Sandoz B2B Discontinued
FDA Approved Drugs

Sandoz B2B Discontinued

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
  • Total Records 316
  • Latest Approval Date Sep 26, 2022
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
751
View
Unclassified
50
View
Discontinued
316
View
OTC
2
View
RX
383
View
Company Overview

Company

Sandoz B2B Discontinued

Country

Switzerland

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Company Snapshot

Sandoz B2B Discontinued

Forum 1, Novartis Campus, CH-4056 Basel

Switzerland

www.sandoz.com/ sandoz.b2b@sandoz.com View on Map
FDA Approved Drug Records ( 316 records )
1982
01 Jan
Discontinued Application: 85291

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

2

Dosage Form

-

Strength

300MG;30MG

Approval Date

1982-01-01

85291 / 2

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

85291

Product Number

2

Dosage Form

-

Strength

300MG;30MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85917

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

1982-01-01

85917 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

85917

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85964

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

1982-01-01

85964 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

85964

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87423

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

1982-01-01

87423 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

87423

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87433

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;15MG

Approval Date

1982-01-01

87433 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

87433

Product Number

1

Dosage Form

-

Strength

300MG;15MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85153

Drug Name

ALKERGOT

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

1982-01-01

85153 / 1

Active Ingredient

ERGOLOID MESYLATES

Application Number

85153

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87417

Drug Name

ALKERGOT

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

87417 / 1

Active Ingredient

ERGOLOID MESYLATES

Application Number

87417

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1985
31 Dec
Discontinued Application: 70269

Drug Name

ALLOPURINOL

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1985-12-31

70269 / 1

Active Ingredient

ALLOPURINOL

Application Number

70269

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1985-12-31

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85034

Drug Name

ALPHAZINE

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

1982-01-01

85034 / 1

Active Ingredient

PHENDIMETRAZINE TARTRATE

Application Number

85034

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2006
25 Jul
Discontinued Application: 65310

Drug Name

AMPICILLIN AND SULBACTAM

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL

Approval Date

2006-07-25

65310 / 1

Active Ingredient

AMPICILLIN SODIUM; SULBACTAM SODIUM

Application Number

65310

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL

Approval Date

2006-07-25

Regulatory Status

Discontinued

2006
25 Jul
Discontinued Application: 65310

Drug Name

AMPICILLIN AND SULBACTAM

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL

Approval Date

2006-07-25

65310 / 2

Active Ingredient

AMPICILLIN SODIUM; SULBACTAM SODIUM

Application Number

65310

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL

Approval Date

2006-07-25

Regulatory Status

Discontinued

1987
19 Feb
Discontinued Application: 62738

Drug Name

AMPICILLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1987-02-19

62738 / 1

Active Ingredient

AMPICILLIN SODIUM

Application Number

62738

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1987-02-19

Regulatory Status

Discontinued

1987
19 Feb
Discontinued Application: 62738

Drug Name

AMPICILLIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1987-02-19

62738 / 2

Active Ingredient

AMPICILLIN SODIUM

Application Number

62738

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1987-02-19

Regulatory Status

Discontinued

1995
29 Aug
Discontinued Application: 64082

Drug Name

AMPICILLIN TRIHYDRATE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1995-08-29

64082 / 1

Active Ingredient

AMPICILLIN/AMPICILLIN TRIHYDRATE

Application Number

64082

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1995-08-29

Regulatory Status

Discontinued

2010
28 Jun
Discontinued Application: 79007

Drug Name

ANASTROZOLE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2010-06-28

79007 / 1

Active Ingredient

ANASTROZOLE

Application Number

79007

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2010-06-28

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 8453

Drug Name

ANECTINE

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

1982-01-01

Active Ingredient

SUCCINYLCHOLINE CHLORIDE

Application Number

8453

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 8453

Drug Name

ANECTINE

Product Number

3

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

Active Ingredient

SUCCINYLCHOLINE CHLORIDE

Application Number

8453

Product Number

3

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 8453

Drug Name

ANECTINE

Product Number

4

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1982-01-01

Active Ingredient

SUCCINYLCHOLINE CHLORIDE

Application Number

8453

Product Number

4

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

2000
30 Jun
Discontinued Application: 20883

Drug Name

ARGATROBAN

Product Number

1

Dosage Form

-

Strength

250MG/2.5ML (100MG/ML)

Approval Date

2000-06-30

20883 / 1

Active Ingredient

ARGATROBAN

Application Number

20883

Product Number

1

Dosage Form

-

Strength

250MG/2.5ML (100MG/ML)

Approval Date

2000-06-30

Regulatory Status

Discontinued

2011
09 May
Discontinued Application: 201743

Drug Name

ARGATROBAN IN DEXTROSE

Product Number

1

Dosage Form

-

Strength

125MG/125ML (1MG/ML)

Approval Date

2011-05-09

201743 / 1

Active Ingredient

ARGATROBAN

Application Number

201743

Product Number

1

Dosage Form

-

Strength

125MG/125ML (1MG/ML)

Approval Date

2011-05-09

Regulatory Status

Discontinued

2006
18 Sep
Discontinued Application: 65297

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/5ML

Approval Date

2006-09-18

65297 / 1

Active Ingredient

AZITHROMYCIN

Application Number

65297

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/5ML

Approval Date

2006-09-18

Regulatory Status

Discontinued

2006
18 Sep
Discontinued Application: 65297

Drug Name

AZITHROMYCIN

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE/5ML

Approval Date

2006-09-18

65297 / 2

Active Ingredient

AZITHROMYCIN

Application Number

65297

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE/5ML

Approval Date

2006-09-18

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84353

Drug Name

BETHANECHOL CHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

84353 / 1

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

84353

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84378

Drug Name

BETHANECHOL CHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

84378 / 1

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

84378

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84379

Drug Name

BETHANECHOL CHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

84379 / 1

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

84379

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84383

Drug Name

BETHANECHOL CHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

84383 / 1

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

84383

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84384

Drug Name

BETHANECHOL CHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

84384 / 1

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

84384

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2022
26 Sep
Discontinued Application: 213570

Drug Name

BREXPIPRAZOLE

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2022-09-26

213570 / 1

Active Ingredient

BREXPIPRAZOLE

Application Number

213570

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2022-09-26

Regulatory Status

Discontinued

2022
26 Sep
Discontinued Application: 213570

Drug Name

BREXPIPRAZOLE

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2022-09-26

213570 / 2

Active Ingredient

BREXPIPRAZOLE

Application Number

213570

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2022-09-26

Regulatory Status

Discontinued

2022
26 Sep
Discontinued Application: 213570

Drug Name

BREXPIPRAZOLE

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2022-09-26

213570 / 3

Active Ingredient

BREXPIPRAZOLE

Application Number

213570

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2022-09-26

Regulatory Status

Discontinued

2022
26 Sep
Discontinued Application: 213570

Drug Name

BREXPIPRAZOLE

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2022-09-26

213570 / 4

Active Ingredient

BREXPIPRAZOLE

Application Number

213570

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2022-09-26

Regulatory Status

Discontinued

2022
26 Sep
Discontinued Application: 213570

Drug Name

BREXPIPRAZOLE

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2022-09-26

213570 / 5

Active Ingredient

BREXPIPRAZOLE

Application Number

213570

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2022-09-26

Regulatory Status

Discontinued

2022
26 Sep
Discontinued Application: 213570

Drug Name

BREXPIPRAZOLE

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2022-09-26

213570 / 6

Active Ingredient

BREXPIPRAZOLE

Application Number

213570

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2022-09-26

Regulatory Status

Discontinued

2013
27 Sep
Discontinued Application: 201966

Drug Name

BUDESONIDE

Product Number

1

Dosage Form

-

Strength

1MG/2ML

Approval Date

2013-09-27

201966 / 1

Active Ingredient

BUDESONIDE

Application Number

201966

Product Number

1

Dosage Form

-

Strength

1MG/2ML

Approval Date

2013-09-27

Regulatory Status

Discontinued

2013
27 Sep
Discontinued Application: 201966

Drug Name

BUDESONIDE

Product Number

2

Dosage Form

-

Strength

0.5MG/2ML

Approval Date

2013-09-27

201966 / 2

Active Ingredient

BUDESONIDE

Application Number

201966

Product Number

2

Dosage Form

-

Strength

0.5MG/2ML

Approval Date

2013-09-27

Regulatory Status

Discontinued

2013
27 Sep
Discontinued Application: 201966

Drug Name

BUDESONIDE

Product Number

3

Dosage Form

-

Strength

0.25MG/2ML

Approval Date

2013-09-27

201966 / 3

Active Ingredient

BUDESONIDE

Application Number

201966

Product Number

3

Dosage Form

-

Strength

0.25MG/2ML

Approval Date

2013-09-27

Regulatory Status

Discontinued

2005
14 Jul
Discontinued Application: 76845

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2005-07-14

76845 / 1

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

76845

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2005-07-14

Regulatory Status

Discontinued

2005
14 Jul
Discontinued Application: 76845

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2005-07-14

76845 / 2

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

76845

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2005-07-14

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84272

Drug Name

BUTABARBITAL SODIUM

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

84272 / 2

Active Ingredient

BUTABARBITAL SODIUM

Application Number

84272

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
09 Feb
Discontinued Application: 84292

Drug Name

BUTABARBITAL SODIUM

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

1982-02-09

84292 / 3

Active Ingredient

BUTABARBITAL SODIUM

Application Number

84292

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

1982-02-09

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85934

Drug Name

BUTABARBITAL SODIUM

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

85934 / 1

Active Ingredient

BUTABARBITAL SODIUM

Application Number

85934

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85938

Drug Name

BUTABARBITAL SODIUM

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

85938 / 1

Active Ingredient

BUTABARBITAL SODIUM

Application Number

85938

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1996
13 Feb
Discontinued Application: 74481

Drug Name

CAPTOPRIL

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

1996-02-13

74481 / 1

Active Ingredient

CAPTOPRIL

Application Number

74481

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

1996-02-13

Regulatory Status

Discontinued

1996
13 Feb
Discontinued Application: 74481

Drug Name

CAPTOPRIL

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1996-02-13

74481 / 2

Active Ingredient

CAPTOPRIL

Application Number

74481

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1996-02-13

Regulatory Status

Discontinued

1996
13 Feb
Discontinued Application: 74481

Drug Name

CAPTOPRIL

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1996-02-13

74481 / 3

Active Ingredient

CAPTOPRIL

Application Number

74481

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1996-02-13

Regulatory Status

Discontinued

1996
13 Feb
Discontinued Application: 74481

Drug Name

CAPTOPRIL

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

1996-02-13

74481 / 4

Active Ingredient

CAPTOPRIL

Application Number

74481

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

1996-02-13

Regulatory Status

Discontinued

2005
18 Mar
Discontinued Application: 76959

Drug Name

CARBOPLATIN

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2005-03-18

76959 / 1

Active Ingredient

CARBOPLATIN

Application Number

76959

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2005-03-18

Regulatory Status

Discontinued

2005
18 Mar
Discontinued Application: 76959

Drug Name

CARBOPLATIN

Product Number

2

Dosage Form

-

Strength

150MG/VIAL

Approval Date

2005-03-18

76959 / 2

Active Ingredient

CARBOPLATIN

Application Number

76959

Product Number

2

Dosage Form

-

Strength

150MG/VIAL

Approval Date

2005-03-18

Regulatory Status

Discontinued

2005
18 Mar
Discontinued Application: 76959

Drug Name

CARBOPLATIN

Product Number

3

Dosage Form

-

Strength

450MG/VIAL

Approval Date

2005-03-18

76959 / 3

Active Ingredient

CARBOPLATIN

Application Number

76959

Product Number

3

Dosage Form

-

Strength

450MG/VIAL

Approval Date

2005-03-18

Regulatory Status

Discontinued

1988
30 Aug
Discontinued Application: 89566

Drug Name

CARISOPRODOL

Product Number

1

Dosage Form

-

Strength

350MG

Approval Date

1988-08-30

89566 / 1

Active Ingredient

CARISOPRODOL

Application Number

89566

Product Number

1

Dosage Form

-

Strength

350MG

Approval Date

1988-08-30

Regulatory Status

Discontinued

1996
16 Apr
Discontinued Application: 40118

Drug Name

CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

325MG;200MG;16MG

Approval Date

1996-04-16

40118 / 1

Active Ingredient

ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE

Application Number

40118

Product Number

1

Dosage Form

-

Strength

325MG;200MG;16MG

Approval Date

1996-04-16

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62291

Drug Name

CEFADROXIL

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

62291 / 1

Active Ingredient

CEFADROXIL/CEFADROXIL HEMIHYDRATE

Application Number

62291

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

2007
09 May
Discontinued Application: 65345

Drug Name

CEFAZOLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2007-05-09

65345 / 1

Active Ingredient

CEFAZOLIN SODIUM

Application Number

65345

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2007-05-09

Regulatory Status

Discontinued

2005
08 Dec
Discontinued Application: 65257

Drug Name

CEFPROZIL

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

2005-12-08

65257 / 1

Active Ingredient

CEFPROZIL

Application Number

65257

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

2005-12-08

Regulatory Status

Discontinued

2005
08 Dec
Discontinued Application: 65257

Drug Name

CEFPROZIL

Product Number

2

Dosage Form

-

Strength

250MG/5ML

Approval Date

2005-12-08

65257 / 2

Active Ingredient

CEFPROZIL

Application Number

65257

Product Number

2

Dosage Form

-

Strength

250MG/5ML

Approval Date

2005-12-08

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85485

Drug Name

CHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

85485 / 1

Active Ingredient

CHLOROTHIAZIDE

Application Number

85485

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84669

Drug Name

CHLORPROPAMIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

84669 / 1

Active Ingredient

CHLORPROPAMIDE

Application Number

84669

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87118

Drug Name

CHLORTHALIDONE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

87118 / 1

Active Ingredient

CHLORTHALIDONE

Application Number

87118

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1995
29 Jun
Discontinued Application: 74250

Drug Name

CIMETIDINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1995-06-29

74250 / 1

Active Ingredient

CIMETIDINE

Application Number

74250

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1995-06-29

Regulatory Status

Discontinued

1995
29 Jun
Discontinued Application: 74250

Drug Name

CIMETIDINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1995-06-29

74250 / 2

Active Ingredient

CIMETIDINE

Application Number

74250

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1995-06-29

Regulatory Status

Discontinued

1995
29 Jun
Discontinued Application: 74250

Drug Name

CIMETIDINE

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

1995-06-29

74250 / 3

Active Ingredient

CIMETIDINE

Application Number

74250

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

1995-06-29

Regulatory Status

Discontinued

1995
29 Jun
Discontinued Application: 74250

Drug Name

CIMETIDINE

Product Number

4

Dosage Form

-

Strength

800MG

Approval Date

1995-06-29

74250 / 4

Active Ingredient

CIMETIDINE

Application Number

74250

Product Number

4

Dosage Form

-

Strength

800MG

Approval Date

1995-06-29

Regulatory Status

Discontinued

1998
19 Jun
Discontinued Application: 75122

Drug Name

CIMETIDINE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1998-06-19

75122 / 1

Active Ingredient

CIMETIDINE

Application Number

75122

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1998-06-19

Regulatory Status

Discontinued

1998
19 Jun
Discontinued Application: 75122

Drug Name

CIMETIDINE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1998-06-19

75122 / 2

Active Ingredient

CIMETIDINE

Application Number

75122

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1998-06-19

Regulatory Status

Discontinued

1988
02 May
Discontinued Application: 72191

Drug Name

CLOFIBRATE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1988-05-02

72191 / 1

Active Ingredient

CLOFIBRATE

Application Number

72191

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1988-05-02

Regulatory Status

Discontinued

1996
30 Aug
Discontinued Application: 74546

Drug Name

CLOZAPINE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1996-08-30

74546 / 1

Active Ingredient

CLOZAPINE

Application Number

74546

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1996-08-30

Regulatory Status

Discontinued

1996
30 Aug
Discontinued Application: 74546

Drug Name

CLOZAPINE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1996-08-30

74546 / 2

Active Ingredient

CLOZAPINE

Application Number

74546

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1996-08-30

Regulatory Status

Discontinued

2008
21 Feb
Discontinued Application: 22028

Drug Name

COSYNTROPIN

Product Number

1

Dosage Form

-

Strength

0.25MG/ML (0.25MG/ML)

Approval Date

2008-02-21

22028 / 1

Active Ingredient

COSYNTROPIN

Application Number

22028

Product Number

1

Dosage Form

-

Strength

0.25MG/ML (0.25MG/ML)

Approval Date

2008-02-21

Regulatory Status

Discontinued

1993
26 Feb
Discontinued Application: 73683

Drug Name

CYCLOBENZAPRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1993-02-26

73683 / 1

Active Ingredient

CYCLOBENZAPRINE HYDROCHLORIDE

Application Number

73683

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1993-02-26

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85371

Drug Name

DEXTROAMPHETAMINE SULFATE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

85371 / 1

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

85371

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2013
09 May
Discontinued Application: 200158

Drug Name

DICLOFENAC SODIUM AND MISOPROSTOL

Product Number

1

Dosage Form

-

Strength

50MG;0.2MG

Approval Date

2013-05-09

200158 / 1

Active Ingredient

DICLOFENAC SODIUM; MISOPROSTOL

Application Number

200158

Product Number

1

Dosage Form

-

Strength

50MG;0.2MG

Approval Date

2013-05-09

Regulatory Status

Discontinued

2013
09 May
Discontinued Application: 200158

Drug Name

DICLOFENAC SODIUM AND MISOPROSTOL

Product Number

2

Dosage Form

-

Strength

75MG;0.2MG

Approval Date

2013-05-09

200158 / 2

Active Ingredient

DICLOFENAC SODIUM; MISOPROSTOL

Application Number

200158

Product Number

2

Dosage Form

-

Strength

75MG;0.2MG

Approval Date

2013-05-09

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85916

Drug Name

DIETHYLPROPION HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

85916 / 1

Active Ingredient

DIETHYLPROPION HYDROCHLORIDE

Application Number

85916

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1991
30 Sep
Discontinued Application: 70770

Drug Name

DISOBROM

Product Number

1

Dosage Form

-

Strength

6MG;120MG

Approval Date

1991-09-30

70770 / 1

Active Ingredient

DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

Application Number

70770

Product Number

1

Dosage Form

-

Strength

6MG;120MG

Approval Date

1991-09-30

Regulatory Status

Discontinued

1986
15 May
Discontinued Application: 70825

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

1986-05-15

70825 / 1

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

70825

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

1986-05-15

Regulatory Status

Discontinued

1986
15 May
Discontinued Application: 70827

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

1986-05-15

70827 / 1

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

70827

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

1986-05-15

Regulatory Status

Discontinued

1986
15 May
Discontinued Application: 70828

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1986-05-15

70828 / 1

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

70828

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1986-05-15

Regulatory Status

Discontinued

1987
02 Mar
Discontinued Application: 71487

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1987-03-02

71487 / 1

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

71487

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1987-03-02

Regulatory Status

Discontinued

1987
02 Mar
Discontinued Application: 71562

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1987-03-02

71562 / 1

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

71562

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1987-03-02

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84617

Drug Name

DRALSERP

Product Number

1

Dosage Form

-

Strength

25MG;0.1MG

Approval Date

1982-01-01

84617 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE; RESERPINE

Application Number

84617

Product Number

1

Dosage Form

-

Strength

25MG;0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2009
22 Dec
Discontinued Application: 65339

Drug Name

EPIRUBICIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/25ML (2MG/ML)

Approval Date

2009-12-22

65339 / 1

Active Ingredient

EPIRUBICIN HYDROCHLORIDE

Application Number

65339

Product Number

1

Dosage Form

-

Strength

50MG/25ML (2MG/ML)

Approval Date

2009-12-22

Regulatory Status

Discontinued

2009
22 Dec
Discontinued Application: 65339

Drug Name

EPIRUBICIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2009-12-22

65339 / 2

Active Ingredient

EPIRUBICIN HYDROCHLORIDE

Application Number

65339

Product Number

2

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2009-12-22

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85302

Drug Name

ESTERIFIED ESTROGENS

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

1982-01-01

85302 / 1

Active Ingredient

ESTROGENS, ESTERIFIED

Application Number

85302

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1997
30 Sep
Discontinued Application: 74942

Drug Name

ETODOLAC

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1997-09-30

74942 / 1

Active Ingredient

ETODOLAC

Application Number

74942

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1997-09-30

Regulatory Status

Discontinued

1997
30 Sep
Discontinued Application: 74942

Drug Name

ETODOLAC

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1997-09-30

74942 / 2

Active Ingredient

ETODOLAC

Application Number

74942

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1997-09-30

Regulatory Status

Discontinued

2001
10 May
Discontinued Application: 75607

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2001-05-10

75607 / 1

Active Ingredient

FAMOTIDINE

Application Number

75607

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2001-05-10

Regulatory Status

Discontinued

2001
10 May
Discontinued Application: 75607

Drug Name

FAMOTIDINE

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2001-05-10

75607 / 2

Active Ingredient

FAMOTIDINE

Application Number

75607

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2001-05-10

Regulatory Status

Discontinued

2001
16 Apr
Discontinued Application: 75793

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2001-04-16

75793 / 1

Active Ingredient

FAMOTIDINE

Application Number

75793

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2001-04-16

Regulatory Status

Discontinued

2001
16 Apr
Discontinued Application: 75793

Drug Name

FAMOTIDINE

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2001-04-16

75793 / 2

Active Ingredient

FAMOTIDINE

Application Number

75793

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2001-04-16

Regulatory Status

Discontinued

2002
21 Oct
Discontinued Application: 76101

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2002-10-21

76101 / 1

Active Ingredient

FAMOTIDINE

Application Number

76101

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2002-10-21

Regulatory Status

Discontinued

2005
15 Feb
Discontinued Application: 77155

Drug Name

FENOLDOPAM MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2005-02-15

77155 / 1

Active Ingredient

FENOLDOPAM MESYLATE

Application Number

77155

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2005-02-15

Regulatory Status

Discontinued

2008
11 Aug
Discontinued Application: 40772

Drug Name

FLUOROURACIL

Product Number

1

Dosage Form

-

Strength

500MG/10ML (50MG/ML)

Approval Date

2008-08-11

40772 / 1

Active Ingredient

FLUOROURACIL

Application Number

40772

Product Number

1

Dosage Form

-

Strength

500MG/10ML (50MG/ML)

Approval Date

2008-08-11

Regulatory Status

Discontinued

2011
02 May
Discontinued Application: 91299

Drug Name

FLUOROURACIL

Product Number

1

Dosage Form

-

Strength

2.5GM/50ML (50MG/ML)

Approval Date

2011-05-02

91299 / 1

Active Ingredient

FLUOROURACIL

Application Number

91299

Product Number

1

Dosage Form

-

Strength

2.5GM/50ML (50MG/ML)

Approval Date

2011-05-02

Regulatory Status

Discontinued

2011
02 May
Discontinued Application: 91299

Drug Name

FLUOROURACIL

Product Number

2

Dosage Form

-

Strength

5GM/100ML (50MG/ML)

Approval Date

2011-05-02

91299 / 2

Active Ingredient

FLUOROURACIL

Application Number

91299

Product Number

2

Dosage Form

-

Strength

5GM/100ML (50MG/ML)

Approval Date

2011-05-02

Regulatory Status

Discontinued

2008
17 Nov
Discontinued Application: 77469

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2008-11-17

77469 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

77469

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2008-11-17

Regulatory Status

Discontinued

2008
17 Nov
Discontinued Application: 77469

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2008-11-17

77469 / 2

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

77469

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2008-11-17

Regulatory Status

Discontinued

1987
16 Oct
Discontinued Application: 89586

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1987-10-16

89586 / 1

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

89586

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1987-10-16

Regulatory Status

Discontinued

1987
16 Oct
Discontinued Application: 89586

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

1987-10-16

89586 / 2

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

89586

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

1987-10-16

Regulatory Status

Discontinued

1987
16 Oct
Discontinued Application: 89586

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

2.5MG

Approval Date

1987-10-16

89586 / 3

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

89586

Product Number

3

Dosage Form

-

Strength

2.5MG

Approval Date

1987-10-16

Regulatory Status

Discontinued

1987
16 Oct
Discontinued Application: 89586

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

5MG

Approval Date

1987-10-16

89586 / 4

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

89586

Product Number

4

Dosage Form

-

Strength

5MG

Approval Date

1987-10-16

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84472

Drug Name

FOLIC ACID

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

84472 / 1

Active Ingredient

FOLIC ACID

Application Number

84472

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2006
24 Jan
Discontinued Application: 75428

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2006-01-24

75428 / 1

Active Ingredient

GABAPENTIN

Application Number

75428

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2006-01-24

Regulatory Status

Discontinued

2006
24 Jan
Discontinued Application: 75428

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2006-01-24

75428 / 2

Active Ingredient

GABAPENTIN

Application Number

75428

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2006-01-24

Regulatory Status

Discontinued

2006
24 Jan
Discontinued Application: 75428

Drug Name

GABAPENTIN

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2006-01-24

75428 / 3

Active Ingredient

GABAPENTIN

Application Number

75428

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2006-01-24

Regulatory Status

Discontinued

2005
06 Apr
Discontinued Application: 75539

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2005-04-06

75539 / 1

Active Ingredient

GABAPENTIN

Application Number

75539

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2005-04-06

Regulatory Status

Discontinued

2005
06 Apr
Discontinued Application: 75539

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2005-04-06

75539 / 2

Active Ingredient

GABAPENTIN

Application Number

75539

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2005-04-06

Regulatory Status

Discontinued

2005
06 Apr
Discontinued Application: 75539

Drug Name

GABAPENTIN

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2005-04-06

75539 / 3

Active Ingredient

GABAPENTIN

Application Number

75539

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2005-04-06

Regulatory Status

Discontinued

2008
29 Apr
Discontinued Application: 78808

Drug Name

GRANISETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)

Approval Date

2008-04-29

78808 / 1

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

78808

Product Number

1

Dosage Form

-

Strength

EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)

Approval Date

2008-04-29

Regulatory Status

Discontinued

2005
24 Jun
Discontinued Application: 76463

Drug Name

HALOPERIDOL DECANOATE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

2005-06-24

76463 / 1

Active Ingredient

HALOPERIDOL DECANOATE

Application Number

76463

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

2005-06-24

Regulatory Status

Discontinued

2005
24 Jun
Discontinued Application: 76463

Drug Name

HALOPERIDOL DECANOATE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

2005-06-24

76463 / 2

Active Ingredient

HALOPERIDOL DECANOATE

Application Number

76463

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

2005-06-24

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84876

Drug Name

HYDRAP-ES

Product Number

1

Dosage Form

-

Strength

25MG;15MG;0.1MG

Approval Date

1982-01-01

84876 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE

Application Number

84876

Product Number

1

Dosage Form

-

Strength

25MG;15MG;0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84827

Drug Name

HYDRO-SERP "25"

Product Number

1

Dosage Form

-

Strength

25MG;0.125MG

Approval Date

1982-01-01

84827 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; RESERPINE

Application Number

84827

Product Number

1

Dosage Form

-

Strength

25MG;0.125MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85213

Drug Name

HYDRO-SERP "50"

Product Number

1

Dosage Form

-

Strength

50MG;0.125MG

Approval Date

1982-01-01

85213 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; RESERPINE

Application Number

85213

Product Number

1

Dosage Form

-

Strength

50MG;0.125MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1997
27 Jan
Discontinued Application: 40149

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

1997-01-27

40149 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40149

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

1997-01-27

Regulatory Status

Discontinued

1997
27 Jan
Discontinued Application: 40149

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

750MG;7.5MG

Approval Date

1997-01-27

40149 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40149

Product Number

2

Dosage Form

-

Strength

750MG;7.5MG

Approval Date

1997-01-27

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80642

Drug Name

HYDROCORTISONE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

1982-01-01

80642 / 2

Active Ingredient

HYDROCORTISONE

Application Number

80642

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85247

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

85247 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

85247

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87245

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

87245 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

87245

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87246

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

87246 / 2

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

87246

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1991
28 Jun
Discontinued Application: 81128

Drug Name

HYDROXYZINE PAMOATE

Product Number

1

Dosage Form

-

Strength

EQ 50MG HYDROCHLORIDE

Approval Date

1991-06-28

81128 / 1

Active Ingredient

HYDROXYZINE PAMOATE

Application Number

81128

Product Number

1

Dosage Form

-

Strength

EQ 50MG HYDROCHLORIDE

Approval Date

1991-06-28

Regulatory Status

Discontinued

1991
28 Jun
Discontinued Application: 81129

Drug Name

HYDROXYZINE PAMOATE

Product Number

1

Dosage Form

-

Strength

EQ 100MG HYDROCHLORIDE

Approval Date

1991-06-28

81129 / 1

Active Ingredient

HYDROXYZINE PAMOATE

Application Number

81129

Product Number

1

Dosage Form

-

Strength

EQ 100MG HYDROCHLORIDE

Approval Date

1991-06-28

Regulatory Status

Discontinued

1988
25 Feb
Discontinued Application: 71807

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1988-02-25

71807 / 1

Active Ingredient

IBUPROFEN

Application Number

71807

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1988-02-25

Regulatory Status

Discontinued

1988
14 Jan
Discontinued Application: 72064

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1988-01-14

72064 / 1

Active Ingredient

IBUPROFEN

Application Number

72064

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1988-01-14

Regulatory Status

Discontinued

1988
14 Jan
Discontinued Application: 72065

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

1988-01-14

72065 / 1

Active Ingredient

IBUPROFEN

Application Number

72065

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

1988-01-14

Regulatory Status

Discontinued

1987
11 Dec
Discontinued Application: 72169

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

1987-12-11

72169 / 1

Active Ingredient

IBUPROFEN

Application Number

72169

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

1987-12-11

Regulatory Status

Discontinued

1995
15 Dec
Discontinued Application: 74525

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1995-12-15

74525 / 1

Active Ingredient

IBUPROFEN

Application Number

74525

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1995-12-15

Regulatory Status

Discontinued

1995
15 Dec
Discontinued Application: 74533

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1995-12-15

74533 / 1

Active Ingredient

IBUPROFEN

Application Number

74533

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1995-12-15

Regulatory Status

Discontinued

2011
29 Mar
Discontinued Application: 91293

Drug Name

IDARUBICIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML (1MG/ML)

Approval Date

2011-03-29

91293 / 1

Active Ingredient

IDARUBICIN HYDROCHLORIDE

Application Number

91293

Product Number

1

Dosage Form

-

Strength

5MG/5ML (1MG/ML)

Approval Date

2011-03-29

Regulatory Status

Discontinued

2011
29 Mar
Discontinued Application: 91293

Drug Name

IDARUBICIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG/10ML (1MG/ML)

Approval Date

2011-03-29

91293 / 2

Active Ingredient

IDARUBICIN HYDROCHLORIDE

Application Number

91293

Product Number

2

Dosage Form

-

Strength

10MG/10ML (1MG/ML)

Approval Date

2011-03-29

Regulatory Status

Discontinued

2011
29 Mar
Discontinued Application: 91293

Drug Name

IDARUBICIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

20MG/20ML (1MG/ML)

Approval Date

2011-03-29

91293 / 3

Active Ingredient

IDARUBICIN HYDROCHLORIDE

Application Number

91293

Product Number

3

Dosage Form

-

Strength

20MG/20ML (1MG/ML)

Approval Date

2011-03-29

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84869

Drug Name

IMIPRAMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

84869 / 2

Active Ingredient

IMIPRAMINE HYDROCHLORIDE

Application Number

84869

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85133

Drug Name

IMIPRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

85133 / 1

Active Ingredient

IMIPRAMINE HYDROCHLORIDE

Application Number

85133

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85200

Drug Name

IMIPRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

85200 / 1

Active Ingredient

IMIPRAMINE HYDROCHLORIDE

Application Number

85200

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1998
28 May
Discontinued Application: 74464

Drug Name

INDOMETHACIN

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

1998-05-28

74464 / 1

Active Ingredient

INDOMETHACIN

Application Number

74464

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

1998-05-28

Regulatory Status

Discontinued

2008
27 Feb
Discontinued Application: 77994

Drug Name

IRINOTECAN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG/2ML (20MG/ML)

Approval Date

2008-02-27

77994 / 1

Active Ingredient

IRINOTECAN HYDROCHLORIDE

Application Number

77994

Product Number

1

Dosage Form

-

Strength

40MG/2ML (20MG/ML)

Approval Date

2008-02-27

Regulatory Status

Discontinued

2008
27 Feb
Discontinued Application: 77994

Drug Name

IRINOTECAN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG/5ML (20MG/ML)

Approval Date

2008-02-27

77994 / 2

Active Ingredient

IRINOTECAN HYDROCHLORIDE

Application Number

77994

Product Number

2

Dosage Form

-

Strength

100MG/5ML (20MG/ML)

Approval Date

2008-02-27

Regulatory Status

Discontinued

2009
12 Nov
Discontinued Application: 90137

Drug Name

IRINOTECAN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG/2ML (20MG/ML)

Approval Date

2009-11-12

90137 / 1

Active Ingredient

IRINOTECAN HYDROCHLORIDE

Application Number

90137

Product Number

1

Dosage Form

-

Strength

40MG/2ML (20MG/ML)

Approval Date

2009-11-12

Regulatory Status

Discontinued

2009
12 Nov
Discontinued Application: 90137

Drug Name

IRINOTECAN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG/5ML (20MG/ML)

Approval Date

2009-11-12

90137 / 2

Active Ingredient

IRINOTECAN HYDROCHLORIDE

Application Number

90137

Product Number

2

Dosage Form

-

Strength

100MG/5ML (20MG/ML)

Approval Date

2009-11-12

Regulatory Status

Discontinued

1988
19 Feb
Discontinued Application: 86222

Drug Name

ISOSORBIDE DINITRATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1988-02-19

86222 / 1

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

86222

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1988-02-19

Regulatory Status

Discontinued

1988
19 Feb
Discontinued Application: 86225

Drug Name

ISOSORBIDE DINITRATE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1988-02-19

86225 / 1

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

86225

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1988-02-19

Regulatory Status

Discontinued

2004
06 Oct
Discontinued Application: 76271

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

15MG/ML

Approval Date

2004-10-06

76271 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

76271

Product Number

1

Dosage Form

-

Strength

15MG/ML

Approval Date

2004-10-06

Regulatory Status

Discontinued

2009
05 Nov
Discontinued Application: 78721

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

0.4%

Approval Date

2009-11-05

78721 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

78721

Product Number

1

Dosage Form

-

Strength

0.4%

Approval Date

2009-11-05

Regulatory Status

Discontinued

2010
23 Apr
Discontinued Application: 90331

Drug Name

LANSOPRAZOLE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2010-04-23

90331 / 1

Active Ingredient

LANSOPRAZOLE

Application Number

90331

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2010-04-23

Regulatory Status

Discontinued

2010
23 Apr
Discontinued Application: 90331

Drug Name

LANSOPRAZOLE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2010-04-23

90331 / 2

Active Ingredient

LANSOPRAZOLE

Application Number

90331

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2010-04-23

Regulatory Status

Discontinued

2005
13 Sep
Discontinued Application: 77085

Drug Name

LEFLUNOMIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2005-09-13

77085 / 1

Active Ingredient

LEFLUNOMIDE

Application Number

77085

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2005-09-13

Regulatory Status

Discontinued

2005
13 Sep
Discontinued Application: 77085

Drug Name

LEFLUNOMIDE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2005-09-13

77085 / 2

Active Ingredient

LEFLUNOMIDE

Application Number

77085

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2005-09-13

Regulatory Status

Discontinued

2012
01 Nov
Discontinued Application: 91668

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2012-11-01

91668 / 1

Active Ingredient

LEVETIRACETAM

Application Number

91668

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2012-11-01

Regulatory Status

Discontinued

2012
01 Nov
Discontinued Application: 91668

Drug Name

LEVETIRACETAM

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2012-11-01

91668 / 2

Active Ingredient

LEVETIRACETAM

Application Number

91668

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2012-11-01

Regulatory Status

Discontinued

2011
20 Jun
Discontinued Application: 77438

Drug Name

LEVOFLOXACIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2011-06-20

77438 / 1

Active Ingredient

LEVOFLOXACIN

Application Number

77438

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2011-06-20

Regulatory Status

Discontinued

2011
20 Jun
Discontinued Application: 77438

Drug Name

LEVOFLOXACIN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2011-06-20

77438 / 2

Active Ingredient

LEVOFLOXACIN

Application Number

77438

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2011-06-20

Regulatory Status

Discontinued

2011
20 Jun
Discontinued Application: 77438

Drug Name

LEVOFLOXACIN

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2011-06-20

77438 / 3

Active Ingredient

LEVOFLOXACIN

Application Number

77438

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2011-06-20

Regulatory Status

Discontinued

2015
09 Mar
Discontinued Application: 203563

Drug Name

LEVOLEUCOVORIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/25ML (EQ 10MG BASE/ML)

Approval Date

2015-03-09

203563 / 2

Active Ingredient

LEVOLEUCOVORIN CALCIUM

Application Number

203563

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/25ML (EQ 10MG BASE/ML)

Approval Date

2015-03-09

Regulatory Status

Discontinued

1988
15 Apr
Discontinued Application: 71193

Drug Name

LORAZEPAM

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

1988-04-15

71193 / 1

Active Ingredient

LORAZEPAM

Application Number

71193

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

1988-04-15

Regulatory Status

Discontinued

1988
15 Apr
Discontinued Application: 71194

Drug Name

LORAZEPAM

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1988-04-15

71194 / 1

Active Ingredient

LORAZEPAM

Application Number

71194

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1988-04-15

Regulatory Status

Discontinued

1988
15 Apr
Discontinued Application: 71195

Drug Name

LORAZEPAM

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1988-04-15

71195 / 1

Active Ingredient

LORAZEPAM

Application Number

71195

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1988-04-15

Regulatory Status

Discontinued

1995
03 Mar
Discontinued Application: 20364

Drug Name

LOTREL

Product Number

2

Dosage Form

-

Strength

EQ 2.5MG BASE;10MG

Approval Date

1995-03-03

20364 / 2

Active Ingredient

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Application Number

20364

Product Number

2

Dosage Form

-

Strength

EQ 2.5MG BASE;10MG

Approval Date

1995-03-03

Regulatory Status

Discontinued

1995
03 Mar
Discontinued Application: 20364

Drug Name

LOTREL

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE;10MG

Approval Date

1995-03-03

20364 / 3

Active Ingredient

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Application Number

20364

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE;10MG

Approval Date

1995-03-03

Regulatory Status

Discontinued

1995
03 Mar
Discontinued Application: 20364

Drug Name

LOTREL

Product Number

4

Dosage Form

-

Strength

EQ 5MG BASE;20MG

Approval Date

1995-03-03

20364 / 4

Active Ingredient

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Application Number

20364

Product Number

4

Dosage Form

-

Strength

EQ 5MG BASE;20MG

Approval Date

1995-03-03

Regulatory Status

Discontinued

2002
20 Jun
Discontinued Application: 20364

Drug Name

LOTREL

Product Number

5

Dosage Form

-

Strength

EQ 10MG BASE;20MG

Approval Date

2002-06-20

20364 / 5

Active Ingredient

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Application Number

20364

Product Number

5

Dosage Form

-

Strength

EQ 10MG BASE;20MG

Approval Date

2002-06-20

Regulatory Status

Discontinued

2006
11 Apr
Discontinued Application: 20364

Drug Name

LOTREL

Product Number

6

Dosage Form

-

Strength

EQ 10MG BASE;40MG

Approval Date

2006-04-11

20364 / 6

Active Ingredient

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Application Number

20364

Product Number

6

Dosage Form

-

Strength

EQ 10MG BASE;40MG

Approval Date

2006-04-11

Regulatory Status

Discontinued

2006
11 Apr
Discontinued Application: 20364

Drug Name

LOTREL

Product Number

7

Dosage Form

-

Strength

EQ 5MG BASE;40MG

Approval Date

2006-04-11

20364 / 7

Active Ingredient

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Application Number

20364

Product Number

7

Dosage Form

-

Strength

EQ 5MG BASE;40MG

Approval Date

2006-04-11

Regulatory Status

Discontinued

2009
20 May
Discontinued Application: 78711

Drug Name

MEDROXYPROGESTERONE ACETATE

Product Number

1

Dosage Form

-

Strength

150MG/ML

Approval Date

2009-05-20

78711 / 1

Active Ingredient

MEDROXYPROGESTERONE ACETATE

Application Number

78711

Product Number

1

Dosage Form

-

Strength

150MG/ML

Approval Date

2009-05-20

Regulatory Status

Discontinued

1987
02 Mar
Discontinued Application: 89127

Drug Name

MEPRO-ASPIRIN

Product Number

1

Dosage Form

-

Strength

325MG;200MG

Approval Date

1987-03-02

89127 / 1

Active Ingredient

ASPIRIN; MEPROBAMATE

Application Number

89127

Product Number

1

Dosage Form

-

Strength

325MG;200MG

Approval Date

1987-03-02

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 14547

Drug Name

MEPROBAMATE

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1982-01-01

14547 / 1

Active Ingredient

MEPROBAMATE

Application Number

14547

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 14547

Drug Name

MEPROBAMATE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

14547 / 2

Active Ingredient

MEPROBAMATE

Application Number

14547

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2011
29 Mar
Discontinued Application: 91201

Drug Name

MEROPENEM

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2011-03-29

91201 / 1

Active Ingredient

MEROPENEM

Application Number

91201

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2011-03-29

Regulatory Status

Discontinued

2011
29 Mar
Discontinued Application: 91201

Drug Name

MEROPENEM

Product Number

2

Dosage Form

-

Strength

1GM/VIAL

Approval Date

2011-03-29

91201 / 2

Active Ingredient

MEROPENEM

Application Number

91201

Product Number

2

Dosage Form

-

Strength

1GM/VIAL

Approval Date

2011-03-29

Regulatory Status

Discontinued

2002
25 Jan
Discontinued Application: 75985

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2002-01-25

75985 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

75985

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2002-01-25

Regulatory Status

Discontinued

2002
25 Jan
Discontinued Application: 75985

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

850MG

Approval Date

2002-01-25

75985 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

75985

Product Number

2

Dosage Form

-

Strength

850MG

Approval Date

2002-01-25

Regulatory Status

Discontinued

2002
25 Jan
Discontinued Application: 75985

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

2002-01-25

75985 / 3

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

75985

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

2002-01-25

Regulatory Status

Discontinued

2004
14 Dec
Discontinued Application: 76223

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2004-12-14

76223 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

76223

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2004-12-14

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87282

Drug Name

METHOCARBAMOL

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

1982-01-01

87282 / 1

Active Ingredient

METHOCARBAMOL

Application Number

87282

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87283

Drug Name

METHOCARBAMOL

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

87283 / 1

Active Ingredient

METHOCARBAMOL

Application Number

87283

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1987
09 Mar
Discontinued Application: 70829

Drug Name

METHYLDOPA AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

15MG;250MG

Approval Date

1987-03-09

70829 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; METHYLDOPA

Application Number

70829

Product Number

1

Dosage Form

-

Strength

15MG;250MG

Approval Date

1987-03-09

Regulatory Status

Discontinued

1987
09 Mar
Discontinued Application: 70830

Drug Name

METHYLDOPA AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG;250MG

Approval Date

1987-03-09

70830 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; METHYLDOPA

Application Number

70830

Product Number

1

Dosage Form

-

Strength

25MG;250MG

Approval Date

1987-03-09

Regulatory Status

Discontinued

2001
06 Aug
Discontinued Application: 75720

Drug Name

METIPRANOLOL

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2001-08-06

75720 / 1

Active Ingredient

METIPRANOLOL HYDROCHLORIDE

Application Number

75720

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2001-08-06

Regulatory Status

Discontinued

1987
03 Feb
Discontinued Application: 70850

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1987-02-03

70850 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

70850

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1987-02-03

Regulatory Status

Discontinued

1989
22 Jun
Discontinued Application: 72436

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1989-06-22

72436 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

72436

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1989-06-22

Regulatory Status

Discontinued

2006
31 Jul
Discontinued Application: 76969

Drug Name

METOPROLOL SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG TARTRATE

Approval Date

2006-07-31

76969 / 1

Active Ingredient

METOPROLOL SUCCINATE

Application Number

76969

Product Number

1

Dosage Form

-

Strength

EQ 25MG TARTRATE

Approval Date

2006-07-31

Regulatory Status

Discontinued

2007
18 May
Discontinued Application: 76969

Drug Name

METOPROLOL SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG TARTRATE

Approval Date

2007-05-18

76969 / 2

Active Ingredient

METOPROLOL SUCCINATE

Application Number

76969

Product Number

2

Dosage Form

-

Strength

EQ 50MG TARTRATE

Approval Date

2007-05-18

Regulatory Status

Discontinued

2008
20 Mar
Discontinued Application: 76969

Drug Name

METOPROLOL SUCCINATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG TARTRATE

Approval Date

2008-03-20

76969 / 3

Active Ingredient

METOPROLOL SUCCINATE

Application Number

76969

Product Number

3

Dosage Form

-

Strength

EQ 100MG TARTRATE

Approval Date

2008-03-20

Regulatory Status

Discontinued

2008
20 Mar
Discontinued Application: 76969

Drug Name

METOPROLOL SUCCINATE

Product Number

4

Dosage Form

-

Strength

EQ 200MG TARTRATE

Approval Date

2008-03-20

76969 / 4

Active Ingredient

METOPROLOL SUCCINATE

Application Number

76969

Product Number

4

Dosage Form

-

Strength

EQ 200MG TARTRATE

Approval Date

2008-03-20

Regulatory Status

Discontinued

1984
02 Aug
Discontinued Application: 62527

Drug Name

NAFCILLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1984-08-02

62527 / 1

Active Ingredient

NAFCILLIN SODIUM

Application Number

62527

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1984-08-02

Regulatory Status

Discontinued

1984
02 Aug
Discontinued Application: 62527

Drug Name

NAFCILLIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1984-08-02

62527 / 2

Active Ingredient

NAFCILLIN SODIUM

Application Number

62527

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1984-08-02

Regulatory Status

Discontinued

1984
02 Aug
Discontinued Application: 62527

Drug Name

NAFCILLIN SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1984-08-02

62527 / 3

Active Ingredient

NAFCILLIN SODIUM

Application Number

62527

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1984-08-02

Regulatory Status

Discontinued

1984
02 Aug
Discontinued Application: 62527

Drug Name

NAFCILLIN SODIUM

Product Number

4

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1984-08-02

62527 / 4

Active Ingredient

NAFCILLIN SODIUM

Application Number

62527

Product Number

4

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1984-08-02

Regulatory Status

Discontinued

1986
23 Dec
Discontinued Application: 62732

Drug Name

NAFCILLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1986-12-23

62732 / 1

Active Ingredient

NAFCILLIN SODIUM

Application Number

62732

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1986-12-23

Regulatory Status

Discontinued

1986
23 Dec
Discontinued Application: 62732

Drug Name

NAFCILLIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1986-12-23

62732 / 2

Active Ingredient

NAFCILLIN SODIUM

Application Number

62732

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1986-12-23

Regulatory Status

Discontinued

1993
21 Dec
Discontinued Application: 74162

Drug Name

NAPROXEN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1993-12-21

74162 / 1

Active Ingredient

NAPROXEN SODIUM

Application Number

74162

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1993-12-21

Regulatory Status

Discontinued

1993
21 Dec
Discontinued Application: 74162

Drug Name

NAPROXEN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1993-12-21

74162 / 2

Active Ingredient

NAPROXEN SODIUM

Application Number

74162

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1993-12-21

Regulatory Status

Discontinued

1994
05 Dec
Discontinued Application: 74495

Drug Name

NAPROXEN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1994-12-05

74495 / 1

Active Ingredient

NAPROXEN SODIUM

Application Number

74495

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1994-12-05

Regulatory Status

Discontinued

1994
05 Dec
Discontinued Application: 74495

Drug Name

NAPROXEN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1994-12-05

74495 / 2

Active Ingredient

NAPROXEN SODIUM

Application Number

74495

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1994-12-05

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61586

Drug Name

NEOMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

61586 / 1

Active Ingredient

NEOMYCIN SULFATE

Application Number

61586

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83306

Drug Name

NIACIN

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

83306 / 1

Active Ingredient

NIACIN

Application Number

83306

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80043

Drug Name

NITROFURANTOIN

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

80043 / 1

Active Ingredient

NITROFURANTOIN

Application Number

80043

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80043

Drug Name

NITROFURANTOIN

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

80043 / 2

Active Ingredient

NITROFURANTOIN

Application Number

80043

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 8662

Drug Name

NYDRAZID

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Active Ingredient

ISONIAZID

Application Number

8662

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61965

Drug Name

NYSTATIN

Product Number

1

Dosage Form

-

Strength

100,000 UNITS

Approval Date

1982-01-01

61965 / 1

Active Ingredient

NYSTATIN

Application Number

61965

Product Number

1

Dosage Form

-

Strength

100,000 UNITS

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62065

Drug Name

NYSTATIN

Product Number

1

Dosage Form

-

Strength

500,000 UNITS

Approval Date

1982-01-01

62065 / 1

Active Ingredient

NYSTATIN

Application Number

62065

Product Number

1

Dosage Form

-

Strength

500,000 UNITS

Approval Date

1982-01-01

Regulatory Status

Discontinued

2004
14 May
Discontinued Application: 76231

Drug Name

OFLOXACIN

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2004-05-14

76231 / 1

Active Ingredient

OFLOXACIN

Application Number

76231

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2004-05-14

Regulatory Status

Discontinued

2008
25 Nov
Discontinued Application: 76848

Drug Name

OFLOXACIN

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2008-11-25

76848 / 1

Active Ingredient

OFLOXACIN

Application Number

76848

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2008-11-25

Regulatory Status

Discontinued

2008
17 Mar
Discontinued Application: 78222

Drug Name

OFLOXACIN

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2008-03-17

78222 / 1

Active Ingredient

OFLOXACIN

Application Number

78222

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2008-03-17

Regulatory Status

Discontinued

2020
13 Apr
Discontinued Application: 90237

Drug Name

OLMESARTAN MEDOXOMIL

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2020-04-13

90237 / 1

Active Ingredient

OLMESARTAN MEDOXOMIL

Application Number

90237

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2020-04-13

Regulatory Status

Discontinued

2020
13 Apr
Discontinued Application: 90237

Drug Name

OLMESARTAN MEDOXOMIL

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2020-04-13

90237 / 2

Active Ingredient

OLMESARTAN MEDOXOMIL

Application Number

90237

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2020-04-13

Regulatory Status

Discontinued

2020
13 Apr
Discontinued Application: 90237

Drug Name

OLMESARTAN MEDOXOMIL

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2020-04-13

90237 / 3

Active Ingredient

OLMESARTAN MEDOXOMIL

Application Number

90237

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2020-04-13

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85046

Drug Name

ORPHENADRINE CITRATE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

85046 / 1

Active Ingredient

ORPHENADRINE CITRATE

Application Number

85046

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1996
31 Dec
Discontinued Application: 74654

Drug Name

ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

385MG;30MG;25MG

Approval Date

1996-12-31

74654 / 1

Active Ingredient

ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE

Application Number

74654

Product Number

1

Dosage Form

-

Strength

385MG;30MG;25MG

Approval Date

1996-12-31

Regulatory Status

Discontinued

1996
31 Dec
Discontinued Application: 74654

Drug Name

ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE

Product Number

2

Dosage Form

-

Strength

770MG;60MG;50MG

Approval Date

1996-12-31

74654 / 2

Active Ingredient

ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE

Application Number

74654

Product Number

2

Dosage Form

-

Strength

770MG;60MG;50MG

Approval Date

1996-12-31

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61490

Drug Name

OXACILLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

1982-01-01

61490 / 1

Active Ingredient

OXACILLIN SODIUM

Application Number

61490

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61490

Drug Name

OXACILLIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1982-01-01

61490 / 2

Active Ingredient

OXACILLIN SODIUM

Application Number

61490

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61490

Drug Name

OXACILLIN SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1982-01-01

61490 / 3

Active Ingredient

OXACILLIN SODIUM

Application Number

61490

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61490

Drug Name

OXACILLIN SODIUM

Product Number

4

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1982-01-01

61490 / 4

Active Ingredient

OXACILLIN SODIUM

Application Number

61490

Product Number

4

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1991
09 May
Discontinued Application: 61490

Drug Name

OXACILLIN SODIUM

Product Number

6

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1991-05-09

61490 / 6

Active Ingredient

OXACILLIN SODIUM

Application Number

61490

Product Number

6

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1991-05-09

Regulatory Status

Discontinued

1986
23 Dec
Discontinued Application: 62737

Drug Name

OXACILLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1986-12-23

62737 / 1

Active Ingredient

OXACILLIN SODIUM

Application Number

62737

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1986-12-23

Regulatory Status

Discontinued

1986
23 Dec
Discontinued Application: 62737

Drug Name

OXACILLIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1986-12-23

62737 / 2

Active Ingredient

OXACILLIN SODIUM

Application Number

62737

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1986-12-23

Regulatory Status

Discontinued

2009
07 Aug
Discontinued Application: 78812

Drug Name

OXALIPLATIN

Product Number

1

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

2009-08-07

78812 / 1

Active Ingredient

OXALIPLATIN

Application Number

78812

Product Number

1

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

2009-08-07

Regulatory Status

Discontinued

2009
07 Aug
Discontinued Application: 78812

Drug Name

OXALIPLATIN

Product Number

2

Dosage Form

-

Strength

100MG/20ML (5MG/ML)

Approval Date

2009-08-07

78812 / 2

Active Ingredient

OXALIPLATIN

Application Number

78812

Product Number

2

Dosage Form

-

Strength

100MG/20ML (5MG/ML)

Approval Date

2009-08-07

Regulatory Status

Discontinued

2011
28 Apr
Discontinued Application: 90849

Drug Name

OXALIPLATIN

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2011-04-28

90849 / 1

Active Ingredient

OXALIPLATIN

Application Number

90849

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2011-04-28

Regulatory Status

Discontinued

2011
28 Apr
Discontinued Application: 90849

Drug Name

OXALIPLATIN

Product Number

2

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2011-04-28

90849 / 2

Active Ingredient

OXALIPLATIN

Application Number

90849

Product Number

2

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2011-04-28

Regulatory Status

Discontinued

2006
01 Dec
Discontinued Application: 76897

Drug Name

OXANDROLONE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2006-12-01

76897 / 1

Active Ingredient

OXANDROLONE

Application Number

76897

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2006-12-01

Regulatory Status

Discontinued

2006
01 Dec
Discontinued Application: 76897

Drug Name

OXANDROLONE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2006-12-01

76897 / 2

Active Ingredient

OXANDROLONE

Application Number

76897

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2006-12-01

Regulatory Status

Discontinued

2001
27 Apr
Discontinued Application: 75850

Drug Name

OXAPROZIN

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2001-04-27

75850 / 1

Active Ingredient

OXAPROZIN

Application Number

75850

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2001-04-27

Regulatory Status

Discontinued

2007
26 Dec
Discontinued Application: 78167

Drug Name

PACLITAXEL

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2007-12-26

78167 / 1

Active Ingredient

PACLITAXEL

Application Number

78167

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2007-12-26

Regulatory Status

Discontinued

2015
14 Jul
Discontinued Application: 90296

Drug Name

PANTOPRAZOLE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2015-07-14

90296 / 1

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

90296

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2015-07-14

Regulatory Status

Discontinued

1993
31 Aug
Discontinued Application: 73098

Drug Name

PEG-LYTE

Product Number

1

Dosage Form

-

Strength

236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT

Approval Date

1993-08-31

73098 / 1

Active Ingredient

POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS

Application Number

73098

Product Number

1

Dosage Form

-

Strength

236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT

Approval Date

1993-08-31

Regulatory Status

Discontinued

2002
30 Aug
Discontinued Application: 65079

Drug Name

PENICILLIN G POTASSIUM

Product Number

1

Dosage Form

-

Strength

1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2002-08-30

65079 / 1

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

65079

Product Number

1

Dosage Form

-

Strength

1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2002-08-30

Regulatory Status

Discontinued

1995
30 Nov
Discontinued Application: 64071

Drug Name

PENICILLIN V POTASSIUM

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1995-11-30

64071 / 1

Active Ingredient

PENICILLIN V POTASSIUM

Application Number

64071

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1995-11-30

Regulatory Status

Discontinued

1995
30 Nov
Discontinued Application: 64071

Drug Name

PENICILLIN V POTASSIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1995-11-30

64071 / 2

Active Ingredient

PENICILLIN V POTASSIUM

Application Number

64071

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1995-11-30

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85402

Drug Name

PHENDIMETRAZINE TARTRATE

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

1982-01-01

85402 / 1

Active Ingredient

PHENDIMETRAZINE TARTRATE

Application Number

85402

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85633

Drug Name

PHENDIMETRAZINE TARTRATE

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

1982-01-01

85633 / 1

Active Ingredient

PHENDIMETRAZINE TARTRATE

Application Number

85633

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85694

Drug Name

PHENDIMETRAZINE TARTRATE

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

1982-01-01

85694 / 1

Active Ingredient

PHENDIMETRAZINE TARTRATE

Application Number

85694

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85702

Drug Name

PHENDIMETRAZINE TARTRATE

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

1982-01-01

85702 / 1

Active Ingredient

PHENDIMETRAZINE TARTRATE

Application Number

85702

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85830

Drug Name

PHENDIMETRAZINE TARTRATE

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

1982-01-01

85830 / 1

Active Ingredient

PHENDIMETRAZINE TARTRATE

Application Number

85830

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86370

Drug Name

PHENDIMETRAZINE TARTRATE

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

1982-01-01

86370 / 1

Active Ingredient

PHENDIMETRAZINE TARTRATE

Application Number

86370

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85671

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

1982-01-01

85671 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

85671

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85689

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

1982-01-01

85689 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

85689

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87208

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

87208 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

87208

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87223

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

87223 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

87223

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1983
19 Oct
Discontinued Application: 88414

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

37.5MG

Approval Date

1983-10-19

88414 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

88414

Product Number

1

Dosage Form

-

Strength

37.5MG

Approval Date

1983-10-19

Regulatory Status

Discontinued

2010
21 Oct
Discontinued Application: 65363

Drug Name

PIPERACILLIN AND TAZOBACTAM

Product Number

1

Dosage Form

-

Strength

EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL

Approval Date

2010-10-21

65363 / 1

Active Ingredient

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Application Number

65363

Product Number

1

Dosage Form

-

Strength

EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL

Approval Date

2010-10-21

Regulatory Status

Discontinued

2010
21 Oct
Discontinued Application: 65363

Drug Name

PIPERACILLIN AND TAZOBACTAM

Product Number

2

Dosage Form

-

Strength

EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL

Approval Date

2010-10-21

65363 / 2

Active Ingredient

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Application Number

65363

Product Number

2

Dosage Form

-

Strength

EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL

Approval Date

2010-10-21

Regulatory Status

Discontinued

2010
21 Oct
Discontinued Application: 65363

Drug Name

PIPERACILLIN AND TAZOBACTAM

Product Number

3

Dosage Form

-

Strength

EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL

Approval Date

2010-10-21

65363 / 3

Active Ingredient

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Application Number

65363

Product Number

3

Dosage Form

-

Strength

EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL

Approval Date

2010-10-21

Regulatory Status

Discontinued

2010
06 Jul
Discontinued Application: 90190

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2010-07-06

90190 / 1

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

90190

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2010-07-06

Regulatory Status

Discontinued

2010
06 Jul
Discontinued Application: 90190

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2010-07-06

90190 / 2

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

90190

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2010-07-06

Regulatory Status

Discontinued

2010
06 Jul
Discontinued Application: 90190

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

2010-07-06

90190 / 3

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

90190

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

2010-07-06

Regulatory Status

Discontinued

2010
06 Jul
Discontinued Application: 90190

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

2010-07-06

90190 / 4

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

90190

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

2010-07-06

Regulatory Status

Discontinued

2010
06 Jul
Discontinued Application: 90190

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

1.5MG

Approval Date

2010-07-06

90190 / 5

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

90190

Product Number

5

Dosage Form

-

Strength

1.5MG

Approval Date

2010-07-06

Regulatory Status

Discontinued

2010
08 Oct
Discontinued Application: 90190

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

0.75MG

Approval Date

2010-10-08

90190 / 6

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

90190

Product Number

6

Dosage Form

-

Strength

0.75MG

Approval Date

2010-10-08

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86130

Drug Name

PROBENECID AND COLCHICINE

Product Number

1

Dosage Form

-

Strength

0.5MG;500MG

Approval Date

1982-01-01

86130 / 1

Active Ingredient

COLCHICINE; PROBENECID

Application Number

86130

Product Number

1

Dosage Form

-

Strength

0.5MG;500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1986
23 Jun
Discontinued Application: 89284

Drug Name

PROCAINAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1986-06-23

89284 / 1

Active Ingredient

PROCAINAMIDE HYDROCHLORIDE

Application Number

89284

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1986-06-23

Regulatory Status

Discontinued

2006
08 Nov
Discontinued Application: 40593

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

2006-11-08

40593 / 1

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

40593

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

2006-11-08

Regulatory Status

Discontinued

2006
08 Nov
Discontinued Application: 40593

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG/ML

Approval Date

2006-11-08

40593 / 2

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

40593

Product Number

2

Dosage Form

-

Strength

50MG/ML

Approval Date

2006-11-08

Regulatory Status

Discontinued

2009
22 May
Discontinued Application: 84176

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

12.5MG

Approval Date

2009-05-22

84176 / 2

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

84176

Product Number

2

Dosage Form

-

Strength

12.5MG

Approval Date

2009-05-22

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80928

Drug Name

PROPANTHELINE BROMIDE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

80928 / 1

Active Ingredient

PROPANTHELINE BROMIDE

Application Number

80928

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1983
16 Sep
Discontinued Application: 80044

Drug Name

PROPOXYPHENE COMPOUND 65

Product Number

2

Dosage Form

-

Strength

389MG;32.4MG;65MG

Approval Date

1983-09-16

80044 / 2

Active Ingredient

ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE

Application Number

80044

Product Number

2

Dosage Form

-

Strength

389MG;32.4MG;65MG

Approval Date

1983-09-16

Regulatory Status

Discontinued

1985
24 Jun
Discontinued Application: 83101

Drug Name

PROPOXYPHENE COMPOUND-65

Product Number

2

Dosage Form

-

Strength

389MG;32.4MG;65MG

Approval Date

1985-06-24

83101 / 2

Active Ingredient

ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE

Application Number

83101

Product Number

2

Dosage Form

-

Strength

389MG;32.4MG;65MG

Approval Date

1985-06-24

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83125

Drug Name

PROPOXYPHENE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

65MG

Approval Date

1982-01-01

83125 / 2

Active Ingredient

PROPOXYPHENE HYDROCHLORIDE

Application Number

83125

Product Number

2

Dosage Form

-

Strength

65MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83688

Drug Name

PROPOXYPHENE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

65MG

Approval Date

1982-01-01

83688 / 1

Active Ingredient

PROPOXYPHENE HYDROCHLORIDE

Application Number

83688

Product Number

1

Dosage Form

-

Strength

65MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83870

Drug Name

PROPOXYPHENE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

65MG

Approval Date

1982-01-01

83870 / 2

Active Ingredient

PROPOXYPHENE HYDROCHLORIDE

Application Number

83870

Product Number

2

Dosage Form

-

Strength

65MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84014

Drug Name

PROPOXYPHENE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

32MG

Approval Date

1982-01-01

84014 / 1

Active Ingredient

PROPOXYPHENE HYDROCHLORIDE

Application Number

84014

Product Number

1

Dosage Form

-

Strength

32MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86495

Drug Name

PROPOXYPHENE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

65MG

Approval Date

1982-01-01

86495 / 1

Active Ingredient

PROPOXYPHENE HYDROCHLORIDE

Application Number

86495

Product Number

1

Dosage Form

-

Strength

65MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1989
18 Jul
Discontinued Application: 89959

Drug Name

PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;65MG

Approval Date

1989-07-18

89959 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE

Application Number

89959

Product Number

1

Dosage Form

-

Strength

650MG;65MG

Approval Date

1989-07-18

Regulatory Status

Discontinued

1986
23 Jan
Discontinued Application: 70443

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

1986-01-23

70443 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Application Number

70443

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

1986-01-23

Regulatory Status

Discontinued

1988
05 Jul
Discontinued Application: 71658

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1988-07-05

71658 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

71658

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1988-07-05

Regulatory Status

Discontinued

1988
05 Jul
Discontinued Application: 71687

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1988-07-05

71687 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

71687

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1988-07-05

Regulatory Status

Discontinued

1988
05 Jul
Discontinued Application: 71688

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1988-07-05

71688 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

71688

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1988-07-05

Regulatory Status

Discontinued

1988
05 Jul
Discontinued Application: 71689

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

1988-07-05

71689 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

71689

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

1988-07-05

Regulatory Status

Discontinued

1988
05 Jul
Discontinued Application: 72197

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

1988-07-05

72197 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

72197

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

1988-07-05

Regulatory Status

Discontinued

1988
05 Jul
Discontinued Application: 72198

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

1988-07-05

72198 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

72198

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

1988-07-05

Regulatory Status

Discontinued

1983
17 May
Discontinued Application: 88193

Drug Name

PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

60MG;2.5MG

Approval Date

1983-05-17

88193 / 1

Active Ingredient

PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

Application Number

88193

Product Number

1

Dosage Form

-

Strength

60MG;2.5MG

Approval Date

1983-05-17

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84631

Drug Name

QUINIDINE SULFATE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

84631 / 1

Active Ingredient

QUINIDINE SULFATE

Application Number

84631

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84914

Drug Name

QUINIDINE SULFATE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

84914 / 1

Active Ingredient

QUINIDINE SULFATE

Application Number

84914

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2002
26 Sep
Discontinued Application: 75519

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2002-09-26

75519 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

75519

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2002-09-26

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9838

Drug Name

RESERPINE

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

1982-01-01

Active Ingredient

RESERPINE

Application Number

9838

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9838

Drug Name

RESERPINE

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

1982-01-01

Active Ingredient

RESERPINE

Application Number

9838

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
31 Jan
Discontinued Application: 88200

Drug Name

RESERPINE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

50MG;0.125MG

Approval Date

1984-01-31

88200 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; RESERPINE

Application Number

88200

Product Number

1

Dosage Form

-

Strength

50MG;0.125MG

Approval Date

1984-01-31

Regulatory Status

Discontinued

2014
27 Oct
Discontinued Application: 21284

Drug Name

RITALIN LA

Product Number

5

Dosage Form

-

Strength

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

Approval Date

2014-10-27

21284 / 5

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

21284

Product Number

5

Dosage Form

-

Strength

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

Approval Date

2014-10-27

Regulatory Status

Discontinued

2012
31 Dec
Discontinued Application: 79230

Drug Name

RIZATRIPTAN BENZOATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-12-31

79230 / 1

Active Ingredient

RIZATRIPTAN BENZOATE

Application Number

79230

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-12-31

Regulatory Status

Discontinued

2012
31 Dec
Discontinued Application: 79230

Drug Name

RIZATRIPTAN BENZOATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-12-31

79230 / 2

Active Ingredient

RIZATRIPTAN BENZOATE

Application Number

79230

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-12-31

Regulatory Status

Discontinued

2016
19 Jul
Discontinued Application: 79171

Drug Name

ROSUVASTATIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2016-07-19

79171 / 1

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

79171

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2016-07-19

Regulatory Status

Discontinued

2016
19 Jul
Discontinued Application: 79171

Drug Name

ROSUVASTATIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2016-07-19

79171 / 2

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

79171

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2016-07-19

Regulatory Status

Discontinued

2016
19 Jul
Discontinued Application: 79171

Drug Name

ROSUVASTATIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2016-07-19

79171 / 3

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

79171

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2016-07-19

Regulatory Status

Discontinued

2016
19 Jul
Discontinued Application: 79171

Drug Name

ROSUVASTATIN CALCIUM

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2016-07-19

79171 / 4

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

79171

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2016-07-19

Regulatory Status

Discontinued

2009
06 Feb
Discontinued Application: 78067

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2009-02-06

78067 / 1

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

78067

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2009-02-06

Regulatory Status

Discontinued

2009
06 Feb
Discontinued Application: 78067

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2009-02-06

78067 / 2

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

78067

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2009-02-06

Regulatory Status

Discontinued

2010
27 Apr
Discontinued Application: 78015

Drug Name

TAMSULOSIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.4MG

Approval Date

2010-04-27

78015 / 1

Active Ingredient

TAMSULOSIN HYDROCHLORIDE

Application Number

78015

Product Number

1

Dosage Form

-

Strength

0.4MG

Approval Date

2010-04-27

Regulatory Status

Discontinued

1998
31 Dec
Discontinued Application: 74315

Drug Name

TERAZOSIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

1998-12-31

74315 / 1

Active Ingredient

TERAZOSIN HYDROCHLORIDE

Application Number

74315

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

1998-12-31

Regulatory Status

Discontinued

1998
31 Dec
Discontinued Application: 74315

Drug Name

TERAZOSIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

1998-12-31

74315 / 2

Active Ingredient

TERAZOSIN HYDROCHLORIDE

Application Number

74315

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

1998-12-31

Regulatory Status

Discontinued

1998
31 Dec
Discontinued Application: 74315

Drug Name

TERAZOSIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1998-12-31

74315 / 3

Active Ingredient

TERAZOSIN HYDROCHLORIDE

Application Number

74315

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1998-12-31

Regulatory Status

Discontinued

1998
31 Dec
Discontinued Application: 74315

Drug Name

TERAZOSIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1998-12-31

74315 / 4

Active Ingredient

TERAZOSIN HYDROCHLORIDE

Application Number

74315

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1998-12-31

Regulatory Status

Discontinued

1982
11 May
Discontinued Application: 87462

Drug Name

THEOPHYLLINE

Product Number

1

Dosage Form

-

Strength

260MG

Approval Date

1982-05-11

87462 / 1

Active Ingredient

THEOPHYLLINE

Application Number

87462

Product Number

1

Dosage Form

-

Strength

260MG

Approval Date

1982-05-11

Regulatory Status

Discontinued

1983
23 Nov
Discontinued Application: 88307

Drug Name

THIORIDAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

1983-11-23

88307 / 1

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

88307

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

1983-11-23

Regulatory Status

Discontinued

1983
23 Nov
Discontinued Application: 88308

Drug Name

THIORIDAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1983-11-23

88308 / 1

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

88308

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1983-11-23

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12678

Drug Name

TOLBUTAMIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

12678 / 1

Active Ingredient

TOLBUTAMIDE

Application Number

12678

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85601

Drug Name

TRIAMCINOLONE

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

85601 / 1

Active Ingredient

TRIAMCINOLONE

Application Number

85601

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2009
01 Jun
Discontinued Application: 90164

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2009-06-01

90164 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

90164

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2009-06-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86171

Drug Name

TRICHLORMETHIAZIDE

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

86171 / 1

Active Ingredient

TRICHLORMETHIAZIDE

Application Number

86171

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2008
13 Feb
Discontinued Application: 78408

Drug Name

VINORELBINE TARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2008-02-13

78408 / 1

Active Ingredient

VINORELBINE TARTRATE

Application Number

78408

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2008-02-13

Regulatory Status

Discontinued

1994
28 Oct
Discontinued Application: 20323

Drug Name

VIVELLE

Product Number

1

Dosage Form

-

Strength

0.0375MG/24HR

Approval Date

1994-10-28

20323 / 1

Active Ingredient

ESTRADIOL

Application Number

20323

Product Number

1

Dosage Form

-

Strength

0.0375MG/24HR

Approval Date

1994-10-28

Regulatory Status

Discontinued

1994
28 Oct
Discontinued Application: 20323

Drug Name

VIVELLE

Product Number

2

Dosage Form

-

Strength

0.05MG/24HR

Approval Date

1994-10-28

20323 / 2

Active Ingredient

ESTRADIOL

Application Number

20323

Product Number

2

Dosage Form

-

Strength

0.05MG/24HR

Approval Date

1994-10-28

Regulatory Status

Discontinued

1994
28 Oct
Discontinued Application: 20323

Drug Name

VIVELLE

Product Number

3

Dosage Form

-

Strength

0.075MG/24HR

Approval Date

1994-10-28

20323 / 3

Active Ingredient

ESTRADIOL

Application Number

20323

Product Number

3

Dosage Form

-

Strength

0.075MG/24HR

Approval Date

1994-10-28

Regulatory Status

Discontinued

1994
28 Oct
Discontinued Application: 20323

Drug Name

VIVELLE

Product Number

4

Dosage Form

-

Strength

0.1MG/24HR

Approval Date

1994-10-28

20323 / 4

Active Ingredient

ESTRADIOL

Application Number

20323

Product Number

4

Dosage Form

-

Strength

0.1MG/24HR

Approval Date

1994-10-28

Regulatory Status

Discontinued

2000
16 Aug
Discontinued Application: 20323

Drug Name

VIVELLE

Product Number

5

Dosage Form

-

Strength

0.025MG/24HR

Approval Date

2000-08-16

20323 / 5

Active Ingredient

ESTRADIOL

Application Number

20323

Product Number

5

Dosage Form

-

Strength

0.025MG/24HR

Approval Date

2000-08-16

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17108

Drug Name

WESTADONE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1982-01-01

17108 / 1

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

17108

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17108

Drug Name

WESTADONE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

17108 / 2

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

17108

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17108

Drug Name

WESTADONE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

17108 / 3

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

17108

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17108

Drug Name

WESTADONE

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

1982-01-01

17108 / 4

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

17108

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12737

Drug Name

WILPO

Product Number

1

Dosage Form

-

Strength

8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

12737 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

12737

Product Number

1

Dosage Form

-

Strength

8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1991
04 Jan
Discontinued Application: 20007

Drug Name

ZOFRAN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1991-01-04

20007 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

20007

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1991-01-04

Regulatory Status

Discontinued

1992
31 Dec
Discontinued Application: 20103

Drug Name

ZOFRAN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1992-12-31

20103 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

20103

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1992-12-31

Regulatory Status

Discontinued

1992
31 Dec
Discontinued Application: 20103

Drug Name

ZOFRAN

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-12-31

20103 / 2

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

20103

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-12-31

Regulatory Status

Discontinued

1999
27 Aug
Discontinued Application: 20103

Drug Name

ZOFRAN

Product Number

3

Dosage Form

-

Strength

EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-08-27

20103 / 3

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

20103

Product Number

3

Dosage Form

-

Strength

EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-08-27

Regulatory Status

Discontinued

1997
24 Jan
Discontinued Application: 20605

Drug Name

ZOFRAN

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-01-24

20605 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

20605

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-01-24

Regulatory Status

Discontinued

1999
27 Jan
Discontinued Application: 20781

Drug Name

ZOFRAN ODT

Product Number

1

Dosage Form

-

Strength

4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-01-27

20781 / 1

Active Ingredient

ONDANSETRON

Application Number

20781

Product Number

1

Dosage Form

-

Strength

4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-01-27

Regulatory Status

Discontinued

1999
27 Jan
Discontinued Application: 20781

Drug Name

ZOFRAN ODT

Product Number

2

Dosage Form

-

Strength

8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-01-27

20781 / 2

Active Ingredient

ONDANSETRON

Application Number

20781

Product Number

2

Dosage Form

-

Strength

8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-01-27

Regulatory Status

Discontinued

1993
10 Dec
Discontinued Application: 20007

Drug Name

ZOFRAN PRESERVATIVE FREE

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1993-12-10

20007 / 3

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

20007

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1993-12-10

Regulatory Status

Discontinued

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Drug Status Breakdown
316 total
  • Discontinued
Official Source

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

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Application Number

85291

Product Number

2

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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