Endo International RX
FDA Approved Drugs

Endo International RX

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

Company

Endo International RX

Country

Ireland

Website

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Company Snapshot

Endo International RX

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

Ireland

www.endo.com/ View on Map
FDA Approved Drug Records ( 15 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

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

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

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Drug Status Breakdown
15 total
  • RX
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

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