Natco Pharma
FDA Approved Drugs

Natco Pharma

FDA Approved Drugs Database

FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.

RX Discontinued Unclassified OTC
  • Total Records 147
  • Latest Approval Date Jun 01, 2026
  • Data Source FDA
  • First Approval Date Jan 02, 1986
All
147
View
Unclassified
5
View
Discontinued
86
View
OTC
1
View
RX
55
View
Company Overview

Company

Natco Pharma

Country

India

Website

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Social Profiles

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Company Snapshot

Natco Pharma

Banjara Hills, Hyderabad-500 034

India

www.natcopharma.co.in/ View on Map
FDA Approved Drug Records ( 147 records )
2015
15 Apr
RX Application: 200739

Drug Name

ALPRAZOLAM

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2015-04-15

200739 / 1

Active Ingredient

ALPRAZOLAM

Application Number

200739

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2015-04-15

Regulatory Status

RX

2015
15 Apr
RX Application: 200739

Drug Name

ALPRAZOLAM

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2015-04-15

200739 / 2

Active Ingredient

ALPRAZOLAM

Application Number

200739

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2015-04-15

Regulatory Status

RX

2015
15 Apr
RX Application: 200739

Drug Name

ALPRAZOLAM

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2015-04-15

200739 / 3

Active Ingredient

ALPRAZOLAM

Application Number

200739

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2015-04-15

Regulatory Status

RX

2015
15 Apr
RX Application: 200739

Drug Name

ALPRAZOLAM

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2015-04-15

200739 / 4

Active Ingredient

ALPRAZOLAM

Application Number

200739

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2015-04-15

Regulatory Status

RX

2010
28 Jun
RX Application: 79220

Drug Name

ANASTROZOLE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2010-06-28

79220 / 1

Active Ingredient

ANASTROZOLE

Application Number

79220

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2010-06-28

Regulatory Status

RX

2016
28 Nov
RX Application: 202768

Drug Name

ARMODAFINIL

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2016-11-28

202768 / 1

Active Ingredient

ARMODAFINIL

Application Number

202768

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2016-11-28

Regulatory Status

RX

2016
28 Nov
RX Application: 202768

Drug Name

ARMODAFINIL

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2016-11-28

202768 / 2

Active Ingredient

ARMODAFINIL

Application Number

202768

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2016-11-28

Regulatory Status

RX

2016
28 Nov
RX Application: 202768

Drug Name

ARMODAFINIL

Product Number

3

Dosage Form

-

Strength

250MG

Approval Date

2016-11-28

202768 / 3

Active Ingredient

ARMODAFINIL

Application Number

202768

Product Number

3

Dosage Form

-

Strength

250MG

Approval Date

2016-11-28

Regulatory Status

RX

2017
28 Sep
RX Application: 202768

Drug Name

ARMODAFINIL

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2017-09-28

202768 / 4

Active Ingredient

ARMODAFINIL

Application Number

202768

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2017-09-28

Regulatory Status

RX

2017
28 Sep
RX Application: 202768

Drug Name

ARMODAFINIL

Product Number

5

Dosage Form

-

Strength

200MG

Approval Date

2017-09-28

202768 / 5

Active Ingredient

ARMODAFINIL

Application Number

202768

Product Number

5

Dosage Form

-

Strength

200MG

Approval Date

2017-09-28

Regulatory Status

RX

2017
23 Jun
RX Application: 207234

Drug Name

AZACITIDINE

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2017-06-23

207234 / 1

Active Ingredient

AZACITIDINE

Application Number

207234

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2017-06-23

Regulatory Status

RX

2019
26 Apr
Discontinued Application: 206987

Drug Name

BOSENTAN

Product Number

1

Dosage Form

-

Strength

62.5MG

Approval Date

2019-04-26

206987 / 1

Active Ingredient

BOSENTAN

Application Number

206987

Product Number

1

Dosage Form

-

Strength

62.5MG

Approval Date

2019-04-26

Regulatory Status

Discontinued

2019
26 Apr
Discontinued Application: 206987

Drug Name

BOSENTAN

Product Number

2

Dosage Form

-

Strength

125MG

Approval Date

2019-04-26

206987 / 2

Active Ingredient

BOSENTAN

Application Number

206987

Product Number

2

Dosage Form

-

Strength

125MG

Approval Date

2019-04-26

Regulatory Status

Discontinued

2025
05 Feb
RX Application: 213154

Drug Name

BOSENTAN

Product Number

1

Dosage Form

-

Strength

32MG

Approval Date

2025-02-05

213154 / 1

Active Ingredient

BOSENTAN

Application Number

213154

Product Number

1

Dosage Form

-

Strength

32MG

Approval Date

2025-02-05

Regulatory Status

RX

2016
23 Nov
Discontinued Application: 206724

Drug Name

BUDESONIDE

Product Number

1

Dosage Form

-

Strength

3MG

Approval Date

2016-11-23

206724 / 1

Active Ingredient

BUDESONIDE

Application Number

206724

Product Number

1

Dosage Form

-

Strength

3MG

Approval Date

2016-11-23

Regulatory Status

Discontinued

2014
28 Oct
RX Application: 90988

Drug Name

CARISOPRODOL

Product Number

1

Dosage Form

-

Strength

350MG

Approval Date

2014-10-28

90988 / 1

Active Ingredient

CARISOPRODOL

Application Number

90988

Product Number

1

Dosage Form

-

Strength

350MG

Approval Date

2014-10-28

Regulatory Status

RX

2011
21 Jan
RX Application: 90612

Drug Name

CHLOROQUINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2011-01-21

90612 / 1

Active Ingredient

CHLOROQUINE PHOSPHATE

Application Number

90612

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2011-01-21

Regulatory Status

RX

2011
21 Jan
RX Application: 91621

Drug Name

CHLOROQUINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2011-01-21

91621 / 1

Active Ingredient

CHLOROQUINE PHOSPHATE

Application Number

91621

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2011-01-21

Regulatory Status

RX

2004
09 Jun
Discontinued Application: 75685

Drug Name

CIPROFLOXACIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2004-06-09

75685 / 1

Active Ingredient

CIPROFLOXACIN HYDROCHLORIDE

Application Number

75685

Product Number

1

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2004-06-09

Regulatory Status

Discontinued

2004
09 Jun
Discontinued Application: 75685

Drug Name

CIPROFLOXACIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2004-06-09

75685 / 2

Active Ingredient

CIPROFLOXACIN HYDROCHLORIDE

Application Number

75685

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2004-06-09

Regulatory Status

Discontinued

2004
09 Jun
Discontinued Application: 75685

Drug Name

CIPROFLOXACIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2004-06-09

75685 / 3

Active Ingredient

CIPROFLOXACIN HYDROCHLORIDE

Application Number

75685

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2004-06-09

Regulatory Status

Discontinued

2008
10 Apr
Discontinued Application: 77141

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2008-04-10

77141 / 1

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

77141

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2008-04-10

Regulatory Status

Discontinued

2008
10 Apr
Discontinued Application: 77141

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2008-04-10

77141 / 2

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

77141

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2008-04-10

Regulatory Status

Discontinued

1987
09 Feb
Discontinued Application: 71325

Drug Name

CLORPRES

Product Number

1

Dosage Form

-

Strength

15MG;0.3MG

Approval Date

1987-02-09

71325 / 1

Active Ingredient

CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE

Application Number

71325

Product Number

1

Dosage Form

-

Strength

15MG;0.3MG

Approval Date

1987-02-09

Regulatory Status

Discontinued

1987
09 Feb
Discontinued Application: 71325

Drug Name

CLORPRES

Product Number

2

Dosage Form

-

Strength

15MG;0.2MG

Approval Date

1987-02-09

71325 / 2

Active Ingredient

CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE

Application Number

71325

Product Number

2

Dosage Form

-

Strength

15MG;0.2MG

Approval Date

1987-02-09

Regulatory Status

Discontinued

1987
09 Feb
Discontinued Application: 71325

Drug Name

CLORPRES

Product Number

3

Dosage Form

-

Strength

15MG;0.1MG

Approval Date

1987-02-09

71325 / 3

Active Ingredient

CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE

Application Number

71325

Product Number

3

Dosage Form

-

Strength

15MG;0.1MG

Approval Date

1987-02-09

Regulatory Status

Discontinued

2011
31 May
Discontinued Application: 90521

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-05-31

90521 / 1

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

90521

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-05-31

Regulatory Status

Discontinued

2011
31 May
Discontinued Application: 90521

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-05-31

90521 / 2

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

90521

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-05-31

Regulatory Status

Discontinued

-
Unclassified Application: 218578

Drug Name

ERDAFITINIB

Product Number

1

Dosage Form

-

Strength

Approval Date

-

218578 / 1

Active Ingredient

ERDAFITINIB

Application Number

218578

Product Number

1

Dosage Form

-

Strength

Approval Date

-

Regulatory Status

Unclassified

2026
01 Jun
RX Application: 217085

Drug Name

ERIBULIN MESYLATE

Product Number

1

Dosage Form

-

Strength

1MG/2ML (0.5MG/ML)

Approval Date

2026-06-01

217085 / 1

Active Ingredient

ERIBULIN MESYLATE

Application Number

217085

Product Number

1

Dosage Form

-

Strength

1MG/2ML (0.5MG/ML)

Approval Date

2026-06-01

Regulatory Status

RX

2019
05 Nov
Discontinued Application: 208488

Drug Name

ERLOTINIB HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2019-11-05

208488 / 1

Active Ingredient

ERLOTINIB HYDROCHLORIDE

Application Number

208488

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2019-11-05

Regulatory Status

Discontinued

2019
05 Nov
Discontinued Application: 208488

Drug Name

ERLOTINIB HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2019-11-05

208488 / 2

Active Ingredient

ERLOTINIB HYDROCHLORIDE

Application Number

208488

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2019-11-05

Regulatory Status

Discontinued

2019
05 Nov
Discontinued Application: 208488

Drug Name

ERLOTINIB HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2019-11-05

208488 / 3

Active Ingredient

ERLOTINIB HYDROCHLORIDE

Application Number

208488

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2019-11-05

Regulatory Status

Discontinued

1997
16 May
Discontinued Application: 74932

Drug Name

ETODOLAC

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1997-05-16

74932 / 1

Active Ingredient

ETODOLAC

Application Number

74932

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1997-05-16

Regulatory Status

Discontinued

1997
16 May
Discontinued Application: 74932

Drug Name

ETODOLAC

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1997-05-16

74932 / 2

Active Ingredient

ETODOLAC

Application Number

74932

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1997-05-16

Regulatory Status

Discontinued

1998
06 Feb
Discontinued Application: 75104

Drug Name

ETODOLAC

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1998-02-06

75104 / 1

Active Ingredient

ETODOLAC

Application Number

75104

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1998-02-06

Regulatory Status

Discontinued

1998
20 Nov
Discontinued Application: 75104

Drug Name

ETODOLAC

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1998-11-20

75104 / 2

Active Ingredient

ETODOLAC

Application Number

75104

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1998-11-20

Regulatory Status

Discontinued

2025
28 Jan
RX Application: 217640

Drug Name

EVEROLIMUS

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2025-01-28

217640 / 1

Active Ingredient

EVEROLIMUS

Application Number

217640

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2025-01-28

Regulatory Status

RX

2025
28 Jan
RX Application: 217640

Drug Name

EVEROLIMUS

Product Number

2

Dosage Form

-

Strength

3MG

Approval Date

2025-01-28

217640 / 2

Active Ingredient

EVEROLIMUS

Application Number

217640

Product Number

2

Dosage Form

-

Strength

3MG

Approval Date

2025-01-28

Regulatory Status

RX

2025
28 Jan
RX Application: 217640

Drug Name

EVEROLIMUS

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2025-01-28

217640 / 3

Active Ingredient

EVEROLIMUS

Application Number

217640

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2025-01-28

Regulatory Status

RX

2011
24 Mar
Discontinued Application: 201333

Drug Name

FAMCICLOVIR

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2011-03-24

201333 / 1

Active Ingredient

FAMCICLOVIR

Application Number

201333

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2011-03-24

Regulatory Status

Discontinued

2011
24 Mar
Discontinued Application: 201333

Drug Name

FAMCICLOVIR

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2011-03-24

201333 / 2

Active Ingredient

FAMCICLOVIR

Application Number

201333

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2011-03-24

Regulatory Status

Discontinued

2011
24 Mar
Discontinued Application: 201333

Drug Name

FAMCICLOVIR

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2011-03-24

201333 / 3

Active Ingredient

FAMCICLOVIR

Application Number

201333

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2011-03-24

Regulatory Status

Discontinued

2001
21 Dec
Discontinued Application: 75674

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2001-12-21

75674 / 1

Active Ingredient

FAMOTIDINE

Application Number

75674

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2001-12-21

Regulatory Status

Discontinued

2013
05 Nov
Discontinued Application: 78161

Drug Name

FINASTERIDE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2013-11-05

78161 / 1

Active Ingredient

FINASTERIDE

Application Number

78161

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2013-11-05

Regulatory Status

Discontinued

1994
20 Jun
Discontinued Application: 74358

Drug Name

FLURBIPROFEN

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1994-06-20

74358 / 1

Active Ingredient

FLURBIPROFEN

Application Number

74358

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1994-06-20

Regulatory Status

Discontinued

1994
20 Jun
Discontinued Application: 74358

Drug Name

FLURBIPROFEN

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1994-06-20

74358 / 2

Active Ingredient

FLURBIPROFEN

Application Number

74358

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1994-06-20

Regulatory Status

Discontinued

2023
31 May
RX Application: 212827

Drug Name

GEFITINIB

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2023-05-31

212827 / 1

Active Ingredient

GEFITINIB

Application Number

212827

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2023-05-31

Regulatory Status

RX

1993
25 Jan
Discontinued Application: 73466

Drug Name

GEMFIBROZIL

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1993-01-25

73466 / 1

Active Ingredient

GEMFIBROZIL

Application Number

73466

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1993-01-25

Regulatory Status

Discontinued

1998
26 Jun
Discontinued Application: 74792

Drug Name

GLYBURIDE (MICRONIZED)

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

1998-06-26

74792 / 1

Active Ingredient

GLYBURIDE

Application Number

74792

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

1998-06-26

Regulatory Status

Discontinued

1998
26 Jun
Discontinued Application: 74792

Drug Name

GLYBURIDE (MICRONIZED)

Product Number

2

Dosage Form

-

Strength

3MG

Approval Date

1998-06-26

74792 / 2

Active Ingredient

GLYBURIDE

Application Number

74792

Product Number

2

Dosage Form

-

Strength

3MG

Approval Date

1998-06-26

Regulatory Status

Discontinued

1999
17 Aug
Discontinued Application: 74792

Drug Name

GLYBURIDE (MICRONIZED)

Product Number

3

Dosage Form

-

Strength

6MG

Approval Date

1999-08-17

74792 / 3

Active Ingredient

GLYBURIDE

Application Number

74792

Product Number

3

Dosage Form

-

Strength

6MG

Approval Date

1999-08-17

Regulatory Status

Discontinued

2016
20 Jun
RX Application: 91413

Drug Name

GLYCOPYRROLATE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2016-06-20

91413 / 1

Active Ingredient

GLYCOPYRROLATE

Application Number

91413

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2016-06-20

Regulatory Status

RX

2016
20 Jun
RX Application: 91413

Drug Name

GLYCOPYRROLATE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2016-06-20

91413 / 2

Active Ingredient

GLYCOPYRROLATE

Application Number

91413

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2016-06-20

Regulatory Status

RX

2009
22 Jun
RX Application: 78969

Drug Name

GRANISETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2009-06-22

78969 / 1

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

78969

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2009-06-22

Regulatory Status

RX

2026
17 Feb
RX Application: 216921

Drug Name

IDELALISIB

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2026-02-17

216921 / 1

Active Ingredient

IDELALISIB

Application Number

216921

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2026-02-17

Regulatory Status

RX

2026
17 Feb
RX Application: 216921

Drug Name

IDELALISIB

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2026-02-17

216921 / 2

Active Ingredient

IDELALISIB

Application Number

216921

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2026-02-17

Regulatory Status

RX

2019
01 Mar
RX Application: 207818

Drug Name

IMATINIB MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2019-03-01

207818 / 1

Active Ingredient

IMATINIB MESYLATE

Application Number

207818

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2019-03-01

Regulatory Status

RX

2019
01 Mar
RX Application: 207818

Drug Name

IMATINIB MESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2019-03-01

207818 / 2

Active Ingredient

IMATINIB MESYLATE

Application Number

207818

Product Number

2

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2019-03-01

Regulatory Status

RX

2016
04 Mar
Discontinued Application: 204528

Drug Name

LAMIVUDINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2016-03-04

204528 / 1

Active Ingredient

LAMIVUDINE

Application Number

204528

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2016-03-04

Regulatory Status

Discontinued

2016
04 Mar
Discontinued Application: 204528

Drug Name

LAMIVUDINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2016-03-04

204528 / 2

Active Ingredient

LAMIVUDINE

Application Number

204528

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2016-03-04

Regulatory Status

Discontinued

2014
28 Aug
Discontinued Application: 204005

Drug Name

LAMIVUDINE AND ZIDOVUDINE

Product Number

1

Dosage Form

-

Strength

150MG;300MG

Approval Date

2014-08-28

204005 / 1

Active Ingredient

LAMIVUDINE; ZIDOVUDINE

Application Number

204005

Product Number

1

Dosage Form

-

Strength

150MG;300MG

Approval Date

2014-08-28

Regulatory Status

Discontinued

2009
27 Jan
Discontinued Application: 77428

Drug Name

LAMOTRIGINE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-01-27

77428 / 1

Active Ingredient

LAMOTRIGINE

Application Number

77428

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-01-27

Regulatory Status

Discontinued

2009
27 Jan
Discontinued Application: 77428

Drug Name

LAMOTRIGINE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2009-01-27

77428 / 2

Active Ingredient

LAMOTRIGINE

Application Number

77428

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2009-01-27

Regulatory Status

Discontinued

2009
27 Jan
Discontinued Application: 77428

Drug Name

LAMOTRIGINE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2009-01-27

77428 / 3

Active Ingredient

LAMOTRIGINE

Application Number

77428

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2009-01-27

Regulatory Status

Discontinued

2009
27 Jan
Discontinued Application: 77428

Drug Name

LAMOTRIGINE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2009-01-27

77428 / 4

Active Ingredient

LAMOTRIGINE

Application Number

77428

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2009-01-27

Regulatory Status

Discontinued

2012
18 Dec
RX Application: 201921

Drug Name

LANSOPRAZOLE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2012-12-18

201921 / 1

Active Ingredient

LANSOPRAZOLE

Application Number

201921

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2012-12-18

Regulatory Status

RX

2012
18 Dec
RX Application: 201921

Drug Name

LANSOPRAZOLE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2012-12-18

201921 / 2

Active Ingredient

LANSOPRAZOLE

Application Number

201921

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2012-12-18

Regulatory Status

RX

2016
13 Jan
OTC Application: 203306

Drug Name

LANSOPRAZOLE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2016-01-13

203306 / 1

Active Ingredient

LANSOPRAZOLE

Application Number

203306

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2016-01-13

Regulatory Status

OTC

2017
11 Aug
RX Application: 90978

Drug Name

LANTHANUM CARBONATE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2017-08-11

90978 / 1

Active Ingredient

LANTHANUM CARBONATE

Application Number

90978

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2017-08-11

Regulatory Status

RX

2017
11 Aug
RX Application: 90978

Drug Name

LANTHANUM CARBONATE

Product Number

2

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2017-08-11

90978 / 2

Active Ingredient

LANTHANUM CARBONATE

Application Number

90978

Product Number

2

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2017-08-11

Regulatory Status

RX

2017
11 Aug
RX Application: 90978

Drug Name

LANTHANUM CARBONATE

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

2017-08-11

90978 / 3

Active Ingredient

LANTHANUM CARBONATE

Application Number

90978

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

2017-08-11

Regulatory Status

RX

2020
29 Sep
RX Application: 203007

Drug Name

LAPATINIB DITOSYLATE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2020-09-29

203007 / 1

Active Ingredient

LAPATINIB DITOSYLATE

Application Number

203007

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2020-09-29

Regulatory Status

RX

2011
03 Jun
RX Application: 200161

Drug Name

LETROZOLE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2011-06-03

200161 / 1

Active Ingredient

LETROZOLE

Application Number

200161

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2011-06-03

Regulatory Status

RX

2011
20 Jun
Discontinued Application: 76276

Drug Name

LEVOFLOXACIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2011-06-20

76276 / 1

Active Ingredient

LEVOFLOXACIN

Application Number

76276

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2011-06-20

Regulatory Status

Discontinued

2011
20 Jun
Discontinued Application: 76276

Drug Name

LEVOFLOXACIN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2011-06-20

76276 / 2

Active Ingredient

LEVOFLOXACIN

Application Number

76276

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2011-06-20

Regulatory Status

Discontinued

2011
20 Jun
Discontinued Application: 77097

Drug Name

LEVOFLOXACIN

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

2011-06-20

77097 / 1

Active Ingredient

LEVOFLOXACIN

Application Number

77097

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

2011-06-20

Regulatory Status

Discontinued

2006
19 Jul
Discontinued Application: 77923

Drug Name

MELOXICAM

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2006-07-19

77923 / 1

Active Ingredient

MELOXICAM

Application Number

77923

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2006-07-19

Regulatory Status

Discontinued

2006
19 Jul
Discontinued Application: 77923

Drug Name

MELOXICAM

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2006-07-19

77923 / 2

Active Ingredient

MELOXICAM

Application Number

77923

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2006-07-19

Regulatory Status

Discontinued

2012
16 Jul
Discontinued Application: 76594

Drug Name

MODAFINIL

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2012-07-16

76594 / 1

Active Ingredient

MODAFINIL

Application Number

76594

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2012-07-16

Regulatory Status

Discontinued

2012
16 Jul
Discontinued Application: 76594

Drug Name

MODAFINIL

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2012-07-16

76594 / 2

Active Ingredient

MODAFINIL

Application Number

76594

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2012-07-16

Regulatory Status

Discontinued

2012
03 Aug
Discontinued Application: 79142

Drug Name

MONTELUKAST SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2012-08-03

79142 / 1

Active Ingredient

MONTELUKAST SODIUM

Application Number

79142

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2012-08-03

Regulatory Status

Discontinued

2012
03 Aug
Discontinued Application: 79142

Drug Name

MONTELUKAST SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-08-03

79142 / 2

Active Ingredient

MONTELUKAST SODIUM

Application Number

79142

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-08-03

Regulatory Status

Discontinued

2015
31 Aug
Discontinued Application: 204635

Drug Name

MOXIFLOXACIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2015-08-31

204635 / 1

Active Ingredient

MOXIFLOXACIN HYDROCHLORIDE

Application Number

204635

Product Number

1

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2015-08-31

Regulatory Status

Discontinued

2008
15 Feb
Discontinued Application: 78688

Drug Name

NADOLOL AND BENDROFLUMETHIAZIDE

Product Number

1

Dosage Form

-

Strength

5MG;40MG

Approval Date

2008-02-15

78688 / 1

Active Ingredient

BENDROFLUMETHIAZIDE; NADOLOL

Application Number

78688

Product Number

1

Dosage Form

-

Strength

5MG;40MG

Approval Date

2008-02-15

Regulatory Status

Discontinued

2008
15 Feb
Discontinued Application: 78688

Drug Name

NADOLOL AND BENDROFLUMETHIAZIDE

Product Number

2

Dosage Form

-

Strength

5MG;80MG

Approval Date

2008-02-15

78688 / 2

Active Ingredient

BENDROFLUMETHIAZIDE; NADOLOL

Application Number

78688

Product Number

2

Dosage Form

-

Strength

5MG;80MG

Approval Date

2008-02-15

Regulatory Status

Discontinued

2019
30 Apr
RX Application: 211604

Drug Name

NITROGLYCERIN

Product Number

1

Dosage Form

-

Strength

0.3MG

Approval Date

2019-04-30

211604 / 1

Active Ingredient

NITROGLYCERIN

Application Number

211604

Product Number

1

Dosage Form

-

Strength

0.3MG

Approval Date

2019-04-30

Regulatory Status

RX

2019
30 Apr
RX Application: 211604

Drug Name

NITROGLYCERIN

Product Number

2

Dosage Form

-

Strength

0.4MG

Approval Date

2019-04-30

211604 / 2

Active Ingredient

NITROGLYCERIN

Application Number

211604

Product Number

2

Dosage Form

-

Strength

0.4MG

Approval Date

2019-04-30

Regulatory Status

RX

2019
30 Apr
RX Application: 211604

Drug Name

NITROGLYCERIN

Product Number

3

Dosage Form

-

Strength

0.6MG

Approval Date

2019-04-30

211604 / 3

Active Ingredient

NITROGLYCERIN

Application Number

211604

Product Number

3

Dosage Form

-

Strength

0.6MG

Approval Date

2019-04-30

Regulatory Status

RX

2012
23 Apr
Discontinued Application: 76866

Drug Name

OLANZAPINE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2012-04-23

76866 / 1

Active Ingredient

OLANZAPINE

Application Number

76866

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2012-04-23

Regulatory Status

Discontinued

2012
23 Apr
Discontinued Application: 76866

Drug Name

OLANZAPINE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2012-04-23

76866 / 2

Active Ingredient

OLANZAPINE

Application Number

76866

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2012-04-23

Regulatory Status

Discontinued

2012
23 Apr
Discontinued Application: 76866

Drug Name

OLANZAPINE

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

2012-04-23

76866 / 3

Active Ingredient

OLANZAPINE

Application Number

76866

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

2012-04-23

Regulatory Status

Discontinued

2012
23 Apr
Discontinued Application: 76866

Drug Name

OLANZAPINE

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2012-04-23

76866 / 4

Active Ingredient

OLANZAPINE

Application Number

76866

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2012-04-23

Regulatory Status

Discontinued

2012
23 Apr
Discontinued Application: 76866

Drug Name

OLANZAPINE

Product Number

5

Dosage Form

-

Strength

15MG

Approval Date

2012-04-23

76866 / 5

Active Ingredient

OLANZAPINE

Application Number

76866

Product Number

5

Dosage Form

-

Strength

15MG

Approval Date

2012-04-23

Regulatory Status

Discontinued

2012
23 Apr
Discontinued Application: 76866

Drug Name

OLANZAPINE

Product Number

6

Dosage Form

-

Strength

20MG

Approval Date

2012-04-23

76866 / 6

Active Ingredient

OLANZAPINE

Application Number

76866

Product Number

6

Dosage Form

-

Strength

20MG

Approval Date

2012-04-23

Regulatory Status

Discontinued

-
Unclassified Application: 218044

Drug Name

OLAPARIB

Product Number

1

Dosage Form

-

Strength

Approval Date

-

218044 / 1

Active Ingredient

OLAPARIB

Application Number

218044

Product Number

1

Dosage Form

-

Strength

Approval Date

-

Regulatory Status

Unclassified

2007
25 Jun
RX Application: 77851

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2007-06-25

77851 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77851

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2007-06-25

Regulatory Status

RX

2007
25 Jun
RX Application: 77851

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2007-06-25

77851 / 2

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77851

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2007-06-25

Regulatory Status

RX

2016
03 Aug
RX Application: 202595

Drug Name

OSELTAMIVIR PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2016-08-03

202595 / 1

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

202595

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2016-08-03

Regulatory Status

RX

2016
03 Aug
RX Application: 202595

Drug Name

OSELTAMIVIR PHOSPHATE

Product Number

2

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2016-08-03

202595 / 2

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

202595

Product Number

2

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2016-08-03

Regulatory Status

RX

2016
03 Aug
RX Application: 202595

Drug Name

OSELTAMIVIR PHOSPHATE

Product Number

3

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2016-08-03

202595 / 3

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

202595

Product Number

3

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2016-08-03

Regulatory Status

RX

-
Unclassified Application: 213089

Drug Name

PALBOCICLIB

Product Number

2

Dosage Form

-

Strength

125MG

Approval Date

-

213089 / 2

Active Ingredient

PALBOCICLIB

Application Number

213089

Product Number

2

Dosage Form

-

Strength

125MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 213089

Drug Name

PALBOCICLIB

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

-

213089 / 3

Active Ingredient

PALBOCICLIB

Application Number

213089

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

2010
08 Oct
Discontinued Application: 77854

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2010-10-08

77854 / 1

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

77854

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2010-10-08

Regulatory Status

Discontinued

2010
08 Oct
Discontinued Application: 77854

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2010-10-08

77854 / 2

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

77854

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2010-10-08

Regulatory Status

Discontinued

2010
08 Oct
Discontinued Application: 77854

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

2010-10-08

77854 / 3

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

77854

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

2010-10-08

Regulatory Status

Discontinued

2010
08 Oct
Discontinued Application: 77854

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

2010-10-08

77854 / 4

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

77854

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

2010-10-08

Regulatory Status

Discontinued

2010
08 Oct
Discontinued Application: 77854

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

1.5MG

Approval Date

2010-10-08

77854 / 5

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

77854

Product Number

5

Dosage Form

-

Strength

1.5MG

Approval Date

2010-10-08

Regulatory Status

Discontinued

2010
09 Apr
Discontinued Application: 90764

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.75MG

Approval Date

2010-04-09

90764 / 1

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

90764

Product Number

1

Dosage Form

-

Strength

0.75MG

Approval Date

2010-04-09

Regulatory Status

Discontinued

2011
30 Jun
Discontinued Application: 90650

Drug Name

RAMIPRIL

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

2011-06-30

90650 / 1

Active Ingredient

RAMIPRIL

Application Number

90650

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

2011-06-30

Regulatory Status

Discontinued

2011
30 Jun
Discontinued Application: 90650

Drug Name

RAMIPRIL

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2011-06-30

90650 / 2

Active Ingredient

RAMIPRIL

Application Number

90650

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2011-06-30

Regulatory Status

Discontinued

2011
30 Jun
Discontinued Application: 90650

Drug Name

RAMIPRIL

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2011-06-30

90650 / 3

Active Ingredient

RAMIPRIL

Application Number

90650

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2011-06-30

Regulatory Status

Discontinued

2011
30 Jun
Discontinued Application: 90650

Drug Name

RAMIPRIL

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2011-06-30

90650 / 4

Active Ingredient

RAMIPRIL

Application Number

90650

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2011-06-30

Regulatory Status

Discontinued

2012
31 Dec
Discontinued Application: 200482

Drug Name

RIZATRIPTAN BENZOATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-12-31

200482 / 1

Active Ingredient

RIZATRIPTAN BENZOATE

Application Number

200482

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-12-31

Regulatory Status

Discontinued

2012
31 Dec
Discontinued Application: 200482

Drug Name

RIZATRIPTAN BENZOATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-12-31

200482 / 2

Active Ingredient

RIZATRIPTAN BENZOATE

Application Number

200482

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-12-31

Regulatory Status

Discontinued

2013
01 Jul
Discontinued Application: 203478

Drug Name

RIZATRIPTAN BENZOATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2013-07-01

203478 / 1

Active Ingredient

RIZATRIPTAN BENZOATE

Application Number

203478

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2013-07-01

Regulatory Status

Discontinued

2013
01 Jul
Discontinued Application: 203478

Drug Name

RIZATRIPTAN BENZOATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2013-07-01

203478 / 2

Active Ingredient

RIZATRIPTAN BENZOATE

Application Number

203478

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2013-07-01

Regulatory Status

Discontinued

2023
24 Oct
RX Application: 218024

Drug Name

SUNITINIB MALATE

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE

Approval Date

2023-10-24

218024 / 1

Active Ingredient

SUNITINIB MALATE

Application Number

218024

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE

Approval Date

2023-10-24

Regulatory Status

RX

2023
24 Oct
RX Application: 218024

Drug Name

SUNITINIB MALATE

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2023-10-24

218024 / 2

Active Ingredient

SUNITINIB MALATE

Application Number

218024

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2023-10-24

Regulatory Status

RX

2023
24 Oct
RX Application: 218024

Drug Name

SUNITINIB MALATE

Product Number

3

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2023-10-24

218024 / 3

Active Ingredient

SUNITINIB MALATE

Application Number

218024

Product Number

3

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2023-10-24

Regulatory Status

RX

2023
24 Oct
RX Application: 218024

Drug Name

SUNITINIB MALATE

Product Number

4

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2023-10-24

218024 / 4

Active Ingredient

SUNITINIB MALATE

Application Number

218024

Product Number

4

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2023-10-24

Regulatory Status

RX

2014
25 Feb
Discontinued Application: 91648

Drug Name

TELMISARTAN AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;40MG

Approval Date

2014-02-25

91648 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; TELMISARTAN

Application Number

91648

Product Number

1

Dosage Form

-

Strength

12.5MG;40MG

Approval Date

2014-02-25

Regulatory Status

Discontinued

2014
25 Feb
Discontinued Application: 91648

Drug Name

TELMISARTAN AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;80MG

Approval Date

2014-02-25

91648 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; TELMISARTAN

Application Number

91648

Product Number

2

Dosage Form

-

Strength

12.5MG;80MG

Approval Date

2014-02-25

Regulatory Status

Discontinued

2014
25 Feb
Discontinued Application: 91648

Drug Name

TELMISARTAN AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;80MG

Approval Date

2014-02-25

91648 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; TELMISARTAN

Application Number

91648

Product Number

3

Dosage Form

-

Strength

25MG;80MG

Approval Date

2014-02-25

Regulatory Status

Discontinued

2007
02 Jul
Discontinued Application: 77195

Drug Name

TERBINAFINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2007-07-02

77195 / 1

Active Ingredient

TERBINAFINE HYDROCHLORIDE

Application Number

77195

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2007-07-02

Regulatory Status

Discontinued

2023
15 May
RX Application: 209555

Drug Name

TERIFLUNOMIDE

Product Number

1

Dosage Form

-

Strength

7MG

Approval Date

2023-05-15

209555 / 1

Active Ingredient

TERIFLUNOMIDE

Application Number

209555

Product Number

1

Dosage Form

-

Strength

7MG

Approval Date

2023-05-15

Regulatory Status

RX

2023
15 May
RX Application: 209555

Drug Name

TERIFLUNOMIDE

Product Number

2

Dosage Form

-

Strength

14MG

Approval Date

2023-05-15

209555 / 2

Active Ingredient

TERIFLUNOMIDE

Application Number

209555

Product Number

2

Dosage Form

-

Strength

14MG

Approval Date

2023-05-15

Regulatory Status

RX

2023
27 Apr
Discontinued Application: 213267

Drug Name

THALIDOMIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2023-04-27

213267 / 1

Active Ingredient

THALIDOMIDE

Application Number

213267

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2023-04-27

Regulatory Status

Discontinued

2026
24 Apr
RX Application: 213267

Drug Name

THALIDOMIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2026-04-24

213267 / 2

Active Ingredient

THALIDOMIDE

Application Number

213267

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2026-04-24

Regulatory Status

RX

2026
24 Apr
RX Application: 213267

Drug Name

THALIDOMIDE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2026-04-24

213267 / 3

Active Ingredient

THALIDOMIDE

Application Number

213267

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2026-04-24

Regulatory Status

RX

2026
24 Apr
RX Application: 213267

Drug Name

THALIDOMIDE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2026-04-24

213267 / 4

Active Ingredient

THALIDOMIDE

Application Number

213267

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2026-04-24

Regulatory Status

RX

1999
02 Nov
Discontinued Application: 75316

Drug Name

TICLOPIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1999-11-02

75316 / 1

Active Ingredient

TICLOPIDINE HYDROCHLORIDE

Application Number

75316

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1999-11-02

Regulatory Status

Discontinued

2023
13 Jun
RX Application: 214008

Drug Name

TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE

Product Number

1

Dosage Form

-

Strength

EQ 6.14MG BASE;15MG

Approval Date

2023-06-13

214008 / 1

Active Ingredient

TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE

Application Number

214008

Product Number

1

Dosage Form

-

Strength

EQ 6.14MG BASE;15MG

Approval Date

2023-06-13

Regulatory Status

RX

2023
13 Jun
RX Application: 214008

Drug Name

TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE

Product Number

2

Dosage Form

-

Strength

EQ 8.19MG BASE;20MG

Approval Date

2023-06-13

214008 / 2

Active Ingredient

TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE

Application Number

214008

Product Number

2

Dosage Form

-

Strength

EQ 8.19MG BASE;20MG

Approval Date

2023-06-13

Regulatory Status

RX

1986
02 Jan
Discontinued Application: 70259

Drug Name

TOLAZAMIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1986-01-02

70259 / 1

Active Ingredient

TOLAZAMIDE

Application Number

70259

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1986-01-02

Regulatory Status

Discontinued

1986
17 Mar
Discontinued Application: 70259

Drug Name

TOLAZAMIDE

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1986-03-17

70259 / 3

Active Ingredient

TOLAZAMIDE

Application Number

70259

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1986-03-17

Regulatory Status

Discontinued

2009
27 Mar
Discontinued Application: 76314

Drug Name

TOPIRAMATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-03-27

76314 / 1

Active Ingredient

TOPIRAMATE

Application Number

76314

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-03-27

Regulatory Status

Discontinued

2009
27 Mar
Discontinued Application: 76314

Drug Name

TOPIRAMATE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2009-03-27

76314 / 2

Active Ingredient

TOPIRAMATE

Application Number

76314

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2009-03-27

Regulatory Status

Discontinued

2009
27 Mar
Discontinued Application: 76314

Drug Name

TOPIRAMATE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2009-03-27

76314 / 3

Active Ingredient

TOPIRAMATE

Application Number

76314

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2009-03-27

Regulatory Status

Discontinued

2009
27 Mar
Discontinued Application: 76314

Drug Name

TOPIRAMATE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2009-03-27

76314 / 4

Active Ingredient

TOPIRAMATE

Application Number

76314

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2009-03-27

Regulatory Status

Discontinued

-
Unclassified Application: 214837

Drug Name

TRABECTEDIN

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

-

214837 / 1

Active Ingredient

TRABECTEDIN

Application Number

214837

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

-

Regulatory Status

Unclassified

1991
27 Feb
Discontinued Application: 71405

Drug Name

TRAZODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1991-02-27

71405 / 1

Active Ingredient

TRAZODONE HYDROCHLORIDE

Application Number

71405

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1991-02-27

Regulatory Status

Discontinued

1991
27 Feb
Discontinued Application: 71406

Drug Name

TRAZODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1991-02-27

71406 / 1

Active Ingredient

TRAZODONE HYDROCHLORIDE

Application Number

71406

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1991-02-27

Regulatory Status

Discontinued

2010
17 Nov
RX Application: 91630

Drug Name

TRIHEXYPHENIDYL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2010-11-17

91630 / 1

Active Ingredient

TRIHEXYPHENIDYL HYDROCHLORIDE

Application Number

91630

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2010-11-17

Regulatory Status

RX

2010
17 Nov
RX Application: 91630

Drug Name

TRIHEXYPHENIDYL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2010-11-17

91630 / 2

Active Ingredient

TRIHEXYPHENIDYL HYDROCHLORIDE

Application Number

91630

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2010-11-17

Regulatory Status

RX

2008
06 Jun
Discontinued Application: 77238

Drug Name

ZALEPLON

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2008-06-06

77238 / 1

Active Ingredient

ZALEPLON

Application Number

77238

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2008-06-06

Regulatory Status

Discontinued

2008
06 Jun
Discontinued Application: 77238

Drug Name

ZALEPLON

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2008-06-06

77238 / 2

Active Ingredient

ZALEPLON

Application Number

77238

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2008-06-06

Regulatory Status

Discontinued

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Drug Status Breakdown
147 total
  • RX
  • Discontinued
  • Unclassified
  • OTC
Official Source

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

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FDA Approved Drug Record Details Preview

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

Drug Name

ALPRAZOLAM

Application Number

200739

Product Number

1

Active Ingredient

ALPRAZOLAM

Dosage Form

-

Strength

0.25MG

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

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Organized FDA drug records

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