Prinston RX
FDA Approved Drugs

Prinston RX

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
  • Total Records 245
  • Latest Approval Date Mar 06, 2026
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
272
View
Unclassified
5
View
Discontinued
22
View
RX
245
View
Company Overview

Company

Prinston RX

Country

U.S.A

Website

Visit Website

Email

contact@prinstonpharm.com

Social Profiles

LinkedIn
Company Snapshot

Prinston RX

700 Atrium Dr. Somerset, New Jersey 08873

U.S.A

www.prinstonpharm.com/ contact@prinstonpharm.com View on Map
FDA Approved Drug Records ( 245 records )
2020
11 Mar
RX Application: 211861

Drug Name

AMPHETAMINE SULFATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2020-03-11

211861 / 1

Active Ingredient

AMPHETAMINE SULFATE

Application Number

211861

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2020-03-11

Regulatory Status

RX

2020
11 Mar
RX Application: 211861

Drug Name

AMPHETAMINE SULFATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2020-03-11

211861 / 2

Active Ingredient

AMPHETAMINE SULFATE

Application Number

211861

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2020-03-11

Regulatory Status

RX

2017
04 Dec
RX Application: 205363

Drug Name

ARIPIPRAZOLE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2017-12-04

205363 / 1

Active Ingredient

ARIPIPRAZOLE

Application Number

205363

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2017-12-04

Regulatory Status

RX

2017
04 Dec
RX Application: 205363

Drug Name

ARIPIPRAZOLE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2017-12-04

205363 / 2

Active Ingredient

ARIPIPRAZOLE

Application Number

205363

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2017-12-04

Regulatory Status

RX

2017
04 Dec
RX Application: 205363

Drug Name

ARIPIPRAZOLE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2017-12-04

205363 / 3

Active Ingredient

ARIPIPRAZOLE

Application Number

205363

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2017-12-04

Regulatory Status

RX

2017
04 Dec
RX Application: 205363

Drug Name

ARIPIPRAZOLE

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2017-12-04

205363 / 4

Active Ingredient

ARIPIPRAZOLE

Application Number

205363

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2017-12-04

Regulatory Status

RX

2017
04 Dec
RX Application: 205363

Drug Name

ARIPIPRAZOLE

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2017-12-04

205363 / 5

Active Ingredient

ARIPIPRAZOLE

Application Number

205363

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2017-12-04

Regulatory Status

RX

2017
04 Dec
RX Application: 205363

Drug Name

ARIPIPRAZOLE

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2017-12-04

205363 / 6

Active Ingredient

ARIPIPRAZOLE

Application Number

205363

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2017-12-04

Regulatory Status

RX

2004
11 Feb
RX Application: 76118

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2004-02-11

76118 / 1

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

76118

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2004-02-11

Regulatory Status

RX

2004
11 Feb
RX Application: 76118

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2004-02-11

76118 / 2

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

76118

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2004-02-11

Regulatory Status

RX

2004
11 Feb
RX Application: 76118

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2004-02-11

76118 / 3

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

76118

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2004-02-11

Regulatory Status

RX

2004
11 Feb
RX Application: 76118

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2004-02-11

76118 / 4

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

76118

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2004-02-11

Regulatory Status

RX

2023
14 Jul
RX Application: 217368

Drug Name

BISOPROLOL FUMARATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2023-07-14

217368 / 1

Active Ingredient

BISOPROLOL FUMARATE

Application Number

217368

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2023-07-14

Regulatory Status

RX

2023
14 Jul
RX Application: 217368

Drug Name

BISOPROLOL FUMARATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2023-07-14

217368 / 2

Active Ingredient

BISOPROLOL FUMARATE

Application Number

217368

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2023-07-14

Regulatory Status

RX

2015
26 May
RX Application: 202304

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2015-05-26

202304 / 1

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

202304

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2015-05-26

Regulatory Status

RX

2015
26 May
RX Application: 202304

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2015-05-26

202304 / 2

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

202304

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2015-05-26

Regulatory Status

RX

2015
26 May
RX Application: 202304

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2015-05-26

202304 / 3

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

202304

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2015-05-26

Regulatory Status

RX

2024
11 Sep
RX Application: 215235

Drug Name

BUSULFAN

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2024-09-11

215235 / 1

Active Ingredient

BUSULFAN

Application Number

215235

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2024-09-11

Regulatory Status

RX

2023
21 Aug
RX Application: 206233

Drug Name

CANDESARTAN CILEXETIL

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

2023-08-21

206233 / 1

Active Ingredient

CANDESARTAN CILEXETIL

Application Number

206233

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

2023-08-21

Regulatory Status

RX

2023
21 Aug
RX Application: 206233

Drug Name

CANDESARTAN CILEXETIL

Product Number

2

Dosage Form

-

Strength

16MG

Approval Date

2023-08-21

206233 / 2

Active Ingredient

CANDESARTAN CILEXETIL

Application Number

206233

Product Number

2

Dosage Form

-

Strength

16MG

Approval Date

2023-08-21

Regulatory Status

RX

2023
21 Aug
RX Application: 206233

Drug Name

CANDESARTAN CILEXETIL

Product Number

3

Dosage Form

-

Strength

32MG

Approval Date

2023-08-21

206233 / 3

Active Ingredient

CANDESARTAN CILEXETIL

Application Number

206233

Product Number

3

Dosage Form

-

Strength

32MG

Approval Date

2023-08-21

Regulatory Status

RX

2018
11 Apr
RX Application: 207455

Drug Name

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

16MG;12.5MG

Approval Date

2018-04-11

207455 / 1

Active Ingredient

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Application Number

207455

Product Number

1

Dosage Form

-

Strength

16MG;12.5MG

Approval Date

2018-04-11

Regulatory Status

RX

2018
11 Apr
RX Application: 207455

Drug Name

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

32MG;12.5MG

Approval Date

2018-04-11

207455 / 2

Active Ingredient

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Application Number

207455

Product Number

2

Dosage Form

-

Strength

32MG;12.5MG

Approval Date

2018-04-11

Regulatory Status

RX

2018
11 Apr
RX Application: 207455

Drug Name

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

32MG;25MG

Approval Date

2018-04-11

207455 / 3

Active Ingredient

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Application Number

207455

Product Number

3

Dosage Form

-

Strength

32MG;25MG

Approval Date

2018-04-11

Regulatory Status

RX

1996
13 Feb
RX Application: 74477

Drug Name

CAPTOPRIL

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

1996-02-13

74477 / 1

Active Ingredient

CAPTOPRIL

Application Number

74477

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

1996-02-13

Regulatory Status

RX

1996
13 Feb
RX Application: 74477

Drug Name

CAPTOPRIL

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1996-02-13

74477 / 2

Active Ingredient

CAPTOPRIL

Application Number

74477

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1996-02-13

Regulatory Status

RX

1996
13 Feb
RX Application: 74477

Drug Name

CAPTOPRIL

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1996-02-13

74477 / 3

Active Ingredient

CAPTOPRIL

Application Number

74477

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1996-02-13

Regulatory Status

RX

1996
13 Feb
RX Application: 74477

Drug Name

CAPTOPRIL

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

1996-02-13

74477 / 4

Active Ingredient

CAPTOPRIL

Application Number

74477

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

1996-02-13

Regulatory Status

RX

2006
28 Jun
RX Application: 77856

Drug Name

CLONAZEPAM

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2006-06-28

77856 / 1

Active Ingredient

CLONAZEPAM

Application Number

77856

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2006-06-28

Regulatory Status

RX

2006
28 Jun
RX Application: 77856

Drug Name

CLONAZEPAM

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2006-06-28

77856 / 2

Active Ingredient

CLONAZEPAM

Application Number

77856

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2006-06-28

Regulatory Status

RX

2006
28 Jun
RX Application: 77856

Drug Name

CLONAZEPAM

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2006-06-28

77856 / 3

Active Ingredient

CLONAZEPAM

Application Number

77856

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2006-06-28

Regulatory Status

RX

2007
09 Mar
RX Application: 77901

Drug Name

CLONIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2007-03-09

77901 / 1

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

77901

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2007-03-09

Regulatory Status

RX

2007
09 Mar
RX Application: 77901

Drug Name

CLONIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

0.2MG

Approval Date

2007-03-09

77901 / 2

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

77901

Product Number

2

Dosage Form

-

Strength

0.2MG

Approval Date

2007-03-09

Regulatory Status

RX

2007
09 Mar
RX Application: 77901

Drug Name

CLONIDINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

0.3MG

Approval Date

2007-03-09

77901 / 3

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

77901

Product Number

3

Dosage Form

-

Strength

0.3MG

Approval Date

2007-03-09

Regulatory Status

RX

2018
07 May
RX Application: 206376

Drug Name

CLOPIDOGREL BISULFATE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2018-05-07

206376 / 1

Active Ingredient

CLOPIDOGREL BISULFATE

Application Number

206376

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2018-05-07

Regulatory Status

RX

2018
07 May
RX Application: 206376

Drug Name

CLOPIDOGREL BISULFATE

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2018-05-07

206376 / 2

Active Ingredient

CLOPIDOGREL BISULFATE

Application Number

206376

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2018-05-07

Regulatory Status

RX

2007
28 Feb
RX Application: 77797

Drug Name

CYCLOBENZAPRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-02-28

77797 / 1

Active Ingredient

CYCLOBENZAPRINE HYDROCHLORIDE

Application Number

77797

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-02-28

Regulatory Status

RX

2007
28 Feb
RX Application: 77797

Drug Name

CYCLOBENZAPRINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-02-28

77797 / 2

Active Ingredient

CYCLOBENZAPRINE HYDROCHLORIDE

Application Number

77797

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-02-28

Regulatory Status

RX

2023
30 Aug
RX Application: 217531

Drug Name

DICYCLOMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2023-08-30

217531 / 1

Active Ingredient

DICYCLOMINE HYDROCHLORIDE

Application Number

217531

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2023-08-30

Regulatory Status

RX

2025
06 Jun
RX Application: 218310

Drug Name

DICYCLOMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2025-06-06

218310 / 1

Active Ingredient

DICYCLOMINE HYDROCHLORIDE

Application Number

218310

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2025-06-06

Regulatory Status

RX

2022
18 Oct
RX Application: 210414

Drug Name

DIMETHYL FUMARATE

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2022-10-18

210414 / 1

Active Ingredient

DIMETHYL FUMARATE

Application Number

210414

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2022-10-18

Regulatory Status

RX

2022
18 Oct
RX Application: 210414

Drug Name

DIMETHYL FUMARATE

Product Number

2

Dosage Form

-

Strength

240MG

Approval Date

2022-10-18

210414 / 2

Active Ingredient

DIMETHYL FUMARATE

Application Number

210414

Product Number

2

Dosage Form

-

Strength

240MG

Approval Date

2022-10-18

Regulatory Status

RX

2009
30 Nov
RX Application: 90210

Drug Name

DIVALPROEX SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 125MG VALPROIC ACID

Approval Date

2009-11-30

90210 / 1

Active Ingredient

DIVALPROEX SODIUM

Application Number

90210

Product Number

1

Dosage Form

-

Strength

EQ 125MG VALPROIC ACID

Approval Date

2009-11-30

Regulatory Status

RX

2009
30 Nov
RX Application: 90210

Drug Name

DIVALPROEX SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

2009-11-30

90210 / 2

Active Ingredient

DIVALPROEX SODIUM

Application Number

90210

Product Number

2

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

2009-11-30

Regulatory Status

RX

2009
30 Nov
RX Application: 90210

Drug Name

DIVALPROEX SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

2009-11-30

90210 / 3

Active Ingredient

DIVALPROEX SODIUM

Application Number

90210

Product Number

3

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

2009-11-30

Regulatory Status

RX

2011
31 May
RX Application: 200292

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-05-31

200292 / 1

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

200292

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-05-31

Regulatory Status

RX

2011
31 May
RX Application: 200292

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-05-31

200292 / 2

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

200292

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-05-31

Regulatory Status

RX

2025
27 Jan
RX Application: 217098

Drug Name

DOXYCYCLINE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2025-01-27

217098 / 1

Active Ingredient

DOXYCYCLINE

Application Number

217098

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2025-01-27

Regulatory Status

RX

2016
15 Nov
RX Application: 207494

Drug Name

DOXYCYCLINE HYCLATE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2016-11-15

207494 / 1

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

207494

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2016-11-15

Regulatory Status

RX

2016
15 Nov
RX Application: 207494

Drug Name

DOXYCYCLINE HYCLATE

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2016-11-15

207494 / 2

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

207494

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2016-11-15

Regulatory Status

RX

2019
19 Feb
RX Application: 207494

Drug Name

DOXYCYCLINE HYCLATE

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2019-02-19

207494 / 3

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

207494

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2019-02-19

Regulatory Status

RX

2017
18 May
RX Application: 206653

Drug Name

DULOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2017-05-18

206653 / 1

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

206653

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2017-05-18

Regulatory Status

RX

2017
18 May
RX Application: 206653

Drug Name

DULOXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2017-05-18

206653 / 2

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

206653

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2017-05-18

Regulatory Status

RX

2017
18 May
RX Application: 206653

Drug Name

DULOXETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2017-05-18

206653 / 3

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

206653

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2017-05-18

Regulatory Status

RX

2022
07 Jul
RX Application: 213273

Drug Name

ENALAPRIL MALEATE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2022-07-07

213273 / 1

Active Ingredient

ENALAPRIL MALEATE

Application Number

213273

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2022-07-07

Regulatory Status

RX

2022
07 Jul
RX Application: 213273

Drug Name

ENALAPRIL MALEATE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2022-07-07

213273 / 2

Active Ingredient

ENALAPRIL MALEATE

Application Number

213273

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2022-07-07

Regulatory Status

RX

2022
07 Jul
RX Application: 213273

Drug Name

ENALAPRIL MALEATE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2022-07-07

213273 / 3

Active Ingredient

ENALAPRIL MALEATE

Application Number

213273

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2022-07-07

Regulatory Status

RX

2022
07 Jul
RX Application: 213273

Drug Name

ENALAPRIL MALEATE

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2022-07-07

213273 / 4

Active Ingredient

ENALAPRIL MALEATE

Application Number

213273

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2022-07-07

Regulatory Status

RX

2015
28 Aug
RX Application: 78032

Drug Name

ESCITALOPRAM OXALATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2015-08-28

78032 / 1

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

78032

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2015-08-28

Regulatory Status

RX

2015
28 Aug
RX Application: 78032

Drug Name

ESCITALOPRAM OXALATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2015-08-28

78032 / 2

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

78032

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2015-08-28

Regulatory Status

RX

2015
28 Aug
RX Application: 78032

Drug Name

ESCITALOPRAM OXALATE

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2015-08-28

78032 / 3

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

78032

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2015-08-28

Regulatory Status

RX

2023
28 Mar
RX Application: 214920

Drug Name

ESOMEPRAZOLE MAGNESIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2023-03-28

214920 / 1

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

214920

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2023-03-28

Regulatory Status

RX

2023
28 Mar
RX Application: 214920

Drug Name

ESOMEPRAZOLE MAGNESIUM

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2023-03-28

214920 / 2

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

214920

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2023-03-28

Regulatory Status

RX

2022
28 Mar
RX Application: 206266

Drug Name

FEBUXOSTAT

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2022-03-28

206266 / 1

Active Ingredient

FEBUXOSTAT

Application Number

206266

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2022-03-28

Regulatory Status

RX

2022
28 Mar
RX Application: 206266

Drug Name

FEBUXOSTAT

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2022-03-28

206266 / 2

Active Ingredient

FEBUXOSTAT

Application Number

206266

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2022-03-28

Regulatory Status

RX

2018
28 Aug
RX Application: 211080

Drug Name

FENOFIBRATE

Product Number

1

Dosage Form

-

Strength

48MG

Approval Date

2018-08-28

211080 / 1

Active Ingredient

FENOFIBRATE

Application Number

211080

Product Number

1

Dosage Form

-

Strength

48MG

Approval Date

2018-08-28

Regulatory Status

RX

2018
28 Aug
RX Application: 211080

Drug Name

FENOFIBRATE

Product Number

2

Dosage Form

-

Strength

145MG

Approval Date

2018-08-28

211080 / 2

Active Ingredient

FENOFIBRATE

Application Number

211080

Product Number

2

Dosage Form

-

Strength

145MG

Approval Date

2018-08-28

Regulatory Status

RX

2022
07 Sep
RX Application: 208003

Drug Name

FINGOLIMOD HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2022-09-07

208003 / 1

Active Ingredient

FINGOLIMOD HYDROCHLORIDE

Application Number

208003

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2022-09-07

Regulatory Status

RX

2016
29 Aug
RX Application: 205670

Drug Name

FOSINOPRIL SODIUM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2016-08-29

205670 / 1

Active Ingredient

FOSINOPRIL SODIUM

Application Number

205670

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2016-08-29

Regulatory Status

RX

2016
29 Aug
RX Application: 205670

Drug Name

FOSINOPRIL SODIUM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2016-08-29

205670 / 2

Active Ingredient

FOSINOPRIL SODIUM

Application Number

205670

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2016-08-29

Regulatory Status

RX

2016
29 Aug
RX Application: 205670

Drug Name

FOSINOPRIL SODIUM

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2016-08-29

205670 / 3

Active Ingredient

FOSINOPRIL SODIUM

Application Number

205670

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2016-08-29

Regulatory Status

RX

2004
26 Mar
RX Application: 76796

Drug Name

FUROSEMIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2004-03-26

76796 / 1

Active Ingredient

FUROSEMIDE

Application Number

76796

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2004-03-26

Regulatory Status

RX

2004
26 Mar
RX Application: 76796

Drug Name

FUROSEMIDE

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2004-03-26

76796 / 2

Active Ingredient

FUROSEMIDE

Application Number

76796

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2004-03-26

Regulatory Status

RX

2004
26 Mar
RX Application: 76796

Drug Name

FUROSEMIDE

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

2004-03-26

76796 / 3

Active Ingredient

FUROSEMIDE

Application Number

76796

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

2004-03-26

Regulatory Status

RX

2026
06 Mar
RX Application: 219814

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2026-03-06

219814 / 1

Active Ingredient

GABAPENTIN

Application Number

219814

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2026-03-06

Regulatory Status

RX

2026
06 Mar
RX Application: 219814

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2026-03-06

219814 / 2

Active Ingredient

GABAPENTIN

Application Number

219814

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2026-03-06

Regulatory Status

RX

2026
06 Mar
RX Application: 219814

Drug Name

GABAPENTIN

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2026-03-06

219814 / 3

Active Ingredient

GABAPENTIN

Application Number

219814

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2026-03-06

Regulatory Status

RX

2005
23 Dec
RX Application: 77370

Drug Name

GLIMEPIRIDE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2005-12-23

77370 / 1

Active Ingredient

GLIMEPIRIDE

Application Number

77370

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2005-12-23

Regulatory Status

RX

2005
23 Dec
RX Application: 77370

Drug Name

GLIMEPIRIDE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2005-12-23

77370 / 2

Active Ingredient

GLIMEPIRIDE

Application Number

77370

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2005-12-23

Regulatory Status

RX

2005
23 Dec
RX Application: 77370

Drug Name

GLIMEPIRIDE

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

2005-12-23

77370 / 3

Active Ingredient

GLIMEPIRIDE

Application Number

77370

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

2005-12-23

Regulatory Status

RX

2005
23 Dec
RX Application: 77370

Drug Name

GLIMEPIRIDE

Product Number

4

Dosage Form

-

Strength

8MG

Approval Date

2005-12-23

77370 / 4

Active Ingredient

GLIMEPIRIDE

Application Number

77370

Product Number

4

Dosage Form

-

Strength

8MG

Approval Date

2005-12-23

Regulatory Status

RX

2018
31 Oct
RX Application: 210927

Drug Name

GLYCOPYRROLATE

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2018-10-31

210927 / 1

Active Ingredient

GLYCOPYRROLATE

Application Number

210927

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2018-10-31

Regulatory Status

RX

2002
17 Sep
RX Application: 75907

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2002-09-17

75907 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

75907

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2002-09-17

Regulatory Status

RX

2005
27 May
RX Application: 40580

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2005-05-27

40580 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

40580

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2005-05-27

Regulatory Status

RX

2005
27 May
RX Application: 40580

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2005-05-27

40580 / 2

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

40580

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2005-05-27

Regulatory Status

RX

2005
27 May
RX Application: 40580

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2005-05-27

40580 / 3

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

40580

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2005-05-27

Regulatory Status

RX

2012
27 Sep
RX Application: 203071

Drug Name

IRBESARTAN

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2012-09-27

203071 / 1

Active Ingredient

IRBESARTAN

Application Number

203071

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2012-09-27

Regulatory Status

RX

2012
27 Sep
RX Application: 203071

Drug Name

IRBESARTAN

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2012-09-27

203071 / 2

Active Ingredient

IRBESARTAN

Application Number

203071

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2012-09-27

Regulatory Status

RX

2012
27 Sep
RX Application: 203071

Drug Name

IRBESARTAN

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2012-09-27

203071 / 3

Active Ingredient

IRBESARTAN

Application Number

203071

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2012-09-27

Regulatory Status

RX

2014
09 May
RX Application: 203072

Drug Name

IRBESARTAN AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;150MG

Approval Date

2014-05-09

203072 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; IRBESARTAN

Application Number

203072

Product Number

1

Dosage Form

-

Strength

12.5MG;150MG

Approval Date

2014-05-09

Regulatory Status

RX

2014
09 May
RX Application: 203072

Drug Name

IRBESARTAN AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;300MG

Approval Date

2014-05-09

203072 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; IRBESARTAN

Application Number

203072

Product Number

2

Dosage Form

-

Strength

12.5MG;300MG

Approval Date

2014-05-09

Regulatory Status

RX

2009
10 Feb
RX Application: 78106

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2009-02-10

78106 / 1

Active Ingredient

LEVETIRACETAM

Application Number

78106

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2009-02-10

Regulatory Status

RX

2009
10 Feb
RX Application: 78106

Drug Name

LEVETIRACETAM

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2009-02-10

78106 / 2

Active Ingredient

LEVETIRACETAM

Application Number

78106

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2009-02-10

Regulatory Status

RX

2009
10 Feb
RX Application: 78106

Drug Name

LEVETIRACETAM

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2009-02-10

78106 / 3

Active Ingredient

LEVETIRACETAM

Application Number

78106

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2009-02-10

Regulatory Status

RX

2009
10 Feb
RX Application: 78106

Drug Name

LEVETIRACETAM

Product Number

4

Dosage Form

-

Strength

1GM

Approval Date

2009-02-10

78106 / 4

Active Ingredient

LEVETIRACETAM

Application Number

78106

Product Number

4

Dosage Form

-

Strength

1GM

Approval Date

2009-02-10

Regulatory Status

RX

2015
21 May
RX Application: 203468

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2015-05-21

203468 / 1

Active Ingredient

LEVETIRACETAM

Application Number

203468

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2015-05-21

Regulatory Status

RX

2015
21 May
RX Application: 203468

Drug Name

LEVETIRACETAM

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2015-05-21

203468 / 2

Active Ingredient

LEVETIRACETAM

Application Number

203468

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2015-05-21

Regulatory Status

RX

2022
28 Mar
RX Application: 209474

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

500MG/5ML (100MG/ML)

Approval Date

2022-03-28

209474 / 1

Active Ingredient

LEVETIRACETAM

Application Number

209474

Product Number

1

Dosage Form

-

Strength

500MG/5ML (100MG/ML)

Approval Date

2022-03-28

Regulatory Status

RX

2023
20 Mar
RX Application: 210771

Drug Name

LEVOMILNACIPRAN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2023-03-20

210771 / 1

Active Ingredient

LEVOMILNACIPRAN HYDROCHLORIDE

Application Number

210771

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2023-03-20

Regulatory Status

RX

2023
20 Mar
RX Application: 210771

Drug Name

LEVOMILNACIPRAN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2023-03-20

210771 / 2

Active Ingredient

LEVOMILNACIPRAN HYDROCHLORIDE

Application Number

210771

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2023-03-20

Regulatory Status

RX

2023
20 Mar
RX Application: 210771

Drug Name

LEVOMILNACIPRAN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2023-03-20

210771 / 3

Active Ingredient

LEVOMILNACIPRAN HYDROCHLORIDE

Application Number

210771

Product Number

3

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2023-03-20

Regulatory Status

RX

2023
20 Mar
RX Application: 210771

Drug Name

LEVOMILNACIPRAN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 120MG BASE

Approval Date

2023-03-20

210771 / 4

Active Ingredient

LEVOMILNACIPRAN HYDROCHLORIDE

Application Number

210771

Product Number

4

Dosage Form

-

Strength

EQ 120MG BASE

Approval Date

2023-03-20

Regulatory Status

RX

2023
25 Aug
RX Application: 216266

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2023-08-25

216266 / 1

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

216266

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 216266

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2023-08-25

216266 / 2

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

216266

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 216266

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2023-08-25

216266 / 3

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

216266

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 216266

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2023-08-25

216266 / 4

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

216266

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 216266

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2023-08-25

216266 / 5

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

216266

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 216266

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2023-08-25

216266 / 6

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

216266

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 216266

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

7

Dosage Form

-

Strength

70MG

Approval Date

2023-08-25

216266 / 7

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

216266

Product Number

7

Dosage Form

-

Strength

70MG

Approval Date

2023-08-25

Regulatory Status

RX

2002
01 Jul
RX Application: 75743

Drug Name

LISINOPRIL

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2002-07-01

75743 / 1

Active Ingredient

LISINOPRIL

Application Number

75743

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2002-07-01

Regulatory Status

RX

2002
01 Jul
RX Application: 75743

Drug Name

LISINOPRIL

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2002-07-01

75743 / 2

Active Ingredient

LISINOPRIL

Application Number

75743

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2002-07-01

Regulatory Status

RX

2002
01 Jul
RX Application: 75743

Drug Name

LISINOPRIL

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2002-07-01

75743 / 3

Active Ingredient

LISINOPRIL

Application Number

75743

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2002-07-01

Regulatory Status

RX

2002
01 Jul
RX Application: 75743

Drug Name

LISINOPRIL

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2002-07-01

75743 / 4

Active Ingredient

LISINOPRIL

Application Number

75743

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2002-07-01

Regulatory Status

RX

2002
01 Jul
RX Application: 75743

Drug Name

LISINOPRIL

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

2002-07-01

75743 / 5

Active Ingredient

LISINOPRIL

Application Number

75743

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

2002-07-01

Regulatory Status

RX

2002
01 Jul
RX Application: 75743

Drug Name

LISINOPRIL

Product Number

6

Dosage Form

-

Strength

40MG

Approval Date

2002-07-01

75743 / 6

Active Ingredient

LISINOPRIL

Application Number

75743

Product Number

6

Dosage Form

-

Strength

40MG

Approval Date

2002-07-01

Regulatory Status

RX

2002
01 Jul
RX Application: 76164

Drug Name

LISINOPRIL

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2002-07-01

76164 / 1

Active Ingredient

LISINOPRIL

Application Number

76164

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2002-07-01

Regulatory Status

RX

2002
01 Jul
RX Application: 76164

Drug Name

LISINOPRIL

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2002-07-01

76164 / 2

Active Ingredient

LISINOPRIL

Application Number

76164

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2002-07-01

Regulatory Status

RX

2002
01 Jul
RX Application: 76164

Drug Name

LISINOPRIL

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2002-07-01

76164 / 3

Active Ingredient

LISINOPRIL

Application Number

76164

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2002-07-01

Regulatory Status

RX

2002
01 Jul
RX Application: 76164

Drug Name

LISINOPRIL

Product Number

4

Dosage Form

-

Strength

2.5MG

Approval Date

2002-07-01

76164 / 4

Active Ingredient

LISINOPRIL

Application Number

76164

Product Number

4

Dosage Form

-

Strength

2.5MG

Approval Date

2002-07-01

Regulatory Status

RX

2002
01 Jul
RX Application: 76164

Drug Name

LISINOPRIL

Product Number

5

Dosage Form

-

Strength

5MG

Approval Date

2002-07-01

76164 / 5

Active Ingredient

LISINOPRIL

Application Number

76164

Product Number

5

Dosage Form

-

Strength

5MG

Approval Date

2002-07-01

Regulatory Status

RX

2002
01 Jul
RX Application: 76164

Drug Name

LISINOPRIL

Product Number

6

Dosage Form

-

Strength

10MG

Approval Date

2002-07-01

76164 / 6

Active Ingredient

LISINOPRIL

Application Number

76164

Product Number

6

Dosage Form

-

Strength

10MG

Approval Date

2002-07-01

Regulatory Status

RX

2002
01 Jul
RX Application: 76230

Drug Name

LISINOPRIL AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;10MG

Approval Date

2002-07-01

76230 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; LISINOPRIL

Application Number

76230

Product Number

1

Dosage Form

-

Strength

12.5MG;10MG

Approval Date

2002-07-01

Regulatory Status

RX

2002
01 Jul
RX Application: 76230

Drug Name

LISINOPRIL AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;20MG

Approval Date

2002-07-01

76230 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; LISINOPRIL

Application Number

76230

Product Number

2

Dosage Form

-

Strength

12.5MG;20MG

Approval Date

2002-07-01

Regulatory Status

RX

2002
01 Jul
RX Application: 76230

Drug Name

LISINOPRIL AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;20MG

Approval Date

2002-07-01

76230 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; LISINOPRIL

Application Number

76230

Product Number

3

Dosage Form

-

Strength

25MG;20MG

Approval Date

2002-07-01

Regulatory Status

RX

2011
06 Jun
RX Application: 91497

Drug Name

LOSARTAN POTASSIUM

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2011-06-06

91497 / 1

Active Ingredient

LOSARTAN POTASSIUM

Application Number

91497

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2011-06-06

Regulatory Status

RX

2011
06 Jun
RX Application: 91497

Drug Name

LOSARTAN POTASSIUM

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2011-06-06

91497 / 2

Active Ingredient

LOSARTAN POTASSIUM

Application Number

91497

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2011-06-06

Regulatory Status

RX

2011
06 Jun
RX Application: 91497

Drug Name

LOSARTAN POTASSIUM

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2011-06-06

91497 / 3

Active Ingredient

LOSARTAN POTASSIUM

Application Number

91497

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2011-06-06

Regulatory Status

RX

2017
06 Nov
RX Application: 204901

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;50MG

Approval Date

2017-11-06

204901 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

204901

Product Number

1

Dosage Form

-

Strength

12.5MG;50MG

Approval Date

2017-11-06

Regulatory Status

RX

2017
06 Nov
RX Application: 204901

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;100MG

Approval Date

2017-11-06

204901 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

204901

Product Number

2

Dosage Form

-

Strength

12.5MG;100MG

Approval Date

2017-11-06

Regulatory Status

RX

2017
06 Nov
RX Application: 204901

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;100MG

Approval Date

2017-11-06

204901 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

204901

Product Number

3

Dosage Form

-

Strength

25MG;100MG

Approval Date

2017-11-06

Regulatory Status

RX

2018
10 Sep
RX Application: 208880

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2018-09-10

208880 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

208880

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2018-09-10

Regulatory Status

RX

2018
10 Sep
RX Application: 208880

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2018-09-10

208880 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

208880

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2018-09-10

Regulatory Status

RX

2022
09 Jun
RX Application: 212681

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2022-06-09

212681 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

212681

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2022-06-09

Regulatory Status

RX

2022
09 Jun
RX Application: 212681

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2022-06-09

212681 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

212681

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2022-06-09

Regulatory Status

RX

1982
01 Jan
RX Application: 86988

Drug Name

METHOCARBAMOL

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

1982-01-01

86988 / 1

Active Ingredient

METHOCARBAMOL

Application Number

86988

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 86988

Drug Name

METHOCARBAMOL

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

86988 / 2

Active Ingredient

METHOCARBAMOL

Application Number

86988

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

RX

2020
23 Jul
RX Application: 212697

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2020-07-23

212697 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

212697

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2020-07-23

Regulatory Status

RX

2020
23 Jul
RX Application: 212697

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2020-07-23

212697 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

212697

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2020-07-23

Regulatory Status

RX

2020
23 Jul
RX Application: 212697

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2020-07-23

212697 / 3

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

212697

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2020-07-23

Regulatory Status

RX

2022
07 Apr
RX Application: 212682

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2022-04-07

212682 / 1

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

212682

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2022-04-07

Regulatory Status

RX

2022
07 Apr
RX Application: 212682

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2022-04-07

212682 / 2

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

212682

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2022-04-07

Regulatory Status

RX

2022
07 Apr
RX Application: 212682

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2022-04-07

212682 / 3

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

212682

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2022-04-07

Regulatory Status

RX

2022
07 Apr
RX Application: 212682

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2022-04-07

212682 / 4

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

212682

Product Number

4

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2022-04-07

Regulatory Status

RX

2022
02 Dec
RX Application: 206720

Drug Name

OLMESARTAN MEDOXOMIL

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2022-12-02

206720 / 1

Active Ingredient

OLMESARTAN MEDOXOMIL

Application Number

206720

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2022-12-02

Regulatory Status

RX

2022
02 Dec
RX Application: 206720

Drug Name

OLMESARTAN MEDOXOMIL

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2022-12-02

206720 / 2

Active Ingredient

OLMESARTAN MEDOXOMIL

Application Number

206720

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2022-12-02

Regulatory Status

RX

2022
02 Dec
RX Application: 206720

Drug Name

OLMESARTAN MEDOXOMIL

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2022-12-02

206720 / 3

Active Ingredient

OLMESARTAN MEDOXOMIL

Application Number

206720

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2022-12-02

Regulatory Status

RX

2017
24 Apr
RX Application: 207804

Drug Name

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;20MG

Approval Date

2017-04-24

207804 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

207804

Product Number

1

Dosage Form

-

Strength

12.5MG;20MG

Approval Date

2017-04-24

Regulatory Status

RX

2017
24 Apr
RX Application: 207804

Drug Name

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;40MG

Approval Date

2017-04-24

207804 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

207804

Product Number

2

Dosage Form

-

Strength

12.5MG;40MG

Approval Date

2017-04-24

Regulatory Status

RX

2017
24 Apr
RX Application: 207804

Drug Name

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;40MG

Approval Date

2017-04-24

207804 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

207804

Product Number

3

Dosage Form

-

Strength

25MG;40MG

Approval Date

2017-04-24

Regulatory Status

RX

2014
31 Oct
RX Application: 203854

Drug Name

PAROXETINE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2014-10-31

203854 / 1

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

203854

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2014-10-31

Regulatory Status

RX

2014
31 Oct
RX Application: 203854

Drug Name

PAROXETINE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2014-10-31

203854 / 2

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

203854

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2014-10-31

Regulatory Status

RX

2014
31 Oct
RX Application: 203854

Drug Name

PAROXETINE

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2014-10-31

203854 / 3

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

203854

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2014-10-31

Regulatory Status

RX

2014
31 Oct
RX Application: 203854

Drug Name

PAROXETINE

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2014-10-31

203854 / 4

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

203854

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2014-10-31

Regulatory Status

RX

2024
04 Jan
RX Application: 209748

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE

Approval Date

2024-01-04

209748 / 1

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

209748

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE

Approval Date

2024-01-04

Regulatory Status

RX

2024
04 Jan
RX Application: 209748

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2024-01-04

209748 / 2

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

209748

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2024-01-04

Regulatory Status

RX

2017
18 Aug
RX Application: 207188

Drug Name

PAROXETINE MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 7.5MG BASE

Approval Date

2017-08-18

207188 / 1

Active Ingredient

PAROXETINE MESYLATE

Application Number

207188

Product Number

1

Dosage Form

-

Strength

EQ 7.5MG BASE

Approval Date

2017-08-18

Regulatory Status

RX

2023
11 Dec
RX Application: 216582

Drug Name

PEMETREXED DISODIUM

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2023-12-11

216582 / 1

Active Ingredient

PEMETREXED DISODIUM

Application Number

216582

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2023-12-11

Regulatory Status

RX

2002
04 Jan
RX Application: 40377

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

37.5MG

Approval Date

2002-01-04

40377 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

40377

Product Number

1

Dosage Form

-

Strength

37.5MG

Approval Date

2002-01-04

Regulatory Status

RX

2018
17 Apr
RX Application: 207806

Drug Name

PIOGLITAZONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2018-04-17

207806 / 1

Active Ingredient

PIOGLITAZONE HYDROCHLORIDE

Application Number

207806

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2018-04-17

Regulatory Status

RX

2018
17 Apr
RX Application: 207806

Drug Name

PIOGLITAZONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2018-04-17

207806 / 2

Active Ingredient

PIOGLITAZONE HYDROCHLORIDE

Application Number

207806

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2018-04-17

Regulatory Status

RX

2018
17 Apr
RX Application: 207806

Drug Name

PIOGLITAZONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2018-04-17

207806 / 3

Active Ingredient

PIOGLITAZONE HYDROCHLORIDE

Application Number

207806

Product Number

3

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2018-04-17

Regulatory Status

RX

2019
11 Jun
RX Application: 209026

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

2019-06-11

209026 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

209026

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

2019-06-11

Regulatory Status

RX

2019
11 Jun
RX Application: 209026

Drug Name

POTASSIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2019-06-11

209026 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

209026

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2019-06-11

Regulatory Status

RX

2019
30 Apr
RX Application: 209922

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

10MEQ

Approval Date

2019-04-30

209922 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

209922

Product Number

1

Dosage Form

-

Strength

10MEQ

Approval Date

2019-04-30

Regulatory Status

RX

2019
30 Apr
RX Application: 209922

Drug Name

POTASSIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

15MEQ

Approval Date

2019-04-30

209922 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

209922

Product Number

2

Dosage Form

-

Strength

15MEQ

Approval Date

2019-04-30

Regulatory Status

RX

2019
30 Apr
RX Application: 209922

Drug Name

POTASSIUM CHLORIDE

Product Number

3

Dosage Form

-

Strength

20MEQ

Approval Date

2019-04-30

209922 / 3

Active Ingredient

POTASSIUM CHLORIDE

Application Number

209922

Product Number

3

Dosage Form

-

Strength

20MEQ

Approval Date

2019-04-30

Regulatory Status

RX

2022
01 Sep
RX Application: 207883

Drug Name

PREGABALIN

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2022-09-01

207883 / 1

Active Ingredient

PREGABALIN

Application Number

207883

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2022-09-01

Regulatory Status

RX

2022
01 Sep
RX Application: 207883

Drug Name

PREGABALIN

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2022-09-01

207883 / 2

Active Ingredient

PREGABALIN

Application Number

207883

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2022-09-01

Regulatory Status

RX

2022
01 Sep
RX Application: 207883

Drug Name

PREGABALIN

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2022-09-01

207883 / 3

Active Ingredient

PREGABALIN

Application Number

207883

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2022-09-01

Regulatory Status

RX

2022
01 Sep
RX Application: 207883

Drug Name

PREGABALIN

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2022-09-01

207883 / 4

Active Ingredient

PREGABALIN

Application Number

207883

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2022-09-01

Regulatory Status

RX

2022
01 Sep
RX Application: 207883

Drug Name

PREGABALIN

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2022-09-01

207883 / 5

Active Ingredient

PREGABALIN

Application Number

207883

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2022-09-01

Regulatory Status

RX

2022
01 Sep
RX Application: 207883

Drug Name

PREGABALIN

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

2022-09-01

207883 / 6

Active Ingredient

PREGABALIN

Application Number

207883

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

2022-09-01

Regulatory Status

RX

2022
01 Sep
RX Application: 207883

Drug Name

PREGABALIN

Product Number

7

Dosage Form

-

Strength

225MG

Approval Date

2022-09-01

207883 / 7

Active Ingredient

PREGABALIN

Application Number

207883

Product Number

7

Dosage Form

-

Strength

225MG

Approval Date

2022-09-01

Regulatory Status

RX

2022
01 Sep
RX Application: 207883

Drug Name

PREGABALIN

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

2022-09-01

207883 / 8

Active Ingredient

PREGABALIN

Application Number

207883

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

2022-09-01

Regulatory Status

RX

2006
18 Jul
RX Application: 40622

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2006-07-18

40622 / 1

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

40622

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2006-07-18

Regulatory Status

RX

2006
18 Jul
RX Application: 40622

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2006-07-18

40622 / 2

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

40622

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2006-07-18

Regulatory Status

RX

2006
18 Jul
RX Application: 40622

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2006-07-18

40622 / 3

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

40622

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2006-07-18

Regulatory Status

RX

2022
24 Aug
RX Application: 206954

Drug Name

QUETIAPINE FUMARATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2022-08-24

206954 / 1

Active Ingredient

QUETIAPINE FUMARATE

Application Number

206954

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2022-08-24

Regulatory Status

RX

2022
24 Aug
RX Application: 206954

Drug Name

QUETIAPINE FUMARATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2022-08-24

206954 / 2

Active Ingredient

QUETIAPINE FUMARATE

Application Number

206954

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2022-08-24

Regulatory Status

RX

2022
24 Aug
RX Application: 206954

Drug Name

QUETIAPINE FUMARATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2022-08-24

206954 / 3

Active Ingredient

QUETIAPINE FUMARATE

Application Number

206954

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2022-08-24

Regulatory Status

RX

2022
24 Aug
RX Application: 206954

Drug Name

QUETIAPINE FUMARATE

Product Number

4

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2022-08-24

206954 / 4

Active Ingredient

QUETIAPINE FUMARATE

Application Number

206954

Product Number

4

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2022-08-24

Regulatory Status

RX

2022
24 Aug
RX Application: 206954

Drug Name

QUETIAPINE FUMARATE

Product Number

5

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2022-08-24

206954 / 5

Active Ingredient

QUETIAPINE FUMARATE

Application Number

206954

Product Number

5

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2022-08-24

Regulatory Status

RX

2022
24 Aug
RX Application: 206954

Drug Name

QUETIAPINE FUMARATE

Product Number

6

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2022-08-24

206954 / 6

Active Ingredient

QUETIAPINE FUMARATE

Application Number

206954

Product Number

6

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2022-08-24

Regulatory Status

RX

2022
26 Apr
RX Application: 208781

Drug Name

QUETIAPINE FUMARATE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2022-04-26

208781 / 1

Active Ingredient

QUETIAPINE FUMARATE

Application Number

208781

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2022-04-26

Regulatory Status

RX

2022
26 Apr
RX Application: 208781

Drug Name

QUETIAPINE FUMARATE

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2022-04-26

208781 / 2

Active Ingredient

QUETIAPINE FUMARATE

Application Number

208781

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2022-04-26

Regulatory Status

RX

2022
26 Apr
RX Application: 208781

Drug Name

QUETIAPINE FUMARATE

Product Number

3

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2022-04-26

208781 / 3

Active Ingredient

QUETIAPINE FUMARATE

Application Number

208781

Product Number

3

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2022-04-26

Regulatory Status

RX

2022
26 Apr
RX Application: 208781

Drug Name

QUETIAPINE FUMARATE

Product Number

4

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2022-04-26

208781 / 4

Active Ingredient

QUETIAPINE FUMARATE

Application Number

208781

Product Number

4

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2022-04-26

Regulatory Status

RX

2024
11 Mar
RX Application: 208781

Drug Name

QUETIAPINE FUMARATE

Product Number

5

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2024-03-11

208781 / 5

Active Ingredient

QUETIAPINE FUMARATE

Application Number

208781

Product Number

5

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2024-03-11

Regulatory Status

RX

2016
15 Sep
RX Application: 205823

Drug Name

QUINAPRIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2016-09-15

205823 / 1

Active Ingredient

QUINAPRIL HYDROCHLORIDE

Application Number

205823

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2016-09-15

Regulatory Status

RX

2016
15 Sep
RX Application: 205823

Drug Name

QUINAPRIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2016-09-15

205823 / 2

Active Ingredient

QUINAPRIL HYDROCHLORIDE

Application Number

205823

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2016-09-15

Regulatory Status

RX

2016
15 Sep
RX Application: 205823

Drug Name

QUINAPRIL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2016-09-15

205823 / 3

Active Ingredient

QUINAPRIL HYDROCHLORIDE

Application Number

205823

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2016-09-15

Regulatory Status

RX

2016
15 Sep
RX Application: 205823

Drug Name

QUINAPRIL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2016-09-15

205823 / 4

Active Ingredient

QUINAPRIL HYDROCHLORIDE

Application Number

205823

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2016-09-15

Regulatory Status

RX

2011
29 Nov
RX Application: 77493

Drug Name

RISPERIDONE

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2011-11-29

77493 / 1

Active Ingredient

RISPERIDONE

Application Number

77493

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2011-11-29

Regulatory Status

RX

2011
29 Nov
RX Application: 77493

Drug Name

RISPERIDONE

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2011-11-29

77493 / 2

Active Ingredient

RISPERIDONE

Application Number

77493

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2011-11-29

Regulatory Status

RX

2011
29 Nov
RX Application: 77493

Drug Name

RISPERIDONE

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2011-11-29

77493 / 3

Active Ingredient

RISPERIDONE

Application Number

77493

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2011-11-29

Regulatory Status

RX

2011
29 Nov
RX Application: 77493

Drug Name

RISPERIDONE

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2011-11-29

77493 / 4

Active Ingredient

RISPERIDONE

Application Number

77493

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2011-11-29

Regulatory Status

RX

2011
29 Nov
RX Application: 77493

Drug Name

RISPERIDONE

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2011-11-29

77493 / 5

Active Ingredient

RISPERIDONE

Application Number

77493

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2011-11-29

Regulatory Status

RX

2011
29 Nov
RX Application: 77493

Drug Name

RISPERIDONE

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2011-11-29

77493 / 6

Active Ingredient

RISPERIDONE

Application Number

77493

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2011-11-29

Regulatory Status

RX

2022
26 May
RX Application: 212668

Drug Name

ROCURONIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2022-05-26

212668 / 1

Active Ingredient

ROCURONIUM BROMIDE

Application Number

212668

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2022-05-26

Regulatory Status

RX

2022
26 May
RX Application: 212668

Drug Name

ROCURONIUM BROMIDE

Product Number

2

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2022-05-26

212668 / 2

Active Ingredient

ROCURONIUM BROMIDE

Application Number

212668

Product Number

2

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2022-05-26

Regulatory Status

RX

2022
10 May
RX Application: 208299

Drug Name

ROFLUMILAST

Product Number

1

Dosage Form

-

Strength

500MCG

Approval Date

2022-05-10

208299 / 1

Active Ingredient

ROFLUMILAST

Application Number

208299

Product Number

1

Dosage Form

-

Strength

500MCG

Approval Date

2022-05-10

Regulatory Status

RX

2008
05 May
RX Application: 78110

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE

Approval Date

2008-05-05

78110 / 1

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

78110

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE

Approval Date

2008-05-05

Regulatory Status

RX

2008
05 May
RX Application: 78110

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2008-05-05

78110 / 2

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

78110

Product Number

2

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2008-05-05

Regulatory Status

RX

2008
05 May
RX Application: 78110

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2008-05-05

78110 / 3

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

78110

Product Number

3

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2008-05-05

Regulatory Status

RX

2008
05 May
RX Application: 78110

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2008-05-05

78110 / 4

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

78110

Product Number

4

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2008-05-05

Regulatory Status

RX

2008
05 May
RX Application: 78110

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2008-05-05

78110 / 5

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

78110

Product Number

5

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2008-05-05

Regulatory Status

RX

2008
05 May
RX Application: 78110

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2008-05-05

78110 / 6

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

78110

Product Number

6

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2008-05-05

Regulatory Status

RX

2008
11 Jul
RX Application: 78110

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

7

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2008-07-11

78110 / 7

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

78110

Product Number

7

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2008-07-11

Regulatory Status

RX

2022
11 May
RX Application: 204413

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2022-05-11

204413 / 1

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

204413

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2022-05-11

Regulatory Status

RX

2022
11 May
RX Application: 204413

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2022-05-11

204413 / 2

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

204413

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2022-05-11

Regulatory Status

RX

2022
11 May
RX Application: 204413

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 6MG BASE

Approval Date

2022-05-11

204413 / 3

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

204413

Product Number

3

Dosage Form

-

Strength

EQ 6MG BASE

Approval Date

2022-05-11

Regulatory Status

RX

2022
11 May
RX Application: 204413

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2022-05-11

204413 / 4

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

204413

Product Number

4

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2022-05-11

Regulatory Status

RX

2022
11 May
RX Application: 204413

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

EQ 12MG BASE

Approval Date

2022-05-11

204413 / 5

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

204413

Product Number

5

Dosage Form

-

Strength

EQ 12MG BASE

Approval Date

2022-05-11

Regulatory Status

RX

2024
25 Apr
RX Application: 215739

Drug Name

SAFINAMIDE MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2024-04-25

215739 / 1

Active Ingredient

SAFINAMIDE MESYLATE

Application Number

215739

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2024-04-25

Regulatory Status

RX

2024
25 Apr
RX Application: 215739

Drug Name

SAFINAMIDE MESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2024-04-25

215739 / 2

Active Ingredient

SAFINAMIDE MESYLATE

Application Number

215739

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2024-04-25

Regulatory Status

RX

2022
04 Jan
RX Application: 209029

Drug Name

SILODOSIN

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2022-01-04

209029 / 1

Active Ingredient

SILODOSIN

Application Number

209029

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2022-01-04

Regulatory Status

RX

2022
04 Jan
RX Application: 209029

Drug Name

SILODOSIN

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

2022-01-04

209029 / 2

Active Ingredient

SILODOSIN

Application Number

209029

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

2022-01-04

Regulatory Status

RX

2022
11 Aug
RX Application: 210608

Drug Name

TADALAFIL

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2022-08-11

210608 / 1

Active Ingredient

TADALAFIL

Application Number

210608

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2022-08-11

Regulatory Status

RX

2022
11 Aug
RX Application: 210609

Drug Name

TADALAFIL

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2022-08-11

210609 / 1

Active Ingredient

TADALAFIL

Application Number

210609

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2022-08-11

Regulatory Status

RX

2022
11 Aug
RX Application: 210609

Drug Name

TADALAFIL

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2022-08-11

210609 / 2

Active Ingredient

TADALAFIL

Application Number

210609

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2022-08-11

Regulatory Status

RX

2022
11 Aug
RX Application: 210609

Drug Name

TADALAFIL

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2022-08-11

210609 / 3

Active Ingredient

TADALAFIL

Application Number

210609

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2022-08-11

Regulatory Status

RX

2022
11 Aug
RX Application: 210609

Drug Name

TADALAFIL

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2022-08-11

210609 / 4

Active Ingredient

TADALAFIL

Application Number

210609

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2022-08-11

Regulatory Status

RX

2017
03 May
RX Application: 207882

Drug Name

TELMISARTAN

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2017-05-03

207882 / 1

Active Ingredient

TELMISARTAN

Application Number

207882

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2017-05-03

Regulatory Status

RX

2017
03 May
RX Application: 207882

Drug Name

TELMISARTAN

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2017-05-03

207882 / 2

Active Ingredient

TELMISARTAN

Application Number

207882

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2017-05-03

Regulatory Status

RX

2017
03 May
RX Application: 207882

Drug Name

TELMISARTAN

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

2017-05-03

207882 / 3

Active Ingredient

TELMISARTAN

Application Number

207882

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

2017-05-03

Regulatory Status

RX

2017
06 Nov
RX Application: 209028

Drug Name

TELMISARTAN AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;40MG

Approval Date

2017-11-06

209028 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; TELMISARTAN

Application Number

209028

Product Number

1

Dosage Form

-

Strength

12.5MG;40MG

Approval Date

2017-11-06

Regulatory Status

RX

2017
06 Nov
RX Application: 209028

Drug Name

TELMISARTAN AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;80MG

Approval Date

2017-11-06

209028 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; TELMISARTAN

Application Number

209028

Product Number

2

Dosage Form

-

Strength

12.5MG;80MG

Approval Date

2017-11-06

Regulatory Status

RX

2017
06 Nov
RX Application: 209028

Drug Name

TELMISARTAN AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;80MG

Approval Date

2017-11-06

209028 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; TELMISARTAN

Application Number

209028

Product Number

3

Dosage Form

-

Strength

25MG;80MG

Approval Date

2017-11-06

Regulatory Status

RX

2015
04 Jun
RX Application: 201781

Drug Name

TEMAZEPAM

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2015-06-04

201781 / 1

Active Ingredient

TEMAZEPAM

Application Number

201781

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2015-06-04

Regulatory Status

RX

2015
04 Jun
RX Application: 201781

Drug Name

TEMAZEPAM

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2015-06-04

201781 / 2

Active Ingredient

TEMAZEPAM

Application Number

201781

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2015-06-04

Regulatory Status

RX

2015
04 Jun
RX Application: 201781

Drug Name

TEMAZEPAM

Product Number

3

Dosage Form

-

Strength

22.5MG

Approval Date

2015-06-04

201781 / 3

Active Ingredient

TEMAZEPAM

Application Number

201781

Product Number

3

Dosage Form

-

Strength

22.5MG

Approval Date

2015-06-04

Regulatory Status

RX

2015
04 Jun
RX Application: 201781

Drug Name

TEMAZEPAM

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2015-06-04

201781 / 4

Active Ingredient

TEMAZEPAM

Application Number

201781

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2015-06-04

Regulatory Status

RX

2024
16 Aug
RX Application: 208599

Drug Name

TICAGRELOR

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2024-08-16

208599 / 1

Active Ingredient

TICAGRELOR

Application Number

208599

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2024-08-16

Regulatory Status

RX

2015
09 Jun
RX Application: 204821

Drug Name

VALSARTAN

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2015-06-09

204821 / 1

Active Ingredient

VALSARTAN

Application Number

204821

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2015-06-09

Regulatory Status

RX

2015
09 Jun
RX Application: 204821

Drug Name

VALSARTAN

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2015-06-09

204821 / 2

Active Ingredient

VALSARTAN

Application Number

204821

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2015-06-09

Regulatory Status

RX

2015
09 Jun
RX Application: 204821

Drug Name

VALSARTAN

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2015-06-09

204821 / 3

Active Ingredient

VALSARTAN

Application Number

204821

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2015-06-09

Regulatory Status

RX

2015
09 Jun
RX Application: 204821

Drug Name

VALSARTAN

Product Number

4

Dosage Form

-

Strength

320MG

Approval Date

2015-06-09

204821 / 4

Active Ingredient

VALSARTAN

Application Number

204821

Product Number

4

Dosage Form

-

Strength

320MG

Approval Date

2015-06-09

Regulatory Status

RX

2016
08 Feb
RX Application: 206083

Drug Name

VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;80MG

Approval Date

2016-02-08

206083 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

206083

Product Number

1

Dosage Form

-

Strength

12.5MG;80MG

Approval Date

2016-02-08

Regulatory Status

RX

2016
08 Feb
RX Application: 206083

Drug Name

VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;160MG

Approval Date

2016-02-08

206083 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

206083

Product Number

2

Dosage Form

-

Strength

12.5MG;160MG

Approval Date

2016-02-08

Regulatory Status

RX

2016
08 Feb
RX Application: 206083

Drug Name

VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

12.5MG;320MG

Approval Date

2016-02-08

206083 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

206083

Product Number

3

Dosage Form

-

Strength

12.5MG;320MG

Approval Date

2016-02-08

Regulatory Status

RX

2016
08 Feb
RX Application: 206083

Drug Name

VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

4

Dosage Form

-

Strength

25MG;160MG

Approval Date

2016-02-08

206083 / 4

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

206083

Product Number

4

Dosage Form

-

Strength

25MG;160MG

Approval Date

2016-02-08

Regulatory Status

RX

2016
08 Feb
RX Application: 206083

Drug Name

VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

5

Dosage Form

-

Strength

25MG;320MG

Approval Date

2016-02-08

206083 / 5

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

206083

Product Number

5

Dosage Form

-

Strength

25MG;320MG

Approval Date

2016-02-08

Regulatory Status

RX

2016
08 Aug
RX Application: 206654

Drug Name

VORICONAZOLE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2016-08-08

206654 / 1

Active Ingredient

VORICONAZOLE

Application Number

206654

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2016-08-08

Regulatory Status

RX

2016
08 Aug
RX Application: 206654

Drug Name

VORICONAZOLE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2016-08-08

206654 / 2

Active Ingredient

VORICONAZOLE

Application Number

206654

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2016-08-08

Regulatory Status

RX

2022
19 Sep
RX Application: 210596

Drug Name

VYDUO

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;80MG

Approval Date

2022-09-19

210596 / 1

Active Ingredient

NEBIVOLOL HYDROCHLORIDE; VALSARTAN

Application Number

210596

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;80MG

Approval Date

2022-09-19

Regulatory Status

RX

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Drug Status Breakdown
245 total
  • RX
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

AMPHETAMINE SULFATE

Application Number

211861

Product Number

1

Active Ingredient

AMPHETAMINE SULFATE

Dosage Form

-

Strength

5MG

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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