Endo Pharm
FDA Approved Drugs

Endo Pharm

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.

Discontinued Unclassified
  • Total Records 21
  • Latest Approval Date Dec 09, 2011
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
21
View
Unclassified
1
View
Discontinued
20
View
Company Overview

Company

Endo Pharm

Country

Ireland

Website

Visit Website

Email

rajiv.desilva@endo.com

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Company Snapshot

Endo Pharm

First Floor, Minerva House, Simmonscourt Road Ballsbridge, Ireland Dublin 4

Ireland

www.endo.com rajiv.desilva@endo.com View on Map
FDA Approved Drug Records ( 21 records )
1982
01 Jan
Discontinued Application: 9165

Drug Name

DELATESTRYL

Product Number

1

Dosage Form

-

Strength

200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

9165 / 1

Active Ingredient

TESTOSTERONE ENANTHATE

Application Number

9165

Product Number

1

Dosage Form

-

Strength

200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9165

Drug Name

DELATESTRYL

Product Number

3

Dosage Form

-

Strength

200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

9165 / 3

Active Ingredient

TESTOSTERONE ENANTHATE

Application Number

9165

Product Number

3

Dosage Form

-

Strength

200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17938

Drug Name

MOBAN

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

1982-01-01

17938 / 1

Active Ingredient

MOLINDONE HYDROCHLORIDE

Application Number

17938

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11738

Drug Name

NUMORPHAN

Product Number

4

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

11738 / 4

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

11738

Product Number

4

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11707

Drug Name

OPANA

Product Number

1

Dosage Form

-

Strength

1.5MG/ML

Approval Date

1982-01-01

11707 / 1

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

11707

Product Number

1

Dosage Form

-

Strength

1.5MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11707

Drug Name

OPANA

Product Number

2

Dosage Form

-

Strength

1MG/ML

Approval Date

1982-01-01

11707 / 2

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

11707

Product Number

2

Dosage Form

-

Strength

1MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2006
22 Jun
Discontinued Application: 21611

Drug Name

OPANA

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

21611 / 1

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

21611

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

2006
22 Jun
Discontinued Application: 21611

Drug Name

OPANA

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

21611 / 2

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

21611

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

2011
09 Dec
Discontinued Application: 201655

Drug Name

OPANA ER

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-12-09

201655 / 1

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

201655

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-12-09

Regulatory Status

Discontinued

2011
09 Dec
Discontinued Application: 201655

Drug Name

OPANA ER

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2011-12-09

201655 / 2

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

201655

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2011-12-09

Regulatory Status

Discontinued

2011
09 Dec
Discontinued Application: 201655

Drug Name

OPANA ER

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2011-12-09

201655 / 3

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

201655

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2011-12-09

Regulatory Status

Discontinued

2011
09 Dec
Discontinued Application: 201655

Drug Name

OPANA ER

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2011-12-09

201655 / 4

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

201655

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2011-12-09

Regulatory Status

Discontinued

2011
09 Dec
Discontinued Application: 201655

Drug Name

OPANA ER

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2011-12-09

201655 / 5

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

201655

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2011-12-09

Regulatory Status

Discontinued

2011
09 Dec
Discontinued Application: 201655

Drug Name

OPANA ER

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2011-12-09

201655 / 6

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

201655

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2011-12-09

Regulatory Status

Discontinued

2011
09 Dec
Discontinued Application: 201655

Drug Name

OPANA ER

Product Number

7

Dosage Form

-

Strength

40MG

Approval Date

2011-12-09

201655 / 7

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

201655

Product Number

7

Dosage Form

-

Strength

40MG

Approval Date

2011-12-09

Regulatory Status

Discontinued

2003
19 Jun
Discontinued Application: 21543

Drug Name

STRIANT

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2003-06-19

21543 / 1

Active Ingredient

TESTOSTERONE

Application Number

21543

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2003-06-19

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16020

Drug Name

SYMMETREL

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

16020 / 1

Active Ingredient

AMANTADINE HYDROCHLORIDE

Application Number

16020

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

1982
01 Jan
Discontinued Application: 16023

Drug Name

SYMMETREL

Product Number

2

Dosage Form

-

Strength

50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

16023 / 2

Active Ingredient

AMANTADINE HYDROCHLORIDE

Application Number

16023

Product Number

2

Dosage Form

-

Strength

50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18101

Drug Name

SYMMETREL

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

18101 / 1

Active Ingredient

AMANTADINE HYDROCHLORIDE

Application Number

18101

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

1982
01 Jan
Discontinued Application: 13428

Drug Name

VALPIN 50

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

13428 / 1

Active Ingredient

ANISOTROPINE METHYLBROMIDE

Application Number

13428

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

-
Unclassified Application: 125338

Drug Name

XIAFLEX

Product Number

1

Dosage Form

-

Strength

0.9MG

Approval Date

-

125338 / 1

Active Ingredient

COLLAGENASE CLOSTRIDIUM HISTOLYTICUM

Application Number

125338

Product Number

1

Dosage Form

-

Strength

0.9MG

Approval Date

-

Regulatory Status

Unclassified

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Drug Status Breakdown
21 total
  • Discontinued
  • Unclassified
Official Source

FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.

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Explore important FDA approved drug information available in the records above.

Drug Name

DELATESTRYL

Application Number

9165

Product Number

1

Active Ingredient

TESTOSTERONE ENANTHATE

Dosage Form

-

Strength

200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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