Lupin Ltd Discontinued
FDA Approved Drugs

Lupin Ltd 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 204
  • Latest Approval Date Dec 13, 2024
  • Data Source FDA
  • First Approval Date Feb 04, 2000
All
584
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Unclassified
46
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Discontinued
204
View
OTC
1
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RX
333
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Company Overview

Company

Lupin Ltd Discontinued

Country

India

Website

Visit Website

Email

info@lupin.com

Social Profiles

LinkedIn
Company Snapshot

Lupin Ltd Discontinued

Kalina, Santacruz East, Mumbai 400 098

India

www.lupin.com/ info@lupin.com View on Map
FDA Approved Drug Records ( 204 records )
2013
05 Dec
Discontinued Application: 202912

Drug Name

ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE;150MG;300MG

Approval Date

2013-12-05

202912 / 1

Active Ingredient

ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

Application Number

202912

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE;150MG;300MG

Approval Date

2013-12-05

Regulatory Status

Discontinued

2000
04 Feb
Discontinued Application: 20120

Drug Name

ALLERNAZE

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2000-02-04

20120 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

20120

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2000-02-04

Regulatory Status

Discontinued

2023
14 Dec
Discontinued Application: 211807

Drug Name

ALLOPURINOL

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2023-12-14

211807 / 1

Active Ingredient

ALLOPURINOL

Application Number

211807

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2023-12-14

Regulatory Status

Discontinued

2023
14 Dec
Discontinued Application: 211807

Drug Name

ALLOPURINOL

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2023-12-14

211807 / 2

Active Ingredient

ALLOPURINOL

Application Number

211807

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2023-12-14

Regulatory Status

Discontinued

2015
30 Mar
Discontinued Application: 90245

Drug Name

AMLODIPINE BESYLATE AND VALSARTAN

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;160MG

Approval Date

2015-03-30

90245 / 1

Active Ingredient

AMLODIPINE BESYLATE; VALSARTAN

Application Number

90245

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;160MG

Approval Date

2015-03-30

Regulatory Status

Discontinued

2015
30 Mar
Discontinued Application: 90245

Drug Name

AMLODIPINE BESYLATE AND VALSARTAN

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE;160MG

Approval Date

2015-03-30

90245 / 2

Active Ingredient

AMLODIPINE BESYLATE; VALSARTAN

Application Number

90245

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE;160MG

Approval Date

2015-03-30

Regulatory Status

Discontinued

2015
30 Mar
Discontinued Application: 90245

Drug Name

AMLODIPINE BESYLATE AND VALSARTAN

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE;320MG

Approval Date

2015-03-30

90245 / 3

Active Ingredient

AMLODIPINE BESYLATE; VALSARTAN

Application Number

90245

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE;320MG

Approval Date

2015-03-30

Regulatory Status

Discontinued

2015
30 Mar
Discontinued Application: 90245

Drug Name

AMLODIPINE BESYLATE AND VALSARTAN

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;320MG

Approval Date

2015-03-30

90245 / 4

Active Ingredient

AMLODIPINE BESYLATE; VALSARTAN

Application Number

90245

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;320MG

Approval Date

2015-03-30

Regulatory Status

Discontinued

2015
03 Jun
Discontinued Application: 200797

Drug Name

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;12.5MG;160MG

Approval Date

2015-06-03

200797 / 1

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

200797

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;12.5MG;160MG

Approval Date

2015-06-03

Regulatory Status

Discontinued

2015
03 Jun
Discontinued Application: 200797

Drug Name

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;25MG;160MG

Approval Date

2015-06-03

200797 / 2

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

200797

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;25MG;160MG

Approval Date

2015-06-03

Regulatory Status

Discontinued

2015
03 Jun
Discontinued Application: 200797

Drug Name

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE;12.5MG;160MG

Approval Date

2015-06-03

200797 / 3

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

200797

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE;12.5MG;160MG

Approval Date

2015-06-03

Regulatory Status

Discontinued

2015
03 Jun
Discontinued Application: 200797

Drug Name

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;25MG;160MG

Approval Date

2015-06-03

200797 / 4

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

200797

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;25MG;160MG

Approval Date

2015-06-03

Regulatory Status

Discontinued

2015
03 Jun
Discontinued Application: 200797

Drug Name

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

5

Dosage Form

-

Strength

EQ 10MG BASE;25MG;320MG

Approval Date

2015-06-03

200797 / 5

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

200797

Product Number

5

Dosage Form

-

Strength

EQ 10MG BASE;25MG;320MG

Approval Date

2015-06-03

Regulatory Status

Discontinued

2004
30 Nov
Discontinued Application: 21695

Drug Name

ANTARA (MICRONIZED)

Product Number

2

Dosage Form

-

Strength

87MG

Approval Date

2004-11-30

21695 / 2

Active Ingredient

FENOFIBRATE

Application Number

21695

Product Number

2

Dosage Form

-

Strength

87MG

Approval Date

2004-11-30

Regulatory Status

Discontinued

2013
18 Oct
Discontinued Application: 21695

Drug Name

ANTARA (MICRONIZED)

Product Number

4

Dosage Form

-

Strength

30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2013-10-18

21695 / 4

Active Ingredient

FENOFIBRATE

Application Number

21695

Product Number

4

Dosage Form

-

Strength

30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2013-10-18

Regulatory Status

Discontinued

2013
18 Oct
Discontinued Application: 21695

Drug Name

ANTARA (MICRONIZED)

Product Number

5

Dosage Form

-

Strength

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

Approval Date

2013-10-18

21695 / 5

Active Ingredient

FENOFIBRATE

Application Number

21695

Product Number

5

Dosage Form

-

Strength

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

Approval Date

2013-10-18

Regulatory Status

Discontinued

2024
18 Mar
Discontinued Application: 205589

Drug Name

ARIPIPRAZOLE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2024-03-18

205589 / 1

Active Ingredient

ARIPIPRAZOLE

Application Number

205589

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2024-03-18

Regulatory Status

Discontinued

2024
18 Mar
Discontinued Application: 205589

Drug Name

ARIPIPRAZOLE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2024-03-18

205589 / 2

Active Ingredient

ARIPIPRAZOLE

Application Number

205589

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2024-03-18

Regulatory Status

Discontinued

2024
18 Mar
Discontinued Application: 205589

Drug Name

ARIPIPRAZOLE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2024-03-18

205589 / 3

Active Ingredient

ARIPIPRAZOLE

Application Number

205589

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2024-03-18

Regulatory Status

Discontinued

2024
18 Mar
Discontinued Application: 205589

Drug Name

ARIPIPRAZOLE

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2024-03-18

205589 / 4

Active Ingredient

ARIPIPRAZOLE

Application Number

205589

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2024-03-18

Regulatory Status

Discontinued

2024
18 Mar
Discontinued Application: 205589

Drug Name

ARIPIPRAZOLE

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2024-03-18

205589 / 5

Active Ingredient

ARIPIPRAZOLE

Application Number

205589

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2024-03-18

Regulatory Status

Discontinued

2024
18 Mar
Discontinued Application: 205589

Drug Name

ARIPIPRAZOLE

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2024-03-18

205589 / 6

Active Ingredient

ARIPIPRAZOLE

Application Number

205589

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2024-03-18

Regulatory Status

Discontinued

2016
28 Nov
Discontinued Application: 200751

Drug Name

ARMODAFINIL

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2016-11-28

200751 / 1

Active Ingredient

ARMODAFINIL

Application Number

200751

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2016-11-28

Regulatory Status

Discontinued

2016
28 Nov
Discontinued Application: 200751

Drug Name

ARMODAFINIL

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2016-11-28

200751 / 3

Active Ingredient

ARMODAFINIL

Application Number

200751

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2016-11-28

Regulatory Status

Discontinued

2016
28 Nov
Discontinued Application: 200751

Drug Name

ARMODAFINIL

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2016-11-28

200751 / 4

Active Ingredient

ARMODAFINIL

Application Number

200751

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2016-11-28

Regulatory Status

Discontinued

2016
28 Nov
Discontinued Application: 200751

Drug Name

ARMODAFINIL

Product Number

5

Dosage Form

-

Strength

250MG

Approval Date

2016-11-28

200751 / 5

Active Ingredient

ARMODAFINIL

Application Number

200751

Product Number

5

Dosage Form

-

Strength

250MG

Approval Date

2016-11-28

Regulatory Status

Discontinued

2019
06 Mar
Discontinued Application: 204991

Drug Name

ATORVASTATIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2019-03-06

204991 / 1

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

204991

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2019-03-06

Regulatory Status

Discontinued

2019
06 Mar
Discontinued Application: 204991

Drug Name

ATORVASTATIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2019-03-06

204991 / 2

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

204991

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2019-03-06

Regulatory Status

Discontinued

2019
06 Mar
Discontinued Application: 204991

Drug Name

ATORVASTATIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2019-03-06

204991 / 3

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

204991

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2019-03-06

Regulatory Status

Discontinued

2019
06 Mar
Discontinued Application: 204991

Drug Name

ATORVASTATIN CALCIUM

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2019-03-06

204991 / 4

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

204991

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2019-03-06

Regulatory Status

Discontinued

2018
11 Sep
Discontinued Application: 209105

Drug Name

ATOVAQUONE

Product Number

1

Dosage Form

-

Strength

750MG/5ML

Approval Date

2018-09-11

209105 / 1

Active Ingredient

ATOVAQUONE

Application Number

209105

Product Number

1

Dosage Form

-

Strength

750MG/5ML

Approval Date

2018-09-11

Regulatory Status

Discontinued

2019
27 Feb
Discontinued Application: 210748

Drug Name

AZACITIDINE

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2019-02-27

210748 / 1

Active Ingredient

AZACITIDINE

Application Number

210748

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2019-02-27

Regulatory Status

Discontinued

2015
20 Feb
Discontinued Application: 203991

Drug Name

BIMATOPROST

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

2015-02-20

203991 / 1

Active Ingredient

BIMATOPROST

Application Number

203991

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

2015-02-20

Regulatory Status

Discontinued

2023
17 Mar
Discontinued Application: 213512

Drug Name

BREXPIPRAZOLE

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2023-03-17

213512 / 1

Active Ingredient

BREXPIPRAZOLE

Application Number

213512

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2023-03-17

Regulatory Status

Discontinued

2023
17 Mar
Discontinued Application: 213512

Drug Name

BREXPIPRAZOLE

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2023-03-17

213512 / 2

Active Ingredient

BREXPIPRAZOLE

Application Number

213512

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2023-03-17

Regulatory Status

Discontinued

2023
17 Mar
Discontinued Application: 213512

Drug Name

BREXPIPRAZOLE

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2023-03-17

213512 / 3

Active Ingredient

BREXPIPRAZOLE

Application Number

213512

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2023-03-17

Regulatory Status

Discontinued

2023
17 Mar
Discontinued Application: 213512

Drug Name

BREXPIPRAZOLE

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2023-03-17

213512 / 4

Active Ingredient

BREXPIPRAZOLE

Application Number

213512

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2023-03-17

Regulatory Status

Discontinued

2023
17 Mar
Discontinued Application: 213512

Drug Name

BREXPIPRAZOLE

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2023-03-17

213512 / 5

Active Ingredient

BREXPIPRAZOLE

Application Number

213512

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2023-03-17

Regulatory Status

Discontinued

2023
17 Mar
Discontinued Application: 213512

Drug Name

BREXPIPRAZOLE

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2023-03-17

213512 / 6

Active Ingredient

BREXPIPRAZOLE

Application Number

213512

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2023-03-17

Regulatory Status

Discontinued

2022
20 Dec
Discontinued Application: 214918

Drug Name

BRIVARACETAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2022-12-20

214918 / 1

Active Ingredient

BRIVARACETAM

Application Number

214918

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2022-12-20

Regulatory Status

Discontinued

2022
20 Dec
Discontinued Application: 214918

Drug Name

BRIVARACETAM

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2022-12-20

214918 / 2

Active Ingredient

BRIVARACETAM

Application Number

214918

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2022-12-20

Regulatory Status

Discontinued

2022
20 Dec
Discontinued Application: 214918

Drug Name

BRIVARACETAM

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2022-12-20

214918 / 3

Active Ingredient

BRIVARACETAM

Application Number

214918

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2022-12-20

Regulatory Status

Discontinued

2022
20 Dec
Discontinued Application: 214918

Drug Name

BRIVARACETAM

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

2022-12-20

214918 / 4

Active Ingredient

BRIVARACETAM

Application Number

214918

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

2022-12-20

Regulatory Status

Discontinued

2022
20 Dec
Discontinued Application: 214918

Drug Name

BRIVARACETAM

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

2022-12-20

214918 / 5

Active Ingredient

BRIVARACETAM

Application Number

214918

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

2022-12-20

Regulatory Status

Discontinued

2006
06 Oct
Discontinued Application: 21912

Drug Name

BROVANA

Product Number

1

Dosage Form

-

Strength

EQ 0.015MG BASE/2ML

Approval Date

2006-10-06

21912 / 1

Active Ingredient

ARFORMOTEROL TARTRATE

Application Number

21912

Product Number

1

Dosage Form

-

Strength

EQ 0.015MG BASE/2ML

Approval Date

2006-10-06

Regulatory Status

Discontinued

2015
09 Jul
Discontinued Application: 202127

Drug Name

CALCIUM ACETATE

Product Number

1

Dosage Form

-

Strength

667MG

Approval Date

2015-07-09

202127 / 1

Active Ingredient

CALCIUM ACETATE

Application Number

202127

Product Number

1

Dosage Form

-

Strength

667MG

Approval Date

2015-07-09

Regulatory Status

Discontinued

2007
05 Sep
Discontinued Application: 78217

Drug Name

CARVEDILOL

Product Number

1

Dosage Form

-

Strength

3.125MG

Approval Date

2007-09-05

78217 / 1

Active Ingredient

CARVEDILOL

Application Number

78217

Product Number

1

Dosage Form

-

Strength

3.125MG

Approval Date

2007-09-05

Regulatory Status

Discontinued

2007
05 Sep
Discontinued Application: 78217

Drug Name

CARVEDILOL

Product Number

2

Dosage Form

-

Strength

6.25MG

Approval Date

2007-09-05

78217 / 2

Active Ingredient

CARVEDILOL

Application Number

78217

Product Number

2

Dosage Form

-

Strength

6.25MG

Approval Date

2007-09-05

Regulatory Status

Discontinued

2007
05 Sep
Discontinued Application: 78217

Drug Name

CARVEDILOL

Product Number

3

Dosage Form

-

Strength

12.5MG

Approval Date

2007-09-05

78217 / 3

Active Ingredient

CARVEDILOL

Application Number

78217

Product Number

3

Dosage Form

-

Strength

12.5MG

Approval Date

2007-09-05

Regulatory Status

Discontinued

2007
05 Sep
Discontinued Application: 78217

Drug Name

CARVEDILOL

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2007-09-05

78217 / 4

Active Ingredient

CARVEDILOL

Application Number

78217

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2007-09-05

Regulatory Status

Discontinued

2003
24 Sep
Discontinued Application: 65124

Drug Name

CEFOTAXIME SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2003-09-24

65124 / 1

Active Ingredient

CEFOTAXIME SODIUM

Application Number

65124

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2003-09-24

Regulatory Status

Discontinued

2003
24 Sep
Discontinued Application: 65124

Drug Name

CEFOTAXIME SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2003-09-24

65124 / 2

Active Ingredient

CEFOTAXIME SODIUM

Application Number

65124

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2003-09-24

Regulatory Status

Discontinued

2003
24 Sep
Discontinued Application: 65124

Drug Name

CEFOTAXIME SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2003-09-24

65124 / 3

Active Ingredient

CEFOTAXIME SODIUM

Application Number

65124

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2003-09-24

Regulatory Status

Discontinued

2003
30 Sep
Discontinued Application: 65125

Drug Name

CEFTRIAXONE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

2003-09-30

65125 / 1

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65125

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

2003-09-30

Regulatory Status

Discontinued

2003
30 Sep
Discontinued Application: 65125

Drug Name

CEFTRIAXONE

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2003-09-30

65125 / 2

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65125

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2003-09-30

Regulatory Status

Discontinued

2003
30 Sep
Discontinued Application: 65125

Drug Name

CEFTRIAXONE

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2003-09-30

65125 / 3

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65125

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2003-09-30

Regulatory Status

Discontinued

2003
30 Sep
Discontinued Application: 65125

Drug Name

CEFTRIAXONE

Product Number

4

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2003-09-30

65125 / 4

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65125

Product Number

4

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2003-09-30

Regulatory Status

Discontinued

2006
12 Sep
Discontinued Application: 65263

Drug Name

CEFTRIAXONE

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2006-09-12

65263 / 1

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65263

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2006-09-12

Regulatory Status

Discontinued

2003
25 Jul
Discontinued Application: 65135

Drug Name

CEFUROXIME AXETIL

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2003-07-25

65135 / 1

Active Ingredient

CEFUROXIME AXETIL

Application Number

65135

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2003-07-25

Regulatory Status

Discontinued

2003
25 Jul
Discontinued Application: 65135

Drug Name

CEFUROXIME AXETIL

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2003-07-25

65135 / 2

Active Ingredient

CEFUROXIME AXETIL

Application Number

65135

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2003-07-25

Regulatory Status

Discontinued

2019
28 Jun
Discontinued Application: 210548

Drug Name

CINACALCET HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2019-06-28

210548 / 1

Active Ingredient

CINACALCET HYDROCHLORIDE

Application Number

210548

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2019-06-28

Regulatory Status

Discontinued

2019
28 Jun
Discontinued Application: 210548

Drug Name

CINACALCET HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2019-06-28

210548 / 2

Active Ingredient

CINACALCET HYDROCHLORIDE

Application Number

210548

Product Number

2

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2019-06-28

Regulatory Status

Discontinued

2019
28 Jun
Discontinued Application: 210548

Drug Name

CINACALCET HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 90MG BASE

Approval Date

2019-06-28

210548 / 3

Active Ingredient

CINACALCET HYDROCHLORIDE

Application Number

210548

Product Number

3

Dosage Form

-

Strength

EQ 90MG BASE

Approval Date

2019-06-28

Regulatory Status

Discontinued

2015
15 Sep
Discontinued Application: 202532

Drug Name

CLARITHROMYCIN

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2015-09-15

202532 / 1

Active Ingredient

CLARITHROMYCIN

Application Number

202532

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2015-09-15

Regulatory Status

Discontinued

2018
28 Dec
Discontinued Application: 210546

Drug Name

CLOBAZAM

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

2018-12-28

210546 / 1

Active Ingredient

CLOBAZAM

Application Number

210546

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

2018-12-28

Regulatory Status

Discontinued

2018
26 Mar
Discontinued Application: 208125

Drug Name

CLOBETASOL PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2018-03-26

208125 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

208125

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2018-03-26

Regulatory Status

Discontinued

2018
09 Nov
Discontinued Application: 210756

Drug Name

DECITABINE

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2018-11-09

210756 / 1

Active Ingredient

DECITABINE

Application Number

210756

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2018-11-09

Regulatory Status

Discontinued

2008
29 Jul
Discontinued Application: 78790

Drug Name

DIVALPROEX SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 125MG VALPROIC ACID

Approval Date

2008-07-29

78790 / 1

Active Ingredient

DIVALPROEX SODIUM

Application Number

78790

Product Number

1

Dosage Form

-

Strength

EQ 125MG VALPROIC ACID

Approval Date

2008-07-29

Regulatory Status

Discontinued

2008
29 Jul
Discontinued Application: 78790

Drug Name

DIVALPROEX SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

2008-07-29

78790 / 2

Active Ingredient

DIVALPROEX SODIUM

Application Number

78790

Product Number

2

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

2008-07-29

Regulatory Status

Discontinued

2008
29 Jul
Discontinued Application: 78790

Drug Name

DIVALPROEX SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

2008-07-29

78790 / 3

Active Ingredient

DIVALPROEX SODIUM

Application Number

78790

Product Number

3

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

2008-07-29

Regulatory Status

Discontinued

2015
30 Oct
Discontinued Application: 202782

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

23MG

Approval Date

2015-10-30

202782 / 1

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

202782

Product Number

1

Dosage Form

-

Strength

23MG

Approval Date

2015-10-30

Regulatory Status

Discontinued

2018
01 Nov
Discontinued Application: 210801

Drug Name

DOXERCALCIFEROL

Product Number

1

Dosage Form

-

Strength

4MCG/2ML (2MCG/ML)

Approval Date

2018-11-01

210801 / 1

Active Ingredient

DOXERCALCIFEROL

Application Number

210801

Product Number

1

Dosage Form

-

Strength

4MCG/2ML (2MCG/ML)

Approval Date

2018-11-01

Regulatory Status

Discontinued

2023
11 Aug
Discontinued Application: 208741

Drug Name

DOXYCYCLINE HYCLATE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2023-08-11

208741 / 1

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

208741

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2023-08-11

Regulatory Status

Discontinued

2023
11 Aug
Discontinued Application: 208741

Drug Name

DOXYCYCLINE HYCLATE

Product Number

2

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2023-08-11

208741 / 2

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

208741

Product Number

2

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2023-08-11

Regulatory Status

Discontinued

2023
11 Aug
Discontinued Application: 208741

Drug Name

DOXYCYCLINE HYCLATE

Product Number

3

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2023-08-11

208741 / 3

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

208741

Product Number

3

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2023-08-11

Regulatory Status

Discontinued

2023
11 Aug
Discontinued Application: 208741

Drug Name

DOXYCYCLINE HYCLATE

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2023-08-11

208741 / 4

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

208741

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2023-08-11

Regulatory Status

Discontinued

2023
11 Aug
Discontinued Application: 208741

Drug Name

DOXYCYCLINE HYCLATE

Product Number

5

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2023-08-11

208741 / 5

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

208741

Product Number

5

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2023-08-11

Regulatory Status

Discontinued

2023
11 Aug
Discontinued Application: 208741

Drug Name

DOXYCYCLINE HYCLATE

Product Number

6

Dosage Form

-

Strength

EQ 120MG BASE

Approval Date

2023-08-11

208741 / 6

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

208741

Product Number

6

Dosage Form

-

Strength

EQ 120MG BASE

Approval Date

2023-08-11

Regulatory Status

Discontinued

2023
11 Aug
Discontinued Application: 208741

Drug Name

DOXYCYCLINE HYCLATE

Product Number

7

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2023-08-11

208741 / 7

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

208741

Product Number

7

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2023-08-11

Regulatory Status

Discontinued

2023
11 Aug
Discontinued Application: 208741

Drug Name

DOXYCYCLINE HYCLATE

Product Number

8

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2023-08-11

208741 / 8

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

208741

Product Number

8

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2023-08-11

Regulatory Status

Discontinued

2024
31 Jan
Discontinued Application: 205904

Drug Name

DRONEDARONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2024-01-31

205904 / 1

Active Ingredient

DRONEDARONE HYDROCHLORIDE

Application Number

205904

Product Number

1

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2024-01-31

Regulatory Status

Discontinued

2022
02 Mar
Discontinued Application: 212169

Drug Name

EFINACONAZOLE

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

2022-03-02

212169 / 1

Active Ingredient

EFINACONAZOLE

Application Number

212169

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

2022-03-02

Regulatory Status

Discontinued

2024
13 Dec
Discontinued Application: 213926

Drug Name

EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE

Product Number

1

Dosage Form

-

Strength

200MG;EQ 25MG BASE

Approval Date

2024-12-13

213926 / 1

Active Ingredient

EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Application Number

213926

Product Number

1

Dosage Form

-

Strength

200MG;EQ 25MG BASE

Approval Date

2024-12-13

Regulatory Status

Discontinued

2011
13 Sep
Discontinued Application: 91124

Drug Name

ESZOPICLONE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2011-09-13

91124 / 1

Active Ingredient

ESZOPICLONE

Application Number

91124

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2011-09-13

Regulatory Status

Discontinued

2011
13 Sep
Discontinued Application: 91124

Drug Name

ESZOPICLONE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2011-09-13

91124 / 2

Active Ingredient

ESZOPICLONE

Application Number

91124

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2011-09-13

Regulatory Status

Discontinued

2011
13 Sep
Discontinued Application: 91124

Drug Name

ESZOPICLONE

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2011-09-13

91124 / 3

Active Ingredient

ESZOPICLONE

Application Number

91124

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2011-09-13

Regulatory Status

Discontinued

2019
30 Sep
Discontinued Application: 211633

Drug Name

EXTENDED PHENYTOIN SODIUM

Product Number

1

Dosage Form

-

Strength

100MG EXTENDED

Approval Date

2019-09-30

211633 / 1

Active Ingredient

PHENYTOIN SODIUM

Application Number

211633

Product Number

1

Dosage Form

-

Strength

100MG EXTENDED

Approval Date

2019-09-30

Regulatory Status

Discontinued

2016
29 Mar
Discontinued Application: 205943

Drug Name

FAYOSIM

Product Number

1

Dosage Form

-

Strength

0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A

Approval Date

2016-03-29

205943 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

205943

Product Number

1

Dosage Form

-

Strength

0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A

Approval Date

2016-03-29

Regulatory Status

Discontinued

2024
17 Jan
Discontinued Application: 205406

Drug Name

FEBUXOSTAT

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2024-01-17

205406 / 1

Active Ingredient

FEBUXOSTAT

Application Number

205406

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2024-01-17

Regulatory Status

Discontinued

2024
17 Jan
Discontinued Application: 205406

Drug Name

FEBUXOSTAT

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2024-01-17

205406 / 2

Active Ingredient

FEBUXOSTAT

Application Number

205406

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2024-01-17

Regulatory Status

Discontinued

2023
20 Oct
Discontinued Application: 209146

Drug Name

FLUCONAZOLE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2023-10-20

209146 / 1

Active Ingredient

FLUCONAZOLE

Application Number

209146

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2023-10-20

Regulatory Status

Discontinued

2023
20 Oct
Discontinued Application: 209146

Drug Name

FLUCONAZOLE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2023-10-20

209146 / 2

Active Ingredient

FLUCONAZOLE

Application Number

209146

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2023-10-20

Regulatory Status

Discontinued

2023
20 Oct
Discontinued Application: 209146

Drug Name

FLUCONAZOLE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2023-10-20

209146 / 3

Active Ingredient

FLUCONAZOLE

Application Number

209146

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2023-10-20

Regulatory Status

Discontinued

2023
20 Oct
Discontinued Application: 209146

Drug Name

FLUCONAZOLE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2023-10-20

209146 / 4

Active Ingredient

FLUCONAZOLE

Application Number

209146

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2023-10-20

Regulatory Status

Discontinued

2019
08 Feb
Discontinued Application: 211632

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2019-02-08

211632 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

211632

Product Number

1

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2019-02-08

Regulatory Status

Discontinued

2019
05 Sep
Discontinued Application: 210689

Drug Name

FOSAPREPITANT DIMEGLUMINE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/VIAL

Approval Date

2019-09-05

210689 / 1

Active Ingredient

FOSAPREPITANT DIMEGLUMINE

Application Number

210689

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/VIAL

Approval Date

2019-09-05

Regulatory Status

Discontinued

2018
24 Aug
Discontinued Application: 209306

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2018-08-24

209306 / 1

Active Ingredient

GABAPENTIN

Application Number

209306

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2018-08-24

Regulatory Status

Discontinued

2018
24 Aug
Discontinued Application: 209306

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

2018-08-24

209306 / 2

Active Ingredient

GABAPENTIN

Application Number

209306

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

2018-08-24

Regulatory Status

Discontinued

2013
28 Aug
Discontinued Application: 202653

Drug Name

GATIFLOXACIN

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2013-08-28

202653 / 1

Active Ingredient

GATIFLOXACIN

Application Number

202653

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2013-08-28

Regulatory Status

Discontinued

2023
07 Feb
Discontinued Application: 213655

Drug Name

GLYCOPYRROLATE

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2023-02-07

213655 / 1

Active Ingredient

GLYCOPYRROLATE

Application Number

213655

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2023-02-07

Regulatory Status

Discontinued

2022
05 May
Discontinued Application: 206890

Drug Name

ILOPERIDONE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2022-05-05

206890 / 1

Active Ingredient

ILOPERIDONE

Application Number

206890

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2022-05-05

Regulatory Status

Discontinued

2022
05 May
Discontinued Application: 206890

Drug Name

ILOPERIDONE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2022-05-05

206890 / 2

Active Ingredient

ILOPERIDONE

Application Number

206890

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2022-05-05

Regulatory Status

Discontinued

2022
05 May
Discontinued Application: 206890

Drug Name

ILOPERIDONE

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

2022-05-05

206890 / 3

Active Ingredient

ILOPERIDONE

Application Number

206890

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

2022-05-05

Regulatory Status

Discontinued

2022
05 May
Discontinued Application: 206890

Drug Name

ILOPERIDONE

Product Number

4

Dosage Form

-

Strength

6MG

Approval Date

2022-05-05

206890 / 4

Active Ingredient

ILOPERIDONE

Application Number

206890

Product Number

4

Dosage Form

-

Strength

6MG

Approval Date

2022-05-05

Regulatory Status

Discontinued

2022
05 May
Discontinued Application: 206890

Drug Name

ILOPERIDONE

Product Number

5

Dosage Form

-

Strength

8MG

Approval Date

2022-05-05

206890 / 5

Active Ingredient

ILOPERIDONE

Application Number

206890

Product Number

5

Dosage Form

-

Strength

8MG

Approval Date

2022-05-05

Regulatory Status

Discontinued

2022
05 May
Discontinued Application: 206890

Drug Name

ILOPERIDONE

Product Number

6

Dosage Form

-

Strength

10MG

Approval Date

2022-05-05

206890 / 6

Active Ingredient

ILOPERIDONE

Application Number

206890

Product Number

6

Dosage Form

-

Strength

10MG

Approval Date

2022-05-05

Regulatory Status

Discontinued

2022
05 May
Discontinued Application: 206890

Drug Name

ILOPERIDONE

Product Number

7

Dosage Form

-

Strength

12MG

Approval Date

2022-05-05

206890 / 7

Active Ingredient

ILOPERIDONE

Application Number

206890

Product Number

7

Dosage Form

-

Strength

12MG

Approval Date

2022-05-05

Regulatory Status

Discontinued

2012
15 Oct
Discontinued Application: 201531

Drug Name

IRBESARTAN

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2012-10-15

201531 / 1

Active Ingredient

IRBESARTAN

Application Number

201531

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2012-10-15

Regulatory Status

Discontinued

2012
15 Oct
Discontinued Application: 201531

Drug Name

IRBESARTAN

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2012-10-15

201531 / 2

Active Ingredient

IRBESARTAN

Application Number

201531

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2012-10-15

Regulatory Status

Discontinued

2012
15 Oct
Discontinued Application: 201531

Drug Name

IRBESARTAN

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2012-10-15

201531 / 3

Active Ingredient

IRBESARTAN

Application Number

201531

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2012-10-15

Regulatory Status

Discontinued

2014
18 Dec
Discontinued Application: 205217

Drug Name

LAMIVUDINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2014-12-18

205217 / 1

Active Ingredient

LAMIVUDINE

Application Number

205217

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2014-12-18

Regulatory Status

Discontinued

2014
18 Dec
Discontinued Application: 205217

Drug Name

LAMIVUDINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2014-12-18

205217 / 2

Active Ingredient

LAMIVUDINE

Application Number

205217

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2014-12-18

Regulatory Status

Discontinued

2012
15 May
Discontinued Application: 90246

Drug Name

LAMIVUDINE AND ZIDOVUDINE

Product Number

1

Dosage Form

-

Strength

150MG;300MG

Approval Date

2012-05-15

90246 / 1

Active Ingredient

LAMIVUDINE; ZIDOVUDINE

Application Number

90246

Product Number

1

Dosage Form

-

Strength

150MG;300MG

Approval Date

2012-05-15

Regulatory Status

Discontinued

2010
01 Jun
Discontinued Application: 78691

Drug Name

LAMOTRIGINE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2010-06-01

78691 / 1

Active Ingredient

LAMOTRIGINE

Application Number

78691

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2010-06-01

Regulatory Status

Discontinued

2010
01 Jun
Discontinued Application: 78691

Drug Name

LAMOTRIGINE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2010-06-01

78691 / 2

Active Ingredient

LAMOTRIGINE

Application Number

78691

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2010-06-01

Regulatory Status

Discontinued

2010
01 Jun
Discontinued Application: 78691

Drug Name

LAMOTRIGINE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2010-06-01

78691 / 3

Active Ingredient

LAMOTRIGINE

Application Number

78691

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2010-06-01

Regulatory Status

Discontinued

2010
01 Jun
Discontinued Application: 78691

Drug Name

LAMOTRIGINE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2010-06-01

78691 / 4

Active Ingredient

LAMOTRIGINE

Application Number

78691

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2010-06-01

Regulatory Status

Discontinued

2011
17 Oct
Discontinued Application: 90893

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2011-10-17

90893 / 1

Active Ingredient

LEVETIRACETAM

Application Number

90893

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2011-10-17

Regulatory Status

Discontinued

2011
20 Jun
Discontinued Application: 78424

Drug Name

LEVOFLOXACIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2011-06-20

78424 / 1

Active Ingredient

LEVOFLOXACIN

Application Number

78424

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2011-06-20

Regulatory Status

Discontinued

2011
20 Jun
Discontinued Application: 78424

Drug Name

LEVOFLOXACIN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2011-06-20

78424 / 2

Active Ingredient

LEVOFLOXACIN

Application Number

78424

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2011-06-20

Regulatory Status

Discontinued

2011
20 Jun
Discontinued Application: 78424

Drug Name

LEVOFLOXACIN

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2011-06-20

78424 / 3

Active Ingredient

LEVOFLOXACIN

Application Number

78424

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2011-06-20

Regulatory Status

Discontinued

2013
23 Jan
Discontinued Application: 91328

Drug Name

LEVONORGESTREL

Product Number

1

Dosage Form

-

Strength

0.75MG

Approval Date

2013-01-23

91328 / 1

Active Ingredient

LEVONORGESTREL

Application Number

91328

Product Number

1

Dosage Form

-

Strength

0.75MG

Approval Date

2013-01-23

Regulatory Status

Discontinued

2013
19 Feb
Discontinued Application: 91407

Drug Name

LORAZEPAM

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2013-02-19

91407 / 1

Active Ingredient

LORAZEPAM

Application Number

91407

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2013-02-19

Regulatory Status

Discontinued

2023
15 Aug
Discontinued Application: 209272

Drug Name

METOPROLOL SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG TARTRATE

Approval Date

2023-08-15

209272 / 1

Active Ingredient

METOPROLOL SUCCINATE

Application Number

209272

Product Number

1

Dosage Form

-

Strength

EQ 25MG TARTRATE

Approval Date

2023-08-15

Regulatory Status

Discontinued

2023
15 Aug
Discontinued Application: 209272

Drug Name

METOPROLOL SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG TARTRATE

Approval Date

2023-08-15

209272 / 2

Active Ingredient

METOPROLOL SUCCINATE

Application Number

209272

Product Number

2

Dosage Form

-

Strength

EQ 50MG TARTRATE

Approval Date

2023-08-15

Regulatory Status

Discontinued

2023
15 Aug
Discontinued Application: 209272

Drug Name

METOPROLOL SUCCINATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG TARTRATE

Approval Date

2023-08-15

209272 / 3

Active Ingredient

METOPROLOL SUCCINATE

Application Number

209272

Product Number

3

Dosage Form

-

Strength

EQ 100MG TARTRATE

Approval Date

2023-08-15

Regulatory Status

Discontinued

2023
15 Aug
Discontinued Application: 209272

Drug Name

METOPROLOL SUCCINATE

Product Number

4

Dosage Form

-

Strength

EQ 200MG TARTRATE

Approval Date

2023-08-15

209272 / 4

Active Ingredient

METOPROLOL SUCCINATE

Application Number

209272

Product Number

4

Dosage Form

-

Strength

EQ 200MG TARTRATE

Approval Date

2023-08-15

Regulatory Status

Discontinued

2017
12 Sep
Discontinued Application: 209096

Drug Name

METRONIDAZOLE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2017-09-12

209096 / 1

Active Ingredient

METRONIDAZOLE

Application Number

209096

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2017-09-12

Regulatory Status

Discontinued

2017
12 Sep
Discontinued Application: 209096

Drug Name

METRONIDAZOLE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2017-09-12

209096 / 2

Active Ingredient

METRONIDAZOLE

Application Number

209096

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2017-09-12

Regulatory Status

Discontinued

2017
04 Aug
Discontinued Application: 209875

Drug Name

NIKITA

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2017-08-04

209875 / 1

Active Ingredient

PITAVASTATIN SODIUM

Application Number

209875

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2017-08-04

Regulatory Status

Discontinued

2017
04 Aug
Discontinued Application: 209875

Drug Name

NIKITA

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2017-08-04

209875 / 2

Active Ingredient

PITAVASTATIN SODIUM

Application Number

209875

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2017-08-04

Regulatory Status

Discontinued

2017
04 Aug
Discontinued Application: 209875

Drug Name

NIKITA

Product Number

3

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2017-08-04

209875 / 3

Active Ingredient

PITAVASTATIN SODIUM

Application Number

209875

Product Number

3

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2017-08-04

Regulatory Status

Discontinued

2023
30 May
Discontinued Application: 214980

Drug Name

OBETICHOLIC ACID

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2023-05-30

214980 / 1

Active Ingredient

OBETICHOLIC ACID

Application Number

214980

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2023-05-30

Regulatory Status

Discontinued

2023
30 May
Discontinued Application: 214980

Drug Name

OBETICHOLIC ACID

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2023-05-30

214980 / 2

Active Ingredient

OBETICHOLIC ACID

Application Number

214980

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2023-05-30

Regulatory Status

Discontinued

2017
27 Apr
Discontinued Application: 206631

Drug Name

OLMESARTAN MEDOXOMIL

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2017-04-27

206631 / 1

Active Ingredient

OLMESARTAN MEDOXOMIL

Application Number

206631

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2017-04-27

Regulatory Status

Discontinued

2017
27 Apr
Discontinued Application: 206631

Drug Name

OLMESARTAN MEDOXOMIL

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2017-04-27

206631 / 2

Active Ingredient

OLMESARTAN MEDOXOMIL

Application Number

206631

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2017-04-27

Regulatory Status

Discontinued

2017
27 Apr
Discontinued Application: 206631

Drug Name

OLMESARTAN MEDOXOMIL

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2017-04-27

206631 / 3

Active Ingredient

OLMESARTAN MEDOXOMIL

Application Number

206631

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2017-04-27

Regulatory Status

Discontinued

2015
25 Aug
Discontinued Application: 202384

Drug Name

OMEPRAZOLE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2015-08-25

202384 / 1

Active Ingredient

OMEPRAZOLE

Application Number

202384

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2015-08-25

Regulatory Status

Discontinued

2022
29 Jun
Discontinued Application: 208643

Drug Name

PALIPERIDONE

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

2022-06-29

208643 / 1

Active Ingredient

PALIPERIDONE

Application Number

208643

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

2022-06-29

Regulatory Status

Discontinued

2022
29 Jun
Discontinued Application: 208643

Drug Name

PALIPERIDONE

Product Number

2

Dosage Form

-

Strength

3MG

Approval Date

2022-06-29

208643 / 2

Active Ingredient

PALIPERIDONE

Application Number

208643

Product Number

2

Dosage Form

-

Strength

3MG

Approval Date

2022-06-29

Regulatory Status

Discontinued

2022
29 Jun
Discontinued Application: 208643

Drug Name

PALIPERIDONE

Product Number

3

Dosage Form

-

Strength

6MG

Approval Date

2022-06-29

208643 / 3

Active Ingredient

PALIPERIDONE

Application Number

208643

Product Number

3

Dosage Form

-

Strength

6MG

Approval Date

2022-06-29

Regulatory Status

Discontinued

2022
29 Jun
Discontinued Application: 208643

Drug Name

PALIPERIDONE

Product Number

4

Dosage Form

-

Strength

9MG

Approval Date

2022-06-29

208643 / 4

Active Ingredient

PALIPERIDONE

Application Number

208643

Product Number

4

Dosage Form

-

Strength

9MG

Approval Date

2022-06-29

Regulatory Status

Discontinued

2017
20 Jan
Discontinued Application: 204134

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE

Approval Date

2017-01-20

204134 / 1

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

204134

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE

Approval Date

2017-01-20

Regulatory Status

Discontinued

2017
20 Jan
Discontinued Application: 204134

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2017-01-20

204134 / 2

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

204134

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2017-01-20

Regulatory Status

Discontinued

2017
20 Jan
Discontinued Application: 204134

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2017-01-20

204134 / 3

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

204134

Product Number

3

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2017-01-20

Regulatory Status

Discontinued

2010
27 Jan
Discontinued Application: 78263

Drug Name

PERINDOPRIL ERBUMINE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2010-01-27

78263 / 1

Active Ingredient

PERINDOPRIL ERBUMINE

Application Number

78263

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2010-01-27

Regulatory Status

Discontinued

2010
27 Jan
Discontinued Application: 78263

Drug Name

PERINDOPRIL ERBUMINE

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2010-01-27

78263 / 2

Active Ingredient

PERINDOPRIL ERBUMINE

Application Number

78263

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2010-01-27

Regulatory Status

Discontinued

2010
27 Jan
Discontinued Application: 78263

Drug Name

PERINDOPRIL ERBUMINE

Product Number

3

Dosage Form

-

Strength

8MG

Approval Date

2010-01-27

78263 / 3

Active Ingredient

PERINDOPRIL ERBUMINE

Application Number

78263

Product Number

3

Dosage Form

-

Strength

8MG

Approval Date

2010-01-27

Regulatory Status

Discontinued

2013
24 Apr
Discontinued Application: 201512

Drug Name

PIRMELLA 1/35

Product Number

1

Dosage Form

-

Strength

0.035MG;1MG

Approval Date

2013-04-24

201512 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE

Application Number

201512

Product Number

1

Dosage Form

-

Strength

0.035MG;1MG

Approval Date

2013-04-24

Regulatory Status

Discontinued

2013
24 Apr
Discontinued Application: 201510

Drug Name

PIRMELLA 7/7/7

Product Number

1

Dosage Form

-

Strength

0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG

Approval Date

2013-04-24

201510 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE

Application Number

201510

Product Number

1

Dosage Form

-

Strength

0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG

Approval Date

2013-04-24

Regulatory Status

Discontinued

2015
18 Dec
Discontinued Application: 203002

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

2015-12-18

203002 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

203002

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

2015-12-18

Regulatory Status

Discontinued

2015
18 Dec
Discontinued Application: 203002

Drug Name

POTASSIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2015-12-18

203002 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

203002

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2015-12-18

Regulatory Status

Discontinued

2023
09 Jan
Discontinued Application: 205930

Drug Name

PRASUGREL

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2023-01-09

205930 / 1

Active Ingredient

PRASUGREL HYDROCHLORIDE

Application Number

205930

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2023-01-09

Regulatory Status

Discontinued

2023
09 Jan
Discontinued Application: 205930

Drug Name

PRASUGREL

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2023-01-09

205930 / 2

Active Ingredient

PRASUGREL HYDROCHLORIDE

Application Number

205930

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2023-01-09

Regulatory Status

Discontinued

2022
03 May
Discontinued Application: 91040

Drug Name

PREGABALIN

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2022-05-03

91040 / 1

Active Ingredient

PREGABALIN

Application Number

91040

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2022-05-03

Regulatory Status

Discontinued

2022
03 May
Discontinued Application: 91040

Drug Name

PREGABALIN

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2022-05-03

91040 / 2

Active Ingredient

PREGABALIN

Application Number

91040

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2022-05-03

Regulatory Status

Discontinued

2022
03 May
Discontinued Application: 91040

Drug Name

PREGABALIN

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2022-05-03

91040 / 3

Active Ingredient

PREGABALIN

Application Number

91040

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2022-05-03

Regulatory Status

Discontinued

2022
03 May
Discontinued Application: 91040

Drug Name

PREGABALIN

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2022-05-03

91040 / 4

Active Ingredient

PREGABALIN

Application Number

91040

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2022-05-03

Regulatory Status

Discontinued

2022
03 May
Discontinued Application: 91040

Drug Name

PREGABALIN

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2022-05-03

91040 / 5

Active Ingredient

PREGABALIN

Application Number

91040

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2022-05-03

Regulatory Status

Discontinued

2022
03 May
Discontinued Application: 91040

Drug Name

PREGABALIN

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

2022-05-03

91040 / 6

Active Ingredient

PREGABALIN

Application Number

91040

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

2022-05-03

Regulatory Status

Discontinued

2022
03 May
Discontinued Application: 91040

Drug Name

PREGABALIN

Product Number

7

Dosage Form

-

Strength

225MG

Approval Date

2022-05-03

91040 / 7

Active Ingredient

PREGABALIN

Application Number

91040

Product Number

7

Dosage Form

-

Strength

225MG

Approval Date

2022-05-03

Regulatory Status

Discontinued

2022
03 May
Discontinued Application: 91040

Drug Name

PREGABALIN

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

2022-05-03

91040 / 8

Active Ingredient

PREGABALIN

Application Number

91040

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

2022-05-03

Regulatory Status

Discontinued

2024
12 Jan
Discontinued Application: 204349

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2024-01-12

204349 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

204349

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2024-01-12

Regulatory Status

Discontinued

2024
12 Jan
Discontinued Application: 204349

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2024-01-12

204349 / 2

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

204349

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2024-01-12

Regulatory Status

Discontinued

2024
12 Jan
Discontinued Application: 204349

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

2024-01-12

204349 / 3

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

204349

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

2024-01-12

Regulatory Status

Discontinued

2024
12 Jan
Discontinued Application: 204349

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

160MG

Approval Date

2024-01-12

204349 / 4

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

204349

Product Number

4

Dosage Form

-

Strength

160MG

Approval Date

2024-01-12

Regulatory Status

Discontinued

2015
15 Jul
Discontinued Application: 200624

Drug Name

REPAGLINIDE AND METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG;1MG

Approval Date

2015-07-15

200624 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE; REPAGLINIDE

Application Number

200624

Product Number

1

Dosage Form

-

Strength

500MG;1MG

Approval Date

2015-07-15

Regulatory Status

Discontinued

2015
15 Jul
Discontinued Application: 200624

Drug Name

REPAGLINIDE AND METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

500MG;2MG

Approval Date

2015-07-15

200624 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE; REPAGLINIDE

Application Number

200624

Product Number

2

Dosage Form

-

Strength

500MG;2MG

Approval Date

2015-07-15

Regulatory Status

Discontinued

2014
24 Feb
Discontinued Application: 90033

Drug Name

RIFABUTIN

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2014-02-24

90033 / 1

Active Ingredient

RIFABUTIN

Application Number

90033

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2014-02-24

Regulatory Status

Discontinued

2017
31 Jul
Discontinued Application: 205587

Drug Name

ROSUVASTATIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2017-07-31

205587 / 1

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

205587

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2017-07-31

Regulatory Status

Discontinued

2017
31 Jul
Discontinued Application: 205587

Drug Name

ROSUVASTATIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2017-07-31

205587 / 2

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

205587

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2017-07-31

Regulatory Status

Discontinued

2017
31 Jul
Discontinued Application: 205587

Drug Name

ROSUVASTATIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2017-07-31

205587 / 3

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

205587

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2017-07-31

Regulatory Status

Discontinued

2017
31 Jul
Discontinued Application: 205587

Drug Name

ROSUVASTATIN CALCIUM

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2017-07-31

205587 / 4

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

205587

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2017-07-31

Regulatory Status

Discontinued

2020
05 Nov
Discontinued Application: 210864

Drug Name

SESQUIENT

Product Number

1

Dosage Form

-

Strength

EQ 100MG PHENYTOIN NA/2ML (EQ 50MG PHENYTOIN NA/ML)

Approval Date

2020-11-05

210864 / 1

Active Ingredient

FOSPHENYTOIN SODIUM

Application Number

210864

Product Number

1

Dosage Form

-

Strength

EQ 100MG PHENYTOIN NA/2ML (EQ 50MG PHENYTOIN NA/ML)

Approval Date

2020-11-05

Regulatory Status

Discontinued

2020
05 Nov
Discontinued Application: 210864

Drug Name

SESQUIENT

Product Number

2

Dosage Form

-

Strength

EQ 500MG PHENYTOIN NA/10ML (EQ 50MG PHENYTOIN NA/ML)

Approval Date

2020-11-05

210864 / 2

Active Ingredient

FOSPHENYTOIN SODIUM

Application Number

210864

Product Number

2

Dosage Form

-

Strength

EQ 500MG PHENYTOIN NA/10ML (EQ 50MG PHENYTOIN NA/ML)

Approval Date

2020-11-05

Regulatory Status

Discontinued

2021
23 Dec
Discontinued Application: 201513

Drug Name

SEVELAMER CARBONATE

Product Number

1

Dosage Form

-

Strength

800MG/PACKET

Approval Date

2021-12-23

201513 / 1

Active Ingredient

SEVELAMER CARBONATE

Application Number

201513

Product Number

1

Dosage Form

-

Strength

800MG/PACKET

Approval Date

2021-12-23

Regulatory Status

Discontinued

2021
23 Dec
Discontinued Application: 201513

Drug Name

SEVELAMER CARBONATE

Product Number

2

Dosage Form

-

Strength

2.4GM/PACKET

Approval Date

2021-12-23

201513 / 2

Active Ingredient

SEVELAMER CARBONATE

Application Number

201513

Product Number

2

Dosage Form

-

Strength

2.4GM/PACKET

Approval Date

2021-12-23

Regulatory Status

Discontinued

2022
23 Mar
Discontinued Application: 211638

Drug Name

SILDENAFIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2022-03-23

211638 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

211638

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2022-03-23

Regulatory Status

Discontinued

2021
05 Jan
Discontinued Application: 212699

Drug Name

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Product Number

1

Dosage Form

-

Strength

200MG/5ML;40MG/5ML

Approval Date

2021-01-05

212699 / 1

Active Ingredient

SULFAMETHOXAZOLE; TRIMETHOPRIM

Application Number

212699

Product Number

1

Dosage Form

-

Strength

200MG/5ML;40MG/5ML

Approval Date

2021-01-05

Regulatory Status

Discontinued

2010
25 Oct
Discontinued Application: 65380

Drug Name

SUPRAX

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2010-10-25

65380 / 1

Active Ingredient

CEFIXIME

Application Number

65380

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2010-10-25

Regulatory Status

Discontinued

2010
25 Oct
Discontinued Application: 65380

Drug Name

SUPRAX

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2010-10-25

65380 / 2

Active Ingredient

CEFIXIME

Application Number

65380

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2010-10-25

Regulatory Status

Discontinued

2010
25 Oct
Discontinued Application: 65380

Drug Name

SUPRAX

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2010-10-25

65380 / 3

Active Ingredient

CEFIXIME

Application Number

65380

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2010-10-25

Regulatory Status

Discontinued

2021
08 Feb
Discontinued Application: 212168

Drug Name

TAVABOROLE

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2021-02-08

212168 / 1

Active Ingredient

TAVABOROLE

Application Number

212168

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2021-02-08

Regulatory Status

Discontinued

2014
08 Jan
Discontinued Application: 201586

Drug Name

TELMISARTAN AND AMLODIPINE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;40MG

Approval Date

2014-01-08

201586 / 1

Active Ingredient

AMLODIPINE BESYLATE; TELMISARTAN

Application Number

201586

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;40MG

Approval Date

2014-01-08

Regulatory Status

Discontinued

2014
08 Jan
Discontinued Application: 201586

Drug Name

TELMISARTAN AND AMLODIPINE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE;40MG

Approval Date

2014-01-08

201586 / 2

Active Ingredient

AMLODIPINE BESYLATE; TELMISARTAN

Application Number

201586

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE;40MG

Approval Date

2014-01-08

Regulatory Status

Discontinued

2014
08 Jan
Discontinued Application: 201586

Drug Name

TELMISARTAN AND AMLODIPINE

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE;80MG

Approval Date

2014-01-08

201586 / 3

Active Ingredient

AMLODIPINE BESYLATE; TELMISARTAN

Application Number

201586

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE;80MG

Approval Date

2014-01-08

Regulatory Status

Discontinued

2014
08 Jan
Discontinued Application: 201586

Drug Name

TELMISARTAN AND AMLODIPINE

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;80MG

Approval Date

2014-01-08

201586 / 4

Active Ingredient

AMLODIPINE BESYLATE; TELMISARTAN

Application Number

201586

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;80MG

Approval Date

2014-01-08

Regulatory Status

Discontinued

2014
07 Aug
Discontinued Application: 91351

Drug Name

TELMISARTAN AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;40MG

Approval Date

2014-08-07

91351 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; TELMISARTAN

Application Number

91351

Product Number

1

Dosage Form

-

Strength

12.5MG;40MG

Approval Date

2014-08-07

Regulatory Status

Discontinued

2014
07 Aug
Discontinued Application: 91351

Drug Name

TELMISARTAN AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;80MG

Approval Date

2014-08-07

91351 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; TELMISARTAN

Application Number

91351

Product Number

2

Dosage Form

-

Strength

12.5MG;80MG

Approval Date

2014-08-07

Regulatory Status

Discontinued

2014
07 Aug
Discontinued Application: 91351

Drug Name

TELMISARTAN AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;80MG

Approval Date

2014-08-07

91351 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; TELMISARTAN

Application Number

91351

Product Number

3

Dosage Form

-

Strength

25MG;80MG

Approval Date

2014-08-07

Regulatory Status

Discontinued

2024
03 May
Discontinued Application: 207040

Drug Name

TRAVOPROST

Product Number

1

Dosage Form

-

Strength

0.004%

Approval Date

2024-05-03

207040 / 1

Active Ingredient

TRAVOPROST

Application Number

207040

Product Number

1

Dosage Form

-

Strength

0.004%

Approval Date

2024-05-03

Regulatory Status

Discontinued

2020
21 May
Discontinued Application: 211637

Drug Name

TRIENTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2020-05-21

211637 / 1

Active Ingredient

TRIENTINE HYDROCHLORIDE

Application Number

211637

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2020-05-21

Regulatory Status

Discontinued

2015
05 Jan
Discontinued Application: 201677

Drug Name

VALSARTAN

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2015-01-05

201677 / 1

Active Ingredient

VALSARTAN

Application Number

201677

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2015-01-05

Regulatory Status

Discontinued

2015
05 Jan
Discontinued Application: 201677

Drug Name

VALSARTAN

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2015-01-05

201677 / 2

Active Ingredient

VALSARTAN

Application Number

201677

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2015-01-05

Regulatory Status

Discontinued

2015
05 Jan
Discontinued Application: 201677

Drug Name

VALSARTAN

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2015-01-05

201677 / 3

Active Ingredient

VALSARTAN

Application Number

201677

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2015-01-05

Regulatory Status

Discontinued

2015
05 Jan
Discontinued Application: 201677

Drug Name

VALSARTAN

Product Number

4

Dosage Form

-

Strength

320MG

Approval Date

2015-01-05

201677 / 4

Active Ingredient

VALSARTAN

Application Number

201677

Product Number

4

Dosage Form

-

Strength

320MG

Approval Date

2015-01-05

Regulatory Status

Discontinued

2013
21 Mar
Discontinued Application: 78946

Drug Name

VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;320MG

Approval Date

2013-03-21

78946 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

78946

Product Number

1

Dosage Form

-

Strength

12.5MG;320MG

Approval Date

2013-03-21

Regulatory Status

Discontinued

2013
21 Mar
Discontinued Application: 78946

Drug Name

VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

25MG;320MG

Approval Date

2013-03-21

78946 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

78946

Product Number

2

Dosage Form

-

Strength

25MG;320MG

Approval Date

2013-03-21

Regulatory Status

Discontinued

2013
21 Mar
Discontinued Application: 78946

Drug Name

VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

12.5MG;80MG

Approval Date

2013-03-21

78946 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

78946

Product Number

3

Dosage Form

-

Strength

12.5MG;80MG

Approval Date

2013-03-21

Regulatory Status

Discontinued

2013
21 Mar
Discontinued Application: 78946

Drug Name

VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

4

Dosage Form

-

Strength

12.5MG;160MG

Approval Date

2013-03-21

78946 / 4

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

78946

Product Number

4

Dosage Form

-

Strength

12.5MG;160MG

Approval Date

2013-03-21

Regulatory Status

Discontinued

2013
21 Mar
Discontinued Application: 78946

Drug Name

VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

5

Dosage Form

-

Strength

25MG;160MG

Approval Date

2013-03-21

78946 / 5

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

78946

Product Number

5

Dosage Form

-

Strength

25MG;160MG

Approval Date

2013-03-21

Regulatory Status

Discontinued

2015
28 Jan
Discontinued Application: 90439

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE

Approval Date

2015-01-28

90439 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

90439

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE

Approval Date

2015-01-28

Regulatory Status

Discontinued

2015
28 Jan
Discontinued Application: 90439

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2015-01-28

90439 / 2

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

90439

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2015-01-28

Regulatory Status

Discontinued

2019
05 Nov
Discontinued Application: 211972

Drug Name

ZILEUTON

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2019-11-05

211972 / 1

Active Ingredient

ZILEUTON

Application Number

211972

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2019-11-05

Regulatory Status

Discontinued

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Drug Status Breakdown
204 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

ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE

Application Number

202912

Product Number

1

Active Ingredient

ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

Dosage Form

-

Strength

EQ 300MG BASE;150MG;300MG

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

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Searchable pharmaceutical data

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Organized FDA drug records

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