Johnson & Johnson Innovative Medicine Discontinued
FDA Approved Drugs
Johnson & Johnson Innovative Medicine Discontinued
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 83
- Latest Approval Date Jan 24, 2018
- Data Source FDA
- First Approval Date Jan 01, 1982
Company Overview
Company
Johnson & Johnson Innovative Medicine Discontinued
Country
U.S.A
Website
Social Profiles
Company Snapshot
Johnson & Johnson Innovative Medicine Discontinued
1125 Trenton-Harbourton Road, P.O. Box 200, Titusville, NJ 08560
U.S.A
www.janssen.com/us/ View on MapFDA Approved Drug Records ( 83 records )
Drug Name
AXERT
Product Number
1
Dosage Form
-
Strength
EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2001-05-07
Active Ingredient
ALMOTRIPTAN MALATE
Application Number
21001
Product Number
1
Dosage Form
-
Strength
EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2001-05-07
Regulatory Status
Discontinued
Drug Name
AXERT
Product Number
2
Dosage Form
-
Strength
EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2001-05-07
Active Ingredient
ALMOTRIPTAN MALATE
Application Number
21001
Product Number
2
Dosage Form
-
Strength
EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2001-05-07
Regulatory Status
Discontinued
Drug Name
DITROPAN
Product Number
1
Dosage Form
-
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
OXYBUTYNIN CHLORIDE
Application Number
17577
Product Number
1
Dosage Form
-
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DITROPAN XL
Product Number
1
Dosage Form
-
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1998-12-16
Active Ingredient
OXYBUTYNIN CHLORIDE
Application Number
20897
Product Number
1
Dosage Form
-
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1998-12-16
Regulatory Status
Discontinued
Drug Name
DITROPAN XL
Product Number
2
Dosage Form
-
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1998-12-16
Active Ingredient
OXYBUTYNIN CHLORIDE
Application Number
20897
Product Number
2
Dosage Form
-
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1998-12-16
Regulatory Status
Discontinued
Drug Name
DITROPAN XL
Product Number
3
Dosage Form
-
Strength
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-06-22
Active Ingredient
OXYBUTYNIN CHLORIDE
Application Number
20897
Product Number
3
Dosage Form
-
Strength
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-06-22
Regulatory Status
Discontinued
Drug Name
DURAGESIC-100
Product Number
1
Dosage Form
-
Strength
100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1990-08-07
Active Ingredient
FENTANYL
Application Number
19813
Product Number
1
Dosage Form
-
Strength
100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1990-08-07
Regulatory Status
Discontinued
Drug Name
DURAGESIC-12
Product Number
5
Dosage Form
-
Strength
12.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2005-02-04
Active Ingredient
FENTANYL
Application Number
19813
Product Number
5
Dosage Form
-
Strength
12.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2005-02-04
Regulatory Status
Discontinued
Drug Name
DURAGESIC-25
Product Number
4
Dosage Form
-
Strength
25MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1990-08-07
Active Ingredient
FENTANYL
Application Number
19813
Product Number
4
Dosage Form
-
Strength
25MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1990-08-07
Regulatory Status
Discontinued
Drug Name
DURAGESIC-37
Product Number
6
Dosage Form
-
Strength
37.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2018-01-24
Active Ingredient
FENTANYL
Application Number
19813
Product Number
6
Dosage Form
-
Strength
37.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2018-01-24
Regulatory Status
Discontinued
Drug Name
DURAGESIC-50
Product Number
3
Dosage Form
-
Strength
50MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1990-08-07
Active Ingredient
FENTANYL
Application Number
19813
Product Number
3
Dosage Form
-
Strength
50MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1990-08-07
Regulatory Status
Discontinued
Drug Name
DURAGESIC-75
Product Number
2
Dosage Form
-
Strength
75MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1990-08-07
Active Ingredient
FENTANYL
Application Number
19813
Product Number
2
Dosage Form
-
Strength
75MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1990-08-07
Regulatory Status
Discontinued
Drug Name
FLOXIN
Product Number
1
Dosage Form
-
Strength
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1990-12-28
Active Ingredient
OFLOXACIN
Application Number
19735
Product Number
1
Dosage Form
-
Strength
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1990-12-28
Regulatory Status
Discontinued
Drug Name
FLOXIN
Product Number
2
Dosage Form
-
Strength
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1990-12-28
Active Ingredient
OFLOXACIN
Application Number
19735
Product Number
2
Dosage Form
-
Strength
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1990-12-28
Regulatory Status
Discontinued
Drug Name
FLOXIN
Product Number
3
Dosage Form
-
Strength
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1990-12-28
Active Ingredient
OFLOXACIN
Application Number
19735
Product Number
3
Dosage Form
-
Strength
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1990-12-28
Regulatory Status
Discontinued
Drug Name
HALDOL
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
HALOPERIDOL LACTATE
Application Number
15923
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HALDOL
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/ML
Approval Date
1986-01-14
Active Ingredient
HALOPERIDOL DECANOATE
Application Number
18701
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/ML
Approval Date
1986-01-14
Regulatory Status
Discontinued
Drug Name
HALDOL
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE/ML
Approval Date
1997-01-31
Active Ingredient
HALOPERIDOL DECANOATE
Application Number
18701
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE/ML
Approval Date
1997-01-31
Regulatory Status
Discontinued
Drug Name
IMODIUM
Product Number
1
Dosage Form
-
Strength
1MG/5ML
Approval Date
1984-07-31
Active Ingredient
LOPERAMIDE HYDROCHLORIDE
Application Number
19037
Product Number
1
Dosage Form
-
Strength
1MG/5ML
Approval Date
1984-07-31
Regulatory Status
Discontinued
Drug Name
INVEGA
Product Number
4
Dosage Form
-
Strength
12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-12-19
Active Ingredient
PALIPERIDONE
Application Number
21999
Product Number
4
Dosage Form
-
Strength
12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-12-19
Regulatory Status
Discontinued
Drug Name
INVEGA
Product Number
6
Dosage Form
-
Strength
1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2008-08-26
Active Ingredient
PALIPERIDONE
Application Number
21999
Product Number
6
Dosage Form
-
Strength
1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2008-08-26
Regulatory Status
Discontinued
Drug Name
LEUSTATIN
Product Number
1
Dosage Form
-
Strength
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1993-02-26
Active Ingredient
CLADRIBINE
Application Number
20229
Product Number
1
Dosage Form
-
Strength
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1993-02-26
Regulatory Status
Discontinued
Drug Name
LEVAQUIN
Product Number
1
Dosage Form
-
Strength
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1996-12-20
Active Ingredient
LEVOFLOXACIN
Application Number
20634
Product Number
1
Dosage Form
-
Strength
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1996-12-20
Regulatory Status
Discontinued
Drug Name
LEVAQUIN
Product Number
2
Dosage Form
-
Strength
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1996-12-20
Active Ingredient
LEVOFLOXACIN
Application Number
20634
Product Number
2
Dosage Form
-
Strength
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1996-12-20
Regulatory Status
Discontinued
Drug Name
LEVAQUIN
Product Number
3
Dosage Form
-
Strength
750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2000-09-08
Active Ingredient
LEVOFLOXACIN
Application Number
20634
Product Number
3
Dosage Form
-
Strength
750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2000-09-08
Regulatory Status
Discontinued
Drug Name
LEVAQUIN
Product Number
1
Dosage Form
-
Strength
EQ 500MG/20ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1996-12-20
Active Ingredient
LEVOFLOXACIN
Application Number
20635
Product Number
1
Dosage Form
-
Strength
EQ 500MG/20ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1996-12-20
Regulatory Status
Discontinued
Drug Name
LEVAQUIN
Product Number
4
Dosage Form
-
Strength
EQ 750MG/30ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1996-12-20
Active Ingredient
LEVOFLOXACIN
Application Number
20635
Product Number
4
Dosage Form
-
Strength
EQ 750MG/30ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1996-12-20
Regulatory Status
Discontinued
Drug Name
LEVAQUIN
Product Number
1
Dosage Form
-
Strength
250MG/10ML
Approval Date
2004-10-21
Active Ingredient
LEVOFLOXACIN
Application Number
21721
Product Number
1
Dosage Form
-
Strength
250MG/10ML
Approval Date
2004-10-21
Regulatory Status
Discontinued
Drug Name
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Product Number
2
Dosage Form
-
Strength
EQ 250MG/50ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1996-12-20
Active Ingredient
LEVOFLOXACIN
Application Number
20635
Product Number
2
Dosage Form
-
Strength
EQ 250MG/50ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1996-12-20
Regulatory Status
Discontinued
Drug Name
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Product Number
3
Dosage Form
-
Strength
EQ 500MG/100ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1996-12-20
Active Ingredient
LEVOFLOXACIN
Application Number
20635
Product Number
3
Dosage Form
-
Strength
EQ 500MG/100ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1996-12-20
Regulatory Status
Discontinued
Drug Name
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Product Number
5
Dosage Form
-
Strength
EQ 750MG/150ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1996-12-20
Active Ingredient
LEVOFLOXACIN
Application Number
20635
Product Number
5
Dosage Form
-
Strength
EQ 750MG/150ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1996-12-20
Regulatory Status
Discontinued
Drug Name
MICRONOR
Product Number
1
Dosage Form
-
Strength
0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
NORETHINDRONE
Application Number
16954
Product Number
1
Dosage Form
-
Strength
0.35MG **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
MODICON 28
Product Number
1
Dosage Form
-
Strength
0.035MG;0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE
Application Number
17735
Product Number
1
Dosage Form
-
Strength
0.035MG;0.5MG **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
NIZORAL
Product Number
1
Dosage Form
-
Strength
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
KETOCONAZOLE
Application Number
18533
Product Number
1
Dosage Form
-
Strength
200MG **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
NIZORAL
Product Number
1
Dosage Form
-
Strength
2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1990-08-31
Active Ingredient
KETOCONAZOLE
Application Number
19927
Product Number
1
Dosage Form
-
Strength
2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1990-08-31
Regulatory Status
Discontinued
Drug Name
OLYSIO
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2013-11-22
Active Ingredient
SIMEPREVIR SODIUM
Application Number
205123
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2013-11-22
Regulatory Status
Discontinued
Drug Name
ORTHO CYCLEN-21
Product Number
1
Dosage Form
-
Strength
0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1989-12-29
Active Ingredient
ETHINYL ESTRADIOL; NORGESTIMATE
Application Number
19653
Product Number
1
Dosage Form
-
Strength
0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1989-12-29
Regulatory Status
Discontinued
Drug Name
ORTHO CYCLEN-28
Product Number
2
Dosage Form
-
Strength
0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1989-12-29
Active Ingredient
ETHINYL ESTRADIOL; NORGESTIMATE
Application Number
19653
Product Number
2
Dosage Form
-
Strength
0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1989-12-29
Regulatory Status
Discontinued
Drug Name
ORTHO EVRA
Product Number
1
Dosage Form
-
Strength
0.035MG/24HR;0.15MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2001-11-20
Active Ingredient
ETHINYL ESTRADIOL; NORELGESTROMIN
Application Number
21180
Product Number
1
Dosage Form
-
Strength
0.035MG/24HR;0.15MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2001-11-20
Regulatory Status
Discontinued
Drug Name
ORTHO TRI-CYCLEN
Product Number
1
Dosage Form
-
Strength
0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1992-07-03
Active Ingredient
ETHINYL ESTRADIOL; NORGESTIMATE
Application Number
19697
Product Number
1
Dosage Form
-
Strength
0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1992-07-03
Regulatory Status
Discontinued
Drug Name
ORTHO TRI-CYCLEN
Product Number
2
Dosage Form
-
Strength
0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1992-07-03
Active Ingredient
ETHINYL ESTRADIOL; NORGESTIMATE
Application Number
19697
Product Number
2
Dosage Form
-
Strength
0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1992-07-03
Regulatory Status
Discontinued
Drug Name
ORTHO TRI-CYCLEN LO
Product Number
1
Dosage Form
-
Strength
0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2002-08-22
Active Ingredient
ETHINYL ESTRADIOL; NORGESTIMATE
Application Number
21241
Product Number
1
Dosage Form
-
Strength
0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2002-08-22
Regulatory Status
Discontinued
Drug Name
ORTHO-CEPT
Product Number
1
Dosage Form
-
Strength
0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1992-12-14
Active Ingredient
DESOGESTREL; ETHINYL ESTRADIOL
Application Number
20301
Product Number
1
Dosage Form
-
Strength
0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1992-12-14
Regulatory Status
Discontinued
Drug Name
ORTHO-CEPT
Product Number
2
Dosage Form
-
Strength
0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1992-12-14
Active Ingredient
DESOGESTREL; ETHINYL ESTRADIOL
Application Number
20301
Product Number
2
Dosage Form
-
Strength
0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1992-12-14
Regulatory Status
Discontinued
Drug Name
ORTHO-NOVUM 1/35-28
Product Number
2
Dosage Form
-
Strength
0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE
Application Number
17919
Product Number
2
Dosage Form
-
Strength
0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ORTHO-NOVUM 7/7/7-21
Product Number
1
Dosage Form
-
Strength
0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG
Approval Date
1984-04-04
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE
Application Number
18985
Product Number
1
Dosage Form
-
Strength
0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG
Approval Date
1984-04-04
Regulatory Status
Discontinued
Drug Name
ORTHO-NOVUM 7/7/7-28
Product Number
2
Dosage Form
-
Strength
0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1984-04-04
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE
Application Number
18985
Product Number
2
Dosage Form
-
Strength
0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1984-04-04
Regulatory Status
Discontinued
Drug Name
PREZISTA
Product Number
1
Dosage Form
-
Strength
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-06-23
Active Ingredient
DARUNAVIR
Application Number
21976
Product Number
1
Dosage Form
-
Strength
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-06-23
Regulatory Status
Discontinued
Drug Name
PREZISTA
Product Number
3
Dosage Form
-
Strength
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2008-10-21
Active Ingredient
DARUNAVIR
Application Number
21976
Product Number
3
Dosage Form
-
Strength
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2008-10-21
Regulatory Status
Discontinued
Drug Name
PROPULSID
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1993-07-29
Active Ingredient
CISAPRIDE MONOHYDRATE
Application Number
20210
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1993-07-29
Regulatory Status
Discontinued
Drug Name
PROPULSID
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
1993-12-23
Active Ingredient
CISAPRIDE MONOHYDRATE
Application Number
20210
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
1993-12-23
Regulatory Status
Discontinued
Drug Name
PROPULSID
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
1995-09-15
Active Ingredient
CISAPRIDE MONOHYDRATE
Application Number
20398
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
1995-09-15
Regulatory Status
Discontinued
Drug Name
RAZADYNE
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2001-02-28
Active Ingredient
GALANTAMINE HYDROBROMIDE
Application Number
21169
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2001-02-28
Regulatory Status
Discontinued
Drug Name
RAZADYNE
Product Number
2
Dosage Form
-
Strength
EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2001-02-28
Active Ingredient
GALANTAMINE HYDROBROMIDE
Application Number
21169
Product Number
2
Dosage Form
-
Strength
EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2001-02-28
Regulatory Status
Discontinued
Drug Name
RAZADYNE
Product Number
3
Dosage Form
-
Strength
EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2001-02-28
Active Ingredient
GALANTAMINE HYDROBROMIDE
Application Number
21169
Product Number
3
Dosage Form
-
Strength
EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2001-02-28
Regulatory Status
Discontinued
Drug Name
RAZADYNE
Product Number
1
Dosage Form
-
Strength
4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2001-06-22
Active Ingredient
GALANTAMINE HYDROBROMIDE
Application Number
21224
Product Number
1
Dosage Form
-
Strength
4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2001-06-22
Regulatory Status
Discontinued
Drug Name
RAZADYNE ER
Product Number
1
Dosage Form
-
Strength
EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2005-04-01
Active Ingredient
GALANTAMINE HYDROBROMIDE
Application Number
21615
Product Number
1
Dosage Form
-
Strength
EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2005-04-01
Regulatory Status
Discontinued
Drug Name
RAZADYNE ER
Product Number
2
Dosage Form
-
Strength
EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2005-04-01
Active Ingredient
GALANTAMINE HYDROBROMIDE
Application Number
21615
Product Number
2
Dosage Form
-
Strength
EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2005-04-01
Regulatory Status
Discontinued
Drug Name
RAZADYNE ER
Product Number
3
Dosage Form
-
Strength
EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2005-04-01
Active Ingredient
GALANTAMINE HYDROBROMIDE
Application Number
21615
Product Number
3
Dosage Form
-
Strength
EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2005-04-01
Regulatory Status
Discontinued
Drug Name
RISPERDAL
Product Number
5
Dosage Form
-
Strength
5MG
Approval Date
1993-12-29
Active Ingredient
RISPERIDONE
Application Number
20272
Product Number
5
Dosage Form
-
Strength
5MG
Approval Date
1993-12-29
Regulatory Status
Discontinued
Drug Name
RISPERDAL
Product Number
1
Dosage Form
-
Strength
0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2003-04-02
Active Ingredient
RISPERIDONE
Application Number
21444
Product Number
1
Dosage Form
-
Strength
0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2003-04-02
Regulatory Status
Discontinued
Drug Name
RISPERDAL
Product Number
2
Dosage Form
-
Strength
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2003-04-02
Active Ingredient
RISPERIDONE
Application Number
21444
Product Number
2
Dosage Form
-
Strength
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2003-04-02
Regulatory Status
Discontinued
Drug Name
RISPERDAL
Product Number
3
Dosage Form
-
Strength
2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2003-04-02
Active Ingredient
RISPERIDONE
Application Number
21444
Product Number
3
Dosage Form
-
Strength
2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2003-04-02
Regulatory Status
Discontinued
Drug Name
RISPERDAL
Product Number
4
Dosage Form
-
Strength
3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2004-12-23
Active Ingredient
RISPERIDONE
Application Number
21444
Product Number
4
Dosage Form
-
Strength
3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2004-12-23
Regulatory Status
Discontinued
Drug Name
RISPERDAL
Product Number
5
Dosage Form
-
Strength
4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2004-12-23
Active Ingredient
RISPERIDONE
Application Number
21444
Product Number
5
Dosage Form
-
Strength
4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2004-12-23
Regulatory Status
Discontinued
Drug Name
SPORANOX
Product Number
1
Dosage Form
-
Strength
10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-02-21
Active Ingredient
ITRACONAZOLE
Application Number
20657
Product Number
1
Dosage Form
-
Strength
10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-02-21
Regulatory Status
Discontinued
Drug Name
SPORANOX
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
1999-03-30
Active Ingredient
ITRACONAZOLE
Application Number
20966
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
1999-03-30
Regulatory Status
Discontinued
Drug Name
TERAZOL 3
Product Number
1
Dosage Form
-
Strength
80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1988-05-24
Active Ingredient
TERCONAZOLE
Application Number
19641
Product Number
1
Dosage Form
-
Strength
80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1988-05-24
Regulatory Status
Discontinued
Drug Name
TERAZOL 3
Product Number
1
Dosage Form
-
Strength
0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1991-02-21
Active Ingredient
TERCONAZOLE
Application Number
19964
Product Number
1
Dosage Form
-
Strength
0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1991-02-21
Regulatory Status
Discontinued
Drug Name
TERAZOL 7
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
1987-12-31
Active Ingredient
TERCONAZOLE
Application Number
19579
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
1987-12-31
Regulatory Status
Discontinued
Drug Name
TOPAMAX
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
1996-12-24
Active Ingredient
TOPIRAMATE
Application Number
20505
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
1996-12-24
Regulatory Status
Discontinued
Drug Name
TOPAMAX
Product Number
6
Dosage Form
-
Strength
400MG
Approval Date
1996-12-24
Active Ingredient
TOPIRAMATE
Application Number
20505
Product Number
6
Dosage Form
-
Strength
400MG
Approval Date
1996-12-24
Regulatory Status
Discontinued
Drug Name
TOPAMAX SPRINKLE
Product Number
3
Dosage Form
-
Strength
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1998-10-26
Active Ingredient
TOPIRAMATE
Application Number
20844
Product Number
3
Dosage Form
-
Strength
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1998-10-26
Regulatory Status
Discontinued
Drug Name
TYLENOL W/ CODEINE NO. 1
Product Number
1
Dosage Form
-
Strength
300MG;7.5MG
Approval Date
1982-01-01
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Application Number
85055
Product Number
1
Dosage Form
-
Strength
300MG;7.5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TYLENOL W/ CODEINE NO. 2
Product Number
2
Dosage Form
-
Strength
300MG;15MG
Approval Date
1982-01-01
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Application Number
85055
Product Number
2
Dosage Form
-
Strength
300MG;15MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TYLENOL W/ CODEINE NO. 3
Product Number
3
Dosage Form
-
Strength
300MG;30MG
Approval Date
1982-01-01
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Application Number
85055
Product Number
3
Dosage Form
-
Strength
300MG;30MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TYLENOL W/ CODEINE NO. 4
Product Number
4
Dosage Form
-
Strength
300MG;60MG
Approval Date
1982-01-01
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Application Number
85055
Product Number
4
Dosage Form
-
Strength
300MG;60MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TYLOX
Product Number
1
Dosage Form
-
Strength
500MG;5MG
Approval Date
1984-12-12
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Application Number
88790
Product Number
1
Dosage Form
-
Strength
500MG;5MG
Approval Date
1984-12-12
Regulatory Status
Discontinued
Drug Name
ULTRACET
Product Number
1
Dosage Form
-
Strength
325MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2001-08-15
Active Ingredient
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Application Number
21123
Product Number
1
Dosage Form
-
Strength
325MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2001-08-15
Regulatory Status
Discontinued
Drug Name
ULTRAM
Product Number
1
Dosage Form
-
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1995-03-03
Active Ingredient
TRAMADOL HYDROCHLORIDE
Application Number
20281
Product Number
1
Dosage Form
-
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1995-03-03
Regulatory Status
Discontinued
Drug Name
ULTRAM
Product Number
2
Dosage Form
-
Strength
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1995-03-03
Active Ingredient
TRAMADOL HYDROCHLORIDE
Application Number
20281
Product Number
2
Dosage Form
-
Strength
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1995-03-03
Regulatory Status
Discontinued
Drug Name
VERMOX
Product Number
1
Dosage Form
-
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
MEBENDAZOLE
Application Number
17481
Product Number
1
Dosage Form
-
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
VERMOX
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2016-10-19
Active Ingredient
MEBENDAZOLE
Application Number
208398
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2016-10-19
Regulatory Status
Discontinued
Drug Status Breakdown
83 total- Discontinued
Official Source
FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.
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Drug Name
AXERT
Application Number
21001
Product Number
1
Active Ingredient
ALMOTRIPTAN MALATE
Dosage Form
-
Strength
EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
FDA Approved Drug Data
Approved drug product information
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