Endo International
FDA Approved Drugs

Endo International

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.

RX Discontinued
  • Total Records 40
  • Latest Approval Date Mar 05, 2014
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
40
View
Discontinued
25
View
RX
15
View
Company Overview

Company

Endo International

Country

Ireland

Website

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Company Snapshot

Endo International

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

Ireland

www.endo.com/ View on Map
FDA Approved Drug Records ( 40 records )
2014
05 Mar
RX Application: 22219

Drug Name

AVEED

Product Number

1

Dosage Form

-

Strength

750MG/3ML (250MG/ML)

Approval Date

2014-03-05

22219 / 1

Active Ingredient

TESTOSTERONE UNDECANOATE

Application Number

22219

Product Number

1

Dosage Form

-

Strength

750MG/3ML (250MG/ML)

Approval Date

2014-03-05

Regulatory Status

RX

1988
02 Sep
Discontinued Application: 19790

Drug Name

DILATRATE-SR

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1988-09-02

19790 / 1

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

19790

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1988-09-02

Regulatory Status

Discontinued

1997
12 Jun
Discontinued Application: 20649

Drug Name

EDEX

Product Number

1

Dosage Form

-

Strength

0.005MG/VIAL

Approval Date

1997-06-12

20649 / 1

Active Ingredient

ALPROSTADIL

Application Number

20649

Product Number

1

Dosage Form

-

Strength

0.005MG/VIAL

Approval Date

1997-06-12

Regulatory Status

Discontinued

1997
12 Jun
RX Application: 20649

Drug Name

EDEX

Product Number

2

Dosage Form

-

Strength

0.01MG/VIAL

Approval Date

1997-06-12

20649 / 2

Active Ingredient

ALPROSTADIL

Application Number

20649

Product Number

2

Dosage Form

-

Strength

0.01MG/VIAL

Approval Date

1997-06-12

Regulatory Status

RX

1997
12 Jun
RX Application: 20649

Drug Name

EDEX

Product Number

3

Dosage Form

-

Strength

0.02MG/VIAL

Approval Date

1997-06-12

20649 / 3

Active Ingredient

ALPROSTADIL

Application Number

20649

Product Number

3

Dosage Form

-

Strength

0.02MG/VIAL

Approval Date

1997-06-12

Regulatory Status

RX

1997
12 Jun
RX Application: 20649

Drug Name

EDEX

Product Number

4

Dosage Form

-

Strength

0.04MG/VIAL

Approval Date

1997-06-12

20649 / 4

Active Ingredient

ALPROSTADIL

Application Number

20649

Product Number

4

Dosage Form

-

Strength

0.04MG/VIAL

Approval Date

1997-06-12

Regulatory Status

RX

1998
30 Jul
RX Application: 20649

Drug Name

EDEX

Product Number

5

Dosage Form

-

Strength

0.01MG/VIAL

Approval Date

1998-07-30

20649 / 5

Active Ingredient

ALPROSTADIL

Application Number

20649

Product Number

5

Dosage Form

-

Strength

0.01MG/VIAL

Approval Date

1998-07-30

Regulatory Status

RX

1998
30 Jul
RX Application: 20649

Drug Name

EDEX

Product Number

6

Dosage Form

-

Strength

0.02MG/VIAL

Approval Date

1998-07-30

20649 / 6

Active Ingredient

ALPROSTADIL

Application Number

20649

Product Number

6

Dosage Form

-

Strength

0.02MG/VIAL

Approval Date

1998-07-30

Regulatory Status

RX

1998
30 Jul
RX Application: 20649

Drug Name

EDEX

Product Number

7

Dosage Form

-

Strength

0.04MG/VIAL

Approval Date

1998-07-30

20649 / 7

Active Ingredient

ALPROSTADIL

Application Number

20649

Product Number

7

Dosage Form

-

Strength

0.04MG/VIAL

Approval Date

1998-07-30

Regulatory Status

RX

2010
29 Dec
Discontinued Application: 21463

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

21463 / 1

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

2001
08 Nov
Discontinued Application: 21006

Drug Name

FROVA

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2001-11-08

21006 / 1

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

1987
30 Dec
Discontinued Application: 18976

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

18976 / 1

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

1989
05 Jan
Discontinued Application: 18976

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

18976 / 4

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

2005
05 Jul
Discontinued Application: 21778

Drug Name

MEGACE ES

Product Number

1

Dosage Form

-

Strength

125MG/ML

Approval Date

2005-07-05

21778 / 1

Active Ingredient

MEGESTROL ACETATE

Application Number

21778

Product Number

1

Dosage Form

-

Strength

125MG/ML

Approval Date

2005-07-05

Regulatory Status

Discontinued

1996
05 Nov
Discontinued Application: 19722

Drug Name

NASCOBAL

Product Number

1

Dosage Form

-

Strength

0.5MG/INH

Approval Date

1996-11-05

19722 / 1

Active Ingredient

CYANOCOBALAMIN

Application Number

19722

Product Number

1

Dosage Form

-

Strength

0.5MG/INH

Approval Date

1996-11-05

Regulatory Status

Discontinued

2005
31 Jan
Discontinued Application: 21642

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

21642 / 1

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

2006
22 Jun
Discontinued Application: 21610

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

21610 / 1

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

2006
22 Jun
Discontinued Application: 21610

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

21610 / 2

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

2006
22 Jun
Discontinued Application: 21610

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

21610 / 3

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

2006
22 Jun
Discontinued Application: 21610

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

21610 / 4

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

2008
29 Feb
Discontinued Application: 21610

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

21610 / 5

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

2008
29 Feb
Discontinued Application: 21610

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

21610 / 6

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

2008
29 Feb
Discontinued Application: 21610

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

21610 / 7

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

1982
01 Jan
Discontinued Application: 7337

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

7337 / 6

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

2005
05 Aug
Discontinued Application: 7337

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

7337 / 7

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

1982
01 Jan
Discontinued Application: 7337

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

7337 / 5

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

1982
01 Jan
Discontinued Application: 11011

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

11011 / 4

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

1982
01 Jan
Discontinued Application: 11011

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

11011 / 6

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

1994
25 Mar
Discontinued Application: 19806

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

19806 / 1

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

2009
15 Jul
Discontinued Application: 22239

Drug Name

SUMAVEL DOSEPRO

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

Approval Date

2009-07-15

22239 / 1

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

2013
26 Nov
Discontinued Application: 22239

Drug Name

SUMAVEL DOSEPRO

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)

Approval Date

2013-11-26

22239 / 2

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

2007
03 May
RX Application: 22058

Drug Name

SUPPRELIN LA

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2007-05-03

22058 / 1

Active Ingredient

HISTRELIN ACETATE

Application Number

22058

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2007-05-03

Regulatory Status

RX

2002
31 Oct
RX Application: 21454

Drug Name

TESTIM

Product Number

1

Dosage Form

-

Strength

50MG/5GM PACKET

Approval Date

2002-10-31

21454 / 1

Active Ingredient

TESTOSTERONE

Application Number

21454

Product Number

1

Dosage Form

-

Strength

50MG/5GM PACKET

Approval Date

2002-10-31

Regulatory Status

RX

1982
01 Jan
RX Application: 80911

Drug Name

TESTOPEL

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

1982-01-01

80911 / 1

Active Ingredient

TESTOSTERONE

Application Number

80911

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

1982-01-01

Regulatory Status

RX

1983
22 Aug
RX Application: 87943

Drug Name

THEO-24

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1983-08-22

87943 / 1

Active Ingredient

THEOPHYLLINE

Application Number

87943

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1983-08-22

Regulatory Status

RX

1983
22 Aug
RX Application: 87943

Drug Name

THEO-24

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1983-08-22

87943 / 2

Active Ingredient

THEOPHYLLINE

Application Number

87943

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1983-08-22

Regulatory Status

RX

1983
22 Aug
RX Application: 87943

Drug Name

THEO-24

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

1983-08-22

87943 / 3

Active Ingredient

THEOPHYLLINE

Application Number

87943

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

1983-08-22

Regulatory Status

RX

1992
28 Feb
RX Application: 87943

Drug Name

THEO-24

Product Number

4

Dosage Form

-

Strength

400MG

Approval Date

1992-02-28

87943 / 4

Active Ingredient

THEOPHYLLINE

Application Number

87943

Product Number

4

Dosage Form

-

Strength

400MG

Approval Date

1992-02-28

Regulatory Status

RX

1998
25 Sep
RX Application: 20892

Drug Name

VALSTAR PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

1998-09-25

20892 / 1

Active Ingredient

VALRUBICIN

Application Number

20892

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

1998-09-25

Regulatory Status

RX

2004
12 Oct
Discontinued Application: 21732

Drug Name

VANTAS

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-10-12

21732 / 1

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
40 total
  • RX
  • Discontinued
Official Source

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

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

AVEED

Application Number

22219

Product Number

1

Active Ingredient

TESTOSTERONE UNDECANOATE

Dosage Form

-

Strength

750MG/3ML (250MG/ML)

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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