Endo International Discontinued
FDA Approved Drugs
Endo International 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 25
- Latest Approval Date Nov 26, 2013
- Data Source FDA
- First Approval Date Jan 01, 1982
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Endo International Discontinued
First Floor, Minerva House, Simmonscourt Road Ballsbridge, Dublin 4, Ireland
Ireland
www.endo.com/ View on MapFDA Approved Drug Records ( 25 records )
Drug Name
DILATRATE-SR
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
1988-09-02
Active Ingredient
ISOSORBIDE DINITRATE
Application Number
19790
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
1988-09-02
Regulatory Status
Discontinued
Drug Name
EDEX
Product Number
1
Dosage Form
-
Strength
0.005MG/VIAL
Approval Date
1997-06-12
Active Ingredient
ALPROSTADIL
Application Number
20649
Product Number
1
Dosage Form
-
Strength
0.005MG/VIAL
Approval Date
1997-06-12
Regulatory Status
Discontinued
Drug Name
FORTESTA
Product Number
1
Dosage Form
-
Strength
10MG/0.5GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2010-12-29
Active Ingredient
TESTOSTERONE
Application Number
21463
Product Number
1
Dosage Form
-
Strength
10MG/0.5GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2010-12-29
Regulatory Status
Discontinued
Drug Name
FROVA
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2001-11-08
Active Ingredient
FROVATRIPTAN SUCCINATE
Application Number
21006
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2001-11-08
Regulatory Status
Discontinued
Drug Name
LEVATOL
Product Number
1
Dosage Form
-
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1987-12-30
Active Ingredient
PENBUTOLOL SULFATE
Application Number
18976
Product Number
1
Dosage Form
-
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1987-12-30
Regulatory Status
Discontinued
Drug Name
LEVATOL
Product Number
4
Dosage Form
-
Strength
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1989-01-05
Active Ingredient
PENBUTOLOL SULFATE
Application Number
18976
Product Number
4
Dosage Form
-
Strength
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1989-01-05
Regulatory Status
Discontinued
Drug Name
MEGACE ES
Product Number
1
Dosage Form
-
Strength
125MG/ML
Approval Date
2005-07-05
Active Ingredient
MEGESTROL ACETATE
Application Number
21778
Product Number
1
Dosage Form
-
Strength
125MG/ML
Approval Date
2005-07-05
Regulatory Status
Discontinued
Drug Name
NASCOBAL
Product Number
1
Dosage Form
-
Strength
0.5MG/INH
Approval Date
1996-11-05
Active Ingredient
CYANOCOBALAMIN
Application Number
19722
Product Number
1
Dosage Form
-
Strength
0.5MG/INH
Approval Date
1996-11-05
Regulatory Status
Discontinued
Drug Name
NASCOBAL
Product Number
1
Dosage Form
-
Strength
0.5MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2005-01-31
Active Ingredient
CYANOCOBALAMIN
Application Number
21642
Product Number
1
Dosage Form
-
Strength
0.5MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2005-01-31
Regulatory Status
Discontinued
Drug Name
OPANA ER
Product Number
1
Dosage Form
-
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-06-22
Active Ingredient
OXYMORPHONE HYDROCHLORIDE
Application Number
21610
Product Number
1
Dosage Form
-
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-06-22
Regulatory Status
Discontinued
Drug Name
OPANA ER
Product Number
2
Dosage Form
-
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-06-22
Active Ingredient
OXYMORPHONE HYDROCHLORIDE
Application Number
21610
Product Number
2
Dosage Form
-
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-06-22
Regulatory Status
Discontinued
Drug Name
OPANA ER
Product Number
3
Dosage Form
-
Strength
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-06-22
Active Ingredient
OXYMORPHONE HYDROCHLORIDE
Application Number
21610
Product Number
3
Dosage Form
-
Strength
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-06-22
Regulatory Status
Discontinued
Drug Name
OPANA ER
Product Number
4
Dosage Form
-
Strength
40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-06-22
Active Ingredient
OXYMORPHONE HYDROCHLORIDE
Application Number
21610
Product Number
4
Dosage Form
-
Strength
40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-06-22
Regulatory Status
Discontinued
Drug Name
OPANA ER
Product Number
5
Dosage Form
-
Strength
7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2008-02-29
Active Ingredient
OXYMORPHONE HYDROCHLORIDE
Application Number
21610
Product Number
5
Dosage Form
-
Strength
7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2008-02-29
Regulatory Status
Discontinued
Drug Name
OPANA ER
Product Number
6
Dosage Form
-
Strength
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2008-02-29
Active Ingredient
OXYMORPHONE HYDROCHLORIDE
Application Number
21610
Product Number
6
Dosage Form
-
Strength
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2008-02-29
Regulatory Status
Discontinued
Drug Name
OPANA ER
Product Number
7
Dosage Form
-
Strength
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2008-02-29
Active Ingredient
OXYMORPHONE HYDROCHLORIDE
Application Number
21610
Product Number
7
Dosage Form
-
Strength
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2008-02-29
Regulatory Status
Discontinued
Drug Name
PERCODAN
Product Number
6
Dosage Form
-
Strength
325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE
Application Number
7337
Product Number
6
Dosage Form
-
Strength
325MG;4.5MG;0.38MG **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
PERCODAN
Product Number
7
Dosage Form
-
Strength
325MG;4.8355MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2005-08-05
Active Ingredient
ASPIRIN; OXYCODONE HYDROCHLORIDE
Application Number
7337
Product Number
7
Dosage Form
-
Strength
325MG;4.8355MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2005-08-05
Regulatory Status
Discontinued
Drug Name
PERCODAN-DEMI
Product Number
5
Dosage Form
-
Strength
325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE
Application Number
7337
Product Number
5
Dosage Form
-
Strength
325MG;2.25MG;0.19MG **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
ROBAXIN
Product Number
4
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
METHOCARBAMOL
Application Number
11011
Product Number
4
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
ROBAXIN-750
Product Number
6
Dosage Form
-
Strength
750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
METHOCARBAMOL
Application Number
11011
Product Number
6
Dosage Form
-
Strength
750MG **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
SEMPREX-D
Product Number
1
Dosage Form
-
Strength
8MG;60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1994-03-25
Active Ingredient
ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE
Application Number
19806
Product Number
1
Dosage Form
-
Strength
8MG;60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1994-03-25
Regulatory Status
Discontinued
Drug Name
SUMAVEL DOSEPRO
Product Number
1
Dosage Form
-
Strength
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Approval Date
2009-07-15
Active Ingredient
SUMATRIPTAN SUCCINATE
Application Number
22239
Product Number
1
Dosage Form
-
Strength
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Approval Date
2009-07-15
Regulatory Status
Discontinued
Drug Name
SUMAVEL DOSEPRO
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
Approval Date
2013-11-26
Active Ingredient
SUMATRIPTAN SUCCINATE
Application Number
22239
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
Approval Date
2013-11-26
Regulatory Status
Discontinued
Drug Name
VANTAS
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2004-10-12
Active Ingredient
HISTRELIN ACETATE
Application Number
21732
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2004-10-12
Regulatory Status
Discontinued
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Drug Status Breakdown
25 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
DILATRATE-SR
Application Number
19790
Product Number
1
Active Ingredient
ISOSORBIDE DINITRATE
Dosage Form
-
Strength
40MG
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