Jubilant Generics
FDA Approved Drugs

Jubilant Generics

FDA Approved Drugs Database

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

Discontinued RX OTC Unclassified
  • Total Records 132
  • Latest Approval Date May 15, 2026
  • Data Source FDA
  • First Approval Date Feb 28, 2011
All
132
View
Unclassified
1
View
Discontinued
50
View
OTC
4
View
RX
77
View
Company Overview

Company

Jubilant Generics

Country

India

Website

Visit Website

Email

support@jubl.com

Social Profiles

Company Snapshot

Jubilant Generics

Bhartiagram Gajraula, Distt. Amroha - 244223, Uttar Pradesh, India

India

www.jubilantgenerics.com/ support@jubl.com View on Map
FDA Approved Drug Records ( 132 records )
2018
07 Feb
Discontinued Application: 210403

Drug Name

AMANTADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2018-02-07

210403 / 1

Active Ingredient

AMANTADINE HYDROCHLORIDE

Application Number

210403

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2018-02-07

Regulatory Status

Discontinued

2017
15 May
Discontinued Application: 207450

Drug Name

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;20MG

Approval Date

2017-05-15

207450 / 1

Active Ingredient

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Application Number

207450

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;20MG

Approval Date

2017-05-15

Regulatory Status

Discontinued

2017
15 May
Discontinued Application: 207450

Drug Name

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;40MG

Approval Date

2017-05-15

207450 / 2

Active Ingredient

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Application Number

207450

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;40MG

Approval Date

2017-05-15

Regulatory Status

Discontinued

2017
15 May
Discontinued Application: 207450

Drug Name

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE;20MG

Approval Date

2017-05-15

207450 / 3

Active Ingredient

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Application Number

207450

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE;20MG

Approval Date

2017-05-15

Regulatory Status

Discontinued

2017
15 May
Discontinued Application: 207450

Drug Name

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;40MG

Approval Date

2017-05-15

207450 / 4

Active Ingredient

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Application Number

207450

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;40MG

Approval Date

2017-05-15

Regulatory Status

Discontinued

2025
05 Aug
RX Application: 212470

Drug Name

BUMETANIDE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2025-08-05

212470 / 1

Active Ingredient

BUMETANIDE

Application Number

212470

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2025-08-05

Regulatory Status

RX

2025
05 Aug
RX Application: 212470

Drug Name

BUMETANIDE

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2025-08-05

212470 / 2

Active Ingredient

BUMETANIDE

Application Number

212470

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2025-08-05

Regulatory Status

RX

2025
05 Aug
RX Application: 212470

Drug Name

BUMETANIDE

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2025-08-05

212470 / 3

Active Ingredient

BUMETANIDE

Application Number

212470

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2025-08-05

Regulatory Status

RX

2013
11 Oct
Discontinued Application: 202774

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2013-10-11

202774 / 1

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

202774

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2013-10-11

Regulatory Status

Discontinued

2013
11 Oct
Discontinued Application: 202774

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2013-10-11

202774 / 2

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

202774

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2013-10-11

Regulatory Status

Discontinued

2013
11 Oct
Discontinued Application: 202774

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2013-10-11

202774 / 3

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

202774

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2013-10-11

Regulatory Status

Discontinued

2013
11 Oct
Discontinued Application: 202775

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2013-10-11

202775 / 1

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

202775

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2013-10-11

Regulatory Status

Discontinued

2017
30 Jun
Discontinued Application: 207459

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2017-06-30

207459 / 1

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

207459

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2017-06-30

Regulatory Status

Discontinued

2017
30 Jun
Discontinued Application: 207459

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2017-06-30

207459 / 2

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

207459

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2017-06-30

Regulatory Status

Discontinued

2017
04 Apr
Discontinued Application: 207061

Drug Name

CELECOXIB

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2017-04-04

207061 / 1

Active Ingredient

CELECOXIB

Application Number

207061

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2017-04-04

Regulatory Status

Discontinued

2017
04 Apr
Discontinued Application: 207061

Drug Name

CELECOXIB

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2017-04-04

207061 / 2

Active Ingredient

CELECOXIB

Application Number

207061

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2017-04-04

Regulatory Status

Discontinued

2017
04 Apr
Discontinued Application: 207061

Drug Name

CELECOXIB

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2017-04-04

207061 / 3

Active Ingredient

CELECOXIB

Application Number

207061

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2017-04-04

Regulatory Status

Discontinued

2017
04 Apr
Discontinued Application: 207061

Drug Name

CELECOXIB

Product Number

4

Dosage Form

-

Strength

400MG

Approval Date

2017-04-04

207061 / 4

Active Ingredient

CELECOXIB

Application Number

207061

Product Number

4

Dosage Form

-

Strength

400MG

Approval Date

2017-04-04

Regulatory Status

Discontinued

2015
19 Feb
OTC Application: 91116

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-02-19

91116 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

91116

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-02-19

Regulatory Status

OTC

2015
19 Feb
OTC Application: 91116

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2015-02-19

91116 / 2

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

91116

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2015-02-19

Regulatory Status

OTC

2015
19 Feb
OTC Application: 91116

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2015-02-19

91116 / 3

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

91116

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2015-02-19

Regulatory Status

OTC

2015
19 Feb
OTC Application: 91116

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2015-02-19

91116 / 4

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

91116

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2015-02-19

Regulatory Status

OTC

2015
23 Dec
Discontinued Application: 205407

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2015-12-23

205407 / 1

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

205407

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2015-12-23

Regulatory Status

Discontinued

2015
23 Dec
Discontinued Application: 205407

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2015-12-23

205407 / 2

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

205407

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2015-12-23

Regulatory Status

Discontinued

2015
23 Dec
Discontinued Application: 205407

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2015-12-23

205407 / 3

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

205407

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2015-12-23

Regulatory Status

Discontinued

2018
29 Jan
RX Application: 210338

Drug Name

CLONIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2018-01-29

210338 / 1

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

210338

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2018-01-29

Regulatory Status

RX

2016
12 Oct
Discontinued Application: 205550

Drug Name

DARIFENACIN HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 7.5MG BASE

Approval Date

2016-10-12

205550 / 1

Active Ingredient

DARIFENACIN HYDROBROMIDE

Application Number

205550

Product Number

1

Dosage Form

-

Strength

EQ 7.5MG BASE

Approval Date

2016-10-12

Regulatory Status

Discontinued

2016
12 Oct
Discontinued Application: 205550

Drug Name

DARIFENACIN HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2016-10-12

205550 / 2

Active Ingredient

DARIFENACIN HYDROBROMIDE

Application Number

205550

Product Number

2

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2016-10-12

Regulatory Status

Discontinued

2025
11 Apr
RX Application: 211660

Drug Name

DEFERASIROX

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2025-04-11

211660 / 1

Active Ingredient

DEFERASIROX

Application Number

211660

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2025-04-11

Regulatory Status

RX

2025
11 Apr
RX Application: 211660

Drug Name

DEFERASIROX

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2025-04-11

211660 / 2

Active Ingredient

DEFERASIROX

Application Number

211660

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2025-04-11

Regulatory Status

RX

2025
11 Apr
RX Application: 211660

Drug Name

DEFERASIROX

Product Number

3

Dosage Form

-

Strength

360MG

Approval Date

2025-04-11

211660 / 3

Active Ingredient

DEFERASIROX

Application Number

211660

Product Number

3

Dosage Form

-

Strength

360MG

Approval Date

2025-04-11

Regulatory Status

RX

2011
31 May
RX Application: 90768

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-05-31

90768 / 1

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

90768

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-05-31

Regulatory Status

RX

2011
31 May
RX Application: 90768

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-05-31

90768 / 2

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

90768

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-05-31

Regulatory Status

RX

2025
04 Aug
RX Application: 211219

Drug Name

ESLICARBAZEPINE ACETATE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2025-08-04

211219 / 1

Active Ingredient

ESLICARBAZEPINE ACETATE

Application Number

211219

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2025-08-04

Regulatory Status

RX

2025
04 Aug
RX Application: 211219

Drug Name

ESLICARBAZEPINE ACETATE

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

2025-08-04

211219 / 2

Active Ingredient

ESLICARBAZEPINE ACETATE

Application Number

211219

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

2025-08-04

Regulatory Status

RX

2025
04 Aug
RX Application: 211219

Drug Name

ESLICARBAZEPINE ACETATE

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2025-08-04

211219 / 3

Active Ingredient

ESLICARBAZEPINE ACETATE

Application Number

211219

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2025-08-04

Regulatory Status

RX

2025
04 Aug
RX Application: 211219

Drug Name

ESLICARBAZEPINE ACETATE

Product Number

4

Dosage Form

-

Strength

800MG

Approval Date

2025-08-04

211219 / 4

Active Ingredient

ESLICARBAZEPINE ACETATE

Application Number

211219

Product Number

4

Dosage Form

-

Strength

800MG

Approval Date

2025-08-04

Regulatory Status

RX

2016
19 Aug
Discontinued Application: 203983

Drug Name

FELODIPINE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2016-08-19

203983 / 1

Active Ingredient

FELODIPINE

Application Number

203983

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2016-08-19

Regulatory Status

Discontinued

2016
19 Aug
Discontinued Application: 203983

Drug Name

FELODIPINE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2016-08-19

203983 / 2

Active Ingredient

FELODIPINE

Application Number

203983

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2016-08-19

Regulatory Status

Discontinued

2016
19 Aug
Discontinued Application: 203983

Drug Name

FELODIPINE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2016-08-19

203983 / 3

Active Ingredient

FELODIPINE

Application Number

203983

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2016-08-19

Regulatory Status

Discontinued

2015
05 Oct
Discontinued Application: 202706

Drug Name

INDOMETHACIN

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2015-10-05

202706 / 1

Active Ingredient

INDOMETHACIN

Application Number

202706

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2015-10-05

Regulatory Status

Discontinued

2017
25 Aug
Discontinued Application: 205215

Drug Name

INDOMETHACIN

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2017-08-25

205215 / 1

Active Ingredient

INDOMETHACIN

Application Number

205215

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2017-08-25

Regulatory Status

Discontinued

2017
25 Aug
Discontinued Application: 205215

Drug Name

INDOMETHACIN

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2017-08-25

205215 / 2

Active Ingredient

INDOMETHACIN

Application Number

205215

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2017-08-25

Regulatory Status

Discontinued

2015
23 Feb
RX Application: 203534

Drug Name

IRBESARTAN

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2015-02-23

203534 / 1

Active Ingredient

IRBESARTAN

Application Number

203534

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2015-02-23

Regulatory Status

RX

2015
23 Feb
RX Application: 203534

Drug Name

IRBESARTAN

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2015-02-23

203534 / 2

Active Ingredient

IRBESARTAN

Application Number

203534

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2015-02-23

Regulatory Status

RX

2015
23 Feb
RX Application: 203534

Drug Name

IRBESARTAN

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2015-02-23

203534 / 3

Active Ingredient

IRBESARTAN

Application Number

203534

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2015-02-23

Regulatory Status

RX

2017
23 Feb
Discontinued Application: 203445

Drug Name

ITRACONAZOLE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2017-02-23

203445 / 1

Active Ingredient

ITRACONAZOLE

Application Number

203445

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2017-02-23

Regulatory Status

Discontinued

2011
28 Feb
Discontinued Application: 200220

Drug Name

LAMOTRIGINE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-02-28

200220 / 1

Active Ingredient

LAMOTRIGINE

Application Number

200220

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-02-28

Regulatory Status

Discontinued

2011
28 Feb
Discontinued Application: 200220

Drug Name

LAMOTRIGINE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2011-02-28

200220 / 2

Active Ingredient

LAMOTRIGINE

Application Number

200220

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2011-02-28

Regulatory Status

Discontinued

2016
02 Jun
Discontinued Application: 206838

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

500MG/5ML (100MG/ML)

Approval Date

2016-06-02

206838 / 1

Active Ingredient

LEVETIRACETAM

Application Number

206838

Product Number

1

Dosage Form

-

Strength

500MG/5ML (100MG/ML)

Approval Date

2016-06-02

Regulatory Status

Discontinued

2015
19 Jun
Discontinued Application: 203613

Drug Name

LEVOFLOXACIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2015-06-19

203613 / 1

Active Ingredient

LEVOFLOXACIN

Application Number

203613

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2015-06-19

Regulatory Status

Discontinued

2015
19 Jun
Discontinued Application: 203613

Drug Name

LEVOFLOXACIN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2015-06-19

203613 / 2

Active Ingredient

LEVOFLOXACIN

Application Number

203613

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2015-06-19

Regulatory Status

Discontinued

2024
06 Dec
RX Application: 210388

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2024-12-06

210388 / 1

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

210388

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2024-12-06

Regulatory Status

RX

2024
06 Dec
RX Application: 210388

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2024-12-06

210388 / 2

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

210388

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2024-12-06

Regulatory Status

RX

2024
06 Dec
RX Application: 210388

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

2024-12-06

210388 / 3

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

210388

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

2024-12-06

Regulatory Status

RX

2024
06 Dec
RX Application: 210388

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

2024-12-06

210388 / 4

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

210388

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

2024-12-06

Regulatory Status

RX

2024
06 Dec
RX Application: 210388

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

120MG

Approval Date

2024-12-06

210388 / 5

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

210388

Product Number

5

Dosage Form

-

Strength

120MG

Approval Date

2024-12-06

Regulatory Status

RX

2015
13 Oct
Discontinued Application: 91585

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-10-13

91585 / 1

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

91585

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-10-13

Regulatory Status

Discontinued

2015
13 Oct
Discontinued Application: 91585

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2015-10-13

91585 / 2

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

91585

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2015-10-13

Regulatory Status

Discontinued

2015
27 Feb
Discontinued Application: 203795

Drug Name

MONTELUKAST SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2015-02-27

203795 / 1

Active Ingredient

MONTELUKAST SODIUM

Application Number

203795

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2015-02-27

Regulatory Status

Discontinued

2015
27 Feb
Discontinued Application: 203795

Drug Name

MONTELUKAST SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2015-02-27

203795 / 2

Active Ingredient

MONTELUKAST SODIUM

Application Number

203795

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2015-02-27

Regulatory Status

Discontinued

2018
14 May
Discontinued Application: 209156

Drug Name

NIACIN

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2018-05-14

209156 / 1

Active Ingredient

NIACIN

Application Number

209156

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2018-05-14

Regulatory Status

Discontinued

2018
14 May
Discontinued Application: 209156

Drug Name

NIACIN

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2018-05-14

209156 / 2

Active Ingredient

NIACIN

Application Number

209156

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2018-05-14

Regulatory Status

Discontinued

2018
14 May
Discontinued Application: 209156

Drug Name

NIACIN

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

2018-05-14

209156 / 3

Active Ingredient

NIACIN

Application Number

209156

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

2018-05-14

Regulatory Status

Discontinued

2012
12 Sep
RX Application: 200221

Drug Name

OLANZAPINE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2012-09-12

200221 / 1

Active Ingredient

OLANZAPINE

Application Number

200221

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2012-09-12

Regulatory Status

RX

2012
12 Sep
RX Application: 200221

Drug Name

OLANZAPINE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2012-09-12

200221 / 2

Active Ingredient

OLANZAPINE

Application Number

200221

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2012-09-12

Regulatory Status

RX

2012
12 Sep
RX Application: 200221

Drug Name

OLANZAPINE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2012-09-12

200221 / 3

Active Ingredient

OLANZAPINE

Application Number

200221

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2012-09-12

Regulatory Status

RX

2012
12 Sep
RX Application: 200221

Drug Name

OLANZAPINE

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2012-09-12

200221 / 4

Active Ingredient

OLANZAPINE

Application Number

200221

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2012-09-12

Regulatory Status

RX

2017
24 Apr
RX Application: 205482

Drug Name

OLMESARTAN MEDOXOMIL

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2017-04-24

205482 / 1

Active Ingredient

OLMESARTAN MEDOXOMIL

Application Number

205482

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2017-04-24

Regulatory Status

RX

2017
24 Apr
RX Application: 205482

Drug Name

OLMESARTAN MEDOXOMIL

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2017-04-24

205482 / 2

Active Ingredient

OLMESARTAN MEDOXOMIL

Application Number

205482

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2017-04-24

Regulatory Status

RX

2017
24 Apr
RX Application: 205482

Drug Name

OLMESARTAN MEDOXOMIL

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2017-04-24

205482 / 3

Active Ingredient

OLMESARTAN MEDOXOMIL

Application Number

205482

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2017-04-24

Regulatory Status

RX

2025
03 Mar
RX Application: 213695

Drug Name

OSELTAMIVIR PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/ML

Approval Date

2025-03-03

213695 / 1

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

213695

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/ML

Approval Date

2025-03-03

Regulatory Status

RX

2011
30 Aug
Discontinued Application: 90901

Drug Name

PANTOPRAZOLE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2011-08-30

90901 / 1

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

90901

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2011-08-30

Regulatory Status

Discontinued

2011
30 Aug
Discontinued Application: 90901

Drug Name

PANTOPRAZOLE SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2011-08-30

90901 / 2

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

90901

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2011-08-30

Regulatory Status

Discontinued

2015
27 Nov
Discontinued Application: 205528

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2015-11-27

205528 / 1

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

205528

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2015-11-27

Regulatory Status

Discontinued

2015
27 Nov
Discontinued Application: 205528

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2015-11-27

205528 / 2

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

205528

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2015-11-27

Regulatory Status

Discontinued

2015
27 Nov
Discontinued Application: 205528

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2015-11-27

205528 / 3

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

205528

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2015-11-27

Regulatory Status

Discontinued

2015
27 Nov
Discontinued Application: 205528

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2015-11-27

205528 / 4

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

205528

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2015-11-27

Regulatory Status

Discontinued

2025
18 Mar
RX Application: 213694

Drug Name

PERPHENAZINE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2025-03-18

213694 / 1

Active Ingredient

PERPHENAZINE

Application Number

213694

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2025-03-18

Regulatory Status

RX

2025
18 Mar
RX Application: 213694

Drug Name

PERPHENAZINE

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2025-03-18

213694 / 2

Active Ingredient

PERPHENAZINE

Application Number

213694

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2025-03-18

Regulatory Status

RX

2025
18 Mar
RX Application: 213694

Drug Name

PERPHENAZINE

Product Number

3

Dosage Form

-

Strength

8MG

Approval Date

2025-03-18

213694 / 3

Active Ingredient

PERPHENAZINE

Application Number

213694

Product Number

3

Dosage Form

-

Strength

8MG

Approval Date

2025-03-18

Regulatory Status

RX

2025
18 Mar
RX Application: 213694

Drug Name

PERPHENAZINE

Product Number

4

Dosage Form

-

Strength

16MG

Approval Date

2025-03-18

213694 / 4

Active Ingredient

PERPHENAZINE

Application Number

213694

Product Number

4

Dosage Form

-

Strength

16MG

Approval Date

2025-03-18

Regulatory Status

RX

2025
20 May
RX Application: 209530

Drug Name

PREGABALIN

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2025-05-20

209530 / 1

Active Ingredient

PREGABALIN

Application Number

209530

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2025-05-20

Regulatory Status

RX

2025
20 May
RX Application: 209530

Drug Name

PREGABALIN

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2025-05-20

209530 / 2

Active Ingredient

PREGABALIN

Application Number

209530

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2025-05-20

Regulatory Status

RX

2025
20 May
RX Application: 209530

Drug Name

PREGABALIN

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2025-05-20

209530 / 3

Active Ingredient

PREGABALIN

Application Number

209530

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2025-05-20

Regulatory Status

RX

2025
20 May
RX Application: 209530

Drug Name

PREGABALIN

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2025-05-20

209530 / 4

Active Ingredient

PREGABALIN

Application Number

209530

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2025-05-20

Regulatory Status

RX

2025
20 May
RX Application: 209530

Drug Name

PREGABALIN

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2025-05-20

209530 / 5

Active Ingredient

PREGABALIN

Application Number

209530

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2025-05-20

Regulatory Status

RX

2025
20 May
RX Application: 209530

Drug Name

PREGABALIN

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

2025-05-20

209530 / 6

Active Ingredient

PREGABALIN

Application Number

209530

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

2025-05-20

Regulatory Status

RX

2025
20 May
RX Application: 209530

Drug Name

PREGABALIN

Product Number

7

Dosage Form

-

Strength

225MG

Approval Date

2025-05-20

209530 / 7

Active Ingredient

PREGABALIN

Application Number

209530

Product Number

7

Dosage Form

-

Strength

225MG

Approval Date

2025-05-20

Regulatory Status

RX

2025
20 May
RX Application: 209530

Drug Name

PREGABALIN

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

2025-05-20

209530 / 8

Active Ingredient

PREGABALIN

Application Number

209530

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

2025-05-20

Regulatory Status

RX

2013
26 Nov
Discontinued Application: 203150

Drug Name

QUETIAPINE FUMARATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2013-11-26

203150 / 1

Active Ingredient

QUETIAPINE FUMARATE

Application Number

203150

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2013-11-26

Regulatory Status

Discontinued

2025
15 Apr
RX Application: 211361

Drug Name

RANOLAZINE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2025-04-15

211361 / 1

Active Ingredient

RANOLAZINE

Application Number

211361

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2025-04-15

Regulatory Status

RX

2025
15 Apr
RX Application: 211361

Drug Name

RANOLAZINE

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2025-04-15

211361 / 2

Active Ingredient

RANOLAZINE

Application Number

211361

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2025-04-15

Regulatory Status

RX

2011
04 Nov
RX Application: 90839

Drug Name

RISPERIDONE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2011-11-04

90839 / 1

Active Ingredient

RISPERIDONE

Application Number

90839

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2011-11-04

Regulatory Status

RX

2011
04 Nov
RX Application: 90839

Drug Name

RISPERIDONE

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2011-11-04

90839 / 2

Active Ingredient

RISPERIDONE

Application Number

90839

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2011-11-04

Regulatory Status

RX

2011
04 Nov
RX Application: 90839

Drug Name

RISPERIDONE

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2011-11-04

90839 / 3

Active Ingredient

RISPERIDONE

Application Number

90839

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2011-11-04

Regulatory Status

RX

2011
04 Nov
RX Application: 90839

Drug Name

RISPERIDONE

Product Number

4

Dosage Form

-

Strength

3MG

Approval Date

2011-11-04

90839 / 4

Active Ingredient

RISPERIDONE

Application Number

90839

Product Number

4

Dosage Form

-

Strength

3MG

Approval Date

2011-11-04

Regulatory Status

RX

2011
04 Nov
RX Application: 90839

Drug Name

RISPERIDONE

Product Number

5

Dosage Form

-

Strength

4MG

Approval Date

2011-11-04

90839 / 5

Active Ingredient

RISPERIDONE

Application Number

90839

Product Number

5

Dosage Form

-

Strength

4MG

Approval Date

2011-11-04

Regulatory Status

RX

2014
31 Dec
Discontinued Application: 203252

Drug Name

RIZATRIPTAN BENZOATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2014-12-31

203252 / 1

Active Ingredient

RIZATRIPTAN BENZOATE

Application Number

203252

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2014-12-31

Regulatory Status

Discontinued

2014
31 Dec
Discontinued Application: 203252

Drug Name

RIZATRIPTAN BENZOATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2014-12-31

203252 / 2

Active Ingredient

RIZATRIPTAN BENZOATE

Application Number

203252

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2014-12-31

Regulatory Status

Discontinued

2015
16 Oct
Discontinued Application: 203334

Drug Name

RIZATRIPTAN BENZOATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2015-10-16

203334 / 1

Active Ingredient

RIZATRIPTAN BENZOATE

Application Number

203334

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2015-10-16

Regulatory Status

Discontinued

2015
16 Oct
Discontinued Application: 203334

Drug Name

RIZATRIPTAN BENZOATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2015-10-16

203334 / 2

Active Ingredient

RIZATRIPTAN BENZOATE

Application Number

203334

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2015-10-16

Regulatory Status

Discontinued

2024
20 Dec
RX Application: 201156

Drug Name

SILDENAFIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2024-12-20

201156 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

201156

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2024-12-20

Regulatory Status

RX

2024
20 Dec
RX Application: 201156

Drug Name

SILDENAFIL CITRATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2024-12-20

201156 / 2

Active Ingredient

SILDENAFIL CITRATE

Application Number

201156

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2024-12-20

Regulatory Status

RX

2024
20 Dec
RX Application: 201156

Drug Name

SILDENAFIL CITRATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2024-12-20

201156 / 3

Active Ingredient

SILDENAFIL CITRATE

Application Number

201156

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2024-12-20

Regulatory Status

RX

2025
06 Mar
RX Application: 202954

Drug Name

SILDENAFIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2025-03-06

202954 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

202954

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2025-03-06

Regulatory Status

RX

2024
02 Oct
RX Application: 205484

Drug Name

SOLIFENACIN SUCCINATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2024-10-02

205484 / 1

Active Ingredient

SOLIFENACIN SUCCINATE

Application Number

205484

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2024-10-02

Regulatory Status

RX

2024
02 Oct
RX Application: 205484

Drug Name

SOLIFENACIN SUCCINATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2024-10-02

205484 / 2

Active Ingredient

SOLIFENACIN SUCCINATE

Application Number

205484

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2024-10-02

Regulatory Status

RX

2014
23 Apr
RX Application: 203253

Drug Name

SPIRONOLACTONE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2014-04-23

203253 / 1

Active Ingredient

SPIRONOLACTONE

Application Number

203253

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2014-04-23

Regulatory Status

RX

2014
23 Apr
RX Application: 203253

Drug Name

SPIRONOLACTONE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2014-04-23

203253 / 2

Active Ingredient

SPIRONOLACTONE

Application Number

203253

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2014-04-23

Regulatory Status

RX

2014
23 Apr
RX Application: 203253

Drug Name

SPIRONOLACTONE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2014-04-23

203253 / 3

Active Ingredient

SPIRONOLACTONE

Application Number

203253

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2014-04-23

Regulatory Status

RX

2026
15 May
RX Application: 210329

Drug Name

TADALAFIL

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2026-05-15

210329 / 1

Active Ingredient

TADALAFIL

Application Number

210329

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2026-05-15

Regulatory Status

RX

2026
15 May
RX Application: 210329

Drug Name

TADALAFIL

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2026-05-15

210329 / 2

Active Ingredient

TADALAFIL

Application Number

210329

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2026-05-15

Regulatory Status

RX

2026
15 May
RX Application: 210329

Drug Name

TADALAFIL

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2026-05-15

210329 / 3

Active Ingredient

TADALAFIL

Application Number

210329

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2026-05-15

Regulatory Status

RX

2026
15 May
RX Application: 210329

Drug Name

TADALAFIL

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2026-05-15

210329 / 4

Active Ingredient

TADALAFIL

Application Number

210329

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2026-05-15

Regulatory Status

RX

-
Unclassified Application: 210592

Drug Name

TADALAFIL

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

-

210592 / 1

Active Ingredient

TADALAFIL

Application Number

210592

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

-

Regulatory Status

Unclassified

2016
22 Aug
RX Application: 204164

Drug Name

TELMISARTAN

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2016-08-22

204164 / 1

Active Ingredient

TELMISARTAN

Application Number

204164

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2016-08-22

Regulatory Status

RX

2016
22 Aug
RX Application: 204164

Drug Name

TELMISARTAN

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2016-08-22

204164 / 2

Active Ingredient

TELMISARTAN

Application Number

204164

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2016-08-22

Regulatory Status

RX

2016
22 Aug
RX Application: 204164

Drug Name

TELMISARTAN

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

2016-08-22

204164 / 3

Active Ingredient

TELMISARTAN

Application Number

204164

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

2016-08-22

Regulatory Status

RX

2017
04 Aug
RX Application: 209605

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2017-08-04

209605 / 1

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

209605

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2017-08-04

Regulatory Status

RX

2017
04 Aug
RX Application: 209605

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2017-08-04

209605 / 2

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

209605

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2017-08-04

Regulatory Status

RX

2017
04 Aug
RX Application: 209605

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 6MG BASE

Approval Date

2017-08-04

209605 / 3

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

209605

Product Number

3

Dosage Form

-

Strength

EQ 6MG BASE

Approval Date

2017-08-04

Regulatory Status

RX

2012
03 Apr
RX Application: 201506

Drug Name

VALACYCLOVIR HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2012-04-03

201506 / 1

Active Ingredient

VALACYCLOVIR HYDROCHLORIDE

Application Number

201506

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2012-04-03

Regulatory Status

RX

2012
03 Apr
RX Application: 201506

Drug Name

VALACYCLOVIR HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

2012-04-03

201506 / 2

Active Ingredient

VALACYCLOVIR HYDROCHLORIDE

Application Number

201506

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

2012-04-03

Regulatory Status

RX

2015
05 Jan
RX Application: 203536

Drug Name

VALSARTAN

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2015-01-05

203536 / 1

Active Ingredient

VALSARTAN

Application Number

203536

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2015-01-05

Regulatory Status

RX

2015
05 Jan
RX Application: 203536

Drug Name

VALSARTAN

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2015-01-05

203536 / 2

Active Ingredient

VALSARTAN

Application Number

203536

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2015-01-05

Regulatory Status

RX

2015
05 Jan
RX Application: 203536

Drug Name

VALSARTAN

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2015-01-05

203536 / 3

Active Ingredient

VALSARTAN

Application Number

203536

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2015-01-05

Regulatory Status

RX

2015
05 Jan
RX Application: 203536

Drug Name

VALSARTAN

Product Number

4

Dosage Form

-

Strength

320MG

Approval Date

2015-01-05

203536 / 4

Active Ingredient

VALSARTAN

Application Number

203536

Product Number

4

Dosage Form

-

Strength

320MG

Approval Date

2015-01-05

Regulatory Status

RX

2014
20 Nov
RX Application: 202279

Drug Name

ZOLMITRIPTAN

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2014-11-20

202279 / 1

Active Ingredient

ZOLMITRIPTAN

Application Number

202279

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2014-11-20

Regulatory Status

RX

2014
20 Nov
RX Application: 202279

Drug Name

ZOLMITRIPTAN

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2014-11-20

202279 / 2

Active Ingredient

ZOLMITRIPTAN

Application Number

202279

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2014-11-20

Regulatory Status

RX

2015
17 Sep
RX Application: 202956

Drug Name

ZOLMITRIPTAN

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2015-09-17

202956 / 1

Active Ingredient

ZOLMITRIPTAN

Application Number

202956

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2015-09-17

Regulatory Status

RX

2015
17 Sep
RX Application: 202956

Drug Name

ZOLMITRIPTAN

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2015-09-17

202956 / 2

Active Ingredient

ZOLMITRIPTAN

Application Number

202956

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2015-09-17

Regulatory Status

RX

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

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

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

AMANTADINE HYDROCHLORIDE

Application Number

210403

Product Number

1

Active Ingredient

AMANTADINE HYDROCHLORIDE

Dosage Form

-

Strength

100MG

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

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