Assia Chemical Industries Ltd
FDA Approved Drugs

Assia Chemical Industries Ltd

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 RX Unclassified
  • Total Records 555
  • Latest Approval Date Jul 01, 2024
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
555
View
Unclassified
5
View
Discontinued
375
View
RX
175
View
Company Overview

Company

Assia Chemical Industries Ltd

Country

Israel

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Company Snapshot

Assia Chemical Industries Ltd

Neot-Hovav Eco-Industrial Park, Emek Sara P.O Box 2049 Be'er Sheva 8412316

Israel

www.teva.co.il/ View on Map
FDA Approved Drug Records ( 555 records )
1983
29 Dec
Discontinued Application: 88324

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

1983-12-29

88324 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

88324

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

1983-12-29

Regulatory Status

Discontinued

1984
04 Jun
Discontinued Application: 88537

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;15MG

Approval Date

1984-06-04

88537 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

88537

Product Number

1

Dosage Form

-

Strength

300MG;15MG

Approval Date

1984-06-04

Regulatory Status

Discontinued

1984
01 Jun
Discontinued Application: 88599

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

1984-06-01

88599 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

88599

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

1984-06-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86535

Drug Name

ACTICORT

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

86535 / 1

Active Ingredient

HYDROCORTISONE

Application Number

86535

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1997
22 Apr
Discontinued Application: 74556

Drug Name

ACYCLOVIR

Product Number

1

Dosage Form

-

Strength

200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-04-22

74556 / 1

Active Ingredient

ACYCLOVIR

Application Number

74556

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1997-04-22

Regulatory Status

Discontinued

1997
22 Apr
RX Application: 74556

Drug Name

ACYCLOVIR

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

1997-04-22

74556 / 2

Active Ingredient

ACYCLOVIR

Application Number

74556

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

1997-04-22

Regulatory Status

RX

1997
22 Apr
RX Application: 74556

Drug Name

ACYCLOVIR

Product Number

3

Dosage Form

-

Strength

800MG

Approval Date

1997-04-22

74556 / 3

Active Ingredient

ACYCLOVIR

Application Number

74556

Product Number

3

Dosage Form

-

Strength

800MG

Approval Date

1997-04-22

Regulatory Status

RX

1997
22 Apr
RX Application: 74578

Drug Name

ACYCLOVIR

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1997-04-22

74578 / 1

Active Ingredient

ACYCLOVIR

Application Number

74578

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1997-04-22

Regulatory Status

RX

1997
22 Apr
Discontinued Application: 74828

Drug Name

ACYCLOVIR

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1997-04-22

74828 / 1

Active Ingredient

ACYCLOVIR

Application Number

74828

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1997-04-22

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 85128

Drug Name

ADIPEX-P

Product Number

1

Dosage Form

-

Strength

37.5MG

Approval Date

1982-01-01

85128 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

85128

Product Number

1

Dosage Form

-

Strength

37.5MG

Approval Date

1982-01-01

Regulatory Status

RX

1983
02 Aug
Discontinued Application: 88023

Drug Name

ADIPEX-P

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1983-08-02

88023 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

88023

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1983-08-02

Regulatory Status

Discontinued

1989
05 Dec
Discontinued Application: 72619

Drug Name

ALBUTEROL SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

1989-12-05

72619 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

72619

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

1989-12-05

Regulatory Status

Discontinued

1989
05 Dec
Discontinued Application: 72620

Drug Name

ALBUTEROL SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

1989-12-05

72620 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

72620

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

1989-12-05

Regulatory Status

Discontinued

1993
25 Jun
Discontinued Application: 72779

Drug Name

ALBUTEROL SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

1993-06-25

72779 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

72779

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

1993-06-25

Regulatory Status

Discontinued

1993
25 Jun
Discontinued Application: 72780

Drug Name

ALBUTEROL SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

1993-06-25

72780 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

72780

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

1993-06-25

Regulatory Status

Discontinued

1990
30 Mar
Discontinued Application: 72938

Drug Name

ALBUTEROL SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

1990-03-30

72938 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

72938

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

1990-03-30

Regulatory Status

Discontinued

1990
30 Mar
Discontinued Application: 72939

Drug Name

ALBUTEROL SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

1990-03-30

72939 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

72939

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

1990-03-30

Regulatory Status

Discontinued

1992
30 Mar
RX Application: 73419

Drug Name

ALBUTEROL SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/5ML

Approval Date

1992-03-30

73419 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

73419

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/5ML

Approval Date

1992-03-30

Regulatory Status

RX

1988
17 Apr
Discontinued Application: 70795

Drug Name

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG ANHYDROUS;50MG

Approval Date

1988-04-17

70795 / 1

Active Ingredient

AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

70795

Product Number

1

Dosage Form

-

Strength

EQ 5MG ANHYDROUS;50MG

Approval Date

1988-04-17

Regulatory Status

Discontinued

1999
16 Apr
Discontinued Application: 74895

Drug Name

AMIODARONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1999-04-16

74895 / 1

Active Ingredient

AMIODARONE HYDROCHLORIDE

Application Number

74895

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1999-04-16

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85836

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

85836 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

85836

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86610

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

86610 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

86610

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86853

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

1982-01-01

86853 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

86853

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86854

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

86854 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

86854

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86857

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

86857 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

86857

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86859

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

86859 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

86859

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86860

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

1982-01-01

86860 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

86860

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2007
28 Jun
RX Application: 76846

Drug Name

AMLODIPINE BESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2007-06-28

76846 / 1

Active Ingredient

AMLODIPINE BESYLATE

Application Number

76846

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2007-06-28

Regulatory Status

RX

2007
28 Jun
RX Application: 76846

Drug Name

AMLODIPINE BESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2007-06-28

76846 / 2

Active Ingredient

AMLODIPINE BESYLATE

Application Number

76846

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2007-06-28

Regulatory Status

RX

2007
28 Jun
RX Application: 76846

Drug Name

AMLODIPINE BESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-06-28

76846 / 3

Active Ingredient

AMLODIPINE BESYLATE

Application Number

76846

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-06-28

Regulatory Status

RX

1987
22 Dec
Discontinued Application: 62853

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1987-12-22

62853 / 1

Active Ingredient

AMOXICILLIN

Application Number

62853

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1987-12-22

Regulatory Status

Discontinued

1987
22 Dec
Discontinued Application: 62854

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1987-12-22

62854 / 1

Active Ingredient

AMOXICILLIN

Application Number

62854

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1987-12-22

Regulatory Status

Discontinued

1988
01 Nov
Discontinued Application: 62946

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

1988-11-01

62946 / 1

Active Ingredient

AMOXICILLIN

Application Number

62946

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

1988-11-01

Regulatory Status

Discontinued

1989
06 Jan
Discontinued Application: 63001

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

250MG/5ML

Approval Date

1989-01-06

63001 / 1

Active Ingredient

AMOXICILLIN

Application Number

63001

Product Number

1

Dosage Form

-

Strength

250MG/5ML

Approval Date

1989-01-06

Regulatory Status

Discontinued

1989
28 Feb
Discontinued Application: 63030

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1989-02-28

63030 / 1

Active Ingredient

AMOXICILLIN

Application Number

63030

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1989-02-28

Regulatory Status

Discontinued

1989
28 Feb
Discontinued Application: 63031

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1989-02-28

63031 / 1

Active Ingredient

AMOXICILLIN

Application Number

63031

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1989-02-28

Regulatory Status

Discontinued

1996
19 Dec
Discontinued Application: 64031

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

1996-12-19

64031 / 1

Active Ingredient

AMOXICILLIN

Application Number

64031

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

1996-12-19

Regulatory Status

Discontinued

1996
19 Dec
Discontinued Application: 64031

Drug Name

AMOXICILLIN

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

1996-12-19

64031 / 2

Active Ingredient

AMOXICILLIN

Application Number

64031

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

1996-12-19

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61370

Drug Name

AMPICILLIN TRIHYDRATE

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1982-01-01

61370 / 1

Active Ingredient

AMPICILLIN/AMPICILLIN TRIHYDRATE

Application Number

61370

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61370

Drug Name

AMPICILLIN TRIHYDRATE

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1982-01-01

61370 / 2

Active Ingredient

AMPICILLIN/AMPICILLIN TRIHYDRATE

Application Number

61370

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1993
28 May
Discontinued Application: 73315

Drug Name

ATENOLOL

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1993-05-28

73315 / 1

Active Ingredient

ATENOLOL

Application Number

73315

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1993-05-28

Regulatory Status

Discontinued

1993
28 May
Discontinued Application: 73316

Drug Name

ATENOLOL

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1993-05-28

73316 / 1

Active Ingredient

ATENOLOL

Application Number

73316

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1993-05-28

Regulatory Status

Discontinued

1995
18 Jan
RX Application: 74056

Drug Name

ATENOLOL

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1995-01-18

74056 / 1

Active Ingredient

ATENOLOL

Application Number

74056

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1995-01-18

Regulatory Status

RX

1995
18 Jan
RX Application: 74056

Drug Name

ATENOLOL

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1995-01-18

74056 / 2

Active Ingredient

ATENOLOL

Application Number

74056

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1995-01-18

Regulatory Status

RX

2004
19 Jul
RX Application: 74056

Drug Name

ATENOLOL

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

2004-07-19

74056 / 3

Active Ingredient

ATENOLOL

Application Number

74056

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

2004-07-19

Regulatory Status

RX

2023
17 Feb
RX Application: 216354

Drug Name

AUSTEDO XR

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

2023-02-17

216354 / 1

Active Ingredient

DEUTETRABENAZINE

Application Number

216354

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

2023-02-17

Regulatory Status

RX

2023
17 Feb
RX Application: 216354

Drug Name

AUSTEDO XR

Product Number

2

Dosage Form

-

Strength

12MG

Approval Date

2023-02-17

216354 / 2

Active Ingredient

DEUTETRABENAZINE

Application Number

216354

Product Number

2

Dosage Form

-

Strength

12MG

Approval Date

2023-02-17

Regulatory Status

RX

2023
17 Feb
RX Application: 216354

Drug Name

AUSTEDO XR

Product Number

3

Dosage Form

-

Strength

24MG

Approval Date

2023-02-17

216354 / 3

Active Ingredient

DEUTETRABENAZINE

Application Number

216354

Product Number

3

Dosage Form

-

Strength

24MG

Approval Date

2023-02-17

Regulatory Status

RX

2024
29 May
RX Application: 216354

Drug Name

AUSTEDO XR

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2024-05-29

216354 / 4

Active Ingredient

DEUTETRABENAZINE

Application Number

216354

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2024-05-29

Regulatory Status

RX

2024
29 May
RX Application: 216354

Drug Name

AUSTEDO XR

Product Number

5

Dosage Form

-

Strength

36MG

Approval Date

2024-05-29

216354 / 5

Active Ingredient

DEUTETRABENAZINE

Application Number

216354

Product Number

5

Dosage Form

-

Strength

36MG

Approval Date

2024-05-29

Regulatory Status

RX

2024
29 May
RX Application: 216354

Drug Name

AUSTEDO XR

Product Number

6

Dosage Form

-

Strength

42MG

Approval Date

2024-05-29

216354 / 6

Active Ingredient

DEUTETRABENAZINE

Application Number

216354

Product Number

6

Dosage Form

-

Strength

42MG

Approval Date

2024-05-29

Regulatory Status

RX

2024
29 May
RX Application: 216354

Drug Name

AUSTEDO XR

Product Number

7

Dosage Form

-

Strength

48MG

Approval Date

2024-05-29

216354 / 7

Active Ingredient

DEUTETRABENAZINE

Application Number

216354

Product Number

7

Dosage Form

-

Strength

48MG

Approval Date

2024-05-29

Regulatory Status

RX

2024
01 Jul
RX Application: 216354

Drug Name

AUSTEDO XR

Product Number

8

Dosage Form

-

Strength

18MG

Approval Date

2024-07-01

216354 / 8

Active Ingredient

DEUTETRABENAZINE

Application Number

216354

Product Number

8

Dosage Form

-

Strength

18MG

Approval Date

2024-07-01

Regulatory Status

RX

2006
16 May
RX Application: 21641

Drug Name

AZILECT

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2006-05-16

21641 / 1

Active Ingredient

RASAGILINE MESYLATE

Application Number

21641

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2006-05-16

Regulatory Status

RX

2006
16 May
RX Application: 21641

Drug Name

AZILECT

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2006-05-16

21641 / 2

Active Ingredient

RASAGILINE MESYLATE

Application Number

21641

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2006-05-16

Regulatory Status

RX

2005
14 Nov
Discontinued Application: 65150

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 600MG BASE

Approval Date

2005-11-14

65150 / 1

Active Ingredient

AZITHROMYCIN

Application Number

65150

Product Number

1

Dosage Form

-

Strength

EQ 600MG BASE

Approval Date

2005-11-14

Regulatory Status

Discontinued

2005
14 Nov
Discontinued Application: 65153

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2005-11-14

65153 / 1

Active Ingredient

AZITHROMYCIN

Application Number

65153

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2005-11-14

Regulatory Status

Discontinued

2005
14 Nov
RX Application: 65193

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2005-11-14

65193 / 1

Active Ingredient

AZITHROMYCIN

Application Number

65193

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2005-11-14

Regulatory Status

RX

1992
27 Feb
Discontinued Application: 73043

Drug Name

BACLOFEN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1992-02-27

73043 / 1

Active Ingredient

BACLOFEN

Application Number

73043

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1992-02-27

Regulatory Status

Discontinued

1992
27 Feb
Discontinued Application: 73044

Drug Name

BACLOFEN

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1992-02-27

73044 / 1

Active Ingredient

BACLOFEN

Application Number

73044

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1992-02-27

Regulatory Status

Discontinued

2004
11 Feb
RX Application: 76211

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2004-02-11

76211 / 1

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

76211

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2004-02-11

Regulatory Status

RX

2004
11 Feb
RX Application: 76211

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2004-02-11

76211 / 2

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

76211

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2004-02-11

Regulatory Status

RX

2004
11 Feb
RX Application: 76211

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2004-02-11

76211 / 3

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

76211

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2004-02-11

Regulatory Status

RX

2004
11 Feb
RX Application: 76211

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2004-02-11

76211 / 4

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

76211

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2004-02-11

Regulatory Status

RX

1987
10 Aug
Discontinued Application: 71476

Drug Name

BETAMETHASONE DIPROPIONATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1987-08-10

71476 / 1

Active Ingredient

BETAMETHASONE DIPROPIONATE

Application Number

71476

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1987-08-10

Regulatory Status

Discontinued

1987
10 Aug
Discontinued Application: 71477

Drug Name

BETAMETHASONE DIPROPIONATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1987-08-10

71477 / 1

Active Ingredient

BETAMETHASONE DIPROPIONATE

Application Number

71477

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1987-08-10

Regulatory Status

Discontinued

2009
06 Jul
Discontinued Application: 76932

Drug Name

BICALUTAMIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2009-07-06

76932 / 1

Active Ingredient

BICALUTAMIDE

Application Number

76932

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2009-07-06

Regulatory Status

Discontinued

2001
19 Jan
Discontinued Application: 75686

Drug Name

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

2.5MG;6.25MG

Approval Date

2001-01-19

75686 / 1

Active Ingredient

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Application Number

75686

Product Number

1

Dosage Form

-

Strength

2.5MG;6.25MG

Approval Date

2001-01-19

Regulatory Status

Discontinued

2001
19 Jan
Discontinued Application: 75686

Drug Name

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

2001-01-19

75686 / 2

Active Ingredient

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Application Number

75686

Product Number

2

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

2001-01-19

Regulatory Status

Discontinued

2001
19 Jan
Discontinued Application: 75686

Drug Name

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

10MG;6.25MG

Approval Date

2001-01-19

75686 / 3

Active Ingredient

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Application Number

75686

Product Number

3

Dosage Form

-

Strength

10MG;6.25MG

Approval Date

2001-01-19

Regulatory Status

Discontinued

2002
28 Feb
RX Application: 75022

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2002-02-28

75022 / 1

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

75022

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2002-02-28

Regulatory Status

RX

2002
28 Feb
RX Application: 75022

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2002-02-28

75022 / 2

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

75022

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2002-02-28

Regulatory Status

RX

2002
28 Feb
RX Application: 75022

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2002-02-28

75022 / 3

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

75022

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2002-02-28

Regulatory Status

RX

2004
25 Mar
RX Application: 75022

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2004-03-25

75022 / 4

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

75022

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2004-03-25

Regulatory Status

RX

1985
01 May
Discontinued Application: 88631

Drug Name

BUTABARBITAL SODIUM

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1985-05-01

88631 / 1

Active Ingredient

BUTABARBITAL SODIUM

Application Number

88631

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1985-05-01

Regulatory Status

Discontinued

1985
18 May
Discontinued Application: 88632

Drug Name

BUTABARBITAL SODIUM

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1985-05-18

88632 / 1

Active Ingredient

BUTABARBITAL SODIUM

Application Number

88632

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1985-05-18

Regulatory Status

Discontinued

2001
12 Oct
RX Application: 75765

Drug Name

CALCITRIOL

Product Number

1

Dosage Form

-

Strength

0.25MCG

Approval Date

2001-10-12

75765 / 1

Active Ingredient

CALCITRIOL

Application Number

75765

Product Number

1

Dosage Form

-

Strength

0.25MCG

Approval Date

2001-10-12

Regulatory Status

RX

2001
12 Oct
RX Application: 75765

Drug Name

CALCITRIOL

Product Number

2

Dosage Form

-

Strength

0.5MCG

Approval Date

2001-10-12

75765 / 2

Active Ingredient

CALCITRIOL

Application Number

75765

Product Number

2

Dosage Form

-

Strength

0.5MCG

Approval Date

2001-10-12

Regulatory Status

RX

1996
13 Feb
Discontinued Application: 74322

Drug Name

CAPTOPRIL

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

1996-02-13

74322 / 1

Active Ingredient

CAPTOPRIL

Application Number

74322

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

1996-02-13

Regulatory Status

Discontinued

1996
13 Feb
Discontinued Application: 74322

Drug Name

CAPTOPRIL

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1996-02-13

74322 / 2

Active Ingredient

CAPTOPRIL

Application Number

74322

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1996-02-13

Regulatory Status

Discontinued

1996
13 Feb
Discontinued Application: 74322

Drug Name

CAPTOPRIL

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1996-02-13

74322 / 3

Active Ingredient

CAPTOPRIL

Application Number

74322

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1996-02-13

Regulatory Status

Discontinued

1996
13 Feb
Discontinued Application: 74322

Drug Name

CAPTOPRIL

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

1996-02-13

74322 / 4

Active Ingredient

CAPTOPRIL

Application Number

74322

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

1996-02-13

Regulatory Status

Discontinued

2007
05 Sep
RX Application: 76373

Drug Name

CARVEDILOL

Product Number

1

Dosage Form

-

Strength

3.125MG

Approval Date

2007-09-05

76373 / 1

Active Ingredient

CARVEDILOL

Application Number

76373

Product Number

1

Dosage Form

-

Strength

3.125MG

Approval Date

2007-09-05

Regulatory Status

RX

2007
05 Sep
RX Application: 76373

Drug Name

CARVEDILOL

Product Number

2

Dosage Form

-

Strength

6.25MG

Approval Date

2007-09-05

76373 / 2

Active Ingredient

CARVEDILOL

Application Number

76373

Product Number

2

Dosage Form

-

Strength

6.25MG

Approval Date

2007-09-05

Regulatory Status

RX

2007
05 Sep
RX Application: 76373

Drug Name

CARVEDILOL

Product Number

3

Dosage Form

-

Strength

12.5MG

Approval Date

2007-09-05

76373 / 3

Active Ingredient

CARVEDILOL

Application Number

76373

Product Number

3

Dosage Form

-

Strength

12.5MG

Approval Date

2007-09-05

Regulatory Status

RX

2007
05 Sep
RX Application: 76373

Drug Name

CARVEDILOL

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2007-09-05

76373 / 4

Active Ingredient

CARVEDILOL

Application Number

76373

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2007-09-05

Regulatory Status

RX

1996
16 Sep
Discontinued Application: 64081

Drug Name

CEFACLOR

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1996-09-16

64081 / 1

Active Ingredient

CEFACLOR

Application Number

64081

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1996-09-16

Regulatory Status

Discontinued

1996
16 Sep
Discontinued Application: 64081

Drug Name

CEFACLOR

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1996-09-16

64081 / 2

Active Ingredient

CEFACLOR

Application Number

64081

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1996-09-16

Regulatory Status

Discontinued

1996
24 Jun
Discontinued Application: 64145

Drug Name

CEFACLOR

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1996-06-24

64145 / 1

Active Ingredient

CEFACLOR

Application Number

64145

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1996-06-24

Regulatory Status

Discontinued

1996
24 Jun
Discontinued Application: 64145

Drug Name

CEFACLOR

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1996-06-24

64145 / 2

Active Ingredient

CEFACLOR

Application Number

64145

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1996-06-24

Regulatory Status

Discontinued

2002
04 Sep
RX Application: 65058

Drug Name

CEFACLOR

Product Number

1

Dosage Form

-

Strength

EQ 375MG BASE

Approval Date

2002-09-04

65058 / 1

Active Ingredient

CEFACLOR

Application Number

65058

Product Number

1

Dosage Form

-

Strength

EQ 375MG BASE

Approval Date

2002-09-04

Regulatory Status

RX

2002
04 Sep
RX Application: 65058

Drug Name

CEFACLOR

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2002-09-04

65058 / 2

Active Ingredient

CEFACLOR

Application Number

65058

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2002-09-04

Regulatory Status

RX

1989
10 Feb
Discontinued Application: 62695

Drug Name

CEFADROXIL

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1989-02-10

62695 / 1

Active Ingredient

CEFADROXIL/CEFADROXIL HEMIHYDRATE

Application Number

62695

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1989-02-10

Regulatory Status

Discontinued

2005
06 Dec
RX Application: 65208

Drug Name

CEFPROZIL

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2005-12-06

65208 / 1

Active Ingredient

CEFPROZIL

Application Number

65208

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2005-12-06

Regulatory Status

RX

2005
06 Dec
RX Application: 65208

Drug Name

CEFPROZIL

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2005-12-06

65208 / 2

Active Ingredient

CEFPROZIL

Application Number

65208

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2005-12-06

Regulatory Status

RX

2006
29 Jun
Discontinued Application: 65262

Drug Name

CEFTRIAXONE

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2006-06-29

65262 / 1

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65262

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2006-06-29

Regulatory Status

Discontinued

2006
29 Jun
Discontinued Application: 65262

Drug Name

CEFTRIAXONE

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2006-06-29

65262 / 2

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65262

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2006-06-29

Regulatory Status

Discontinued

2006
01 May
Discontinued Application: 65274

Drug Name

CEFTRIAXONE

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2006-05-01

65274 / 1

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65274

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2006-05-01

Regulatory Status

Discontinued

2014
30 May
RX Application: 76898

Drug Name

CELECOXIB

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2014-05-30

76898 / 1

Active Ingredient

CELECOXIB

Application Number

76898

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2014-05-30

Regulatory Status

RX

2014
30 May
RX Application: 76898

Drug Name

CELECOXIB

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2014-05-30

76898 / 2

Active Ingredient

CELECOXIB

Application Number

76898

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2014-05-30

Regulatory Status

RX

2014
30 May
RX Application: 76898

Drug Name

CELECOXIB

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2014-05-30

76898 / 3

Active Ingredient

CELECOXIB

Application Number

76898

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2014-05-30

Regulatory Status

RX

2014
30 May
RX Application: 76898

Drug Name

CELECOXIB

Product Number

4

Dosage Form

-

Strength

400MG

Approval Date

2014-05-30

76898 / 4

Active Ingredient

CELECOXIB

Application Number

76898

Product Number

4

Dosage Form

-

Strength

400MG

Approval Date

2014-05-30

Regulatory Status

RX

1987
13 Feb
RX Application: 62702

Drug Name

CEPHALEXIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1987-02-13

62702 / 1

Active Ingredient

CEPHALEXIN

Application Number

62702

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1987-02-13

Regulatory Status

RX

1987
13 Feb
RX Application: 62702

Drug Name

CEPHALEXIN

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1987-02-13

62702 / 2

Active Ingredient

CEPHALEXIN

Application Number

62702

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1987-02-13

Regulatory Status

RX

1987
13 Feb
RX Application: 62703

Drug Name

CEPHALEXIN

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1987-02-13

62703 / 1

Active Ingredient

CEPHALEXIN

Application Number

62703

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1987-02-13

Regulatory Status

RX

1987
13 Feb
RX Application: 62703

Drug Name

CEPHALEXIN

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1987-02-13

62703 / 2

Active Ingredient

CEPHALEXIN

Application Number

62703

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1987-02-13

Regulatory Status

RX

1987
24 Apr
Discontinued Application: 62760

Drug Name

CEPHALEXIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1987-04-24

62760 / 1

Active Ingredient

CEPHALEXIN

Application Number

62760

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1987-04-24

Regulatory Status

Discontinued

1987
24 Apr
Discontinued Application: 62761

Drug Name

CEPHALEXIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1987-04-24

62761 / 1

Active Ingredient

CEPHALEXIN

Application Number

62761

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1987-04-24

Regulatory Status

Discontinued

1987
16 Jun
Discontinued Application: 62767

Drug Name

CEPHALEXIN

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1987-06-16

62767 / 1

Active Ingredient

CEPHALEXIN

Application Number

62767

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1987-06-16

Regulatory Status

Discontinued

1987
16 Jun
Discontinued Application: 62768

Drug Name

CEPHALEXIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1987-06-16

62768 / 1

Active Ingredient

CEPHALEXIN

Application Number

62768

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1987-06-16

Regulatory Status

Discontinued

1988
05 Feb
Discontinued Application: 62821

Drug Name

CEPHALEXIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1988-02-05

62821 / 1

Active Ingredient

CEPHALEXIN

Application Number

62821

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1988-02-05

Regulatory Status

Discontinued

1988
05 Feb
Discontinued Application: 62823

Drug Name

CEPHALEXIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1988-02-05

62823 / 1

Active Ingredient

CEPHALEXIN

Application Number

62823

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1988-02-05

Regulatory Status

Discontinued

1988
15 Apr
Discontinued Application: 62867

Drug Name

CEPHALEXIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1988-04-15

62867 / 1

Active Ingredient

CEPHALEXIN

Application Number

62867

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1988-04-15

Regulatory Status

Discontinued

1988
23 May
Discontinued Application: 62873

Drug Name

CEPHALEXIN

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1988-05-23

62873 / 1

Active Ingredient

CEPHALEXIN

Application Number

62873

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1988-05-23

Regulatory Status

Discontinued

1989
12 Jan
RX Application: 63024

Drug Name

CEPHALEXIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1989-01-12

63024 / 1

Active Ingredient

CEPHALEXIN

Application Number

63024

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1989-01-12

Regulatory Status

RX

1989
12 Jan
RX Application: 63024

Drug Name

CEPHALEXIN

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1989-01-12

63024 / 2

Active Ingredient

CEPHALEXIN

Application Number

63024

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1989-01-12

Regulatory Status

RX

1987
09 Jan
Discontinued Application: 62683

Drug Name

CEPHRADINE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1987-01-09

62683 / 1

Active Ingredient

CEPHRADINE

Application Number

62683

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1987-01-09

Regulatory Status

Discontinued

1987
09 Jan
Discontinued Application: 62683

Drug Name

CEPHRADINE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1987-01-09

62683 / 2

Active Ingredient

CEPHRADINE

Application Number

62683

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1987-01-09

Regulatory Status

Discontinued

1987
09 Jan
Discontinued Application: 62693

Drug Name

CEPHRADINE

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

1987-01-09

62693 / 1

Active Ingredient

CEPHRADINE

Application Number

62693

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

1987-01-09

Regulatory Status

Discontinued

1987
09 Jan
Discontinued Application: 62693

Drug Name

CEPHRADINE

Product Number

2

Dosage Form

-

Strength

250MG/5ML

Approval Date

1987-01-09

62693 / 2

Active Ingredient

CEPHRADINE

Application Number

62693

Product Number

2

Dosage Form

-

Strength

250MG/5ML

Approval Date

1987-01-09

Regulatory Status

Discontinued

2011
13 Apr
Discontinued Application: 76447

Drug Name

CHILDRENS FEXOFENADINE HYDROCHLORIDE ALLERGY

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2011-04-13

76447 / 4

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

76447

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2011-04-13

Regulatory Status

Discontinued

2011
13 Apr
Discontinued Application: 76447

Drug Name

CHILDRENS FEXOFENADINE HYDROCHLORIDE HIVES

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

2011-04-13

76447 / 5

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

76447

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

2011-04-13

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86494

Drug Name

CHLORDIAZEPOXIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

86494 / 1

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE

Application Number

86494

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1985
18 Jan
Discontinued Application: 88705

Drug Name

CHLORDIAZEPOXIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1985-01-18

88705 / 1

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE

Application Number

88705

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1985-01-18

Regulatory Status

Discontinued

1985
18 Jan
Discontinued Application: 88706

Drug Name

CHLORDIAZEPOXIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1985-01-18

88706 / 1

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE

Application Number

88706

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1985-01-18

Regulatory Status

Discontinued

1985
18 Jan
Discontinued Application: 88707

Drug Name

CHLORDIAZEPOXIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1985-01-18

88707 / 1

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE

Application Number

88707

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1985-01-18

Regulatory Status

Discontinued

1982
13 Jan
Discontinued Application: 87504

Drug Name

CHLOROQUINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-13

87504 / 1

Active Ingredient

CHLOROQUINE PHOSPHATE

Application Number

87504

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-13

Regulatory Status

Discontinued

1998
28 May
Discontinued Application: 74347

Drug Name

CHOLESTYRAMINE

Product Number

1

Dosage Form

-

Strength

EQ 4GM RESIN/PACKET

Approval Date

1998-05-28

74347 / 1

Active Ingredient

CHOLESTYRAMINE

Application Number

74347

Product Number

1

Dosage Form

-

Strength

EQ 4GM RESIN/PACKET

Approval Date

1998-05-28

Regulatory Status

Discontinued

1998
28 May
Discontinued Application: 74347

Drug Name

CHOLESTYRAMINE

Product Number

2

Dosage Form

-

Strength

EQ 4GM RESIN/SCOOPFUL

Approval Date

1998-05-28

74347 / 2

Active Ingredient

CHOLESTYRAMINE

Application Number

74347

Product Number

2

Dosage Form

-

Strength

EQ 4GM RESIN/SCOOPFUL

Approval Date

1998-05-28

Regulatory Status

Discontinued

1998
28 May
Discontinued Application: 74348

Drug Name

CHOLESTYRAMINE LIGHT

Product Number

1

Dosage Form

-

Strength

EQ 4GM RESIN/PACKET

Approval Date

1998-05-28

74348 / 1

Active Ingredient

CHOLESTYRAMINE

Application Number

74348

Product Number

1

Dosage Form

-

Strength

EQ 4GM RESIN/PACKET

Approval Date

1998-05-28

Regulatory Status

Discontinued

1998
28 May
Discontinued Application: 74348

Drug Name

CHOLESTYRAMINE LIGHT

Product Number

2

Dosage Form

-

Strength

EQ 4GM RESIN/SCOOPFUL

Approval Date

1998-05-28

74348 / 2

Active Ingredient

CHOLESTYRAMINE

Application Number

74348

Product Number

2

Dosage Form

-

Strength

EQ 4GM RESIN/SCOOPFUL

Approval Date

1998-05-28

Regulatory Status

Discontinued

2004
24 Nov
RX Application: 77027

Drug Name

CILOSTAZOL

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-11-24

77027 / 1

Active Ingredient

CILOSTAZOL

Application Number

77027

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-11-24

Regulatory Status

RX

2004
24 Nov
RX Application: 77027

Drug Name

CILOSTAZOL

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2004-11-24

77027 / 2

Active Ingredient

CILOSTAZOL

Application Number

77027

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2004-11-24

Regulatory Status

RX

1994
17 May
RX Application: 74151

Drug Name

CIMETIDINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1994-05-17

74151 / 1

Active Ingredient

CIMETIDINE

Application Number

74151

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1994-05-17

Regulatory Status

RX

1994
17 May
RX Application: 74151

Drug Name

CIMETIDINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1994-05-17

74151 / 2

Active Ingredient

CIMETIDINE

Application Number

74151

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1994-05-17

Regulatory Status

RX

1994
17 May
RX Application: 74151

Drug Name

CIMETIDINE

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

1994-05-17

74151 / 3

Active Ingredient

CIMETIDINE

Application Number

74151

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

1994-05-17

Regulatory Status

RX

1995
28 Feb
Discontinued Application: 74365

Drug Name

CIMETIDINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1995-02-28

74365 / 1

Active Ingredient

CIMETIDINE

Application Number

74365

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1995-02-28

Regulatory Status

Discontinued

1995
28 Feb
Discontinued Application: 74365

Drug Name

CIMETIDINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1995-02-28

74365 / 2

Active Ingredient

CIMETIDINE

Application Number

74365

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1995-02-28

Regulatory Status

Discontinued

1995
28 Feb
Discontinued Application: 74365

Drug Name

CIMETIDINE

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

1995-02-28

74365 / 3

Active Ingredient

CIMETIDINE

Application Number

74365

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

1995-02-28

Regulatory Status

Discontinued

1995
28 Feb
Discontinued Application: 74365

Drug Name

CIMETIDINE

Product Number

4

Dosage Form

-

Strength

800MG

Approval Date

1995-02-28

74365 / 4

Active Ingredient

CIMETIDINE

Application Number

74365

Product Number

4

Dosage Form

-

Strength

800MG

Approval Date

1995-02-28

Regulatory Status

Discontinued

1994
17 May
RX Application: 74463

Drug Name

CIMETIDINE

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

1994-05-17

74463 / 1

Active Ingredient

CIMETIDINE

Application Number

74463

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

1994-05-17

Regulatory Status

RX

1992
28 Feb
Discontinued Application: 73005

Drug Name

CINOXACIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1992-02-28

73005 / 1

Active Ingredient

CINOXACIN

Application Number

73005

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1992-02-28

Regulatory Status

Discontinued

1992
28 Feb
Discontinued Application: 73006

Drug Name

CINOXACIN

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1992-02-28

73006 / 1

Active Ingredient

CINOXACIN

Application Number

73006

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1992-02-28

Regulatory Status

Discontinued

2004
09 Jun
Discontinued Application: 76136

Drug Name

CIPROFLOXACIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2004-06-09

76136 / 1

Active Ingredient

CIPROFLOXACIN HYDROCHLORIDE

Application Number

76136

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2004-06-09

Regulatory Status

Discontinued

2004
09 Jun
Discontinued Application: 76136

Drug Name

CIPROFLOXACIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2004-06-09

76136 / 2

Active Ingredient

CIPROFLOXACIN HYDROCHLORIDE

Application Number

76136

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2004-06-09

Regulatory Status

Discontinued

2004
09 Jun
Discontinued Application: 76136

Drug Name

CIPROFLOXACIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2004-06-09

76136 / 3

Active Ingredient

CIPROFLOXACIN HYDROCHLORIDE

Application Number

76136

Product Number

3

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2004-06-09

Regulatory Status

Discontinued

2005
31 May
Discontinued Application: 65155

Drug Name

CLARITHROMYCIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2005-05-31

65155 / 1

Active Ingredient

CLARITHROMYCIN

Application Number

65155

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2005-05-31

Regulatory Status

Discontinued

2005
31 May
Discontinued Application: 65155

Drug Name

CLARITHROMYCIN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2005-05-31

65155 / 2

Active Ingredient

CLARITHROMYCIN

Application Number

65155

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2005-05-31

Regulatory Status

Discontinued

1989
20 Sep
Discontinued Application: 63027

Drug Name

CLINDAMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

1989-09-20

63027 / 1

Active Ingredient

CLINDAMYCIN HYDROCHLORIDE

Application Number

63027

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

1989-09-20

Regulatory Status

Discontinued

1991
25 Jul
Discontinued Application: 72600

Drug Name

CLOFIBRATE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1991-07-25

72600 / 1

Active Ingredient

CLOFIBRATE

Application Number

72600

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1991-07-25

Regulatory Status

Discontinued

1997
04 Apr
Discontinued Application: 74849

Drug Name

CLOMIPRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1997-04-04

74849 / 1

Active Ingredient

CLOMIPRAMINE HYDROCHLORIDE

Application Number

74849

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1997-04-04

Regulatory Status

Discontinued

1997
04 Apr
Discontinued Application: 74849

Drug Name

CLOMIPRAMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1997-04-04

74849 / 2

Active Ingredient

CLOMIPRAMINE HYDROCHLORIDE

Application Number

74849

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1997-04-04

Regulatory Status

Discontinued

1997
04 Apr
Discontinued Application: 74849

Drug Name

CLOMIPRAMINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

1997-04-04

74849 / 3

Active Ingredient

CLOMIPRAMINE HYDROCHLORIDE

Application Number

74849

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

1997-04-04

Regulatory Status

Discontinued

1997
26 Aug
Discontinued Application: 74958

Drug Name

CLOMIPRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1997-08-26

74958 / 1

Active Ingredient

CLOMIPRAMINE HYDROCHLORIDE

Application Number

74958

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1997-08-26

Regulatory Status

Discontinued

1997
26 Aug
Discontinued Application: 74958

Drug Name

CLOMIPRAMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1997-08-26

74958 / 2

Active Ingredient

CLOMIPRAMINE HYDROCHLORIDE

Application Number

74958

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1997-08-26

Regulatory Status

Discontinued

1997
26 Aug
Discontinued Application: 74958

Drug Name

CLOMIPRAMINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

1997-08-26

74958 / 3

Active Ingredient

CLOMIPRAMINE HYDROCHLORIDE

Application Number

74958

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

1997-08-26

Regulatory Status

Discontinued

1996
10 Sep
RX Application: 74569

Drug Name

CLONAZEPAM

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

1996-09-10

74569 / 1

Active Ingredient

CLONAZEPAM

Application Number

74569

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

1996-09-10

Regulatory Status

RX

1996
10 Sep
RX Application: 74569

Drug Name

CLONAZEPAM

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

1996-09-10

74569 / 2

Active Ingredient

CLONAZEPAM

Application Number

74569

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

1996-09-10

Regulatory Status

RX

1996
10 Sep
RX Application: 74569

Drug Name

CLONAZEPAM

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

1996-09-10

74569 / 3

Active Ingredient

CLONAZEPAM

Application Number

74569

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

1996-09-10

Regulatory Status

RX

1998
04 Aug
Discontinued Application: 74920

Drug Name

CLONAZEPAM

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

1998-08-04

74920 / 1

Active Ingredient

CLONAZEPAM

Application Number

74920

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

1998-08-04

Regulatory Status

Discontinued

1998
04 Aug
Discontinued Application: 74920

Drug Name

CLONAZEPAM

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

1998-08-04

74920 / 2

Active Ingredient

CLONAZEPAM

Application Number

74920

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

1998-08-04

Regulatory Status

Discontinued

1998
04 Aug
Discontinued Application: 74920

Drug Name

CLONAZEPAM

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

1998-08-04

74920 / 3

Active Ingredient

CLONAZEPAM

Application Number

74920

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

1998-08-04

Regulatory Status

Discontinued

1986
08 Jul
Discontinued Application: 70659

Drug Name

CLONIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.3MG

Approval Date

1986-07-08

70659 / 1

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

70659

Product Number

1

Dosage Form

-

Strength

0.3MG

Approval Date

1986-07-08

Regulatory Status

Discontinued

1986
08 Jul
Discontinued Application: 70702

Drug Name

CLONIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.2MG

Approval Date

1986-07-08

70702 / 1

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

70702

Product Number

1

Dosage Form

-

Strength

0.2MG

Approval Date

1986-07-08

Regulatory Status

Discontinued

1986
08 Jul
Discontinued Application: 70747

Drug Name

CLONIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

1986-07-08

70747 / 1

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

70747

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

1986-07-08

Regulatory Status

Discontinued

2012
17 May
RX Application: 76999

Drug Name

CLOPIDOGREL BISULFATE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2012-05-17

76999 / 1

Active Ingredient

CLOPIDOGREL BISULFATE

Application Number

76999

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2012-05-17

Regulatory Status

RX

1995
28 Feb
RX Application: 73306

Drug Name

CLOTRIMAZOLE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1995-02-28

73306 / 1

Active Ingredient

CLOTRIMAZOLE

Application Number

73306

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1995-02-28

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 62240

Drug Name

CLOXACILLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

62240 / 1

Active Ingredient

CLOXACILLIN SODIUM

Application Number

62240

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62240

Drug Name

CLOXACILLIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

62240 / 2

Active Ingredient

CLOXACILLIN SODIUM

Application Number

62240

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62268

Drug Name

CLOXACILLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1982-01-01

62268 / 1

Active Ingredient

CLOXACILLIN SODIUM

Application Number

62268

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1989
06 Apr
Discontinued Application: 62978

Drug Name

CLOXACILLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1989-04-06

62978 / 1

Active Ingredient

CLOXACILLIN SODIUM

Application Number

62978

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1989-04-06

Regulatory Status

Discontinued

1985
16 May
Discontinued Application: 70034

Drug Name

COTRIM

Product Number

1

Dosage Form

-

Strength

400MG;80MG

Approval Date

1985-05-16

70034 / 1

Active Ingredient

SULFAMETHOXAZOLE; TRIMETHOPRIM

Application Number

70034

Product Number

1

Dosage Form

-

Strength

400MG;80MG

Approval Date

1985-05-16

Regulatory Status

Discontinued

1985
18 Mar
Discontinued Application: 70048

Drug Name

COTRIM D.S.

Product Number

1

Dosage Form

-

Strength

800MG;160MG

Approval Date

1985-03-18

70048 / 1

Active Ingredient

SULFAMETHOXAZOLE; TRIMETHOPRIM

Application Number

70048

Product Number

1

Dosage Form

-

Strength

800MG;160MG

Approval Date

1985-03-18

Regulatory Status

Discontinued

1988
04 Aug
Discontinued Application: 62895

Drug Name

CYCLACILLIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1988-08-04

62895 / 1

Active Ingredient

CYCLACILLIN

Application Number

62895

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1988-08-04

Regulatory Status

Discontinued

1988
04 Aug
Discontinued Application: 62895

Drug Name

CYCLACILLIN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1988-08-04

62895 / 2

Active Ingredient

CYCLACILLIN

Application Number

62895

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1988-08-04

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83563

Drug Name

DELCOBESE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

83563 / 1

Active Ingredient

AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE

Application Number

83563

Product Number

1

Dosage Form

-

Strength

5MG;5MG;5MG;5MG **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: 83563

Drug Name

DELCOBESE

Product Number

2

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

83563 / 2

Active Ingredient

AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE

Application Number

83563

Product Number

2

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG **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: 83563

Drug Name

DELCOBESE

Product Number

3

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

83563 / 3

Active Ingredient

AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE

Application Number

83563

Product Number

3

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG **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: 83563

Drug Name

DELCOBESE

Product Number

4

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

83563 / 4

Active Ingredient

AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE

Application Number

83563

Product Number

4

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG **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: 83564

Drug Name

DELCOBESE

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

83564 / 1

Active Ingredient

AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE

Application Number

83564

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG **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: 83564

Drug Name

DELCOBESE

Product Number

2

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

83564 / 2

Active Ingredient

AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE

Application Number

83564

Product Number

2

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG **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: 83564

Drug Name

DELCOBESE

Product Number

3

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

83564 / 3

Active Ingredient

AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE

Application Number

83564

Product Number

3

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG **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: 83564

Drug Name

DELCOBESE

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1982-01-01

83564 / 4

Active Ingredient

AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE

Application Number

83564

Product Number

4

Dosage Form

-

Strength

5MG;5MG;5MG;5MG **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: 83735

Drug Name

DEXAMPEX

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

83735 / 1

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

83735

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83735

Drug Name

DEXAMPEX

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

83735 / 2

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

83735

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85355

Drug Name

DEXAMPEX

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

85355 / 1

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

85355

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2013
29 Apr
Discontinued Application: 77488

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2013-04-29

77488 / 1

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

77488

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2013-04-29

Regulatory Status

Discontinued

2013
29 Apr
Discontinued Application: 77488

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

2

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2013-04-29

77488 / 2

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

77488

Product Number

2

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2013-04-29

Regulatory Status

Discontinued

2013
29 Apr
Discontinued Application: 77488

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

3

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2013-04-29

77488 / 3

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

77488

Product Number

3

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2013-04-29

Regulatory Status

Discontinued

2013
29 Apr
Discontinued Application: 77488

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

4

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2013-04-29

77488 / 4

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

77488

Product Number

4

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2013-04-29

Regulatory Status

Discontinued

2013
29 Apr
Discontinued Application: 77488

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

5

Dosage Form

-

Strength

6.25MG;6.25MG;6.25MG;6.25MG

Approval Date

2013-04-29

77488 / 5

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

77488

Product Number

5

Dosage Form

-

Strength

6.25MG;6.25MG;6.25MG;6.25MG

Approval Date

2013-04-29

Regulatory Status

Discontinued

2013
29 Apr
Discontinued Application: 77488

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

6

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2013-04-29

77488 / 6

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

77488

Product Number

6

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2013-04-29

Regulatory Status

Discontinued

1998
06 Aug
RX Application: 75219

Drug Name

DICLOFENAC POTASSIUM

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1998-08-06

75219 / 1

Active Ingredient

DICLOFENAC POTASSIUM

Application Number

75219

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1998-08-06

Regulatory Status

RX

1996
15 Aug
Discontinued Application: 74390

Drug Name

DICLOFENAC SODIUM

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

1996-08-15

74390 / 1

Active Ingredient

DICLOFENAC SODIUM

Application Number

74390

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

1996-08-15

Regulatory Status

Discontinued

1999
30 Mar
Discontinued Application: 74723

Drug Name

DICLOFENAC SODIUM

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1999-03-30

74723 / 1

Active Ingredient

DICLOFENAC SODIUM

Application Number

74723

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1999-03-30

Regulatory Status

Discontinued

1984
20 Sep
Discontinued Application: 88642

Drug Name

DIETHYLPROPION HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1984-09-20

88642 / 1

Active Ingredient

DIETHYLPROPION HYDROCHLORIDE

Application Number

88642

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1984-09-20

Regulatory Status

Discontinued

1992
31 Jul
RX Application: 73673

Drug Name

DIFLUNISAL

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1992-07-31

73673 / 1

Active Ingredient

DIFLUNISAL

Application Number

73673

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1992-07-31

Regulatory Status

RX

1992
31 Jul
Discontinued Application: 73679

Drug Name

DIFLUNISAL

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1992-07-31

73679 / 1

Active Ingredient

DIFLUNISAL

Application Number

73679

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1992-07-31

Regulatory Status

Discontinued

1993
30 Nov
Discontinued Application: 74079

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

1993-11-30

74079 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

74079

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

1993-11-30

Regulatory Status

Discontinued

1993
30 Nov
Discontinued Application: 74079

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

90MG

Approval Date

1993-11-30

74079 / 2

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

74079

Product Number

2

Dosage Form

-

Strength

90MG

Approval Date

1993-11-30

Regulatory Status

Discontinued

1993
30 Nov
Discontinued Application: 74079

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

1993-11-30

74079 / 3

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

74079

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

1993-11-30

Regulatory Status

Discontinued

1994
25 Feb
Discontinued Application: 74084

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1994-02-25

74084 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

74084

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1994-02-25

Regulatory Status

Discontinued

1994
25 Feb
Discontinued Application: 74084

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

1994-02-25

74084 / 2

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

74084

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

1994-02-25

Regulatory Status

Discontinued

1995
31 May
RX Application: 74185

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1995-05-31

74185 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

74185

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1995-05-31

Regulatory Status

RX

1995
31 May
RX Application: 74185

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

1995-05-31

74185 / 2

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

74185

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

1995-05-31

Regulatory Status

RX

1995
31 May
RX Application: 74185

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

90MG

Approval Date

1995-05-31

74185 / 3

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

74185

Product Number

3

Dosage Form

-

Strength

90MG

Approval Date

1995-05-31

Regulatory Status

RX

1995
31 May
RX Application: 74185

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

120MG

Approval Date

1995-05-31

74185 / 4

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

74185

Product Number

4

Dosage Form

-

Strength

120MG

Approval Date

1995-05-31

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 85874

Drug Name

DIPHENHYDRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

85874 / 1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Application Number

85874

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85874

Drug Name

DIPHENHYDRAMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

85874 / 2

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Application Number

85874

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1985
22 Feb
RX Application: 70101

Drug Name

DISOPYRAMIDE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1985-02-22

70101 / 1

Active Ingredient

DISOPYRAMIDE PHOSPHATE

Application Number

70101

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1985-02-22

Regulatory Status

RX

1985
22 Feb
RX Application: 70102

Drug Name

DISOPYRAMIDE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1985-02-22

70102 / 1

Active Ingredient

DISOPYRAMIDE PHOSPHATE

Application Number

70102

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1985-02-22

Regulatory Status

RX

2008
29 Jul
Discontinued Application: 76941

Drug Name

DIVALPROEX SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 125MG VALPROIC ACID

Approval Date

2008-07-29

76941 / 1

Active Ingredient

DIVALPROEX SODIUM

Application Number

76941

Product Number

1

Dosage Form

-

Strength

EQ 125MG VALPROIC ACID

Approval Date

2008-07-29

Regulatory Status

Discontinued

2008
29 Jul
Discontinued Application: 76941

Drug Name

DIVALPROEX SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

2008-07-29

76941 / 2

Active Ingredient

DIVALPROEX SODIUM

Application Number

76941

Product Number

2

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

2008-07-29

Regulatory Status

Discontinued

2008
29 Jul
Discontinued Application: 76941

Drug Name

DIVALPROEX SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

2008-07-29

76941 / 3

Active Ingredient

DIVALPROEX SODIUM

Application Number

76941

Product Number

3

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

2008-07-29

Regulatory Status

Discontinued

2001
12 Jan
Discontinued Application: 75353

Drug Name

DOXAZOSIN MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2001-01-12

75353 / 1

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

75353

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2001-01-12

Regulatory Status

Discontinued

2001
12 Jan
Discontinued Application: 75353

Drug Name

DOXAZOSIN MESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2001-01-12

75353 / 2

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

75353

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2001-01-12

Regulatory Status

Discontinued

2001
12 Jan
Discontinued Application: 75353

Drug Name

DOXAZOSIN MESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2001-01-12

75353 / 3

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

75353

Product Number

3

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2001-01-12

Regulatory Status

Discontinued

2001
12 Jan
Discontinued Application: 75353

Drug Name

DOXAZOSIN MESYLATE

Product Number

4

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2001-01-12

75353 / 4

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

75353

Product Number

4

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2001-01-12

Regulatory Status

Discontinued

2000
18 Oct
RX Application: 75536

Drug Name

DOXAZOSIN MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2000-10-18

75536 / 1

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

75536

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2000-10-18

Regulatory Status

RX

2000
18 Oct
RX Application: 75536

Drug Name

DOXAZOSIN MESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2000-10-18

75536 / 2

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

75536

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2000-10-18

Regulatory Status

RX

2000
18 Oct
RX Application: 75536

Drug Name

DOXAZOSIN MESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2000-10-18

75536 / 3

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

75536

Product Number

3

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2000-10-18

Regulatory Status

RX

2000
18 Oct
RX Application: 75536

Drug Name

DOXAZOSIN MESYLATE

Product Number

4

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2000-10-18

75536 / 4

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

75536

Product Number

4

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2000-10-18

Regulatory Status

RX

1984
23 Aug
Discontinued Application: 62497

Drug Name

DOXY-LEMMON

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1984-08-23

62497 / 1

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

62497

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1984-08-23

Regulatory Status

Discontinued

1984
15 Jun
Discontinued Application: 62497

Drug Name

DOXY-LEMMON

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1984-06-15

62497 / 2

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

62497

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1984-06-15

Regulatory Status

Discontinued

1985
15 Mar
Discontinued Application: 62581

Drug Name

DOXY-LEMMON

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1985-03-15

62581 / 1

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

62581

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1985-03-15

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84301

Drug Name

DRALZINE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

84301 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

84301

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1986
17 Sep
RX Application: 70541

Drug Name

EPITOL

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1986-09-17

70541 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

70541

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1986-09-17

Regulatory Status

RX

1992
29 Jul
RX Application: 73524

Drug Name

EPITOL

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1992-07-29

73524 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

73524

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1992-07-29

Regulatory Status

RX

2011
23 May
RX Application: 91169

Drug Name

ESZOPICLONE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2011-05-23

91169 / 1

Active Ingredient

ESZOPICLONE

Application Number

91169

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2011-05-23

Regulatory Status

RX

2011
23 May
RX Application: 91169

Drug Name

ESZOPICLONE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2011-05-23

91169 / 2

Active Ingredient

ESZOPICLONE

Application Number

91169

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2011-05-23

Regulatory Status

RX

2011
23 May
RX Application: 91169

Drug Name

ESZOPICLONE

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2011-05-23

91169 / 3

Active Ingredient

ESZOPICLONE

Application Number

91169

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2011-05-23

Regulatory Status

RX

1999
23 Apr
Discontinued Application: 74847

Drug Name

ETODOLAC

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1999-04-23

74847 / 1

Active Ingredient

ETODOLAC

Application Number

74847

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1999-04-23

Regulatory Status

Discontinued

1999
23 Apr
Discontinued Application: 74847

Drug Name

ETODOLAC

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1999-04-23

74847 / 2

Active Ingredient

ETODOLAC

Application Number

74847

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1999-04-23

Regulatory Status

Discontinued

1997
26 Nov
Discontinued Application: 75009

Drug Name

ETODOLAC

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1997-11-26

75009 / 1

Active Ingredient

ETODOLAC

Application Number

75009

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1997-11-26

Regulatory Status

Discontinued

1999
28 Dec
Discontinued Application: 75009

Drug Name

ETODOLAC

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1999-12-28

75009 / 2

Active Ingredient

ETODOLAC

Application Number

75009

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1999-12-28

Regulatory Status

Discontinued

2000
31 Jul
RX Application: 75665

Drug Name

ETODOLAC

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2000-07-31

75665 / 1

Active Ingredient

ETODOLAC

Application Number

75665

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2000-07-31

Regulatory Status

RX

2000
31 Jul
RX Application: 75665

Drug Name

ETODOLAC

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2000-07-31

75665 / 2

Active Ingredient

ETODOLAC

Application Number

75665

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2000-07-31

Regulatory Status

RX

2001
05 Feb
RX Application: 75665

Drug Name

ETODOLAC

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2001-02-05

75665 / 3

Active Ingredient

ETODOLAC

Application Number

75665

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2001-02-05

Regulatory Status

RX

2001
16 Apr
Discontinued Application: 75311

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2001-04-16

75311 / 1

Active Ingredient

FAMOTIDINE

Application Number

75311

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2001-04-16

Regulatory Status

Discontinued

2001
16 Apr
Discontinued Application: 75311

Drug Name

FAMOTIDINE

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2001-04-16

75311 / 2

Active Ingredient

FAMOTIDINE

Application Number

75311

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2001-04-16

Regulatory Status

Discontinued

2001
31 May
Discontinued Application: 75312

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2001-05-31

75312 / 1

Active Ingredient

FAMOTIDINE

Application Number

75312

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2001-05-31

Regulatory Status

Discontinued

2005
01 Sep
Discontinued Application: 76447

Drug Name

FEXOFENADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2005-09-01

76447 / 1

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

76447

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2005-09-01

Regulatory Status

Discontinued

2005
01 Sep
Discontinued Application: 76447

Drug Name

FEXOFENADINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2005-09-01

76447 / 2

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

76447

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2005-09-01

Regulatory Status

Discontinued

2005
01 Sep
Discontinued Application: 76447

Drug Name

FEXOFENADINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

180MG

Approval Date

2005-09-01

76447 / 3

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

76447

Product Number

3

Dosage Form

-

Strength

180MG

Approval Date

2005-09-01

Regulatory Status

Discontinued

2011
13 Apr
Discontinued Application: 76447

Drug Name

FEXOFENADINE HYDROCHLORIDE ALLERGY

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2011-04-13

76447 / 6

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

76447

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2011-04-13

Regulatory Status

Discontinued

2011
13 Apr
Discontinued Application: 76447

Drug Name

FEXOFENADINE HYDROCHLORIDE ALLERGY

Product Number

8

Dosage Form

-

Strength

180MG

Approval Date

2011-04-13

76447 / 8

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

76447

Product Number

8

Dosage Form

-

Strength

180MG

Approval Date

2011-04-13

Regulatory Status

Discontinued

2011
13 Apr
Discontinued Application: 76447

Drug Name

FEXOFENADINE HYDROCHLORIDE HIVES

Product Number

7

Dosage Form

-

Strength

60MG

Approval Date

2011-04-13

76447 / 7

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

76447

Product Number

7

Dosage Form

-

Strength

60MG

Approval Date

2011-04-13

Regulatory Status

Discontinued

-
Unclassified Application: 76447

Drug Name

FEXOFENADINE HYDROCHLORIDE HIVES

Product Number

9

Dosage Form

-

Strength

180MG

Approval Date

-

76447 / 9

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

76447

Product Number

9

Dosage Form

-

Strength

180MG

Approval Date

-

Regulatory Status

Unclassified

2006
15 Dec
RX Application: 76511

Drug Name

FINASTERIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2006-12-15

76511 / 1

Active Ingredient

FINASTERIDE

Application Number

76511

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2006-12-15

Regulatory Status

RX

2013
05 Nov
Discontinued Application: 76905

Drug Name

FINASTERIDE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2013-11-05

76905 / 1

Active Ingredient

FINASTERIDE

Application Number

76905

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2013-11-05

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 74681

Drug Name

FLUCONAZOLE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-07-29

74681 / 1

Active Ingredient

FLUCONAZOLE

Application Number

74681

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-07-29

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 74681

Drug Name

FLUCONAZOLE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2004-07-29

74681 / 2

Active Ingredient

FLUCONAZOLE

Application Number

74681

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2004-07-29

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 74681

Drug Name

FLUCONAZOLE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2004-07-29

74681 / 3

Active Ingredient

FLUCONAZOLE

Application Number

74681

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2004-07-29

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 74681

Drug Name

FLUCONAZOLE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2004-07-29

74681 / 4

Active Ingredient

FLUCONAZOLE

Application Number

74681

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2004-07-29

Regulatory Status

Discontinued

1989
06 Feb
RX Application: 72488

Drug Name

FLUOCINONIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1989-02-06

72488 / 1

Active Ingredient

FLUOCINONIDE

Application Number

72488

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1989-02-06

Regulatory Status

RX

1989
07 Feb
Discontinued Application: 72511

Drug Name

FLUOCINONIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1989-02-07

72511 / 1

Active Ingredient

FLUOCINONIDE

Application Number

72511

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1989-02-07

Regulatory Status

Discontinued

1991
27 Dec
RX Application: 73481

Drug Name

FLUOCINONIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1991-12-27

73481 / 1

Active Ingredient

FLUOCINONIDE

Application Number

73481

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1991-12-27

Regulatory Status

RX

1989
07 Feb
RX Application: 72490

Drug Name

FLUOCINONIDE EMULSIFIED BASE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1989-02-07

72490 / 1

Active Ingredient

FLUOCINONIDE

Application Number

72490

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1989-02-07

Regulatory Status

RX

2002
29 Jan
RX Application: 75452

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2002-01-29

75452 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

75452

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2002-01-29

Regulatory Status

RX

2002
29 Jan
RX Application: 75452

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2002-01-29

75452 / 2

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

75452

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2002-01-29

Regulatory Status

RX

2002
29 Jan
RX Application: 75452

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2002-01-29

75452 / 3

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

75452

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2002-01-29

Regulatory Status

RX

2001
02 Aug
RX Application: 75506

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/5ML

Approval Date

2001-08-02

75506 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

75506

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/5ML

Approval Date

2001-08-02

Regulatory Status

RX

2002
29 Jan
Discontinued Application: 75872

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2002-01-29

75872 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

75872

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2002-01-29

Regulatory Status

Discontinued

2019
04 Jan
Discontinued Application: 75872

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2019-01-04

75872 / 2

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

75872

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2019-01-04

Regulatory Status

Discontinued

1995
24 May
Discontinued Application: 74405

Drug Name

FLURBIPROFEN

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1995-05-24

74405 / 1

Active Ingredient

FLURBIPROFEN

Application Number

74405

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1995-05-24

Regulatory Status

Discontinued

1995
24 May
Discontinued Application: 74405

Drug Name

FLURBIPROFEN

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1995-05-24

74405 / 2

Active Ingredient

FLURBIPROFEN

Application Number

74405

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1995-05-24

Regulatory Status

Discontinued

2002
10 Sep
Discontinued Application: 75893

Drug Name

FLUVOXAMINE MALEATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2002-09-10

75893 / 1

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

75893

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2002-09-10

Regulatory Status

Discontinued

2002
10 Sep
Discontinued Application: 75893

Drug Name

FLUVOXAMINE MALEATE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2002-09-10

75893 / 2

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

75893

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2002-09-10

Regulatory Status

Discontinued

2002
10 Sep
Discontinued Application: 75893

Drug Name

FLUVOXAMINE MALEATE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2002-09-10

75893 / 3

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

75893

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2002-09-10

Regulatory Status

Discontinued

2003
25 Nov
RX Application: 76139

Drug Name

FOSINOPRIL SODIUM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2003-11-25

76139 / 1

Active Ingredient

FOSINOPRIL SODIUM

Application Number

76139

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2003-11-25

Regulatory Status

RX

2003
25 Nov
RX Application: 76139

Drug Name

FOSINOPRIL SODIUM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2003-11-25

76139 / 2

Active Ingredient

FOSINOPRIL SODIUM

Application Number

76139

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2003-11-25

Regulatory Status

RX

2003
25 Nov
RX Application: 76139

Drug Name

FOSINOPRIL SODIUM

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2003-11-25

76139 / 3

Active Ingredient

FOSINOPRIL SODIUM

Application Number

76139

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2003-11-25

Regulatory Status

RX

2006
05 Jul
Discontinued Application: 76945

Drug Name

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2006-07-05

76945 / 1

Active Ingredient

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

Application Number

76945

Product Number

1

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2006-07-05

Regulatory Status

Discontinued

2006
05 Jul
Discontinued Application: 76945

Drug Name

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2006-07-05

76945 / 2

Active Ingredient

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

Application Number

76945

Product Number

2

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2006-07-05

Regulatory Status

Discontinued

2004
15 Dec
Discontinued Application: 75827

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2004-12-15

75827 / 1

Active Ingredient

GABAPENTIN

Application Number

75827

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2004-12-15

Regulatory Status

Discontinued

2004
15 Dec
Discontinued Application: 75827

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

2004-12-15

75827 / 2

Active Ingredient

GABAPENTIN

Application Number

75827

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

2004-12-15

Regulatory Status

Discontinued

1993
31 Oct
Discontinued Application: 74256

Drug Name

GEMFIBROZIL

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

1993-10-31

74256 / 1

Active Ingredient

GEMFIBROZIL

Application Number

74256

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

1993-10-31

Regulatory Status

Discontinued

1995
29 Aug
RX Application: 74388

Drug Name

GLYBURIDE

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

1995-08-29

74388 / 1

Active Ingredient

GLYBURIDE

Application Number

74388

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

1995-08-29

Regulatory Status

RX

1995
29 Aug
RX Application: 74388

Drug Name

GLYBURIDE

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

1995-08-29

74388 / 2

Active Ingredient

GLYBURIDE

Application Number

74388

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

1995-08-29

Regulatory Status

RX

1995
29 Aug
RX Application: 74388

Drug Name

GLYBURIDE

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

1995-08-29

74388 / 3

Active Ingredient

GLYBURIDE

Application Number

74388

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

1995-08-29

Regulatory Status

RX

1999
20 Apr
RX Application: 74686

Drug Name

GLYBURIDE (MICRONIZED)

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

1999-04-20

74686 / 1

Active Ingredient

GLYBURIDE

Application Number

74686

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

1999-04-20

Regulatory Status

RX

1999
20 Apr
RX Application: 74686

Drug Name

GLYBURIDE (MICRONIZED)

Product Number

2

Dosage Form

-

Strength

3MG

Approval Date

1999-04-20

74686 / 2

Active Ingredient

GLYBURIDE

Application Number

74686

Product Number

2

Dosage Form

-

Strength

3MG

Approval Date

1999-04-20

Regulatory Status

RX

1999
20 Apr
RX Application: 74686

Drug Name

GLYBURIDE (MICRONIZED)

Product Number

3

Dosage Form

-

Strength

4.5MG

Approval Date

1999-04-20

74686 / 3

Active Ingredient

GLYBURIDE

Application Number

74686

Product Number

3

Dosage Form

-

Strength

4.5MG

Approval Date

1999-04-20

Regulatory Status

RX

1999
20 Apr
RX Application: 74686

Drug Name

GLYBURIDE (MICRONIZED)

Product Number

4

Dosage Form

-

Strength

6MG

Approval Date

1999-04-20

74686 / 4

Active Ingredient

GLYBURIDE

Application Number

74686

Product Number

4

Dosage Form

-

Strength

6MG

Approval Date

1999-04-20

Regulatory Status

RX

2005
27 Jan
Discontinued Application: 76821

Drug Name

GLYBURIDE AND METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1.25MG;250MG

Approval Date

2005-01-27

76821 / 1

Active Ingredient

GLYBURIDE; METFORMIN HYDROCHLORIDE

Application Number

76821

Product Number

1

Dosage Form

-

Strength

1.25MG;250MG

Approval Date

2005-01-27

Regulatory Status

Discontinued

2005
27 Jan
Discontinued Application: 76821

Drug Name

GLYBURIDE AND METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

2.5MG;500MG

Approval Date

2005-01-27

76821 / 2

Active Ingredient

GLYBURIDE; METFORMIN HYDROCHLORIDE

Application Number

76821

Product Number

2

Dosage Form

-

Strength

2.5MG;500MG

Approval Date

2005-01-27

Regulatory Status

Discontinued

2005
27 Jan
Discontinued Application: 76821

Drug Name

GLYBURIDE AND METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

5MG;500MG

Approval Date

2005-01-27

76821 / 3

Active Ingredient

GLYBURIDE; METFORMIN HYDROCHLORIDE

Application Number

76821

Product Number

3

Dosage Form

-

Strength

5MG;500MG

Approval Date

2005-01-27

Regulatory Status

Discontinued

1987
25 Aug
Discontinued Application: 71015

Drug Name

HALOPERIDOL

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

1987-08-25

71015 / 1

Active Ingredient

HALOPERIDOL LACTATE

Application Number

71015

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

1987-08-25

Regulatory Status

Discontinued

1985
04 Mar
Discontinued Application: 88713

Drug Name

HY-PAM "25"

Product Number

1

Dosage Form

-

Strength

EQ 25MG HYDROCHLORIDE

Approval Date

1985-03-04

88713 / 1

Active Ingredient

HYDROXYZINE PAMOATE

Application Number

88713

Product Number

1

Dosage Form

-

Strength

EQ 25MG HYDROCHLORIDE

Approval Date

1985-03-04

Regulatory Status

Discontinued

1985
07 Feb
Discontinued Application: 88923

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1985-02-07

88923 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

88923

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1985-02-07

Regulatory Status

Discontinued

1985
07 Feb
Discontinued Application: 88924

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1985-02-07

88924 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

88924

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1985-02-07

Regulatory Status

Discontinued

2003
11 Apr
Discontinued Application: 76023

Drug Name

HYDROCODONE BITARTRATE AND IBUPROFEN

Product Number

1

Dosage Form

-

Strength

7.5MG;200MG

Approval Date

2003-04-11

76023 / 1

Active Ingredient

HYDROCODONE BITARTRATE; IBUPROFEN

Application Number

76023

Product Number

1

Dosage Form

-

Strength

7.5MG;200MG

Approval Date

2003-04-11

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80400

Drug Name

HYDROCORTISONE

Product Number

2

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

80400 / 2

Active Ingredient

HYDROCORTISONE

Application Number

80400

Product Number

2

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80400

Drug Name

HYDROCORTISONE

Product Number

3

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

80400 / 3

Active Ingredient

HYDROCORTISONE

Application Number

80400

Product Number

3

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80400

Drug Name

HYDROCORTISONE

Product Number

4

Dosage Form

-

Strength

2.5%

Approval Date

1982-01-01

80400 / 4

Active Ingredient

HYDROCORTISONE

Application Number

80400

Product Number

4

Dosage Form

-

Strength

2.5%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85191

Drug Name

HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

85191 / 1

Active Ingredient

HYDROCORTISONE

Application Number

85191

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1992
29 May
Discontinued Application: 73141

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1992-05-29

73141 / 1

Active Ingredient

IBUPROFEN

Application Number

73141

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1992-05-29

Regulatory Status

Discontinued

1992
30 Jun
Discontinued Application: 73343

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1992-06-30

73343 / 1

Active Ingredient

IBUPROFEN

Application Number

73343

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1992-06-30

Regulatory Status

Discontinued

1992
30 Jun
Discontinued Application: 73344

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

1992-06-30

73344 / 1

Active Ingredient

IBUPROFEN

Application Number

73344

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

1992-06-30

Regulatory Status

Discontinued

1992
30 Jun
Discontinued Application: 73345

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

1992-06-30

73345 / 1

Active Ingredient

IBUPROFEN

Application Number

73345

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

1992-06-30

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83729

Drug Name

IMIPRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

83729 / 1

Active Ingredient

IMIPRAMINE HYDROCHLORIDE

Application Number

83729

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83729

Drug Name

IMIPRAMINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

83729 / 3

Active Ingredient

IMIPRAMINE HYDROCHLORIDE

Application Number

83729

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83729

Drug Name

IMIPRAMINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

83729 / 4

Active Ingredient

IMIPRAMINE HYDROCHLORIDE

Application Number

83729

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1997
04 Apr
Discontinued Application: 74665

Drug Name

INDAPAMIDE

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

1997-04-04

74665 / 1

Active Ingredient

INDAPAMIDE

Application Number

74665

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

1997-04-04

Regulatory Status

Discontinued

1997
04 Apr
Discontinued Application: 74665

Drug Name

INDAPAMIDE

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

1997-04-04

74665 / 2

Active Ingredient

INDAPAMIDE

Application Number

74665

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

1997-04-04

Regulatory Status

Discontinued

1985
07 Nov
Discontinued Application: 70266

Drug Name

INDO-LEMMON

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1985-11-07

70266 / 1

Active Ingredient

INDOMETHACIN

Application Number

70266

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1985-11-07

Regulatory Status

Discontinued

1985
07 Nov
Discontinued Application: 70267

Drug Name

INDO-LEMMON

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1985-11-07

70267 / 1

Active Ingredient

INDOMETHACIN

Application Number

70267

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1985-11-07

Regulatory Status

Discontinued

1988
18 Apr
Discontinued Application: 71342

Drug Name

INDOMETHACIN

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1988-04-18

71342 / 1

Active Ingredient

INDOMETHACIN

Application Number

71342

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1988-04-18

Regulatory Status

Discontinued

1988
18 Apr
Discontinued Application: 71343

Drug Name

INDOMETHACIN

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1988-04-18

71343 / 1

Active Ingredient

INDOMETHACIN

Application Number

71343

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1988-04-18

Regulatory Status

Discontinued

2012
30 Mar
RX Application: 77369

Drug Name

IRBESARTAN AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;150MG

Approval Date

2012-03-30

77369 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; IRBESARTAN

Application Number

77369

Product Number

1

Dosage Form

-

Strength

12.5MG;150MG

Approval Date

2012-03-30

Regulatory Status

RX

2012
30 Mar
RX Application: 77369

Drug Name

IRBESARTAN AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;300MG

Approval Date

2012-03-30

77369 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; IRBESARTAN

Application Number

77369

Product Number

2

Dosage Form

-

Strength

12.5MG;300MG

Approval Date

2012-03-30

Regulatory Status

RX

2012
30 Mar
Discontinued Application: 77369

Drug Name

IRBESARTAN AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;300MG

Approval Date

2012-03-30

77369 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; IRBESARTAN

Application Number

77369

Product Number

3

Dosage Form

-

Strength

25MG;300MG

Approval Date

2012-03-30

Regulatory Status

Discontinued

1999
15 Jun
Discontinued Application: 75273

Drug Name

KETOCONAZOLE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1999-06-15

75273 / 1

Active Ingredient

KETOCONAZOLE

Application Number

75273

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1999-06-15

Regulatory Status

Discontinued

2000
25 Apr
RX Application: 75581

Drug Name

KETOCONAZOLE

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2000-04-25

75581 / 1

Active Ingredient

KETOCONAZOLE

Application Number

75581

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2000-04-25

Regulatory Status

RX

1992
22 Dec
Discontinued Application: 73515

Drug Name

KETOPROFEN

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1992-12-22

73515 / 1

Active Ingredient

KETOPROFEN

Application Number

73515

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1992-12-22

Regulatory Status

Discontinued

1992
22 Dec
RX Application: 73516

Drug Name

KETOPROFEN

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1992-12-22

73516 / 1

Active Ingredient

KETOPROFEN

Application Number

73516

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1992-12-22

Regulatory Status

RX

1992
22 Dec
Discontinued Application: 73517

Drug Name

KETOPROFEN

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

1992-12-22

73517 / 1

Active Ingredient

KETOPROFEN

Application Number

73517

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

1992-12-22

Regulatory Status

Discontinued

1997
16 May
RX Application: 74754

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1997-05-16

74754 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

74754

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1997-05-16

Regulatory Status

RX

1998
30 Sep
Discontinued Application: 74989

Drug Name

LABETALOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1998-09-30

74989 / 1

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

74989

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1998-09-30

Regulatory Status

Discontinued

1998
30 Sep
Discontinued Application: 74989

Drug Name

LABETALOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1998-09-30

74989 / 2

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

74989

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1998-09-30

Regulatory Status

Discontinued

1998
30 Sep
Discontinued Application: 74989

Drug Name

LABETALOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

1998-09-30

74989 / 3

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

74989

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

1998-09-30

Regulatory Status

Discontinued

2006
30 Aug
Discontinued Application: 76388

Drug Name

LAMOTRIGINE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2006-08-30

76388 / 1

Active Ingredient

LAMOTRIGINE

Application Number

76388

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2006-08-30

Regulatory Status

Discontinued

2006
30 Aug
Discontinued Application: 76388

Drug Name

LAMOTRIGINE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2006-08-30

76388 / 2

Active Ingredient

LAMOTRIGINE

Application Number

76388

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2006-08-30

Regulatory Status

Discontinued

2006
30 Aug
Discontinued Application: 76388

Drug Name

LAMOTRIGINE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2006-08-30

76388 / 3

Active Ingredient

LAMOTRIGINE

Application Number

76388

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2006-08-30

Regulatory Status

Discontinued

2006
30 Aug
Discontinued Application: 76388

Drug Name

LAMOTRIGINE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2006-08-30

76388 / 4

Active Ingredient

LAMOTRIGINE

Application Number

76388

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2006-08-30

Regulatory Status

Discontinued

2006
21 Jun
Discontinued Application: 76420

Drug Name

LAMOTRIGINE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2006-06-21

76420 / 1

Active Ingredient

LAMOTRIGINE

Application Number

76420

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2006-06-21

Regulatory Status

Discontinued

2006
21 Jun
Discontinued Application: 76420

Drug Name

LAMOTRIGINE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2006-06-21

76420 / 2

Active Ingredient

LAMOTRIGINE

Application Number

76420

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2006-06-21

Regulatory Status

Discontinued

2011
20 Jun
RX Application: 76361

Drug Name

LEVOFLOXACIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2011-06-20

76361 / 1

Active Ingredient

LEVOFLOXACIN

Application Number

76361

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2011-06-20

Regulatory Status

RX

2011
20 Jun
RX Application: 76361

Drug Name

LEVOFLOXACIN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2011-06-20

76361 / 2

Active Ingredient

LEVOFLOXACIN

Application Number

76361

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2011-06-20

Regulatory Status

RX

2011
20 Jun
RX Application: 76361

Drug Name

LEVOFLOXACIN

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2011-06-20

76361 / 3

Active Ingredient

LEVOFLOXACIN

Application Number

76361

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2011-06-20

Regulatory Status

RX

2002
01 Jul
Discontinued Application: 75783

Drug Name

LISINOPRIL

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2002-07-01

75783 / 1

Active Ingredient

LISINOPRIL

Application Number

75783

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2002-07-01

Regulatory Status

Discontinued

2002
01 Jul
Discontinued Application: 75783

Drug Name

LISINOPRIL

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2002-07-01

75783 / 2

Active Ingredient

LISINOPRIL

Application Number

75783

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2002-07-01

Regulatory Status

Discontinued

2002
01 Jul
Discontinued Application: 75783

Drug Name

LISINOPRIL

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2002-07-01

75783 / 3

Active Ingredient

LISINOPRIL

Application Number

75783

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2002-07-01

Regulatory Status

Discontinued

2002
01 Jul
Discontinued Application: 75783

Drug Name

LISINOPRIL

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2002-07-01

75783 / 4

Active Ingredient

LISINOPRIL

Application Number

75783

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2002-07-01

Regulatory Status

Discontinued

2002
01 Jul
Discontinued Application: 75783

Drug Name

LISINOPRIL

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

2002-07-01

75783 / 5

Active Ingredient

LISINOPRIL

Application Number

75783

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

2002-07-01

Regulatory Status

Discontinued

2002
01 Jul
Discontinued Application: 75783

Drug Name

LISINOPRIL

Product Number

6

Dosage Form

-

Strength

40MG

Approval Date

2002-07-01

75783 / 6

Active Ingredient

LISINOPRIL

Application Number

75783

Product Number

6

Dosage Form

-

Strength

40MG

Approval Date

2002-07-01

Regulatory Status

Discontinued

2002
01 Jul
Discontinued Application: 75869

Drug Name

LISINOPRIL AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;10MG

Approval Date

2002-07-01

75869 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; LISINOPRIL

Application Number

75869

Product Number

1

Dosage Form

-

Strength

12.5MG;10MG

Approval Date

2002-07-01

Regulatory Status

Discontinued

2002
01 Jul
Discontinued Application: 75869

Drug Name

LISINOPRIL AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;20MG

Approval Date

2002-07-01

75869 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; LISINOPRIL

Application Number

75869

Product Number

2

Dosage Form

-

Strength

12.5MG;20MG

Approval Date

2002-07-01

Regulatory Status

Discontinued

2002
01 Jul
Discontinued Application: 75869

Drug Name

LISINOPRIL AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;20MG

Approval Date

2002-07-01

75869 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; LISINOPRIL

Application Number

75869

Product Number

3

Dosage Form

-

Strength

25MG;20MG

Approval Date

2002-07-01

Regulatory Status

Discontinued

1991
30 Aug
Discontinued Application: 73122

Drug Name

LOPERAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1991-08-30

73122 / 1

Active Ingredient

LOPERAMIDE HYDROCHLORIDE

Application Number

73122

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1991-08-30

Regulatory Status

Discontinued

1992
30 Apr
RX Application: 73192

Drug Name

LOPERAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1992-04-30

73192 / 1

Active Ingredient

LOPERAMIDE HYDROCHLORIDE

Application Number

73192

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1992-04-30

Regulatory Status

RX

1995
23 Jun
Discontinued Application: 73478

Drug Name

LOPERAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1MG/5ML

Approval Date

1995-06-23

73478 / 1

Active Ingredient

LOPERAMIDE HYDROCHLORIDE

Application Number

73478

Product Number

1

Dosage Form

-

Strength

1MG/5ML

Approval Date

1995-06-23

Regulatory Status

Discontinued

2003
07 Nov
Discontinued Application: 75505

Drug Name

LORATADINE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2003-11-07

75505 / 1

Active Ingredient

LORATADINE

Application Number

75505

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2003-11-07

Regulatory Status

Discontinued

2010
06 Apr
Discontinued Application: 76958

Drug Name

LOSARTAN POTASSIUM

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2010-04-06

76958 / 1

Active Ingredient

LOSARTAN POTASSIUM

Application Number

76958

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2010-04-06

Regulatory Status

Discontinued

2010
06 Apr
Discontinued Application: 76958

Drug Name

LOSARTAN POTASSIUM

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2010-04-06

76958 / 2

Active Ingredient

LOSARTAN POTASSIUM

Application Number

76958

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2010-04-06

Regulatory Status

Discontinued

2010
06 Apr
Discontinued Application: 76958

Drug Name

LOSARTAN POTASSIUM

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2010-04-06

76958 / 3

Active Ingredient

LOSARTAN POTASSIUM

Application Number

76958

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2010-04-06

Regulatory Status

Discontinued

2001
17 Dec
RX Application: 75551

Drug Name

LOVASTATIN

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2001-12-17

75551 / 1

Active Ingredient

LOVASTATIN

Application Number

75551

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2001-12-17

Regulatory Status

RX

2001
17 Dec
RX Application: 75551

Drug Name

LOVASTATIN

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2001-12-17

75551 / 2

Active Ingredient

LOVASTATIN

Application Number

75551

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2001-12-17

Regulatory Status

RX

2001
17 Dec
RX Application: 75551

Drug Name

LOVASTATIN

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2001-12-17

75551 / 3

Active Ingredient

LOVASTATIN

Application Number

75551

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2001-12-17

Regulatory Status

RX

1998
27 Feb
Discontinued Application: 74745

Drug Name

MEGESTROL ACETATE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1998-02-27

74745 / 1

Active Ingredient

MEGESTROL ACETATE

Application Number

74745

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1998-02-27

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16069

Drug Name

MEPRIAM

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1982-01-01

16069 / 1

Active Ingredient

MEPROBAMATE

Application Number

16069

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2004
18 Jun
RX Application: 76269

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2004-06-18

76269 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

76269

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2004-06-18

Regulatory Status

RX

2002
16 Dec
Discontinued Application: 76328

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2002-12-16

76328 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

76328

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2002-12-16

Regulatory Status

Discontinued

2002
16 Dec
Discontinued Application: 76328

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

850MG

Approval Date

2002-12-16

76328 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

76328

Product Number

2

Dosage Form

-

Strength

850MG

Approval Date

2002-12-16

Regulatory Status

Discontinued

2002
16 Dec
Discontinued Application: 76328

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

2002-12-16

76328 / 3

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

76328

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

2002-12-16

Regulatory Status

Discontinued

2005
12 Apr
RX Application: 76864

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

2005-04-12

76864 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

76864

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

2005-04-12

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 83889

Drug Name

METHAMPEX

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

83889 / 1

Active Ingredient

METHAMPHETAMINE HYDROCHLORIDE

Application Number

83889

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86359

Drug Name

METHAMPHETAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

86359 / 1

Active Ingredient

METHAMPHETAMINE HYDROCHLORIDE

Application Number

86359

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1986
05 Dec
Discontinued Application: 71067

Drug Name

METHYLDOPA

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1986-12-05

71067 / 1

Active Ingredient

METHYLDOPA

Application Number

71067

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1986-12-05

Regulatory Status

Discontinued

1986
05 Dec
Discontinued Application: 71105

Drug Name

METHYLDOPA

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

1986-12-05

71105 / 1

Active Ingredient

METHYLDOPA

Application Number

71105

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

1986-12-05

Regulatory Status

Discontinued

1986
05 Dec
Discontinued Application: 71106

Drug Name

METHYLDOPA

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1986-12-05

71106 / 1

Active Ingredient

METHYLDOPA

Application Number

71106

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1986-12-05

Regulatory Status

Discontinued

1988
08 Apr
Discontinued Application: 71819

Drug Name

METHYLDOPA AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

15MG;250MG

Approval Date

1988-04-08

71819 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; METHYLDOPA

Application Number

71819

Product Number

1

Dosage Form

-

Strength

15MG;250MG

Approval Date

1988-04-08

Regulatory Status

Discontinued

1988
08 Apr
Discontinued Application: 71820

Drug Name

METHYLDOPA AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG;250MG

Approval Date

1988-04-08

71820 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; METHYLDOPA

Application Number

71820

Product Number

1

Dosage Form

-

Strength

25MG;250MG

Approval Date

1988-04-08

Regulatory Status

Discontinued

1988
08 Apr
Discontinued Application: 71821

Drug Name

METHYLDOPA AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

30MG;500MG

Approval Date

1988-04-08

71821 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; METHYLDOPA

Application Number

71821

Product Number

1

Dosage Form

-

Strength

30MG;500MG

Approval Date

1988-04-08

Regulatory Status

Discontinued

1988
08 Apr
Discontinued Application: 71822

Drug Name

METHYLDOPA AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

50MG;500MG

Approval Date

1988-04-08

71822 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; METHYLDOPA

Application Number

71822

Product Number

1

Dosage Form

-

Strength

50MG;500MG

Approval Date

1988-04-08

Regulatory Status

Discontinued

1985
29 Jul
RX Application: 70184

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1985-07-29

70184 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

70184

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1985-07-29

Regulatory Status

RX

1987
10 Jul
Discontinued Application: 70819

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/5ML

Approval Date

1987-07-10

70819 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

70819

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/5ML

Approval Date

1987-07-10

Regulatory Status

Discontinued

1993
30 Jun
Discontinued Application: 71315

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/5ML

Approval Date

1993-06-30

71315 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

71315

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/5ML

Approval Date

1993-06-30

Regulatory Status

Discontinued

1993
15 Jun
RX Application: 72801

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1993-06-15

72801 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

72801

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1993-06-15

Regulatory Status

RX

1994
30 Sep
Discontinued Application: 74143

Drug Name

METOPROLOL TARTRATE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1994-09-30

74143 / 1

Active Ingredient

METOPROLOL TARTRATE

Application Number

74143

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1994-09-30

Regulatory Status

Discontinued

1994
30 Sep
Discontinued Application: 74143

Drug Name

METOPROLOL TARTRATE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1994-09-30

74143 / 2

Active Ingredient

METOPROLOL TARTRATE

Application Number

74143

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1994-09-30

Regulatory Status

Discontinued

1995
16 May
RX Application: 74377

Drug Name

MEXILETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

1995-05-16

74377 / 1

Active Ingredient

MEXILETINE HYDROCHLORIDE

Application Number

74377

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

1995-05-16

Regulatory Status

RX

1995
16 May
RX Application: 74377

Drug Name

MEXILETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1995-05-16

74377 / 2

Active Ingredient

MEXILETINE HYDROCHLORIDE

Application Number

74377

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1995-05-16

Regulatory Status

RX

1995
16 May
RX Application: 74377

Drug Name

MEXILETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

250MG

Approval Date

1995-05-16

74377 / 3

Active Ingredient

MEXILETINE HYDROCHLORIDE

Application Number

74377

Product Number

3

Dosage Form

-

Strength

250MG

Approval Date

1995-05-16

Regulatory Status

RX

1995
04 Jan
Discontinued Application: 74136

Drug Name

MICONAZOLE NITRATE

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1995-01-04

74136 / 1

Active Ingredient

MICONAZOLE NITRATE

Application Number

74136

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1995-01-04

Regulatory Status

Discontinued

1996
05 Apr
Discontinued Application: 74589

Drug Name

MINOXIDIL (FOR MEN)

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1996-04-05

74589 / 1

Active Ingredient

MINOXIDIL

Application Number

74589

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1996-04-05

Regulatory Status

Discontinued

2003
24 Jan
RX Application: 76119

Drug Name

MIRTAZAPINE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2003-01-24

76119 / 1

Active Ingredient

MIRTAZAPINE

Application Number

76119

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2003-01-24

Regulatory Status

RX

2003
24 Jan
RX Application: 76119

Drug Name

MIRTAZAPINE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2003-01-24

76119 / 2

Active Ingredient

MIRTAZAPINE

Application Number

76119

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2003-01-24

Regulatory Status

RX

2003
19 Jun
RX Application: 76119

Drug Name

MIRTAZAPINE

Product Number

3

Dosage Form

-

Strength

45MG

Approval Date

2003-06-19

76119 / 3

Active Ingredient

MIRTAZAPINE

Application Number

76119

Product Number

3

Dosage Form

-

Strength

45MG

Approval Date

2003-06-19

Regulatory Status

RX

2003
08 May
RX Application: 76204

Drug Name

MOEXIPRIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2003-05-08

76204 / 1

Active Ingredient

MOEXIPRIL HYDROCHLORIDE

Application Number

76204

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2003-05-08

Regulatory Status

RX

2003
08 May
RX Application: 76204

Drug Name

MOEXIPRIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2003-05-08

76204 / 2

Active Ingredient

MOEXIPRIL HYDROCHLORIDE

Application Number

76204

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2003-05-08

Regulatory Status

RX

2007
07 Mar
RX Application: 76980

Drug Name

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;7.5MG

Approval Date

2007-03-07

76980 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE

Application Number

76980

Product Number

1

Dosage Form

-

Strength

12.5MG;7.5MG

Approval Date

2007-03-07

Regulatory Status

RX

2007
07 Mar
RX Application: 76980

Drug Name

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

25MG;15MG

Approval Date

2007-03-07

76980 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE

Application Number

76980

Product Number

2

Dosage Form

-

Strength

25MG;15MG

Approval Date

2007-03-07

Regulatory Status

RX

2007
07 Mar
RX Application: 76980

Drug Name

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

12.5MG;15MG

Approval Date

2007-03-07

76980 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE

Application Number

76980

Product Number

3

Dosage Form

-

Strength

12.5MG;15MG

Approval Date

2007-03-07

Regulatory Status

RX

2003
07 Nov
RX Application: 65085

Drug Name

MUPIROCIN

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2003-11-07

65085 / 1

Active Ingredient

MUPIROCIN

Application Number

65085

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2003-11-07

Regulatory Status

RX

1985
20 Sep
Discontinued Application: 61954

Drug Name

MYCO-TRIACET II

Product Number

2

Dosage Form

-

Strength

100,000 UNITS/GM;0.1%

Approval Date

1985-09-20

61954 / 2

Active Ingredient

NYSTATIN; TRIAMCINOLONE ACETONIDE

Application Number

61954

Product Number

2

Dosage Form

-

Strength

100,000 UNITS/GM;0.1%

Approval Date

1985-09-20

Regulatory Status

Discontinued

1985
26 Nov
Discontinued Application: 62045

Drug Name

MYCO-TRIACET II

Product Number

2

Dosage Form

-

Strength

100,000 UNITS/GM;0.1%

Approval Date

1985-11-26

62045 / 2

Active Ingredient

NYSTATIN; TRIAMCINOLONE ACETONIDE

Application Number

62045

Product Number

2

Dosage Form

-

Strength

100,000 UNITS/GM;0.1%

Approval Date

1985-11-26

Regulatory Status

Discontinued

1993
21 Dec
Discontinued Application: 74129

Drug Name

NAPROXEN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1993-12-21

74129 / 1

Active Ingredient

NAPROXEN

Application Number

74129

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1993-12-21

Regulatory Status

Discontinued

1993
21 Dec
Discontinued Application: 74129

Drug Name

NAPROXEN

Product Number

2

Dosage Form

-

Strength

375MG

Approval Date

1993-12-21

74129 / 2

Active Ingredient

NAPROXEN

Application Number

74129

Product Number

2

Dosage Form

-

Strength

375MG

Approval Date

1993-12-21

Regulatory Status

Discontinued

1993
21 Dec
Discontinued Application: 74129

Drug Name

NAPROXEN

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1993-12-21

74129 / 3

Active Ingredient

NAPROXEN

Application Number

74129

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1993-12-21

Regulatory Status

Discontinued

1993
21 Dec
RX Application: 74201

Drug Name

NAPROXEN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1993-12-21

74201 / 1

Active Ingredient

NAPROXEN

Application Number

74201

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1993-12-21

Regulatory Status

RX

1993
21 Dec
RX Application: 74201

Drug Name

NAPROXEN

Product Number

2

Dosage Form

-

Strength

375MG

Approval Date

1993-12-21

74201 / 2

Active Ingredient

NAPROXEN

Application Number

74201

Product Number

2

Dosage Form

-

Strength

375MG

Approval Date

1993-12-21

Regulatory Status

RX

1993
21 Dec
RX Application: 74201

Drug Name

NAPROXEN

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1993-12-21

74201 / 3

Active Ingredient

NAPROXEN

Application Number

74201

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1993-12-21

Regulatory Status

RX

1996
11 Apr
Discontinued Application: 74216

Drug Name

NAPROXEN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1996-04-11

74216 / 1

Active Ingredient

NAPROXEN

Application Number

74216

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1996-04-11

Regulatory Status

Discontinued

1996
11 Apr
Discontinued Application: 74216

Drug Name

NAPROXEN

Product Number

2

Dosage Form

-

Strength

375MG

Approval Date

1996-04-11

74216 / 2

Active Ingredient

NAPROXEN

Application Number

74216

Product Number

2

Dosage Form

-

Strength

375MG

Approval Date

1996-04-11

Regulatory Status

Discontinued

1996
11 Apr
Discontinued Application: 74216

Drug Name

NAPROXEN

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1996-04-11

74216 / 3

Active Ingredient

NAPROXEN

Application Number

74216

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1996-04-11

Regulatory Status

Discontinued

1998
30 Jun
RX Application: 75227

Drug Name

NAPROXEN

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

1998-06-30

75227 / 1

Active Ingredient

NAPROXEN

Application Number

75227

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

1998-06-30

Regulatory Status

RX

1998
30 Jun
RX Application: 75227

Drug Name

NAPROXEN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1998-06-30

75227 / 2

Active Ingredient

NAPROXEN

Application Number

75227

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1998-06-30

Regulatory Status

RX

1993
21 Dec
Discontinued Application: 74142

Drug Name

NAPROXEN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1993-12-21

74142 / 1

Active Ingredient

NAPROXEN SODIUM

Application Number

74142

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1993-12-21

Regulatory Status

Discontinued

1993
21 Dec
Discontinued Application: 74142

Drug Name

NAPROXEN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1993-12-21

74142 / 2

Active Ingredient

NAPROXEN SODIUM

Application Number

74142

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1993-12-21

Regulatory Status

Discontinued

1993
21 Dec
Discontinued Application: 74198

Drug Name

NAPROXEN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1993-12-21

74198 / 1

Active Ingredient

NAPROXEN SODIUM

Application Number

74198

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1993-12-21

Regulatory Status

Discontinued

1993
21 Dec
Discontinued Application: 74198

Drug Name

NAPROXEN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1993-12-21

74198 / 2

Active Ingredient

NAPROXEN SODIUM

Application Number

74198

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1993-12-21

Regulatory Status

Discontinued

2003
16 Sep
RX Application: 76037

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2003-09-16

76037 / 1

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

76037

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2003-09-16

Regulatory Status

RX

2003
16 Sep
RX Application: 76037

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2003-09-16

76037 / 2

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

76037

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2003-09-16

Regulatory Status

RX

2003
16 Sep
RX Application: 76037

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2003-09-16

76037 / 3

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

76037

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2003-09-16

Regulatory Status

RX

2003
16 Sep
RX Application: 76037

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2003-09-16

76037 / 4

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

76037

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2003-09-16

Regulatory Status

RX

2003
16 Sep
RX Application: 76037

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

250MG

Approval Date

2003-09-16

76037 / 5

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

76037

Product Number

5

Dosage Form

-

Strength

250MG

Approval Date

2003-09-16

Regulatory Status

RX

1982
01 Jan
RX Application: 60304

Drug Name

NEOMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

60304 / 1

Active Ingredient

NEOMYCIN SULFATE

Application Number

60304

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 7794

Drug Name

NEOTHYLLINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

7794 / 1

Active Ingredient

DYPHYLLINE

Application Number

7794

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 7794

Drug Name

NEOTHYLLINE

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

1982-01-01

7794 / 2

Active Ingredient

DYPHYLLINE

Application Number

7794

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 7794

Drug Name

NEOTHYLLINE

Product Number

3

Dosage Form

-

Strength

160MG/15ML

Approval Date

1982-01-01

7794 / 3

Active Ingredient

DYPHYLLINE

Application Number

7794

Product Number

3

Dosage Form

-

Strength

160MG/15ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9088

Drug Name

NEOTHYLLINE

Product Number

1

Dosage Form

-

Strength

250MG/ML

Approval Date

1982-01-01

9088 / 1

Active Ingredient

DYPHYLLINE

Application Number

9088

Product Number

1

Dosage Form

-

Strength

250MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1992
19 Feb
Discontinued Application: 72651

Drug Name

NIFEDIPINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1992-02-19

72651 / 1

Active Ingredient

NIFEDIPINE

Application Number

72651

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1992-02-19

Regulatory Status

Discontinued

1996
11 Apr
Discontinued Application: 73667

Drug Name

NORTRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1996-04-11

73667 / 1

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

73667

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1996-04-11

Regulatory Status

Discontinued

1996
11 Apr
Discontinued Application: 73667

Drug Name

NORTRIPTYLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

1996-04-11

73667 / 2

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

73667

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

1996-04-11

Regulatory Status

Discontinued

1996
11 Apr
Discontinued Application: 73667

Drug Name

NORTRIPTYLINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1996-04-11

73667 / 3

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

73667

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1996-04-11

Regulatory Status

Discontinued

1996
11 Apr
Discontinued Application: 73667

Drug Name

NORTRIPTYLINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

1996-04-11

73667 / 4

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

73667

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

1996-04-11

Regulatory Status

Discontinued

1995
27 Mar
RX Application: 74132

Drug Name

NORTRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1995-03-27

74132 / 1

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

74132

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1995-03-27

Regulatory Status

RX

1995
27 Mar
RX Application: 74132

Drug Name

NORTRIPTYLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

1995-03-27

74132 / 2

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

74132

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

1995-03-27

Regulatory Status

RX

1995
27 Mar
RX Application: 74132

Drug Name

NORTRIPTYLINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1995-03-27

74132 / 3

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

74132

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1995-03-27

Regulatory Status

RX

1995
27 Mar
RX Application: 74132

Drug Name

NORTRIPTYLINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

1995-03-27

74132 / 4

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

74132

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

1995-03-27

Regulatory Status

RX

1983
23 Dec
Discontinued Application: 62502

Drug Name

NYSTATIN

Product Number

1

Dosage Form

-

Strength

100,000 UNITS

Approval Date

1983-12-23

62502 / 1

Active Ingredient

NYSTATIN

Application Number

62502

Product Number

1

Dosage Form

-

Strength

100,000 UNITS

Approval Date

1983-12-23

Regulatory Status

Discontinued

1984
16 Jan
RX Application: 62506

Drug Name

NYSTATIN

Product Number

1

Dosage Form

-

Strength

500,000 UNITS

Approval Date

1984-01-16

62506 / 1

Active Ingredient

NYSTATIN

Application Number

62506

Product Number

1

Dosage Form

-

Strength

500,000 UNITS

Approval Date

1984-01-16

Regulatory Status

RX

1987
18 Jun
Discontinued Application: 62670

Drug Name

NYSTATIN

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/ML

Approval Date

1987-06-18

62670 / 1

Active Ingredient

NYSTATIN

Application Number

62670

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/ML

Approval Date

1987-06-18

Regulatory Status

Discontinued

2003
02 Sep
RX Application: 76182

Drug Name

OFLOXACIN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2003-09-02

76182 / 1

Active Ingredient

OFLOXACIN

Application Number

76182

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2003-09-02

Regulatory Status

RX

2003
02 Sep
RX Application: 76182

Drug Name

OFLOXACIN

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2003-09-02

76182 / 2

Active Ingredient

OFLOXACIN

Application Number

76182

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2003-09-02

Regulatory Status

RX

2003
02 Sep
RX Application: 76182

Drug Name

OFLOXACIN

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2003-09-02

76182 / 3

Active Ingredient

OFLOXACIN

Application Number

76182

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2003-09-02

Regulatory Status

RX

2007
25 Jun
Discontinued Application: 76810

Drug Name

ONDANSETRON

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2007-06-25

76810 / 1

Active Ingredient

ONDANSETRON

Application Number

76810

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2007-06-25

Regulatory Status

Discontinued

2007
25 Jun
Discontinued Application: 76810

Drug Name

ONDANSETRON

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

2007-06-25

76810 / 2

Active Ingredient

ONDANSETRON

Application Number

76810

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

2007-06-25

Regulatory Status

Discontinued

2007
25 Jun
Discontinued Application: 76252

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2007-06-25

76252 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

76252

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2007-06-25

Regulatory Status

Discontinued

2007
25 Jun
Discontinued Application: 76252

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2007-06-25

76252 / 2

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

76252

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2007-06-25

Regulatory Status

Discontinued

2007
25 Jun
Discontinued Application: 76252

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 24MG BASE

Approval Date

2007-06-25

76252 / 3

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

76252

Product Number

3

Dosage Form

-

Strength

EQ 24MG BASE

Approval Date

2007-06-25

Regulatory Status

Discontinued

2006
22 Nov
Discontinued Application: 76876

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-11-22

76876 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

76876

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-11-22

Regulatory Status

Discontinued

2006
22 Nov
Discontinued Application: 76759

Drug Name

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-11-22

76759 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

76759

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-11-22

Regulatory Status

Discontinued

1984
31 Jul
Discontinued Application: 17473

Drug Name

ORAP

Product Number

1

Dosage Form

-

Strength

2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-07-31

17473 / 1

Active Ingredient

PIMOZIDE

Application Number

17473

Product Number

1

Dosage Form

-

Strength

2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-07-31

Regulatory Status

Discontinued

1997
27 Aug
Discontinued Application: 17473

Drug Name

ORAP

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1997-08-27

17473 / 3

Active Ingredient

PIMOZIDE

Application Number

17473

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1997-08-27

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62252

Drug Name

OXACILLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1982-01-01

62252 / 1

Active Ingredient

OXACILLIN SODIUM

Application Number

62252

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2002
03 Jul
Discontinued Application: 75849

Drug Name

OXAPROZIN

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2002-07-03

75849 / 1

Active Ingredient

OXAPROZIN

Application Number

75849

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2002-07-03

Regulatory Status

Discontinued

-
Unclassified Application: 76168

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

-

76168 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

76168

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 76610

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

-

76610 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

76610

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 76610

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

-

76610 / 2

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

76610

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 76610

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

-

76610 / 3

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

76610

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

-

Regulatory Status

Unclassified

2011
15 Feb
RX Application: 91443

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2011-02-15

91443 / 1

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

91443

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2011-02-15

Regulatory Status

RX

2011
15 Feb
RX Application: 91443

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2011-02-15

91443 / 2

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

91443

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2011-02-15

Regulatory Status

RX

2007
02 Aug
Discontinued Application: 77056

Drug Name

PANTOPRAZOLE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2007-08-02

77056 / 1

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

77056

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2007-08-02

Regulatory Status

Discontinued

2007
02 Aug
Discontinued Application: 77056

Drug Name

PANTOPRAZOLE SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2007-08-02

77056 / 2

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

77056

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2007-08-02

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60307

Drug Name

PENICILLIN

Product Number

2

Dosage Form

-

Strength

200,000 UNITS/5ML

Approval Date

1982-01-01

60307 / 2

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

60307

Product Number

2

Dosage Form

-

Strength

200,000 UNITS/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60307

Drug Name

PENICILLIN

Product Number

4

Dosage Form

-

Strength

400,000 UNITS/5ML

Approval Date

1982-01-01

60307 / 4

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

60307

Product Number

4

Dosage Form

-

Strength

400,000 UNITS/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60306

Drug Name

PENICILLIN G POTASSIUM

Product Number

1

Dosage Form

-

Strength

200,000 UNITS

Approval Date

1982-01-01

60306 / 1

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

60306

Product Number

1

Dosage Form

-

Strength

200,000 UNITS

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60306

Drug Name

PENICILLIN G POTASSIUM

Product Number

2

Dosage Form

-

Strength

250,000 UNITS

Approval Date

1982-01-01

60306 / 2

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

60306

Product Number

2

Dosage Form

-

Strength

250,000 UNITS

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60306

Drug Name

PENICILLIN G POTASSIUM

Product Number

3

Dosage Form

-

Strength

400,000 UNITS

Approval Date

1982-01-01

60306 / 3

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

60306

Product Number

3

Dosage Form

-

Strength

400,000 UNITS

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60306

Drug Name

PENICILLIN G POTASSIUM

Product Number

4

Dosage Form

-

Strength

500,000 UNITS

Approval Date

1982-01-01

60306 / 4

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

60306

Product Number

4

Dosage Form

-

Strength

500,000 UNITS

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60307

Drug Name

PENICILLIN-2

Product Number

3

Dosage Form

-

Strength

250,000 UNITS/5ML

Approval Date

1982-01-01

60307 / 3

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

60307

Product Number

3

Dosage Form

-

Strength

250,000 UNITS/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86911

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

86911 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

86911

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87126

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

87126 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

87126

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1985
01 Nov
Discontinued Application: 87777

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1985-11-01

87777 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

87777

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1985-11-01

Regulatory Status

Discontinued

1984
04 Apr
Discontinued Application: 88612

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1984-04-04

88612 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

88612

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1984-04-04

Regulatory Status

Discontinued

1984
09 Apr
Discontinued Application: 88613

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1984-04-09

88613 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

88613

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1984-04-09

Regulatory Status

Discontinued

1984
09 Apr
Discontinued Application: 88614

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1984-04-09

88614 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

88614

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1984-04-09

Regulatory Status

Discontinued

1994
28 Jan
Discontinued Application: 73637

Drug Name

PIROXICAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1994-01-28

73637 / 1

Active Ingredient

PIROXICAM

Application Number

73637

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1994-01-28

Regulatory Status

Discontinued

1994
28 Jan
Discontinued Application: 73638

Drug Name

PIROXICAM

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1994-01-28

73638 / 1

Active Ingredient

PIROXICAM

Application Number

73638

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1994-01-28

Regulatory Status

Discontinued

1992
11 Dec
RX Application: 74131

Drug Name

PIROXICAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1992-12-11

74131 / 1

Active Ingredient

PIROXICAM

Application Number

74131

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1992-12-11

Regulatory Status

RX

1992
11 Dec
RX Application: 74131

Drug Name

PIROXICAM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

1992-12-11

74131 / 2

Active Ingredient

PIROXICAM

Application Number

74131

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

1992-12-11

Regulatory Status

RX

1996
26 Apr
Discontinued Application: 73531

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

1996-04-26

73531 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

73531

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

1996-04-26

Regulatory Status

Discontinued

1996
26 Apr
Discontinued Application: 73532

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

10MEQ

Approval Date

1996-04-26

73532 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

73532

Product Number

1

Dosage Form

-

Strength

10MEQ

Approval Date

1996-04-26

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80398

Drug Name

PREDNISOLONE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

80398 / 1

Active Ingredient

PREDNISOLONE

Application Number

80398

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80397

Drug Name

PREDNISONE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

80397 / 1

Active Ingredient

PREDNISONE

Application Number

80397

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1986
04 Feb
RX Application: 89081

Drug Name

PRELONE

Product Number

1

Dosage Form

-

Strength

15MG/5ML

Approval Date

1986-02-04

89081 / 1

Active Ingredient

PREDNISOLONE

Application Number

89081

Product Number

1

Dosage Form

-

Strength

15MG/5ML

Approval Date

1986-02-04

Regulatory Status

RX

1985
10 Sep
Discontinued Application: 89109

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1985-09-10

89109 / 1

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

89109

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1985-09-10

Regulatory Status

Discontinued

1985
12 Jun
Discontinued Application: 70107

Drug Name

PROPACET 100

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

1985-06-12

70107 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Application Number

70107

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

1985-06-12

Regulatory Status

Discontinued

1985
29 Mar
Discontinued Application: 89025

Drug Name

PROPOXYPHENE COMPOUND 65

Product Number

1

Dosage Form

-

Strength

389MG;32.4MG;65MG

Approval Date

1985-03-29

89025 / 1

Active Ingredient

ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE

Application Number

89025

Product Number

1

Dosage Form

-

Strength

389MG;32.4MG;65MG

Approval Date

1985-03-29

Regulatory Status

Discontinued

1984
22 Oct
Discontinued Application: 88615

Drug Name

PROPOXYPHENE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

65MG

Approval Date

1984-10-22

88615 / 1

Active Ingredient

PROPOXYPHENE HYDROCHLORIDE

Application Number

88615

Product Number

1

Dosage Form

-

Strength

65MG

Approval Date

1984-10-22

Regulatory Status

Discontinued

1986
03 Jan
Discontinued Application: 70732

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

1986-01-03

70732 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Application Number

70732

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

1986-01-03

Regulatory Status

Discontinued

1994
19 Dec
Discontinued Application: 74119

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

1994-12-19

74119 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Application Number

74119

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

1994-12-19

Regulatory Status

Discontinued

1987
07 Oct
Discontinued Application: 70232

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1987-10-07

70232 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

70232

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1987-10-07

Regulatory Status

Discontinued

1986
23 Jun
Discontinued Application: 70233

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1986-06-23

70233 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

70233

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1986-06-23

Regulatory Status

Discontinued

1986
23 Jun
Discontinued Application: 70234

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1986-06-23

70234 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

70234

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1986-06-23

Regulatory Status

Discontinued

2003
31 Oct
Discontinued Application: 75557

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2003-10-31

75557 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

75557

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2003-10-31

Regulatory Status

Discontinued

2003
31 Oct
Discontinued Application: 75557

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2003-10-31

75557 / 2

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

75557

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2003-10-31

Regulatory Status

Discontinued

1985
07 Mar
Discontinued Application: 89019

Drug Name

RESERPINE

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

1985-03-07

89019 / 1

Active Ingredient

RESERPINE

Application Number

89019

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

1985-03-07

Regulatory Status

Discontinued

1985
07 Mar
Discontinued Application: 89020

Drug Name

RESERPINE

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

1985-03-07

89020 / 1

Active Ingredient

RESERPINE

Application Number

89020

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

1985-03-07

Regulatory Status

Discontinued

2004
04 Oct
Discontinued Application: 76277

Drug Name

RIBAVIRIN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2004-10-04

76277 / 1

Active Ingredient

RIBAVIRIN

Application Number

76277

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2004-10-04

Regulatory Status

Discontinued

2014
07 May
Discontinued Application: 77337

Drug Name

ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG;EQ 2MG BASE

Approval Date

2014-05-07

77337 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

Application Number

77337

Product Number

1

Dosage Form

-

Strength

500MG;EQ 2MG BASE

Approval Date

2014-05-07

Regulatory Status

Discontinued

2014
07 May
Discontinued Application: 77337

Drug Name

ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

500MG;EQ 4MG BASE

Approval Date

2014-05-07

77337 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

Application Number

77337

Product Number

2

Dosage Form

-

Strength

500MG;EQ 4MG BASE

Approval Date

2014-05-07

Regulatory Status

Discontinued

2014
07 May
Discontinued Application: 77337

Drug Name

ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

1GM;EQ 2MG BASE

Approval Date

2014-05-07

77337 / 3

Active Ingredient

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

Application Number

77337

Product Number

3

Dosage Form

-

Strength

1GM;EQ 2MG BASE

Approval Date

2014-05-07

Regulatory Status

Discontinued

2014
07 May
Discontinued Application: 77337

Drug Name

ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

1GM;EQ 4MG BASE

Approval Date

2014-05-07

77337 / 4

Active Ingredient

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

Application Number

77337

Product Number

4

Dosage Form

-

Strength

1GM;EQ 4MG BASE

Approval Date

2014-05-07

Regulatory Status

Discontinued

2017
19 May
Discontinued Application: 77337

Drug Name

ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

500MG;EQ 1MG BASE

Approval Date

2017-05-19

77337 / 5

Active Ingredient

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

Application Number

77337

Product Number

5

Dosage Form

-

Strength

500MG;EQ 1MG BASE

Approval Date

2017-05-19

Regulatory Status

Discontinued

2016
09 Mar
RX Application: 77342

Drug Name

SILDENAFIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2016-03-09

77342 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

77342

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2016-03-09

Regulatory Status

RX

2016
09 Mar
RX Application: 77342

Drug Name

SILDENAFIL CITRATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2016-03-09

77342 / 2

Active Ingredient

SILDENAFIL CITRATE

Application Number

77342

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2016-03-09

Regulatory Status

RX

2016
09 Mar
RX Application: 77342

Drug Name

SILDENAFIL CITRATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2016-03-09

77342 / 3

Active Ingredient

SILDENAFIL CITRATE

Application Number

77342

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2016-03-09

Regulatory Status

RX

2000
01 May
RX Application: 75429

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

2000-05-01

75429 / 1

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

75429

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

2000-05-01

Regulatory Status

RX

2000
01 May
RX Application: 75429

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2000-05-01

75429 / 2

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

75429

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2000-05-01

Regulatory Status

RX

2000
01 May
RX Application: 75429

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2000-05-01

75429 / 3

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

75429

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2000-05-01

Regulatory Status

RX

2000
01 May
RX Application: 75429

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

240MG

Approval Date

2000-05-01

75429 / 4

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

75429

Product Number

4

Dosage Form

-

Strength

240MG

Approval Date

2000-05-01

Regulatory Status

RX

2004
26 Jul
Discontinued Application: 76883

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

2004-07-26

76883 / 1

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

76883

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

2004-07-26

Regulatory Status

Discontinued

2004
26 Jul
Discontinued Application: 76883

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2004-07-26

76883 / 2

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

76883

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2004-07-26

Regulatory Status

Discontinued

2004
26 Jul
Discontinued Application: 76883

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2004-07-26

76883 / 3

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

76883

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2004-07-26

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85507

Drug Name

STATOBEX

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

1982-01-01

85507 / 1

Active Ingredient

PHENDIMETRAZINE TARTRATE

Application Number

85507

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86013

Drug Name

STATOBEX

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

1982-01-01

86013 / 1

Active Ingredient

PHENDIMETRAZINE TARTRATE

Application Number

86013

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85095

Drug Name

STATOBEX-G

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

1982-01-01

85095 / 1

Active Ingredient

PHENDIMETRAZINE TARTRATE

Application Number

85095

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1996
29 Mar
RX Application: 70848

Drug Name

SUCRALFATE

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

1996-03-29

70848 / 1

Active Ingredient

SUCRALFATE

Application Number

70848

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

1996-03-29

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 18242

Drug Name

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Product Number

1

Dosage Form

-

Strength

400MG;80MG

Approval Date

1982-01-01

18242 / 1

Active Ingredient

SULFAMETHOXAZOLE; TRIMETHOPRIM

Application Number

18242

Product Number

1

Dosage Form

-

Strength

400MG;80MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18242

Drug Name

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Product Number

2

Dosage Form

-

Strength

800MG;160MG

Approval Date

1982-01-01

18242 / 2

Active Ingredient

SULFAMETHOXAZOLE; TRIMETHOPRIM

Application Number

18242

Product Number

2

Dosage Form

-

Strength

800MG;160MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1983
28 Jan
Discontinued Application: 18812

Drug Name

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Product Number

1

Dosage Form

-

Strength

200MG/5ML;40MG/5ML

Approval Date

1983-01-28

18812 / 1

Active Ingredient

SULFAMETHOXAZOLE; TRIMETHOPRIM

Application Number

18812

Product Number

1

Dosage Form

-

Strength

200MG/5ML;40MG/5ML

Approval Date

1983-01-28

Regulatory Status

Discontinued

1983
10 Jun
Discontinued Application: 18812

Drug Name

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Product Number

2

Dosage Form

-

Strength

200MG/5ML;40MG/5ML

Approval Date

1983-06-10

18812 / 2

Active Ingredient

SULFAMETHOXAZOLE; TRIMETHOPRIM

Application Number

18812

Product Number

2

Dosage Form

-

Strength

200MG/5ML;40MG/5ML

Approval Date

1983-06-10

Regulatory Status

Discontinued

2009
09 Feb
Discontinued Application: 76840

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2009-02-09

76840 / 1

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

76840

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2009-02-09

Regulatory Status

Discontinued

2009
09 Feb
Discontinued Application: 76840

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2009-02-09

76840 / 2

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

76840

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2009-02-09

Regulatory Status

Discontinued

2009
09 Feb
Discontinued Application: 76840

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2009-02-09

76840 / 3

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

76840

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2009-02-09

Regulatory Status

Discontinued

2003
28 Apr
Discontinued Application: 74504

Drug Name

TAMOXIFEN CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2003-04-28

74504 / 1

Active Ingredient

TAMOXIFEN CITRATE

Application Number

74504

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2003-04-28

Regulatory Status

Discontinued

2003
28 Apr
Discontinued Application: 74504

Drug Name

TAMOXIFEN CITRATE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2003-04-28

74504 / 2

Active Ingredient

TAMOXIFEN CITRATE

Application Number

74504

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2003-04-28

Regulatory Status

Discontinued

2000
18 May
Discontinued Application: 74446

Drug Name

TERAZOSIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2000-05-18

74446 / 1

Active Ingredient

TERAZOSIN HYDROCHLORIDE

Application Number

74446

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2000-05-18

Regulatory Status

Discontinued

2000
18 May
Discontinued Application: 74446

Drug Name

TERAZOSIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2000-05-18

74446 / 2

Active Ingredient

TERAZOSIN HYDROCHLORIDE

Application Number

74446

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2000-05-18

Regulatory Status

Discontinued

2000
18 May
Discontinued Application: 74446

Drug Name

TERAZOSIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2000-05-18

74446 / 3

Active Ingredient

TERAZOSIN HYDROCHLORIDE

Application Number

74446

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2000-05-18

Regulatory Status

Discontinued

2000
18 May
Discontinued Application: 74446

Drug Name

TERAZOSIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2000-05-18

74446 / 4

Active Ingredient

TERAZOSIN HYDROCHLORIDE

Application Number

74446

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2000-05-18

Regulatory Status

Discontinued

1987
22 Jun
Discontinued Application: 71184

Drug Name

THIOTHIXENE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1987-06-22

71184 / 1

Active Ingredient

THIOTHIXENE HYDROCHLORIDE

Application Number

71184

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1987-06-22

Regulatory Status

Discontinued

1999
20 Aug
Discontinued Application: 75149

Drug Name

TICLOPIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1999-08-20

75149 / 1

Active Ingredient

TICLOPIDINE HYDROCHLORIDE

Application Number

75149

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1999-08-20

Regulatory Status

Discontinued

1993
16 Jun
Discontinued Application: 72648

Drug Name

TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1993-06-16

72648 / 1

Active Ingredient

TIMOLOL MALEATE

Application Number

72648

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1993-06-16

Regulatory Status

Discontinued

1993
16 Jun
Discontinued Application: 72649

Drug Name

TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1993-06-16

72649 / 1

Active Ingredient

TIMOLOL MALEATE

Application Number

72649

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1993-06-16

Regulatory Status

Discontinued

1993
16 Jun
Discontinued Application: 72650

Drug Name

TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1993-06-16

72650 / 1

Active Ingredient

TIMOLOL MALEATE

Application Number

72650

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1993-06-16

Regulatory Status

Discontinued

2009
27 Mar
Discontinued Application: 76317

Drug Name

TOPIRAMATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-03-27

76317 / 1

Active Ingredient

TOPIRAMATE

Application Number

76317

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-03-27

Regulatory Status

Discontinued

2009
27 Mar
Discontinued Application: 76317

Drug Name

TOPIRAMATE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2009-03-27

76317 / 2

Active Ingredient

TOPIRAMATE

Application Number

76317

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2009-03-27

Regulatory Status

Discontinued

2009
27 Mar
Discontinued Application: 76317

Drug Name

TOPIRAMATE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2009-03-27

76317 / 3

Active Ingredient

TOPIRAMATE

Application Number

76317

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2009-03-27

Regulatory Status

Discontinued

2009
27 Mar
Discontinued Application: 76317

Drug Name

TOPIRAMATE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2009-03-27

76317 / 4

Active Ingredient

TOPIRAMATE

Application Number

76317

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2009-03-27

Regulatory Status

Discontinued

2009
17 Apr
Discontinued Application: 76575

Drug Name

TOPIRAMATE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2009-04-17

76575 / 1

Active Ingredient

TOPIRAMATE

Application Number

76575

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2009-04-17

Regulatory Status

Discontinued

2009
17 Apr
Discontinued Application: 76575

Drug Name

TOPIRAMATE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2009-04-17

76575 / 2

Active Ingredient

TOPIRAMATE

Application Number

76575

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2009-04-17

Regulatory Status

Discontinued

2002
14 May
Discontinued Application: 76110

Drug Name

TORSEMIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2002-05-14

76110 / 1

Active Ingredient

TORSEMIDE

Application Number

76110

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2002-05-14

Regulatory Status

Discontinued

2002
14 May
Discontinued Application: 76110

Drug Name

TORSEMIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2002-05-14

76110 / 2

Active Ingredient

TORSEMIDE

Application Number

76110

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2002-05-14

Regulatory Status

Discontinued

2002
14 May
Discontinued Application: 76110

Drug Name

TORSEMIDE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2002-05-14

76110 / 3

Active Ingredient

TORSEMIDE

Application Number

76110

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2002-05-14

Regulatory Status

Discontinued

2002
14 May
Discontinued Application: 76110

Drug Name

TORSEMIDE

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2002-05-14

76110 / 4

Active Ingredient

TORSEMIDE

Application Number

76110

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2002-05-14

Regulatory Status

Discontinued

2002
19 Jun
RX Application: 75977

Drug Name

TRAMADOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2002-06-19

75977 / 1

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

75977

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2002-06-19

Regulatory Status

RX

1997
30 Apr
Discontinued Application: 74357

Drug Name

TRAZODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

1997-04-30

74357 / 1

Active Ingredient

TRAZODONE HYDROCHLORIDE

Application Number

74357

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

1997-04-30

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84908

Drug Name

TRIACET

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

1982-01-01

84908 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

84908

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84908

Drug Name

TRIACET

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

84908 / 2

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

84908

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84908

Drug Name

TRIACET

Product Number

3

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

84908 / 3

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

84908

Product Number

3

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84775

Drug Name

TRIAMCINOLONE

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

84775 / 1

Active Ingredient

TRIAMCINOLONE

Application Number

84775

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1987
18 Jun
Discontinued Application: 71259

Drug Name

TRIMETHOPRIM

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1987-06-18

71259 / 1

Active Ingredient

TRIMETHOPRIM

Application Number

71259

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1987-06-18

Regulatory Status

Discontinued

1984
17 May
Discontinued Application: 88630

Drug Name

TRIPHED

Product Number

1

Dosage Form

-

Strength

60MG;2.5MG

Approval Date

1984-05-17

88630 / 1

Active Ingredient

PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

Application Number

88630

Product Number

1

Dosage Form

-

Strength

60MG;2.5MG

Approval Date

1984-05-17

Regulatory Status

Discontinued

2023
28 Apr
RX Application: 213586

Drug Name

UZEDY

Product Number

1

Dosage Form

-

Strength

50MG/0.14ML (50MG/0.14ML)

Approval Date

2023-04-28

213586 / 1

Active Ingredient

RISPERIDONE

Application Number

213586

Product Number

1

Dosage Form

-

Strength

50MG/0.14ML (50MG/0.14ML)

Approval Date

2023-04-28

Regulatory Status

RX

2023
28 Apr
RX Application: 213586

Drug Name

UZEDY

Product Number

2

Dosage Form

-

Strength

75MG/0.21ML (75MG/0.21ML)

Approval Date

2023-04-28

213586 / 2

Active Ingredient

RISPERIDONE

Application Number

213586

Product Number

2

Dosage Form

-

Strength

75MG/0.21ML (75MG/0.21ML)

Approval Date

2023-04-28

Regulatory Status

RX

2023
28 Apr
RX Application: 213586

Drug Name

UZEDY

Product Number

3

Dosage Form

-

Strength

100MG/0.28ML (100MG/0.28ML)

Approval Date

2023-04-28

213586 / 3

Active Ingredient

RISPERIDONE

Application Number

213586

Product Number

3

Dosage Form

-

Strength

100MG/0.28ML (100MG/0.28ML)

Approval Date

2023-04-28

Regulatory Status

RX

2023
28 Apr
RX Application: 213586

Drug Name

UZEDY

Product Number

4

Dosage Form

-

Strength

125MG/0.35ML (125MG/0.35ML)

Approval Date

2023-04-28

213586 / 4

Active Ingredient

RISPERIDONE

Application Number

213586

Product Number

4

Dosage Form

-

Strength

125MG/0.35ML (125MG/0.35ML)

Approval Date

2023-04-28

Regulatory Status

RX

2023
28 Apr
RX Application: 213586

Drug Name

UZEDY

Product Number

5

Dosage Form

-

Strength

150MG/0.42ML (150MG/0.42ML)

Approval Date

2023-04-28

213586 / 5

Active Ingredient

RISPERIDONE

Application Number

213586

Product Number

5

Dosage Form

-

Strength

150MG/0.42ML (150MG/0.42ML)

Approval Date

2023-04-28

Regulatory Status

RX

2023
28 Apr
RX Application: 213586

Drug Name

UZEDY

Product Number

6

Dosage Form

-

Strength

200MG/0.56ML (200MG/0.56ML)

Approval Date

2023-04-28

213586 / 6

Active Ingredient

RISPERIDONE

Application Number

213586

Product Number

6

Dosage Form

-

Strength

200MG/0.56ML (200MG/0.56ML)

Approval Date

2023-04-28

Regulatory Status

RX

2023
28 Apr
RX Application: 213586

Drug Name

UZEDY

Product Number

7

Dosage Form

-

Strength

250MG/0.7ML (250MG/0.7ML)

Approval Date

2023-04-28

213586 / 7

Active Ingredient

RISPERIDONE

Application Number

213586

Product Number

7

Dosage Form

-

Strength

250MG/0.7ML (250MG/0.7ML)

Approval Date

2023-04-28

Regulatory Status

RX

2010
28 Jun
RX Application: 76565

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2010-06-28

76565 / 1

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

76565

Product Number

1

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2010-06-28

Regulatory Status

RX

2010
28 Jun
RX Application: 76565

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2010-06-28

76565 / 2

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

76565

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2010-06-28

Regulatory Status

RX

2010
28 Jun
RX Application: 76565

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2010-06-28

76565 / 3

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

76565

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2010-06-28

Regulatory Status

RX

2006
03 Aug
RX Application: 76690

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2006-08-03

76690 / 1

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

76690

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2006-08-03

Regulatory Status

RX

2006
03 Aug
RX Application: 76690

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2006-08-03

76690 / 2

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

76690

Product Number

2

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2006-08-03

Regulatory Status

RX

2006
03 Aug
RX Application: 76690

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2006-08-03

76690 / 3

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

76690

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2006-08-03

Regulatory Status

RX

2006
03 Aug
RX Application: 76690

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2006-08-03

76690 / 4

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

76690

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2006-08-03

Regulatory Status

RX

2006
03 Aug
RX Application: 76690

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2006-08-03

76690 / 5

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

76690

Product Number

5

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2006-08-03

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 80921

Drug Name

VITAMIN A SOLUBILIZED

Product Number

1

Dosage Form

-

Strength

EQ 50,000 UNITS BASE

Approval Date

1982-01-01

80921 / 1

Active Ingredient

VITAMIN A PALMITATE

Application Number

80921

Product Number

1

Dosage Form

-

Strength

EQ 50,000 UNITS BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

2007
23 Apr
Discontinued Application: 76410

Drug Name

ZOLPIDEM TARTRATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-04-23

76410 / 1

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

76410

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-04-23

Regulatory Status

Discontinued

2007
23 Apr
Discontinued Application: 76410

Drug Name

ZOLPIDEM TARTRATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-04-23

76410 / 2

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

76410

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-04-23

Regulatory Status

Discontinued

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Drug Status Breakdown
555 total
  • Discontinued
  • RX
  • Unclassified
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

ACETAMINOPHEN AND CODEINE PHOSPHATE

Application Number

88324

Product Number

1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Dosage Form

-

Strength

300MG;30MG

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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