Wyeth Pharmaceuticals Inc
FDA Approved Drugs

Wyeth Pharmaceuticals Inc

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.

Unclassified Discontinued RX
  • Total Records 73
  • Latest Approval Date Oct 03, 2013
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
73
View
Unclassified
4
View
Discontinued
52
View
RX
17
View
Company Overview

Company

Wyeth Pharmaceuticals Inc

Country

U.S.A

Website

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Company Snapshot

Wyeth Pharmaceuticals Inc

500 Arcola Road Collegeville, PA 19426

U.S.A

www.wyeth.com View on Map
FDA Approved Drug Records ( 73 records )
-
Unclassified Application: 761040

Drug Name

BESPONSA

Product Number

1

Dosage Form

-

Strength

0.9/MG/VIAL

Approval Date

-

761040 / 1

Active Ingredient

INOTUZUMAB OZOGAMICIN

Application Number

761040

Product Number

1

Dosage Form

-

Strength

0.9/MG/VIAL

Approval Date

-

Regulatory Status

Unclassified

1985
24 Dec
Discontinued Application: 18972

Drug Name

CORDARONE

Product Number

1

Dosage Form

-

Strength

200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-12-24

18972 / 1

Active Ingredient

AMIODARONE HYDROCHLORIDE

Application Number

18972

Product Number

1

Dosage Form

-

Strength

200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-12-24

Regulatory Status

Discontinued

1995
03 Aug
Discontinued Application: 20377

Drug Name

CORDARONE

Product Number

1

Dosage Form

-

Strength

50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1995-08-03

20377 / 1

Active Ingredient

AMIODARONE HYDROCHLORIDE

Application Number

20377

Product Number

1

Dosage Form

-

Strength

50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1995-08-03

Regulatory Status

Discontinued

2013
03 Oct
RX Application: 22247

Drug Name

DUAVEE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE;0.45MG

Approval Date

2013-10-03

22247 / 1

Active Ingredient

BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED

Application Number

22247

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE;0.45MG

Approval Date

2013-10-03

Regulatory Status

RX

1993
28 Dec
Discontinued Application: 20151

Drug Name

EFFEXOR

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-12-28

20151 / 1

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

20151

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-12-28

Regulatory Status

Discontinued

1993
28 Dec
Discontinued Application: 20151

Drug Name

EFFEXOR

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-12-28

20151 / 2

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

20151

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-12-28

Regulatory Status

Discontinued

1993
28 Dec
Discontinued Application: 20151

Drug Name

EFFEXOR

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-12-28

20151 / 3

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

20151

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-12-28

Regulatory Status

Discontinued

1993
28 Dec
Discontinued Application: 20151

Drug Name

EFFEXOR

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-12-28

20151 / 4

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

20151

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-12-28

Regulatory Status

Discontinued

1993
28 Dec
Discontinued Application: 20151

Drug Name

EFFEXOR

Product Number

5

Dosage Form

-

Strength

EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-12-28

20151 / 5

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

20151

Product Number

5

Dosage Form

-

Strength

EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-12-28

Regulatory Status

Discontinued

1993
28 Dec
Discontinued Application: 20151

Drug Name

EFFEXOR

Product Number

6

Dosage Form

-

Strength

EQ 37.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-12-28

20151 / 6

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

20151

Product Number

6

Dosage Form

-

Strength

EQ 37.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-12-28

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 5897

Drug Name

FOLVITE

Product Number

4

Dosage Form

-

Strength

1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

5897 / 4

Active Ingredient

FOLIC ACID

Application Number

5897

Product Number

4

Dosage Form

-

Strength

1MG **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: 5897

Drug Name

FOLVITE

Product Number

8

Dosage Form

-

Strength

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

Approval Date

1982-01-01

5897 / 8

Active Ingredient

FOLIC ACID

Application Number

5897

Product Number

8

Dosage Form

-

Strength

5MG/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: 16418

Drug Name

INDERAL

Product Number

1

Dosage Form

-

Strength

10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

16418 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

16418

Product Number

1

Dosage Form

-

Strength

10MG **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: 16418

Drug Name

INDERAL

Product Number

2

Dosage Form

-

Strength

40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

16418 / 2

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

16418

Product Number

2

Dosage Form

-

Strength

40MG **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: 16418

Drug Name

INDERAL

Product Number

3

Dosage Form

-

Strength

20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

16418 / 3

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

16418

Product Number

3

Dosage Form

-

Strength

20MG **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: 16418

Drug Name

INDERAL

Product Number

4

Dosage Form

-

Strength

80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

16418 / 4

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

16418

Product Number

4

Dosage Form

-

Strength

80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
18 Oct
Discontinued Application: 16418

Drug Name

INDERAL

Product Number

9

Dosage Form

-

Strength

60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-10-18

16418 / 9

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

16418

Product Number

9

Dosage Form

-

Strength

60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-10-18

Regulatory Status

Discontinued

1982
18 Oct
Discontinued Application: 16418

Drug Name

INDERAL

Product Number

10

Dosage Form

-

Strength

90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-10-18

16418 / 10

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

16418

Product Number

10

Dosage Form

-

Strength

90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-10-18

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18031

Drug Name

INDERIDE-40/25

Product Number

1

Dosage Form

-

Strength

25MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

18031 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE

Application Number

18031

Product Number

1

Dosage Form

-

Strength

25MG;40MG **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: 18031

Drug Name

INDERIDE-80/25

Product Number

2

Dosage Form

-

Strength

25MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

18031 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE

Application Number

18031

Product Number

2

Dosage Form

-

Strength

25MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1996
15 Aug
Discontinued Application: 20627

Drug Name

LEVONORGESTREL

Product Number

1

Dosage Form

-

Strength

75MG/IMPLANT

Approval Date

1996-08-15

20627 / 1

Active Ingredient

LEVONORGESTREL

Application Number

20627

Product Number

1

Dosage Form

-

Strength

75MG/IMPLANT

Approval Date

1996-08-15

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17802

Drug Name

LO/OVRAL-28

Product Number

1

Dosage Form

-

Strength

0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17802 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORGESTREL

Application Number

17802

Product Number

1

Dosage Form

-

Strength

0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1991
31 Jan
Discontinued Application: 18922

Drug Name

LODINE

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1991-01-31

18922 / 2

Active Ingredient

ETODOLAC

Application Number

18922

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1991-01-31

Regulatory Status

Discontinued

1991
31 Jan
Discontinued Application: 18922

Drug Name

LODINE

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

1991-01-31

18922 / 3

Active Ingredient

ETODOLAC

Application Number

18922

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

1991-01-31

Regulatory Status

Discontinued

1993
29 Jul
Discontinued Application: 18922

Drug Name

LODINE

Product Number

4

Dosage Form

-

Strength

400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-07-29

18922 / 4

Active Ingredient

ETODOLAC

Application Number

18922

Product Number

4

Dosage Form

-

Strength

400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-07-29

Regulatory Status

Discontinued

1996
28 Jun
Discontinued Application: 18922

Drug Name

LODINE

Product Number

5

Dosage Form

-

Strength

500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-06-28

18922 / 5

Active Ingredient

ETODOLAC

Application Number

18922

Product Number

5

Dosage Form

-

Strength

500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-06-28

Regulatory Status

Discontinued

1996
25 Oct
Discontinued Application: 20584

Drug Name

LODINE XL

Product Number

1

Dosage Form

-

Strength

400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-10-25

20584 / 1

Active Ingredient

ETODOLAC

Application Number

20584

Product Number

1

Dosage Form

-

Strength

400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-10-25

Regulatory Status

Discontinued

1996
25 Oct
Discontinued Application: 20584

Drug Name

LODINE XL

Product Number

2

Dosage Form

-

Strength

600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-10-25

20584 / 2

Active Ingredient

ETODOLAC

Application Number

20584

Product Number

2

Dosage Form

-

Strength

600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-10-25

Regulatory Status

Discontinued

1998
20 Jan
Discontinued Application: 20584

Drug Name

LODINE XL

Product Number

3

Dosage Form

-

Strength

500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1998-01-20

20584 / 3

Active Ingredient

ETODOLAC

Application Number

20584

Product Number

3

Dosage Form

-

Strength

500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1998-01-20

Regulatory Status

Discontinued

2007
22 May
Discontinued Application: 21864

Drug Name

LYBREL

Product Number

1

Dosage Form

-

Strength

0.02MG;0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2007-05-22

21864 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

21864

Product Number

1

Dosage Form

-

Strength

0.02MG;0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2007-05-22

Regulatory Status

Discontinued

-
Unclassified Application: 761060

Drug Name

MYLOTARG

Product Number

1

Dosage Form

-

Strength

4.5MG

Approval Date

-

761060 / 1

Active Ingredient

GEMTUZUMAB OZOGAMICIN

Application Number

761060

Product Number

1

Dosage Form

-

Strength

4.5MG

Approval Date

-

Regulatory Status

Unclassified

1990
10 Dec
Discontinued Application: 20088

Drug Name

NORPLANT SYSTEM IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

36MG/IMPLANT

Approval Date

1990-12-10

20088 / 1

Active Ingredient

LEVONORGESTREL

Application Number

20088

Product Number

1

Dosage Form

-

Strength

36MG/IMPLANT

Approval Date

1990-12-10

Regulatory Status

Discontinued

1993
24 Sep
Discontinued Application: 19816

Drug Name

ORUVAIL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1993-09-24

19816 / 1

Active Ingredient

KETOPROFEN

Application Number

19816

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1993-09-24

Regulatory Status

Discontinued

1995
08 Feb
Discontinued Application: 19816

Drug Name

ORUVAIL

Product Number

2

Dosage Form

-

Strength

150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1995-02-08

19816 / 2

Active Ingredient

KETOPROFEN

Application Number

19816

Product Number

2

Dosage Form

-

Strength

150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1995-02-08

Regulatory Status

Discontinued

1995
08 Feb
Discontinued Application: 19816

Drug Name

ORUVAIL

Product Number

3

Dosage Form

-

Strength

100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1995-02-08

19816 / 3

Active Ingredient

KETOPROFEN

Application Number

19816

Product Number

3

Dosage Form

-

Strength

100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1995-02-08

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16672

Drug Name

OVRAL

Product Number

1

Dosage Form

-

Strength

0.05MG;0.5MG

Approval Date

1982-01-01

16672 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORGESTREL

Application Number

16672

Product Number

1

Dosage Form

-

Strength

0.05MG;0.5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16806

Drug Name

OVRAL-28

Product Number

1

Dosage Form

-

Strength

0.05MG;0.5MG

Approval Date

1982-01-01

16806 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORGESTREL

Application Number

16806

Product Number

1

Dosage Form

-

Strength

0.05MG;0.5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50545

Drug Name

PIPRACIL

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

50545 / 2

Active Ingredient

PIPERACILLIN SODIUM

Application Number

50545

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL **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: 50545

Drug Name

PIPRACIL

Product Number

3

Dosage Form

-

Strength

EQ 3GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

50545 / 3

Active Ingredient

PIPERACILLIN SODIUM

Application Number

50545

Product Number

3

Dosage Form

-

Strength

EQ 3GM BASE/VIAL **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: 50545

Drug Name

PIPRACIL

Product Number

4

Dosage Form

-

Strength

EQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

50545 / 4

Active Ingredient

PIPERACILLIN SODIUM

Application Number

50545

Product Number

4

Dosage Form

-

Strength

EQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1985
30 Sep
Discontinued Application: 50545

Drug Name

PIPRACIL

Product Number

6

Dosage Form

-

Strength

EQ 40GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-09-30

50545 / 6

Active Ingredient

PIPERACILLIN SODIUM

Application Number

50545

Product Number

6

Dosage Form

-

Strength

EQ 40GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-09-30

Regulatory Status

Discontinued

1987
13 Oct
Discontinued Application: 62750

Drug Name

PIPRACIL

Product Number

1

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1987-10-13

62750 / 1

Active Ingredient

PIPERACILLIN SODIUM

Application Number

62750

Product Number

1

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1987-10-13

Regulatory Status

Discontinued

1987
13 Oct
Discontinued Application: 62750

Drug Name

PIPRACIL

Product Number

2

Dosage Form

-

Strength

EQ 3GM BASE/VIAL

Approval Date

1987-10-13

62750 / 2

Active Ingredient

PIPERACILLIN SODIUM

Application Number

62750

Product Number

2

Dosage Form

-

Strength

EQ 3GM BASE/VIAL

Approval Date

1987-10-13

Regulatory Status

Discontinued

1987
13 Oct
Discontinued Application: 62750

Drug Name

PIPRACIL

Product Number

3

Dosage Form

-

Strength

EQ 4GM BASE/VIAL

Approval Date

1987-10-13

62750 / 3

Active Ingredient

PIPERACILLIN SODIUM

Application Number

62750

Product Number

3

Dosage Form

-

Strength

EQ 4GM BASE/VIAL

Approval Date

1987-10-13

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 4782

Drug Name

PREMARIN

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

1982-01-01

4782 / 1

Active Ingredient

ESTROGENS, CONJUGATED

Application Number

4782

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 4782

Drug Name

PREMARIN

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

1982-01-01

4782 / 2

Active Ingredient

ESTROGENS, CONJUGATED

Application Number

4782

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 4782

Drug Name

PREMARIN

Product Number

3

Dosage Form

-

Strength

0.3MG

Approval Date

1982-01-01

4782 / 3

Active Ingredient

ESTROGENS, CONJUGATED

Application Number

4782

Product Number

3

Dosage Form

-

Strength

0.3MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 4782

Drug Name

PREMARIN

Product Number

4

Dosage Form

-

Strength

0.625MG

Approval Date

1982-01-01

4782 / 4

Active Ingredient

ESTROGENS, CONJUGATED

Application Number

4782

Product Number

4

Dosage Form

-

Strength

0.625MG

Approval Date

1982-01-01

Regulatory Status

RX

1984
26 Jan
RX Application: 4782

Drug Name

PREMARIN

Product Number

5

Dosage Form

-

Strength

0.9MG

Approval Date

1984-01-26

4782 / 5

Active Ingredient

ESTROGENS, CONJUGATED

Application Number

4782

Product Number

5

Dosage Form

-

Strength

0.9MG

Approval Date

1984-01-26

Regulatory Status

RX

2003
16 Jul
RX Application: 4782

Drug Name

PREMARIN

Product Number

6

Dosage Form

-

Strength

0.45MG

Approval Date

2003-07-16

4782 / 6

Active Ingredient

ESTROGENS, CONJUGATED

Application Number

4782

Product Number

6

Dosage Form

-

Strength

0.45MG

Approval Date

2003-07-16

Regulatory Status

RX

1982
01 Jan
RX Application: 10402

Drug Name

PREMARIN

Product Number

1

Dosage Form

-

Strength

25MG/VIAL

Approval Date

1982-01-01

10402 / 1

Active Ingredient

ESTROGENS, CONJUGATED

Application Number

10402

Product Number

1

Dosage Form

-

Strength

25MG/VIAL

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 20216

Drug Name

PREMARIN

Product Number

1

Dosage Form

-

Strength

0.625MG/GM

Approval Date

1982-01-01

20216 / 1

Active Ingredient

ESTROGENS, CONJUGATED

Application Number

20216

Product Number

1

Dosage Form

-

Strength

0.625MG/GM

Approval Date

1982-01-01

Regulatory Status

RX

-
Unclassified Application: 21417

Drug Name

PREMARIN

Product Number

1

Dosage Form

-

Strength

0.3MG

Approval Date

-

21417 / 1

Active Ingredient

ESTROGENS, CONJUGATED

Application Number

21417

Product Number

1

Dosage Form

-

Strength

0.3MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 21417

Drug Name

PREMARIN

Product Number

2

Dosage Form

-

Strength

0.45MG

Approval Date

-

21417 / 2

Active Ingredient

ESTROGENS, CONJUGATED

Application Number

21417

Product Number

2

Dosage Form

-

Strength

0.45MG

Approval Date

-

Regulatory Status

Unclassified

1994
30 Dec
Discontinued Application: 20303

Drug Name

PREMPHASE (PREMARIN;CYCRIN 14/14)

Product Number

2

Dosage Form

-

Strength

0.625MG,0.625MG;N/A,5MG

Approval Date

1994-12-30

20303 / 2

Active Ingredient

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

Application Number

20303

Product Number

2

Dosage Form

-

Strength

0.625MG,0.625MG;N/A,5MG

Approval Date

1994-12-30

Regulatory Status

Discontinued

1995
17 Nov
RX Application: 20527

Drug Name

PREMPHASE 14/14

Product Number

2

Dosage Form

-

Strength

0.625MG,0.625MG;N/A,5MG

Approval Date

1995-11-17

20527 / 2

Active Ingredient

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

Application Number

20527

Product Number

2

Dosage Form

-

Strength

0.625MG,0.625MG;N/A,5MG

Approval Date

1995-11-17

Regulatory Status

RX

1995
17 Nov
RX Application: 20527

Drug Name

PREMPRO

Product Number

1

Dosage Form

-

Strength

0.625MG;2.5MG

Approval Date

1995-11-17

20527 / 1

Active Ingredient

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

Application Number

20527

Product Number

1

Dosage Form

-

Strength

0.625MG;2.5MG

Approval Date

1995-11-17

Regulatory Status

RX

1998
09 Jan
RX Application: 20527

Drug Name

PREMPRO

Product Number

3

Dosage Form

-

Strength

0.625MG;5MG

Approval Date

1998-01-09

20527 / 3

Active Ingredient

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

Application Number

20527

Product Number

3

Dosage Form

-

Strength

0.625MG;5MG

Approval Date

1998-01-09

Regulatory Status

RX

2003
12 Mar
RX Application: 20527

Drug Name

PREMPRO

Product Number

4

Dosage Form

-

Strength

0.45MG;1.5MG

Approval Date

2003-03-12

20527 / 4

Active Ingredient

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

Application Number

20527

Product Number

4

Dosage Form

-

Strength

0.45MG;1.5MG

Approval Date

2003-03-12

Regulatory Status

RX

2003
04 Jun
RX Application: 20527

Drug Name

PREMPRO

Product Number

5

Dosage Form

-

Strength

0.3MG;1.5MG

Approval Date

2003-06-04

20527 / 5

Active Ingredient

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

Application Number

20527

Product Number

5

Dosage Form

-

Strength

0.3MG;1.5MG

Approval Date

2003-06-04

Regulatory Status

RX

1994
30 Dec
Discontinued Application: 20303

Drug Name

PREMPRO (PREMARIN;CYCRIN)

Product Number

1

Dosage Form

-

Strength

0.625MG,0.625MG;2.5MG,2.5MG

Approval Date

1994-12-30

20303 / 1

Active Ingredient

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

Application Number

20303

Product Number

1

Dosage Form

-

Strength

0.625MG,0.625MG;2.5MG,2.5MG

Approval Date

1994-12-30

Regulatory Status

Discontinued

2000
02 Feb
RX Application: 20987

Drug Name

PROTONIX

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2000-02-02

20987 / 1

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

20987

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2000-02-02

Regulatory Status

RX

2001
12 Jun
RX Application: 20987

Drug Name

PROTONIX

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2001-06-12

20987 / 2

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

20987

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2001-06-12

Regulatory Status

RX

2007
14 Nov
RX Application: 22020

Drug Name

PROTONIX

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2007-11-14

22020 / 1

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

22020

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2007-11-14

Regulatory Status

RX

2001
22 Mar
RX Application: 20988

Drug Name

PROTONIX IV

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2001-03-22

20988 / 1

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

20988

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2001-03-22

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 12796

Drug Name

QUINIDEX

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

12796 / 2

Active Ingredient

QUINIDINE SULFATE

Application Number

12796

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 13026

Drug Name

TRECATOR

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

13026 / 2

Active Ingredient

ETHIONAMIDE

Application Number

13026

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
01 Nov
Discontinued Application: 19192

Drug Name

TRIPHASIL-21

Product Number

1

Dosage Form

-

Strength

0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-11-01

19192 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

19192

Product Number

1

Dosage Form

-

Strength

0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-11-01

Regulatory Status

Discontinued

1984
01 Nov
Discontinued Application: 19190

Drug Name

TRIPHASIL-28

Product Number

1

Dosage Form

-

Strength

0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-11-01

19190 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

19190

Product Number

1

Dosage Form

-

Strength

0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-11-01

Regulatory Status

Discontinued

1993
22 Oct
Discontinued Application: 50684

Drug Name

ZOSYN

Product Number

1

Dosage Form

-

Strength

EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-10-22

50684 / 1

Active Ingredient

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Application Number

50684

Product Number

1

Dosage Form

-

Strength

EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-10-22

Regulatory Status

Discontinued

1993
22 Oct
Discontinued Application: 50684

Drug Name

ZOSYN

Product Number

2

Dosage Form

-

Strength

EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-10-22

50684 / 2

Active Ingredient

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Application Number

50684

Product Number

2

Dosage Form

-

Strength

EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-10-22

Regulatory Status

Discontinued

1993
22 Oct
Discontinued Application: 50684

Drug Name

ZOSYN

Product Number

3

Dosage Form

-

Strength

EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-10-22

50684 / 3

Active Ingredient

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Application Number

50684

Product Number

3

Dosage Form

-

Strength

EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-10-22

Regulatory Status

Discontinued

1993
22 Oct
Discontinued Application: 50684

Drug Name

ZOSYN

Product Number

4

Dosage Form

-

Strength

EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-10-22

50684 / 4

Active Ingredient

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Application Number

50684

Product Number

4

Dosage Form

-

Strength

EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-10-22

Regulatory Status

Discontinued

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Drug Status Breakdown
73 total
  • Unclassified
  • Discontinued
  • 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

BESPONSA

Application Number

761040

Product Number

1

Active Ingredient

INOTUZUMAB OZOGAMICIN

Dosage Form

-

Strength

0.9/MG/VIAL

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

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