
Strength
0.05MG/24HR
Approval Date
1996-12-20
Active Ingredient
ESTRADIOL
Application Number
20655
Product Number
1
Dosage Form
-
Strength
0.05MG/24HR
Approval Date
1996-12-20
Regulatory Status
Discontinued
Drug Name
ALORA
Product Number
2
Dosage Form
-
Strength
0.075MG/24HR
Approval Date
1996-12-20
Active Ingredient
ESTRADIOL
Application Number
20655
Product Number
2
Dosage Form
-
Strength
0.075MG/24HR
Approval Date
1996-12-20
Regulatory Status
Discontinued
Drug Name
ALORA
Product Number
3
Dosage Form
-
Strength
0.1MG/24HR
Approval Date
1996-12-20
Active Ingredient
ESTRADIOL
Application Number
20655
Product Number
3
Dosage Form
-
Strength
0.1MG/24HR
Approval Date
1996-12-20
Regulatory Status
Discontinued
Drug Name
ALORA
Product Number
4
Dosage Form
-
Strength
0.025MG/24HR
Approval Date
2002-04-05
Active Ingredient
ESTRADIOL
Application Number
20655
Product Number
4
Dosage Form
-
Strength
0.025MG/24HR
Approval Date
2002-04-05
Regulatory Status
Discontinued
Drug Name
ALPHAGAN P
Product Number
1
Dosage Form
-
Strength
0.15%
Approval Date
2001-03-16
Active Ingredient
BRIMONIDINE TARTRATE
Application Number
21262
Product Number
1
Dosage Form
-
Strength
0.15%
Approval Date
2001-03-16
Regulatory Status
RX
Drug Name
ALPHAGAN P
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2005-08-19
Active Ingredient
BRIMONIDINE TARTRATE
Application Number
21770
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2005-08-19
Regulatory Status
RX
Drug Name
AMINOSOL 5%
Product Number
12
Dosage Form
-
Strength
5%
Approval Date
1985-01-31
Active Ingredient
PROTEIN HYDROLYSATE
Application Number
5932
Product Number
12
Dosage Form
-
Strength
5%
Approval Date
1985-01-31
Regulatory Status
Discontinued
Drug Name
ANDRODERM
Product Number
1
Dosage Form
-
Strength
2.5MG/24HR
Approval Date
1995-09-29
Active Ingredient
TESTOSTERONE
Application Number
20489
Product Number
1
Dosage Form
-
Strength
2.5MG/24HR
Approval Date
1995-09-29
Regulatory Status
Discontinued
Drug Name
ANDRODERM
Product Number
2
Dosage Form
-
Strength
5MG/24HR
Approval Date
1997-05-02
Active Ingredient
TESTOSTERONE
Application Number
20489
Product Number
2
Dosage Form
-
Strength
5MG/24HR
Approval Date
1997-05-02
Regulatory Status
Discontinued
Drug Name
ANDRODERM
Product Number
3
Dosage Form
-
Strength
2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2011-10-20
Active Ingredient
TESTOSTERONE
Application Number
20489
Product Number
3
Dosage Form
-
Strength
2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2011-10-20
Regulatory Status
Discontinued
Drug Name
ANDRODERM
Product Number
4
Dosage Form
-
Strength
4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2011-10-20
Active Ingredient
TESTOSTERONE
Application Number
20489
Product Number
4
Dosage Form
-
Strength
4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2011-10-20
Regulatory Status
Discontinued
Drug Name
ASACOL HD
Product Number
1
Dosage Form
-
Strength
800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2008-05-29
Active Ingredient
MESALAMINE
Application Number
21830
Product Number
1
Dosage Form
-
Strength
800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2008-05-29
Regulatory Status
Discontinued
Drug Name
ATROPINE
Product Number
1
Dosage Form
-
Strength
EQ 2MG SULFATE/0.7ML
Approval Date
1987-01-30
Active Ingredient
ATROPINE
Application Number
71295
Product Number
1
Dosage Form
-
Strength
EQ 2MG SULFATE/0.7ML
Approval Date
1987-01-30
Regulatory Status
Discontinued
Drug Name
ATROPINE AND DEMEROL
Product Number
1
Dosage Form
-
Strength
0.4MG/ML;75MG/ML
Approval Date
1982-11-26
Active Ingredient
ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE
Application Number
87847
Product Number
1
Dosage Form
-
Strength
0.4MG/ML;75MG/ML
Approval Date
1982-11-26
Regulatory Status
Discontinued
Drug Name
ATROPINE AND DEMEROL
Product Number
1
Dosage Form
-
Strength
0.4MG/ML;100MG/ML
Approval Date
1982-11-26
Active Ingredient
ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE
Application Number
87848
Product Number
1
Dosage Form
-
Strength
0.4MG/ML;100MG/ML
Approval Date
1982-11-26
Regulatory Status
Discontinued
Drug Name
ATROPINE AND DEMEROL
Product Number
1
Dosage Form
-
Strength
0.4MG/ML;50MG/ML
Approval Date
1982-11-26
Active Ingredient
ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE
Application Number
87853
Product Number
1
Dosage Form
-
Strength
0.4MG/ML;50MG/ML
Approval Date
1982-11-26
Regulatory Status
Discontinued
Drug Name
AVYCAZ
Product Number
1
Dosage Form
-
Strength
EQ 0.5GM BASE;2GM/VIAL
Approval Date
2015-02-25
Active Ingredient
AVIBACTAM SODIUM; CEFTAZIDIME
Application Number
206494
Product Number
1
Dosage Form
-
Strength
EQ 0.5GM BASE;2GM/VIAL
Approval Date
2015-02-25
Regulatory Status
RX
Drug Name
AZMACORT
Product Number
1
Dosage Form
-
Strength
0.1MG/INH
Approval Date
1982-04-23
Active Ingredient
TRIAMCINOLONE ACETONIDE
Application Number
18117
Product Number
1
Dosage Form
-
Strength
0.1MG/INH
Approval Date
1982-04-23
Regulatory Status
Discontinued
Drug Name
BENTYL
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
1984-10-15
Active Ingredient
DICYCLOMINE HYDROCHLORIDE
Application Number
8370
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
1984-10-15
Regulatory Status
Discontinued
Drug Name
BENTYL PRESERVATIVE FREE
Product Number
2
Dosage Form
-
Strength
10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1984-10-15
Active Ingredient
DICYCLOMINE HYDROCHLORIDE
Application Number
8370
Product Number
2
Dosage Form
-
Strength
10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1984-10-15
Regulatory Status
Discontinued
Drug Name
BIAXIN
Product Number
1
Dosage Form
-
Strength
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1991-10-31
Active Ingredient
CLARITHROMYCIN
Application Number
50662
Product Number
1
Dosage Form
-
Strength
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1991-10-31
Regulatory Status
Discontinued
Drug Name
BIAXIN
Product Number
2
Dosage Form
-
Strength
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1991-10-31
Active Ingredient
CLARITHROMYCIN
Application Number
50662
Product Number
2
Dosage Form
-
Strength
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1991-10-31
Regulatory Status
Discontinued
Drug Name
BIAXIN
Product Number
1
Dosage Form
-
Strength
125MG/5ML
Approval Date
1993-12-23
Active Ingredient
CLARITHROMYCIN
Application Number
50698
Product Number
1
Dosage Form
-
Strength
125MG/5ML
Approval Date
1993-12-23
Regulatory Status
Discontinued
Drug Name
BIAXIN
Product Number
2
Dosage Form
-
Strength
250MG/5ML
Approval Date
1993-12-23
Active Ingredient
CLARITHROMYCIN
Application Number
50698
Product Number
2
Dosage Form
-
Strength
250MG/5ML
Approval Date
1993-12-23
Regulatory Status
Discontinued
Drug Name
BIAXIN
Product Number
3
Dosage Form
-
Strength
187MG/5ML
Approval Date
1998-09-30
Active Ingredient
CLARITHROMYCIN
Application Number
50698
Product Number
3
Dosage Form
-
Strength
187MG/5ML
Approval Date
1998-09-30
Regulatory Status
Discontinued
Drug Name
BIAXIN XL
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
-
Active Ingredient
CLARITHROMYCIN
Application Number
50697
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
BIAXIN XL
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
-
Active Ingredient
CLARITHROMYCIN
Application Number
50697
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
BIAXIN XL
Product Number
1
Dosage Form
-
Strength
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2000-03-03
Active Ingredient
CLARITHROMYCIN
Application Number
50775
Product Number
1
Dosage Form
-
Strength
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2000-03-03
Regulatory Status
Discontinued
Drug Name
BYVALSON
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;80MG
Approval Date
2016-06-03
Active Ingredient
NEBIVOLOL HYDROCHLORIDE; VALSARTAN
Application Number
206302
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;80MG
Approval Date
2016-06-03
Regulatory Status
Discontinued
Drug Name
CALCIJEX
Product Number
1
Dosage Form
-
Strength
0.001MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1986-09-25
Active Ingredient
CALCITRIOL
Application Number
18874
Product Number
1
Dosage Form
-
Strength
0.001MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1986-09-25
Regulatory Status
Discontinued
Drug Name
CALCIJEX
Product Number
2
Dosage Form
-
Strength
0.002MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1986-09-25
Active Ingredient
CALCITRIOL
Application Number
18874
Product Number
2
Dosage Form
-
Strength
0.002MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1986-09-25
Regulatory Status
Discontinued
Drug Name
CANASA
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2001-01-05
Active Ingredient
MESALAMINE
Application Number
21252
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2001-01-05
Regulatory Status
Discontinued
Drug Name
CANASA
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2004-11-05
Active Ingredient
MESALAMINE
Application Number
21252
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2004-11-05
Regulatory Status
RX
Drug Name
CARAFATE
Product Number
1
Dosage Form
-
Strength
1GM
Approval Date
1982-01-01
Active Ingredient
SUCRALFATE
Application Number
18333
Product Number
1
Dosage Form
-
Strength
1GM
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
CARAFATE
Product Number
1
Dosage Form
-
Strength
1GM/10ML
Approval Date
1993-12-16
Active Ingredient
SUCRALFATE
Application Number
19183
Product Number
1
Dosage Form
-
Strength
1GM/10ML
Approval Date
1993-12-16
Regulatory Status
Discontinued
Drug Name
CARTROL
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
1988-12-28
Active Ingredient
CARTEOLOL HYDROCHLORIDE
Application Number
19204
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
1988-12-28
Regulatory Status
Discontinued
Drug Name
CARTROL
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
1988-12-28
Active Ingredient
CARTEOLOL HYDROCHLORIDE
Application Number
19204
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
1988-12-28
Regulatory Status
Discontinued
Drug Name
CARTROL
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
1988-12-28
Active Ingredient
CARTEOLOL HYDROCHLORIDE
Application Number
19204
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
1988-12-28
Regulatory Status
Discontinued
Drug Name
CELEXA
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2000-04-27
Active Ingredient
CITALOPRAM HYDROBROMIDE
Application Number
20822
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2000-04-27
Regulatory Status
RX
Drug Name
CELEXA
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
1998-07-17
Active Ingredient
CITALOPRAM HYDROBROMIDE
Application Number
20822
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
1998-07-17
Regulatory Status
RX
Drug Name
CELEXA
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
1998-07-17
Active Ingredient
CITALOPRAM HYDROBROMIDE
Application Number
20822
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
1998-07-17
Regulatory Status
RX
Drug Name
CELEXA
Product Number
4
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
1998-07-17
Active Ingredient
CITALOPRAM HYDROBROMIDE
Application Number
20822
Product Number
4
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
1998-07-17
Regulatory Status
Discontinued
Drug Name
CHOLOXIN
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
1982-01-01
Active Ingredient
DEXTROTHYROXINE SODIUM
Application Number
12302
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CHOLOXIN
Product Number
4
Dosage Form
-
Strength
4MG
Approval Date
1982-01-01
Active Ingredient
DEXTROTHYROXINE SODIUM
Application Number
12302
Product Number
4
Dosage Form
-
Strength
4MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CHOLOXIN
Product Number
5
Dosage Form
-
Strength
1MG
Approval Date
1982-01-01
Active Ingredient
DEXTROTHYROXINE SODIUM
Application Number
12302
Product Number
5
Dosage Form
-
Strength
1MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CHOLOXIN
Product Number
6
Dosage Form
-
Strength
6MG
Approval Date
1982-01-01
Active Ingredient
DEXTROTHYROXINE SODIUM
Application Number
12302
Product Number
6
Dosage Form
-
Strength
6MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
COMBIGAN
Product Number
1
Dosage Form
-
Strength
0.2%;EQ 0.5% BASE
Approval Date
2007-10-30
Active Ingredient
BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Application Number
21398
Product Number
1
Dosage Form
-
Strength
0.2%;EQ 0.5% BASE
Approval Date
2007-10-30
Regulatory Status
RX
Drug Name
CREON
Product Number
1
Dosage Form
-
Strength
30,000USP UNITS;6,000USP UNITS;19,000USP UNITS
Approval Date
-
Active Ingredient
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
Application Number
20725
Product Number
1
Dosage Form
-
Strength
30,000USP UNITS;6,000USP UNITS;19,000USP UNITS
Approval Date
-
Regulatory Status
Unclassified
Drug Name
CREON
Product Number
2
Dosage Form
-
Strength
60,000USP UNITS;12,000USP UNITS;38,000USP UNITS
Approval Date
-
Active Ingredient
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
Application Number
20725
Product Number
2
Dosage Form
-
Strength
60,000USP UNITS;12,000USP UNITS;38,000USP UNITS
Approval Date
-
Regulatory Status
Unclassified
Drug Name
CREON
Product Number
3
Dosage Form
-
Strength
120,000USP UNITS;24,000USP UNITS;76,000USP UNITS
Approval Date
-
Active Ingredient
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
Application Number
20725
Product Number
3
Dosage Form
-
Strength
120,000USP UNITS;24,000USP UNITS;76,000USP UNITS
Approval Date
-
Regulatory Status
Unclassified
Drug Name
CREON
Product Number
4
Dosage Form
-
Strength
15,000USP UNITS;3,000USP UNITS;9,500USP UNITS
Approval Date
-
Active Ingredient
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
Application Number
20725
Product Number
4
Dosage Form
-
Strength
15,000USP UNITS;3,000USP UNITS;9,500USP UNITS
Approval Date
-
Regulatory Status
Unclassified
Drug Name
CREON
Product Number
5
Dosage Form
-
Strength
180,000USP UNITS;36,000USP UNITS;114,000USP UNITS
Approval Date
-
Active Ingredient
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
Application Number
20725
Product Number
5
Dosage Form
-
Strength
180,000USP UNITS;36,000USP UNITS;114,000USP UNITS
Approval Date
-
Regulatory Status
Unclassified
Drug Name
CRINONE
Product Number
1
Dosage Form
-
Strength
4%
Approval Date
1997-07-31
Active Ingredient
PROGESTERONE
Application Number
20701
Product Number
1
Dosage Form
-
Strength
4%
Approval Date
1997-07-31
Regulatory Status
Discontinued
Drug Name
CRINONE
Product Number
2
Dosage Form
-
Strength
8%
Approval Date
1997-07-31
Active Ingredient
PROGESTERONE
Application Number
20701
Product Number
2
Dosage Form
-
Strength
8%
Approval Date
1997-07-31
Regulatory Status
RX
Drug Name
CYCLOSPORINE
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2000-03-03
Active Ingredient
CYCLOSPORINE
Application Number
65025
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2000-03-03
Regulatory Status
Discontinued
Drug Name
DALVANCE
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2014-05-23
Active Ingredient
DALBAVANCIN HYDROCHLORIDE
Application Number
21883
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2014-05-23
Regulatory Status
RX
Drug Name
DECNUPAZ
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
-
Active Ingredient
PIVEKIMAB SUNIRINE-PVZY
Application Number
761460
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DELZICOL
Product Number
1
Dosage Form
-
Strength
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2013-02-01
Active Ingredient
MESALAMINE
Application Number
204412
Product Number
1
Dosage Form
-
Strength
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2013-02-01
Regulatory Status
Discontinued
Drug Name
DEPACON
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1996-12-30
Active Ingredient
VALPROATE SODIUM
Application Number
20593
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1996-12-30
Regulatory Status
Discontinued
Drug Name
DEPAKENE
Product Number
1
Dosage Form
-
Strength
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
VALPROIC ACID
Application Number
18081
Product Number
1
Dosage Form
-
Strength
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DEPAKENE
Product Number
1
Dosage Form
-
Strength
250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
VALPROIC ACID
Application Number
18082
Product Number
1
Dosage Form
-
Strength
250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DEPAKOTE
Product Number
1
Dosage Form
-
Strength
EQ 250MG VALPROIC ACID
Approval Date
1983-03-10
Active Ingredient
DIVALPROEX SODIUM
Application Number
18723
Product Number
1
Dosage Form
-
Strength
EQ 250MG VALPROIC ACID
Approval Date
1983-03-10
Regulatory Status
RX
Drug Name
DEPAKOTE
Product Number
2
Dosage Form
-
Strength
EQ 500MG VALPROIC ACID
Approval Date
1983-03-10
Active Ingredient
DIVALPROEX SODIUM
Application Number
18723
Product Number
2
Dosage Form
-
Strength
EQ 500MG VALPROIC ACID
Approval Date
1983-03-10
Regulatory Status
RX
Drug Name
DEPAKOTE
Product Number
3
Dosage Form
-
Strength
EQ 125MG VALPROIC ACID
Approval Date
1984-10-26
Active Ingredient
DIVALPROEX SODIUM
Application Number
18723
Product Number
3
Dosage Form
-
Strength
EQ 125MG VALPROIC ACID
Approval Date
1984-10-26
Regulatory Status
RX
Drug Name
DEPAKOTE
Product Number
1
Dosage Form
-
Strength
EQ 125MG VALPROIC ACID
Approval Date
1989-09-12
Active Ingredient
DIVALPROEX SODIUM
Application Number
19680
Product Number
1
Dosage Form
-
Strength
EQ 125MG VALPROIC ACID
Approval Date
1989-09-12
Regulatory Status
RX
Drug Name
DEPAKOTE ER
Product Number
1
Dosage Form
-
Strength
EQ 500MG VALPROIC ACID
Approval Date
2000-08-04
Active Ingredient
DIVALPROEX SODIUM
Application Number
21168
Product Number
1
Dosage Form
-
Strength
EQ 500MG VALPROIC ACID
Approval Date
2000-08-04
Regulatory Status
RX
Drug Name
DEPAKOTE ER
Product Number
2
Dosage Form
-
Strength
EQ 250MG VALPROIC ACID
Approval Date
2002-05-31
Active Ingredient
DIVALPROEX SODIUM
Application Number
21168
Product Number
2
Dosage Form
-
Strength
EQ 250MG VALPROIC ACID
Approval Date
2002-05-31
Regulatory Status
RX
Drug Name
DEPAKOTE ER
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
-
Active Ingredient
DIVALPROEX SODIUM
Application Number
22267
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DEPAKOTE ER
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
-
Active Ingredient
DIVALPROEX SODIUM
Application Number
22267
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DIASONE SODIUM
Product Number
3
Dosage Form
-
Strength
165MG
Approval Date
1982-01-01
Active Ingredient
SULFOXONE SODIUM
Application Number
6044
Product Number
3
Dosage Form
-
Strength
165MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DICUMAROL
Product Number
3
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Active Ingredient
DICUMAROL
Application Number
5545
Product Number
3
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DICUMAROL
Product Number
4
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Active Ingredient
DICUMAROL
Application Number
5545
Product Number
4
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DICUMAROL
Product Number
5
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Active Ingredient
DICUMAROL
Application Number
5545
Product Number
5
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DUOPA
Product Number
1
Dosage Form
-
Strength
4.63MG/ML;20MG/ML
Approval Date
2015-01-09
Active Ingredient
CARBIDOPA; LEVODOPA
Application Number
203952
Product Number
1
Dosage Form
-
Strength
4.63MG/ML;20MG/ML
Approval Date
2015-01-09
Regulatory Status
RX
Drug Name
DURYSTA
Product Number
1
Dosage Form
-
Strength
10MCG
Approval Date
2020-03-04
Active Ingredient
BIMATOPROST
Application Number
211911
Product Number
1
Dosage Form
-
Strength
10MCG
Approval Date
2020-03-04
Regulatory Status
RX
Drug Name
EMBLAVEO
Product Number
1
Dosage Form
-
Strength
EQ 0.5GM BASE/VIAL;1.5GM/VIAL
Approval Date
2025-02-07
Active Ingredient
AVIBACTAM SODIUM; AZTREONAM
Application Number
217906
Product Number
1
Dosage Form
-
Strength
EQ 0.5GM BASE/VIAL;1.5GM/VIAL
Approval Date
2025-02-07
Regulatory Status
RX
Drug Name
EMRELIS
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
-
Active Ingredient
TELISOTUZUMAB VEDOTIN-TLLV
Application Number
761384
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
EMRELIS
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
-
Active Ingredient
TELISOTUZUMAB VEDOTIN-TLLV
Application Number
761384
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ENABLEX
Product Number
1
Dosage Form
-
Strength
EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2004-12-22
Active Ingredient
DARIFENACIN HYDROBROMIDE
Application Number
21513
Product Number
1
Dosage Form
-
Strength
EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2004-12-22
Regulatory Status
Discontinued
Drug Name
ENABLEX
Product Number
2
Dosage Form
-
Strength
EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2004-12-22
Active Ingredient
DARIFENACIN HYDROBROMIDE
Application Number
21513
Product Number
2
Dosage Form
-
Strength
EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2004-12-22
Regulatory Status
Discontinued
Drug Name
ENDURON
Product Number
1
Dosage Form
-
Strength
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
METHYCLOTHIAZIDE
Application Number
12524
Product Number
1
Dosage Form
-
Strength
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ENDURON
Product Number
4
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
METHYCLOTHIAZIDE
Application Number
12524
Product Number
4
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
ESTRACE
Product Number
1
Dosage Form
-
Strength
0.01%
Approval Date
1984-01-31
Active Ingredient
ESTRADIOL
Application Number
86069
Product Number
1
Dosage Form
-
Strength
0.01%
Approval Date
1984-01-31
Regulatory Status
RX
Drug Name
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER
Product Number
1
Dosage Form
-
Strength
0.4MG/ML
Approval Date
2001-12-17
Active Ingredient
FAMOTIDINE
Application Number
75729
Product Number
1
Dosage Form
-
Strength
0.4MG/ML
Approval Date
2001-12-17
Regulatory Status
Discontinued
Drug Name
FETZIMA
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2013-07-25
Active Ingredient
LEVOMILNACIPRAN HYDROCHLORIDE
Application Number
204168
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2013-07-25
Regulatory Status
RX
Drug Name
FETZIMA
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2013-07-25
Active Ingredient
LEVOMILNACIPRAN HYDROCHLORIDE
Application Number
204168
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2013-07-25
Regulatory Status
RX
Drug Name
FETZIMA
Product Number
3
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2013-07-25
Active Ingredient
LEVOMILNACIPRAN HYDROCHLORIDE
Application Number
204168
Product Number
3
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2013-07-25
Regulatory Status
RX
Drug Name
FETZIMA
Product Number
4
Dosage Form
-
Strength
EQ 120MG BASE
Approval Date
2013-07-25
Active Ingredient
LEVOMILNACIPRAN HYDROCHLORIDE
Application Number
204168
Product Number
4
Dosage Form
-
Strength
EQ 120MG BASE
Approval Date
2013-07-25
Regulatory Status
RX
Drug Name
FML
Product Number
2
Dosage Form
-
Strength
0.1%
Approval Date
1982-07-28
Active Ingredient
FLUOROMETHOLONE
Application Number
16851
Product Number
2
Dosage Form
-
Strength
0.1%
Approval Date
1982-07-28
Regulatory Status
RX
Drug Name
FML FORTE
Product Number
1
Dosage Form
-
Strength
0.25%
Approval Date
1986-04-23
Active Ingredient
FLUOROMETHOLONE
Application Number
19216
Product Number
1
Dosage Form
-
Strength
0.25%
Approval Date
1986-04-23
Regulatory Status
RX
Drug Name
GELNIQUE
Product Number
1
Dosage Form
-
Strength
10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2009-01-27
Active Ingredient
OXYBUTYNIN CHLORIDE
Application Number
22204
Product Number
1
Dosage Form
-
Strength
10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2009-01-27
Regulatory Status
Discontinued
Drug Name
GEMONIL
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Active Ingredient
METHARBITAL
Application Number
8322
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
GENGRAF
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2000-05-12
Active Ingredient
CYCLOSPORINE
Application Number
65003
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2000-05-12
Regulatory Status
RX
Drug Name
GENGRAF
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2000-05-12
Active Ingredient
CYCLOSPORINE
Application Number
65003
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2000-05-12
Regulatory Status
Discontinued
Drug Name
GENGRAF
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2000-05-12
Active Ingredient
CYCLOSPORINE
Application Number
65003
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2000-05-12
Regulatory Status
RX
Drug Name
HARMONYL
Product Number
1
Dosage Form
-
Strength
0.1MG
Approval Date
1982-01-01
Active Ingredient
DESERPIDINE
Application Number
10796
Product Number
1
Dosage Form
-
Strength
0.1MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HARMONYL
Product Number
2
Dosage Form
-
Strength
0.25MG
Approval Date
1982-01-01
Active Ingredient
DESERPIDINE
Application Number
10796
Product Number
2
Dosage Form
-
Strength
0.25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HUMIRA
Product Number
1
Dosage Form
-
Strength
40MG/0.8ML
Approval Date
-
Active Ingredient
ADALIMUMAB
Application Number
125057
Product Number
1
Dosage Form
-
Strength
40MG/0.8ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
HUMIRA
Product Number
2
Dosage Form
-
Strength
40MG/0.8ML
Approval Date
-
Active Ingredient
ADALIMUMAB
Application Number
125057
Product Number
2
Dosage Form
-
Strength
40MG/0.8ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
IOPAMIDOL-300
Product Number
1
Dosage Form
-
Strength
61%
Approval Date
1997-04-30
Active Ingredient
IOPAMIDOL
Application Number
74638
Product Number
1
Dosage Form
-
Strength
61%
Approval Date
1997-04-30
Regulatory Status
Discontinued
Drug Name
K-TAB
Product Number
1
Dosage Form
-
Strength
10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
POTASSIUM CHLORIDE
Application Number
18279
Product Number
1
Dosage Form
-
Strength
10MEQ **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
K-TAB
Product Number
2
Dosage Form
-
Strength
8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1988-08-01
Active Ingredient
POTASSIUM CHLORIDE
Application Number
18279
Product Number
2
Dosage Form
-
Strength
8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1988-08-01
Regulatory Status
Discontinued
Drug Name
K-TAB
Product Number
3
Dosage Form
-
Strength
20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2013-11-25
Active Ingredient
POTASSIUM CHLORIDE
Application Number
18279
Product Number
3
Dosage Form
-
Strength
20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2013-11-25
Regulatory Status
Discontinued
Drug Name
KALETRA
Product Number
1
Dosage Form
-
Strength
133.3MG;33.3MG
Approval Date
2000-09-15
Active Ingredient
LOPINAVIR; RITONAVIR
Application Number
21226
Product Number
1
Dosage Form
-
Strength
133.3MG;33.3MG
Approval Date
2000-09-15
Regulatory Status
Discontinued
Drug Name
KALETRA
Product Number
1
Dosage Form
-
Strength
80MG/ML;20MG/ML
Approval Date
2000-09-15
Active Ingredient
LOPINAVIR; RITONAVIR
Application Number
21251
Product Number
1
Dosage Form
-
Strength
80MG/ML;20MG/ML
Approval Date
2000-09-15
Regulatory Status
RX
Drug Name
KALETRA
Product Number
1
Dosage Form
-
Strength
200MG;50MG
Approval Date
2005-10-28
Active Ingredient
LOPINAVIR; RITONAVIR
Application Number
21906
Product Number
1
Dosage Form
-
Strength
200MG;50MG
Approval Date
2005-10-28
Regulatory Status
RX
Drug Name
KALETRA
Product Number
2
Dosage Form
-
Strength
100MG;25MG
Approval Date
2007-11-09
Active Ingredient
LOPINAVIR; RITONAVIR
Application Number
21906
Product Number
2
Dosage Form
-
Strength
100MG;25MG
Approval Date
2007-11-09
Regulatory Status
RX
Drug Name
KYBELLA
Product Number
1
Dosage Form
-
Strength
20MG/2ML (10MG/ML)
Approval Date
2015-04-29
Active Ingredient
DEOXYCHOLIC ACID
Application Number
206333
Product Number
1
Dosage Form
-
Strength
20MG/2ML (10MG/ML)
Approval Date
2015-04-29
Regulatory Status
RX
Drug Name
LASTACAFT
Product Number
1
Dosage Form
-
Strength
0.25%
Approval Date
2010-07-28
Active Ingredient
ALCAFTADINE
Application Number
22134
Product Number
1
Dosage Form
-
Strength
0.25%
Approval Date
2010-07-28
Regulatory Status
OTC
Drug Name
LATISSE
Product Number
1
Dosage Form
-
Strength
0.03%
Approval Date
2008-12-24
Active Ingredient
BIMATOPROST
Application Number
22369
Product Number
1
Dosage Form
-
Strength
0.03%
Approval Date
2008-12-24
Regulatory Status
RX
Drug Name
LEXAPRO
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2002-08-14
Active Ingredient
ESCITALOPRAM OXALATE
Application Number
21323
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2002-08-14
Regulatory Status
RX
Drug Name
LEXAPRO
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2002-08-14
Active Ingredient
ESCITALOPRAM OXALATE
Application Number
21323
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2002-08-14
Regulatory Status
RX
Drug Name
LEXAPRO
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2002-08-14
Active Ingredient
ESCITALOPRAM OXALATE
Application Number
21323
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2002-08-14
Regulatory Status
RX
Drug Name
LEXAPRO
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2002-11-27
Active Ingredient
ESCITALOPRAM OXALATE
Application Number
21365
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2002-11-27
Regulatory Status
Discontinued
Drug Name
LINZESS
Product Number
1
Dosage Form
-
Strength
145MCG
Approval Date
2012-08-30
Active Ingredient
LINACLOTIDE
Application Number
202811
Product Number
1
Dosage Form
-
Strength
145MCG
Approval Date
2012-08-30
Regulatory Status
RX
Drug Name
LINZESS
Product Number
2
Dosage Form
-
Strength
290MCG
Approval Date
2012-08-30
Active Ingredient
LINACLOTIDE
Application Number
202811
Product Number
2
Dosage Form
-
Strength
290MCG
Approval Date
2012-08-30
Regulatory Status
RX
Drug Name
LINZESS
Product Number
3
Dosage Form
-
Strength
72MCG
Approval Date
2017-01-25
Active Ingredient
LINACLOTIDE
Application Number
202811
Product Number
3
Dosage Form
-
Strength
72MCG
Approval Date
2017-01-25
Regulatory Status
RX
Drug Name
LIPIDIL
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1993-12-31
Active Ingredient
FENOFIBRATE
Application Number
19304
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1993-12-31
Regulatory Status
Discontinued
Drug Name
LUMIGAN
Product Number
1
Dosage Form
-
Strength
0.03% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2001-03-16
Active Ingredient
BIMATOPROST
Application Number
21275
Product Number
1
Dosage Form
-
Strength
0.03% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2001-03-16
Regulatory Status
Discontinued
Drug Name
LUMIGAN
Product Number
1
Dosage Form
-
Strength
0.01%
Approval Date
2010-08-31
Active Ingredient
BIMATOPROST
Application Number
22184
Product Number
1
Dosage Form
-
Strength
0.01%
Approval Date
2010-08-31
Regulatory Status
RX
Drug Name
LUPANETA PACK
Product Number
1
Dosage Form
-
Strength
3.75MG/VIAL,N/A;N/A,5MG
Approval Date
2012-12-14
Active Ingredient
LEUPROLIDE ACETATE; NORETHINDRONE ACETATE
Application Number
203696
Product Number
1
Dosage Form
-
Strength
3.75MG/VIAL,N/A;N/A,5MG
Approval Date
2012-12-14
Regulatory Status
Discontinued
Drug Name
LUPANETA PACK
Product Number
2
Dosage Form
-
Strength
11.25MG/VIAL,N/A;N/A,5MG
Approval Date
2012-12-14
Active Ingredient
LEUPROLIDE ACETATE; NORETHINDRONE ACETATE
Application Number
203696
Product Number
2
Dosage Form
-
Strength
11.25MG/VIAL,N/A;N/A,5MG
Approval Date
2012-12-14
Regulatory Status
Discontinued
Drug Name
LUPRON
Product Number
1
Dosage Form
-
Strength
14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1985-04-09
Active Ingredient
LEUPROLIDE ACETATE
Application Number
19010
Product Number
1
Dosage Form
-
Strength
14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1985-04-09
Regulatory Status
Discontinued
Drug Name
LUPRON DEPOT
Product Number
1
Dosage Form
-
Strength
7.5MG
Approval Date
1989-01-26
Active Ingredient
LEUPROLIDE ACETATE
Application Number
19732
Product Number
1
Dosage Form
-
Strength
7.5MG
Approval Date
1989-01-26
Regulatory Status
RX
Drug Name
LUPRON DEPOT
Product Number
2
Dosage Form
-
Strength
3.75MG
Approval Date
-
Active Ingredient
LEUPROLIDE ACETATE
Application Number
19943
Product Number
2
Dosage Form
-
Strength
3.75MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LUPRON DEPOT
Product Number
1
Dosage Form
-
Strength
3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1990-10-22
Active Ingredient
LEUPROLIDE ACETATE
Application Number
20011
Product Number
1
Dosage Form
-
Strength
3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1990-10-22
Regulatory Status
Discontinued
Drug Name
LUPRON DEPOT
Product Number
2
Dosage Form
-
Strength
3.75MG
Approval Date
1995-10-26
Active Ingredient
LEUPROLIDE ACETATE
Application Number
20011
Product Number
2
Dosage Form
-
Strength
3.75MG
Approval Date
1995-10-26
Regulatory Status
RX
Drug Name
LUPRON DEPOT
Product Number
1
Dosage Form
-
Strength
22.5MG
Approval Date
1995-12-22
Active Ingredient
LEUPROLIDE ACETATE
Application Number
20517
Product Number
1
Dosage Form
-
Strength
22.5MG
Approval Date
1995-12-22
Regulatory Status
RX
Drug Name
LUPRON DEPOT
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
1997-05-30
Active Ingredient
LEUPROLIDE ACETATE
Application Number
20517
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
1997-05-30
Regulatory Status
RX
Drug Name
LUPRON DEPOT
Product Number
3
Dosage Form
-
Strength
45MG
Approval Date
2011-06-17
Active Ingredient
LEUPROLIDE ACETATE
Application Number
20517
Product Number
3
Dosage Form
-
Strength
45MG
Approval Date
2011-06-17
Regulatory Status
RX
Drug Name
LUPRON DEPOT
Product Number
1
Dosage Form
-
Strength
11.25MG
Approval Date
1997-03-07
Active Ingredient
LEUPROLIDE ACETATE
Application Number
20708
Product Number
1
Dosage Form
-
Strength
11.25MG
Approval Date
1997-03-07
Regulatory Status
RX
Drug Name
LUPRON DEPOT-PED KIT
Product Number
2
Dosage Form
-
Strength
7.5MG
Approval Date
1993-04-16
Active Ingredient
LEUPROLIDE ACETATE
Application Number
20263
Product Number
2
Dosage Form
-
Strength
7.5MG
Approval Date
1993-04-16
Regulatory Status
RX
Drug Name
LUPRON DEPOT-PED KIT
Product Number
3
Dosage Form
-
Strength
3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1993-04-16
Active Ingredient
LEUPROLIDE ACETATE
Application Number
20263
Product Number
3
Dosage Form
-
Strength
3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1993-04-16
Regulatory Status
Discontinued
Drug Name
LUPRON DEPOT-PED KIT
Product Number
4
Dosage Form
-
Strength
7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1993-04-16
Active Ingredient
LEUPROLIDE ACETATE
Application Number
20263
Product Number
4
Dosage Form
-
Strength
7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1993-04-16
Regulatory Status
Discontinued
Drug Name
LUPRON DEPOT-PED KIT
Product Number
5
Dosage Form
-
Strength
11.25MG
Approval Date
1994-01-21
Active Ingredient
LEUPROLIDE ACETATE
Application Number
20263
Product Number
5
Dosage Form
-
Strength
11.25MG
Approval Date
1994-01-21
Regulatory Status
RX
Drug Name
LUPRON DEPOT-PED KIT
Product Number
6
Dosage Form
-
Strength
15MG
Approval Date
1994-01-21
Active Ingredient
LEUPROLIDE ACETATE
Application Number
20263
Product Number
6
Dosage Form
-
Strength
15MG
Approval Date
1994-01-21
Regulatory Status
RX
Drug Name
LUPRON DEPOT-PED KIT
Product Number
7
Dosage Form
-
Strength
11.25MG
Approval Date
2011-08-15
Active Ingredient
LEUPROLIDE ACETATE
Application Number
20263
Product Number
7
Dosage Form
-
Strength
11.25MG
Approval Date
2011-08-15
Regulatory Status
RX
Drug Name
LUPRON DEPOT-PED KIT
Product Number
8
Dosage Form
-
Strength
30MG
Approval Date
2011-08-15
Active Ingredient
LEUPROLIDE ACETATE
Application Number
20263
Product Number
8
Dosage Form
-
Strength
30MG
Approval Date
2011-08-15
Regulatory Status
RX
Drug Name
LUPRON DEPOT-PED KIT
Product Number
9
Dosage Form
-
Strength
45MG
Approval Date
2023-04-14
Active Ingredient
LEUPROLIDE ACETATE
Application Number
20263
Product Number
9
Dosage Form
-
Strength
45MG
Approval Date
2023-04-14
Regulatory Status
RX
Drug Name
MAVIK
Product Number
1
Dosage Form
-
Strength
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1996-04-26
Active Ingredient
TRANDOLAPRIL
Application Number
20528
Product Number
1
Dosage Form
-
Strength
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1996-04-26
Regulatory Status
Discontinued
Drug Name
MAVIK
Product Number
2
Dosage Form
-
Strength
2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1996-04-26
Active Ingredient
TRANDOLAPRIL
Application Number
20528
Product Number
2
Dosage Form
-
Strength
2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1996-04-26
Regulatory Status
Discontinued
Drug Name
MAVIK
Product Number
3
Dosage Form
-
Strength
4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1996-04-26
Active Ingredient
TRANDOLAPRIL
Application Number
20528
Product Number
3
Dosage Form
-
Strength
4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1996-04-26
Regulatory Status
Discontinued
Drug Name
MAVYRET
Product Number
1
Dosage Form
-
Strength
100MG;40MG
Approval Date
2017-08-03
Active Ingredient
GLECAPREVIR; PIBRENTASVIR
Application Number
209394
Product Number
1
Dosage Form
-
Strength
100MG;40MG
Approval Date
2017-08-03
Regulatory Status
RX
Drug Name
MAVYRET
Product Number
1
Dosage Form
-
Strength
50MG/PACKET;20MG/PACKET
Approval Date
2021-06-10
Active Ingredient
GLECAPREVIR; PIBRENTASVIR
Application Number
215110
Product Number
1
Dosage Form
-
Strength
50MG/PACKET;20MG/PACKET
Approval Date
2021-06-10
Regulatory Status
RX
Drug Name
MIVACRON
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1992-01-22
Active Ingredient
MIVACURIUM CHLORIDE
Application Number
20098
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1992-01-22
Regulatory Status
Discontinued
Drug Name
MIVACRON
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE/5ML (EQ 2MG BASE/ML)
Approval Date
1992-01-22
Active Ingredient
MIVACURIUM CHLORIDE
Application Number
20098
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE/5ML (EQ 2MG BASE/ML)
Approval Date
1992-01-22
Regulatory Status
Discontinued
Drug Name
MIVACRON
Product Number
5
Dosage Form
-
Strength
EQ 20MG BASE/10ML (EQ 2MG BASE/ML)
Approval Date
1992-01-22
Active Ingredient
MIVACURIUM CHLORIDE
Application Number
20098
Product Number
5
Dosage Form
-
Strength
EQ 20MG BASE/10ML (EQ 2MG BASE/ML)
Approval Date
1992-01-22
Regulatory Status
Discontinued
Drug Name
MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER
Product Number
2
Dosage Form
-
Strength
EQ 0.5MG BASE/ML
Approval Date
1992-01-22
Active Ingredient
MIVACURIUM CHLORIDE
Application Number
20098
Product Number
2
Dosage Form
-
Strength
EQ 0.5MG BASE/ML
Approval Date
1992-01-22
Regulatory Status
Discontinued
Drug Name
MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER
Product Number
3
Dosage Form
-
Strength
EQ 50MG BASE/100ML
Approval Date
1992-01-22
Active Ingredient
MIVACURIUM CHLORIDE
Application Number
20098
Product Number
3
Dosage Form
-
Strength
EQ 50MG BASE/100ML
Approval Date
1992-01-22
Regulatory Status
Discontinued
Drug Name
NALBUPHINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
1.5MG/ML
Approval Date
1993-03-12
Active Ingredient
NALBUPHINE HYDROCHLORIDE
Application Number
20200
Product Number
1
Dosage Form
-
Strength
1.5MG/ML
Approval Date
1993-03-12
Regulatory Status
Discontinued
Drug Name
NAMENDA
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2003-10-16
Active Ingredient
MEMANTINE HYDROCHLORIDE
Application Number
21487
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2003-10-16
Regulatory Status
Discontinued
Drug Name
NAMENDA
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2003-10-16
Active Ingredient
MEMANTINE HYDROCHLORIDE
Application Number
21487
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2003-10-16
Regulatory Status
Discontinued
Drug Name
NAMENDA XR
Product Number
1
Dosage Form
-
Strength
7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2010-06-21
Active Ingredient
MEMANTINE HYDROCHLORIDE
Application Number
22525
Product Number
1
Dosage Form
-
Strength
7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2010-06-21
Regulatory Status
Discontinued
Drug Name
NAMENDA XR
Product Number
2
Dosage Form
-
Strength
14MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2010-06-21
Active Ingredient
MEMANTINE HYDROCHLORIDE
Application Number
22525
Product Number
2
Dosage Form
-
Strength
14MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2010-06-21
Regulatory Status
Discontinued
Drug Name
NAMENDA XR
Product Number
3
Dosage Form
-
Strength
21MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2010-06-21
Active Ingredient
MEMANTINE HYDROCHLORIDE
Application Number
22525
Product Number
3
Dosage Form
-
Strength
21MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2010-06-21
Regulatory Status
Discontinued
Drug Name
NAMENDA XR
Product Number
4
Dosage Form
-
Strength
28MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2010-06-21
Active Ingredient
MEMANTINE HYDROCHLORIDE
Application Number
22525
Product Number
4
Dosage Form
-
Strength
28MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2010-06-21
Regulatory Status
Discontinued
Drug Name
NAMZARIC
Product Number
1
Dosage Form
-
Strength
10MG;14MG
Approval Date
2014-12-23
Active Ingredient
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Application Number
206439
Product Number
1
Dosage Form
-
Strength
10MG;14MG
Approval Date
2014-12-23
Regulatory Status
RX
Drug Name
NAMZARIC
Product Number
2
Dosage Form
-
Strength
10MG;28MG
Approval Date
2014-12-23
Active Ingredient
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Application Number
206439
Product Number
2
Dosage Form
-
Strength
10MG;28MG
Approval Date
2014-12-23
Regulatory Status
RX
Drug Name
NAMZARIC
Product Number
3
Dosage Form
-
Strength
10MG;7MG
Approval Date
2016-07-18
Active Ingredient
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Application Number
206439
Product Number
3
Dosage Form
-
Strength
10MG;7MG
Approval Date
2016-07-18
Regulatory Status
RX
Drug Name
NAMZARIC
Product Number
4
Dosage Form
-
Strength
10MG;21MG
Approval Date
2016-07-18
Active Ingredient
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Application Number
206439
Product Number
4
Dosage Form
-
Strength
10MG;21MG
Approval Date
2016-07-18
Regulatory Status
RX
Drug Name
NIASPAN
Product Number
1
Dosage Form
-
Strength
375MG
Approval Date
1997-07-28
Active Ingredient
NIACIN
Application Number
20381
Product Number
1
Dosage Form
-
Strength
375MG
Approval Date
1997-07-28
Regulatory Status
Discontinued
Drug Name
NIASPAN
Product Number
2
Dosage Form
-
Strength
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-07-28
Active Ingredient
NIACIN
Application Number
20381
Product Number
2
Dosage Form
-
Strength
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-07-28
Regulatory Status
Discontinued
Drug Name
NIASPAN
Product Number
3
Dosage Form
-
Strength
750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-07-28
Active Ingredient
NIACIN
Application Number
20381
Product Number
3
Dosage Form
-
Strength
750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-07-28
Regulatory Status
Discontinued
Drug Name
NIASPAN
Product Number
4
Dosage Form
-
Strength
1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-07-28
Active Ingredient
NIACIN
Application Number
20381
Product Number
4
Dosage Form
-
Strength
1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-07-28
Regulatory Status
Discontinued
Drug Name
NIASPAN TITRATION STARTER PACK
Product Number
5
Dosage Form
-
Strength
375MG;500MG;750MG
Approval Date
1997-07-28
Active Ingredient
NIACIN
Application Number
20381
Product Number
5
Dosage Form
-
Strength
375MG;500MG;750MG
Approval Date
1997-07-28
Regulatory Status
Discontinued
Drug Name
NIMBEX
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
1995-12-15
Active Ingredient
CISATRACURIUM BESYLATE
Application Number
20551
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
1995-12-15
Regulatory Status
Discontinued
Drug Name
NIMBEX PRESERVATIVE FREE
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1995-12-15
Active Ingredient
CISATRACURIUM BESYLATE
Application Number
20551
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1995-12-15
Regulatory Status
Discontinued
Drug Name
NIMBEX 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
1995-12-15
Active Ingredient
CISATRACURIUM BESYLATE
Application Number
20551
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
1995-12-15
Regulatory Status
Discontinued
Drug Name
NITROPRESS
Product Number
1
Dosage Form
-
Strength
50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
SODIUM NITROPRUSSIDE
Application Number
18450
Product Number
1
Dosage Form
-
Strength
50MG/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
NORISODRINE
Product Number
2
Dosage Form
-
Strength
25%
Approval Date
1982-01-01
Active Ingredient
ISOPROTERENOL SULFATE
Application Number
6905
Product Number
2
Dosage Form
-
Strength
25%
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NORISODRINE
Product Number
3
Dosage Form
-
Strength
10%
Approval Date
1982-01-01
Active Ingredient
ISOPROTERENOL SULFATE
Application Number
6905
Product Number
3
Dosage Form
-
Strength
10%
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NORVIR
Product Number
1
Dosage Form
-
Strength
80MG/ML
Approval Date
1996-03-01
Active Ingredient
RITONAVIR
Application Number
20659
Product Number
1
Dosage Form
-
Strength
80MG/ML
Approval Date
1996-03-01
Regulatory Status
Discontinued
Drug Name
NORVIR
Product Number
1
Dosage Form
-
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-06-29
Active Ingredient
RITONAVIR
Application Number
20945
Product Number
1
Dosage Form
-
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-06-29
Regulatory Status
Discontinued
Drug Name
NORVIR
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2010-02-10
Active Ingredient
RITONAVIR
Application Number
22417
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2010-02-10
Regulatory Status
RX
Drug Name
NORVIR
Product Number
1
Dosage Form
-
Strength
100MG/PACKET
Approval Date
2017-06-07
Active Ingredient
RITONAVIR
Application Number
209512
Product Number
1
Dosage Form
-
Strength
100MG/PACKET
Approval Date
2017-06-07
Regulatory Status
RX
Drug Name
NUROMAX
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
1991-03-07
Active Ingredient
DOXACURIUM CHLORIDE
Application Number
19946
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
1991-03-07
Regulatory Status
Discontinued
Drug Name
OMNICEF
Product Number
1
Dosage Form
-
Strength
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-12-04
Active Ingredient
CEFDINIR
Application Number
50739
Product Number
1
Dosage Form
-
Strength
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-12-04
Regulatory Status
Discontinued
Drug Name
OMNICEF
Product Number
1
Dosage Form
-
Strength
125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-12-04
Active Ingredient
CEFDINIR
Application Number
50749
Product Number
1
Dosage Form
-
Strength
125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-12-04
Regulatory Status
Discontinued
Drug Name
OMNICEF
Product Number
2
Dosage Form
-
Strength
250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2004-07-29
Active Ingredient
CEFDINIR
Application Number
50749
Product Number
2
Dosage Form
-
Strength
250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2004-07-29
Regulatory Status
Discontinued
Drug Name
ORETIC
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Active Ingredient
HYDROCHLOROTHIAZIDE
Application Number
11971
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ORETIC
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Active Ingredient
HYDROCHLOROTHIAZIDE
Application Number
11971
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ORETICYL 25
Product Number
1
Dosage Form
-
Strength
0.125MG;25MG
Approval Date
1982-01-01
Active Ingredient
DESERPIDINE; HYDROCHLOROTHIAZIDE
Application Number
12148
Product Number
1
Dosage Form
-
Strength
0.125MG;25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ORETICYL 50
Product Number
3
Dosage Form
-
Strength
0.125MG;50MG
Approval Date
1982-01-01
Active Ingredient
DESERPIDINE; HYDROCHLOROTHIAZIDE
Application Number
12148
Product Number
3
Dosage Form
-
Strength
0.125MG;50MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ORETICYL FORTE
Product Number
2
Dosage Form
-
Strength
0.25MG;25MG
Approval Date
1982-01-01
Active Ingredient
DESERPIDINE; HYDROCHLOROTHIAZIDE
Application Number
12148
Product Number
2
Dosage Form
-
Strength
0.25MG;25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ORIAHNN (COPACKAGED)
Product Number
1
Dosage Form
-
Strength
EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE
Approval Date
2020-05-29
Active Ingredient
ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM
Application Number
213388
Product Number
1
Dosage Form
-
Strength
EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE
Approval Date
2020-05-29
Regulatory Status
RX
Drug Name
ORILISSA
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2018-07-23
Active Ingredient
ELAGOLIX SODIUM
Application Number
210450
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2018-07-23
Regulatory Status
RX
Drug Name
ORILISSA
Product Number
2
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2018-07-23
Active Ingredient
ELAGOLIX SODIUM
Application Number
210450
Product Number
2
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2018-07-23
Regulatory Status
RX
Drug Name
OXYTROL FOR WOMEN
Product Number
1
Dosage Form
-
Strength
3.9MG/24HR
Approval Date
2013-01-25
Active Ingredient
OXYBUTYNIN
Application Number
202211
Product Number
1
Dosage Form
-
Strength
3.9MG/24HR
Approval Date
2013-01-25
Regulatory Status
OTC
Drug Name
OZURDEX
Product Number
1
Dosage Form
-
Strength
0.7MG
Approval Date
2009-06-17
Active Ingredient
DEXAMETHASONE
Application Number
22315
Product Number
1
Dosage Form
-
Strength
0.7MG
Approval Date
2009-06-17
Regulatory Status
RX
Drug Name
PARADIONE
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
1982-01-01
Active Ingredient
PARAMETHADIONE
Application Number
6800
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PARADIONE
Product Number
2
Dosage Form
-
Strength
300MG/ML
Approval Date
1982-01-01
Active Ingredient
PARAMETHADIONE
Application Number
6800
Product Number
2
Dosage Form
-
Strength
300MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PARADIONE
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
1982-01-01
Active Ingredient
PARAMETHADIONE
Application Number
6800
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PHENURONE
Product Number
1
Dosage Form
-
Strength
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
PHENACEMIDE
Application Number
7707
Product Number
1
Dosage Form
-
Strength
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PLACIDYL
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Active Ingredient
ETHCHLORVYNOL
Application Number
10021
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PLACIDYL
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Active Ingredient
ETHCHLORVYNOL
Application Number
10021
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PLACIDYL
Product Number
7
Dosage Form
-
Strength
200MG
Approval Date
1982-01-01
Active Ingredient
ETHCHLORVYNOL
Application Number
10021
Product Number
7
Dosage Form
-
Strength
200MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PLACIDYL
Product Number
10
Dosage Form
-
Strength
750MG
Approval Date
1982-01-01
Active Ingredient
ETHCHLORVYNOL
Application Number
10021
Product Number
10
Dosage Form
-
Strength
750MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PRED FORTE
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1982-01-01
Active Ingredient
PREDNISOLONE ACETATE
Application Number
17011
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
PRED MILD
Product Number
1
Dosage Form
-
Strength
0.12%
Approval Date
1982-01-01
Active Ingredient
PREDNISOLONE ACETATE
Application Number
17100
Product Number
1
Dosage Form
-
Strength
0.12%
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
QULIPTA
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2021-09-28
Active Ingredient
ATOGEPANT
Application Number
215206
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2021-09-28
Regulatory Status
RX
Drug Name
QULIPTA
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2021-09-28
Active Ingredient
ATOGEPANT
Application Number
215206
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2021-09-28
Regulatory Status
RX
Drug Name
QULIPTA
Product Number
3
Dosage Form
-
Strength
60MG
Approval Date
2021-09-28
Active Ingredient
ATOGEPANT
Application Number
215206
Product Number
3
Dosage Form
-
Strength
60MG
Approval Date
2021-09-28
Regulatory Status
RX
Drug Name
RAPAFLO
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2008-10-08
Active Ingredient
SILODOSIN
Application Number
22206
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2008-10-08
Regulatory Status
Discontinued
Drug Name
RAPAFLO
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2008-10-08
Active Ingredient
SILODOSIN
Application Number
22206
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2008-10-08
Regulatory Status
Discontinued
Drug Name
RECTIV
Product Number
1
Dosage Form
-
Strength
0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2011-06-21
Active Ingredient
NITROGLYCERIN
Application Number
21359
Product Number
1
Dosage Form
-
Strength
0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2011-06-21
Regulatory Status
Discontinued
Drug Name
RESTASIS
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2002-12-23
Active Ingredient
CYCLOSPORINE
Application Number
50790
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2002-12-23
Regulatory Status
RX
Drug Name
RESTASIS MULTIDOSE
Product Number
2
Dosage Form
-
Strength
0.05%
Approval Date
2016-10-27
Active Ingredient
CYCLOSPORINE
Application Number
50790
Product Number
2
Dosage Form
-
Strength
0.05%
Approval Date
2016-10-27
Regulatory Status
RX
Drug Name
RINVOQ
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2019-08-16
Active Ingredient
UPADACITINIB
Application Number
211675
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2019-08-16
Regulatory Status
RX
Drug Name
RINVOQ
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2022-01-14
Active Ingredient
UPADACITINIB
Application Number
211675
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2022-01-14
Regulatory Status
RX
Drug Name
RINVOQ
Product Number
3
Dosage Form
-
Strength
45MG
Approval Date
2022-03-16
Active Ingredient
UPADACITINIB
Application Number
211675
Product Number
3
Dosage Form
-
Strength
45MG
Approval Date
2022-03-16
Regulatory Status
RX
Drug Name
RINVOQ LQ
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2024-04-26
Active Ingredient
UPADACITINIB
Application Number
218347
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2024-04-26
Regulatory Status
RX
Drug Name
SAPHRIS
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2009-08-13
Active Ingredient
ASENAPINE MALEATE
Application Number
22117
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2009-08-13
Regulatory Status
RX
Drug Name
SAPHRIS
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2009-08-13
Active Ingredient
ASENAPINE MALEATE
Application Number
22117
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2009-08-13
Regulatory Status
RX
Drug Name
SAPHRIS
Product Number
3
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2015-03-12
Active Ingredient
ASENAPINE MALEATE
Application Number
22117
Product Number
3
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2015-03-12
Regulatory Status
RX
Drug Name
SAVELLA
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
2009-01-14
Active Ingredient
MILNACIPRAN HYDROCHLORIDE
Application Number
22256
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
2009-01-14
Regulatory Status
RX
Drug Name
SAVELLA
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2009-01-14
Active Ingredient
MILNACIPRAN HYDROCHLORIDE
Application Number
22256
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2009-01-14
Regulatory Status
RX
Drug Name
SAVELLA
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
2009-01-14
Active Ingredient
MILNACIPRAN HYDROCHLORIDE
Application Number
22256
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
2009-01-14
Regulatory Status
RX
Drug Name
SAVELLA
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
2009-01-14
Active Ingredient
MILNACIPRAN HYDROCHLORIDE
Application Number
22256
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
2009-01-14
Regulatory Status
RX
Drug Name
SKYRIZI
Product Number
1
Dosage Form
-
Strength
75MG/0.83ML
Approval Date
-
Active Ingredient
RISANKIZUMAB-RZAA
Application Number
761105
Product Number
1
Dosage Form
-
Strength
75MG/0.83ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SKYRIZI
Product Number
2
Dosage Form
-
Strength
150MG/ML
Approval Date
-
Active Ingredient
RISANKIZUMAB-RZAA
Application Number
761105
Product Number
2
Dosage Form
-
Strength
150MG/ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SKYRIZI
Product Number
1
Dosage Form
-
Strength
600MG/VIAL
Approval Date
-
Active Ingredient
RISANKIZUMAB-RZAA
Application Number
761262
Product Number
1
Dosage Form
-
Strength
600MG/VIAL
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SULFADIAZINE
Product Number
5
Dosage Form
-
Strength
300MG
Approval Date
1982-01-01
Active Ingredient
SULFADIAZINE
Application Number
4125
Product Number
5
Dosage Form
-
Strength
300MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
SURVANTA
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
-
Active Ingredient
BERACTANT
Application Number
20032
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SYNTHROID
Product Number
1
Dosage Form
-
Strength
0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-07-24
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
21402
Product Number
1
Dosage Form
-
Strength
0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-07-24
Regulatory Status
RX
Drug Name
SYNTHROID
Product Number
2
Dosage Form
-
Strength
0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-07-24
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
21402
Product Number
2
Dosage Form
-
Strength
0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-07-24
Regulatory Status
RX
Drug Name
SYNTHROID
Product Number
3
Dosage Form
-
Strength
0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-07-24
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
21402
Product Number
3
Dosage Form
-
Strength
0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-07-24
Regulatory Status
RX
Drug Name
SYNTHROID
Product Number
4
Dosage Form
-
Strength
0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-07-24
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
21402
Product Number
4
Dosage Form
-
Strength
0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-07-24
Regulatory Status
RX
Drug Name
SYNTHROID
Product Number
5
Dosage Form
-
Strength
0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-07-24
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
21402
Product Number
5
Dosage Form
-
Strength
0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-07-24
Regulatory Status
RX
Drug Name
SYNTHROID
Product Number
6
Dosage Form
-
Strength
0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-07-24
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
21402
Product Number
6
Dosage Form
-
Strength
0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-07-24
Regulatory Status
RX
Drug Name
SYNTHROID
Product Number
7
Dosage Form
-
Strength
0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-07-24
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
21402
Product Number
7
Dosage Form
-
Strength
0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-07-24
Regulatory Status
RX
Drug Name
SYNTHROID
Product Number
8
Dosage Form
-
Strength
0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-07-24
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
21402
Product Number
8
Dosage Form
-
Strength
0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-07-24
Regulatory Status
RX
Drug Name
SYNTHROID
Product Number
9
Dosage Form
-
Strength
0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-07-24
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
21402
Product Number
9
Dosage Form
-
Strength
0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-07-24
Regulatory Status
RX
Drug Name
SYNTHROID
Product Number
10
Dosage Form
-
Strength
0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-07-24
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
21402
Product Number
10
Dosage Form
-
Strength
0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-07-24
Regulatory Status
RX
Drug Name
SYNTHROID
Product Number
11
Dosage Form
-
Strength
0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-07-24
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
21402
Product Number
11
Dosage Form
-
Strength
0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-07-24
Regulatory Status
RX
Drug Name
SYNTHROID
Product Number
12
Dosage Form
-
Strength
0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-07-24
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
21402
Product Number
12
Dosage Form
-
Strength
0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-07-24
Regulatory Status
RX
Drug Name
TARKA
Product Number
1
Dosage Form
-
Strength
2MG;180MG
Approval Date
1996-10-22
Active Ingredient
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE
Application Number
20591
Product Number
1
Dosage Form
-
Strength
2MG;180MG
Approval Date
1996-10-22
Regulatory Status
Discontinued
Drug Name
TARKA
Product Number
2
Dosage Form
-
Strength
4MG;240MG
Approval Date
1996-10-22
Active Ingredient
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE
Application Number
20591
Product Number
2
Dosage Form
-
Strength
4MG;240MG
Approval Date
1996-10-22
Regulatory Status
Discontinued
Drug Name
TARKA
Product Number
3
Dosage Form
-
Strength
1MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1996-10-22
Active Ingredient
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE
Application Number
20591
Product Number
3
Dosage Form
-
Strength
1MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1996-10-22
Regulatory Status
Discontinued
Drug Name
TARKA
Product Number
4
Dosage Form
-
Strength
2MG;240MG
Approval Date
1996-10-22
Active Ingredient
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE
Application Number
20591
Product Number
4
Dosage Form
-
Strength
2MG;240MG
Approval Date
1996-10-22
Regulatory Status
Discontinued
Drug Name
TECHNIVIE
Product Number
1
Dosage Form
-
Strength
12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2015-07-24
Active Ingredient
OMBITASVIR; PARITAPREVIR; RITONAVIR
Application Number
207931
Product Number
1
Dosage Form
-
Strength
12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2015-07-24
Regulatory Status
Discontinued
Drug Name
TEFLARO
Product Number
1
Dosage Form
-
Strength
400MG/VIAL
Approval Date
2010-10-29
Active Ingredient
CEFTAROLINE FOSAMIL
Application Number
200327
Product Number
1
Dosage Form
-
Strength
400MG/VIAL
Approval Date
2010-10-29
Regulatory Status
RX
Drug Name
TEFLARO
Product Number
2
Dosage Form
-
Strength
600MG/VIAL
Approval Date
2010-10-29
Active Ingredient
CEFTAROLINE FOSAMIL
Application Number
200327
Product Number
2
Dosage Form
-
Strength
600MG/VIAL
Approval Date
2010-10-29
Regulatory Status
RX
Drug Name
TEVETEN
Product Number
4
Dosage Form
-
Strength
EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-12-22
Active Ingredient
EPROSARTAN MESYLATE
Application Number
20738
Product Number
4
Dosage Form
-
Strength
EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-12-22
Regulatory Status
Discontinued
Drug Name
TEVETEN
Product Number
5
Dosage Form
-
Strength
EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-12-22
Active Ingredient
EPROSARTAN MESYLATE
Application Number
20738
Product Number
5
Dosage Form
-
Strength
EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-12-22
Regulatory Status
Discontinued
Drug Name
TEVETEN
Product Number
6
Dosage Form
-
Strength
EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-05-27
Active Ingredient
EPROSARTAN MESYLATE
Application Number
20738
Product Number
6
Dosage Form
-
Strength
EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-05-27
Regulatory Status
Discontinued
Drug Name
TEVETEN HCT
Product Number
1
Dosage Form
-
Strength
600MG;12.5MG
Approval Date
2001-11-01
Active Ingredient
EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE
Application Number
21268
Product Number
1
Dosage Form
-
Strength
600MG;12.5MG
Approval Date
2001-11-01
Regulatory Status
Discontinued
Drug Name
TEVETEN HCT
Product Number
2
Dosage Form
-
Strength
600MG;25MG
Approval Date
2001-11-01
Active Ingredient
EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE
Application Number
21268
Product Number
2
Dosage Form
-
Strength
600MG;25MG
Approval Date
2001-11-01
Regulatory Status
Discontinued
Drug Name
TRAL
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Active Ingredient
HEXOCYCLIUM METHYLSULFATE
Application Number
10599
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TRICOR
Product Number
1
Dosage Form
-
Strength
54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2001-09-04
Active Ingredient
FENOFIBRATE
Application Number
21203
Product Number
1
Dosage Form
-
Strength
54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2001-09-04
Regulatory Status
Discontinued
Drug Name
TRICOR
Product Number
3
Dosage Form
-
Strength
160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2001-09-04
Active Ingredient
FENOFIBRATE
Application Number
21203
Product Number
3
Dosage Form
-
Strength
160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2001-09-04
Regulatory Status
Discontinued
Drug Name
TRICOR
Product Number
1
Dosage Form
-
Strength
48MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2004-11-05
Active Ingredient
FENOFIBRATE
Application Number
21656
Product Number
1
Dosage Form
-
Strength
48MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2004-11-05
Regulatory Status
Discontinued
Drug Name
TRICOR
Product Number
2
Dosage Form
-
Strength
145MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2004-11-05
Active Ingredient
FENOFIBRATE
Application Number
21656
Product Number
2
Dosage Form
-
Strength
145MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2004-11-05
Regulatory Status
Discontinued
Drug Name
TRICOR (MICRONIZED)
Product Number
2
Dosage Form
-
Strength
67MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1998-02-09
Active Ingredient
FENOFIBRATE
Application Number
19304
Product Number
2
Dosage Form
-
Strength
67MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1998-02-09
Regulatory Status
Discontinued
Drug Name
TRICOR (MICRONIZED)
Product Number
3
Dosage Form
-
Strength
134MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-06-30
Active Ingredient
FENOFIBRATE
Application Number
19304
Product Number
3
Dosage Form
-
Strength
134MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-06-30
Regulatory Status
Discontinued
Drug Name
TRICOR (MICRONIZED)
Product Number
4
Dosage Form
-
Strength
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-06-30
Active Ingredient
FENOFIBRATE
Application Number
19304
Product Number
4
Dosage Form
-
Strength
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-06-30
Regulatory Status
Discontinued
Drug Name
TRIDIONE
Product Number
2
Dosage Form
-
Strength
200MG/5ML
Approval Date
1982-01-01
Active Ingredient
TRIMETHADIONE
Application Number
5856
Product Number
2
Dosage Form
-
Strength
200MG/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TRIDIONE
Product Number
5
Dosage Form
-
Strength
300MG
Approval Date
1982-01-01
Active Ingredient
TRIMETHADIONE
Application Number
5856
Product Number
5
Dosage Form
-
Strength
300MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TRIDIONE
Product Number
9
Dosage Form
-
Strength
150MG
Approval Date
1982-01-01
Active Ingredient
TRIMETHADIONE
Application Number
5856
Product Number
9
Dosage Form
-
Strength
150MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TRILIPIX
Product Number
1
Dosage Form
-
Strength
EQ 45MG FENOFIBRIC ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2008-12-15
Active Ingredient
CHOLINE FENOFIBRATE
Application Number
22224
Product Number
1
Dosage Form
-
Strength
EQ 45MG FENOFIBRIC ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2008-12-15
Regulatory Status
Discontinued
Drug Name
TRILIPIX
Product Number
2
Dosage Form
-
Strength
EQ 135MG FENOFIBRIC ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2008-12-15
Active Ingredient
CHOLINE FENOFIBRATE
Application Number
22224
Product Number
2
Dosage Form
-
Strength
EQ 135MG FENOFIBRIC ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2008-12-15
Regulatory Status
Discontinued
Drug Name
UBRELVY
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2019-12-23
Active Ingredient
UBROGEPANT
Application Number
211765
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2019-12-23
Regulatory Status
RX
Drug Name
UBRELVY
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2019-12-23
Active Ingredient
UBROGEPANT
Application Number
211765
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2019-12-23
Regulatory Status
RX
Drug Name
ULTANE
Product Number
1
Dosage Form
-
Strength
100%
Approval Date
1995-06-07
Active Ingredient
SEVOFLURANE
Application Number
20478
Product Number
1
Dosage Form
-
Strength
100%
Approval Date
1995-06-07
Regulatory Status
RX
Drug Name
URSO 250
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1997-12-10
Active Ingredient
URSODIOL
Application Number
20675
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1997-12-10
Regulatory Status
Discontinued
Drug Name
URSO FORTE
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2004-07-21
Active Ingredient
URSODIOL
Application Number
20675
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2004-07-21
Regulatory Status
Discontinued
Drug Name
VANIQA
Product Number
1
Dosage Form
-
Strength
13.9%
Approval Date
2000-07-27
Active Ingredient
EFLORNITHINE HYDROCHLORIDE
Application Number
21145
Product Number
1
Dosage Form
-
Strength
13.9%
Approval Date
2000-07-27
Regulatory Status
Discontinued
Drug Name
VENCLEXTA
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2016-04-11
Active Ingredient
VENETOCLAX
Application Number
208573
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2016-04-11
Regulatory Status
RX
Drug Name
VENCLEXTA
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2016-04-11
Active Ingredient
VENETOCLAX
Application Number
208573
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2016-04-11
Regulatory Status
RX
Drug Name
VENCLEXTA
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2016-04-11
Active Ingredient
VENETOCLAX
Application Number
208573
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2016-04-11
Regulatory Status
RX
Drug Name
VIBERZI
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2015-05-27
Active Ingredient
ELUXADOLINE
Application Number
206940
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2015-05-27
Regulatory Status
RX
Drug Name
VIBERZI
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2015-05-27
Active Ingredient
ELUXADOLINE
Application Number
206940
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2015-05-27
Regulatory Status
RX
Drug Name
VICODIN
Product Number
1
Dosage Form
-
Strength
500MG;5MG
Approval Date
1983-01-07
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
88058
Product Number
1
Dosage Form
-
Strength
500MG;5MG
Approval Date
1983-01-07
Regulatory Status
Discontinued
Drug Name
VICODIN ES
Product Number
1
Dosage Form
-
Strength
750MG;7.5MG
Approval Date
1988-12-09
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
89736
Product Number
1
Dosage Form
-
Strength
750MG;7.5MG
Approval Date
1988-12-09
Regulatory Status
Discontinued
Drug Name
VICODIN HP
Product Number
1
Dosage Form
-
Strength
660MG;10MG
Approval Date
1996-09-23
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
40117
Product Number
1
Dosage Form
-
Strength
660MG;10MG
Approval Date
1996-09-23
Regulatory Status
Discontinued
Drug Name
VICOPROFEN
Product Number
1
Dosage Form
-
Strength
7.5MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-09-23
Active Ingredient
HYDROCODONE BITARTRATE; IBUPROFEN
Application Number
20716
Product Number
1
Dosage Form
-
Strength
7.5MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-09-23
Regulatory Status
Discontinued
Drug Name
VIEKIRA PAK (COPACKAGED)
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE;12.5MG, 75MG, 50MG
Approval Date
2014-12-19
Active Ingredient
DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR
Application Number
206619
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE;12.5MG, 75MG, 50MG
Approval Date
2014-12-19
Regulatory Status
Discontinued
Drug Name
VIEKIRA XR
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2016-07-22
Active Ingredient
DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR
Application Number
208624
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2016-07-22
Regulatory Status
Discontinued
Drug Name
VIIBRYD
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2011-01-21
Active Ingredient
VILAZODONE HYDROCHLORIDE
Application Number
22567
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2011-01-21
Regulatory Status
RX
Drug Name
VIIBRYD
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2011-01-21
Active Ingredient
VILAZODONE HYDROCHLORIDE
Application Number
22567
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2011-01-21
Regulatory Status
RX
Drug Name
VIIBRYD
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2011-01-21
Active Ingredient
VILAZODONE HYDROCHLORIDE
Application Number
22567
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2011-01-21
Regulatory Status
RX
Drug Name
VRAYLAR
Product Number
1
Dosage Form
-
Strength
EQ 1.5MG BASE
Approval Date
2015-09-17
Active Ingredient
CARIPRAZINE HYDROCHLORIDE
Application Number
204370
Product Number
1
Dosage Form
-
Strength
EQ 1.5MG BASE
Approval Date
2015-09-17
Regulatory Status
RX
Drug Name
VRAYLAR
Product Number
2
Dosage Form
-
Strength
EQ 3MG BASE
Approval Date
2015-09-17
Active Ingredient
CARIPRAZINE HYDROCHLORIDE
Application Number
204370
Product Number
2
Dosage Form
-
Strength
EQ 3MG BASE
Approval Date
2015-09-17
Regulatory Status
RX
Drug Name
VRAYLAR
Product Number
3
Dosage Form
-
Strength
EQ 4.5MG BASE
Approval Date
2015-09-17
Active Ingredient
CARIPRAZINE HYDROCHLORIDE
Application Number
204370
Product Number
3
Dosage Form
-
Strength
EQ 4.5MG BASE
Approval Date
2015-09-17
Regulatory Status
RX
Drug Name
VRAYLAR
Product Number
4
Dosage Form
-
Strength
EQ 6MG BASE
Approval Date
2015-09-17
Active Ingredient
CARIPRAZINE HYDROCHLORIDE
Application Number
204370
Product Number
4
Dosage Form
-
Strength
EQ 6MG BASE
Approval Date
2015-09-17
Regulatory Status
RX
Drug Name
VRAYLAR
Product Number
5
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2025-12-18
Active Ingredient
CARIPRAZINE HYDROCHLORIDE
Application Number
204370
Product Number
5
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2025-12-18
Regulatory Status
RX
Drug Name
VRAYLAR
Product Number
6
Dosage Form
-
Strength
EQ 0.75MG BASE
Approval Date
2025-12-18
Active Ingredient
CARIPRAZINE HYDROCHLORIDE
Application Number
204370
Product Number
6
Dosage Form
-
Strength
EQ 0.75MG BASE
Approval Date
2025-12-18
Regulatory Status
RX
Drug Name
VUITY
Product Number
1
Dosage Form
-
Strength
1.25%
Approval Date
2021-10-28
Active Ingredient
PILOCARPINE HYDROCHLORIDE
Application Number
214028
Product Number
1
Dosage Form
-
Strength
1.25%
Approval Date
2021-10-28
Regulatory Status
Discontinued
Drug Name
VYALEV
Product Number
1
Dosage Form
-
Strength
120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)
Approval Date
2024-10-16
Active Ingredient
FOSCARBIDOPA; FOSLEVODOPA
Application Number
216962
Product Number
1
Dosage Form
-
Strength
120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)
Approval Date
2024-10-16
Regulatory Status
RX
Drug Name
ZEMPLAR
Product Number
1
Dosage Form
-
Strength
0.005MG/ML (0.005MG/ML)
Approval Date
1998-04-17
Active Ingredient
PARICALCITOL
Application Number
20819
Product Number
1
Dosage Form
-
Strength
0.005MG/ML (0.005MG/ML)
Approval Date
1998-04-17
Regulatory Status
RX
Drug Name
ZEMPLAR
Product Number
2
Dosage Form
-
Strength
0.002MG/ML (0.002MG/ML)
Approval Date
2000-02-01
Active Ingredient
PARICALCITOL
Application Number
20819
Product Number
2
Dosage Form
-
Strength
0.002MG/ML (0.002MG/ML)
Approval Date
2000-02-01
Regulatory Status
RX
Drug Name
ZEMPLAR
Product Number
3
Dosage Form
-
Strength
0.01MG/2ML (0.005MG/ML)
Approval Date
2000-02-01
Active Ingredient
PARICALCITOL
Application Number
20819
Product Number
3
Dosage Form
-
Strength
0.01MG/2ML (0.005MG/ML)
Approval Date
2000-02-01
Regulatory Status
RX
Drug Name
ZEMPLAR
Product Number
1
Dosage Form
-
Strength
1MCG
Approval Date
2005-05-26
Active Ingredient
PARICALCITOL
Application Number
21606
Product Number
1
Dosage Form
-
Strength
1MCG
Approval Date
2005-05-26
Regulatory Status
Discontinued
Drug Name
ZEMPLAR
Product Number
2
Dosage Form
-
Strength
2MCG
Approval Date
2005-05-26
Active Ingredient
PARICALCITOL
Application Number
21606
Product Number
2
Dosage Form
-
Strength
2MCG
Approval Date
2005-05-26
Regulatory Status
Discontinued
Drug Name
ZEMPLAR
Product Number
3
Dosage Form
-
Strength
4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2005-05-26
Active Ingredient
PARICALCITOL
Application Number
21606
Product Number
3
Dosage Form
-
Strength
4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2005-05-26
Regulatory Status
Discontinued
Drug Name
ZYMAXID
Product Number
1
Dosage Form
-
Strength
0.5%
Approval Date
2010-05-18
Active Ingredient
GATIFLOXACIN
Application Number
22548
Product Number
1
Dosage Form
-
Strength
0.5%
Approval Date
2010-05-18
Regulatory Status
RX
Drug Status Breakdown
301 total- RX
- Discontinued
- Unclassified
- OTC
Official Source
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Drug Name
ACULAR
Application Number
19700
Product Number
1
Active Ingredient
KETOROLAC TROMETHAMINE
Dosage Form
-
Strength
0.5%
FDA Approved Drug Data
Approved drug product information
Regular Updates
Data maintained from official sources
Structured Database
Searchable pharmaceutical data
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Organized FDA drug records
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