ScieGen Pharmaceuticals Inc.
FDA Approved Drugs

ScieGen Pharmaceuticals Inc.

FDA Approved Drugs Database

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

RX Discontinued Unclassified OTC
  • Total Records 266
  • Latest Approval Date Jul 01, 2026
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
266
View
Unclassified
6
View
Discontinued
37
View
OTC
4
View
RX
219
View
Company Overview

Company

ScieGen Pharmaceuticals Inc.

Country

U.S.A

Website

Visit Website

Email

info@sciegenpharm.com

Social Profiles

Company Snapshot

ScieGen Pharmaceuticals Inc.

20 Davids Driv, Hauppauge, NY 11788

U.S.A

sciegenpharm.com/ info@sciegenpharm.com View on Map
FDA Approved Drug Records ( 266 records )
2005
24 Feb
RX Application: 40607

Drug Name

ACETIC ACID

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2005-02-24

40607 / 1

Active Ingredient

ACETIC ACID, GLACIAL

Application Number

40607

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2005-02-24

Regulatory Status

RX

2018
03 Dec
RX Application: 209010

Drug Name

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;20MG

Approval Date

2018-12-03

209010 / 1

Active Ingredient

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Application Number

209010

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;20MG

Approval Date

2018-12-03

Regulatory Status

RX

2018
03 Dec
RX Application: 209010

Drug Name

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;40MG

Approval Date

2018-12-03

209010 / 2

Active Ingredient

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Application Number

209010

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;40MG

Approval Date

2018-12-03

Regulatory Status

RX

2018
03 Dec
RX Application: 209010

Drug Name

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE;20MG

Approval Date

2018-12-03

209010 / 3

Active Ingredient

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Application Number

209010

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE;20MG

Approval Date

2018-12-03

Regulatory Status

RX

2018
03 Dec
RX Application: 209010

Drug Name

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;40MG

Approval Date

2018-12-03

209010 / 4

Active Ingredient

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Application Number

209010

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;40MG

Approval Date

2018-12-03

Regulatory Status

RX

2007
09 Jul
Discontinued Application: 77759

Drug Name

AMLODIPINE BESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2007-07-09

77759 / 1

Active Ingredient

AMLODIPINE BESYLATE

Application Number

77759

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2007-07-09

Regulatory Status

Discontinued

2007
09 Jul
Discontinued Application: 77759

Drug Name

AMLODIPINE BESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2007-07-09

77759 / 2

Active Ingredient

AMLODIPINE BESYLATE

Application Number

77759

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2007-07-09

Regulatory Status

Discontinued

2007
09 Jul
Discontinued Application: 77759

Drug Name

AMLODIPINE BESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-07-09

77759 / 3

Active Ingredient

AMLODIPINE BESYLATE

Application Number

77759

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-07-09

Regulatory Status

Discontinued

-
Unclassified Application: 218119

Drug Name

APIXABAN

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

-

218119 / 2

Active Ingredient

APIXABAN

Application Number

218119

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

-

Regulatory Status

Unclassified

2016
29 Sep
RX Application: 206383

Drug Name

ARIPIPRAZOLE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2016-09-29

206383 / 1

Active Ingredient

ARIPIPRAZOLE

Application Number

206383

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2016-09-29

Regulatory Status

RX

2016
29 Sep
RX Application: 206383

Drug Name

ARIPIPRAZOLE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2016-09-29

206383 / 2

Active Ingredient

ARIPIPRAZOLE

Application Number

206383

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2016-09-29

Regulatory Status

RX

2016
29 Sep
RX Application: 206383

Drug Name

ARIPIPRAZOLE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2016-09-29

206383 / 3

Active Ingredient

ARIPIPRAZOLE

Application Number

206383

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2016-09-29

Regulatory Status

RX

2016
29 Sep
RX Application: 206383

Drug Name

ARIPIPRAZOLE

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2016-09-29

206383 / 4

Active Ingredient

ARIPIPRAZOLE

Application Number

206383

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2016-09-29

Regulatory Status

RX

2016
29 Sep
RX Application: 206383

Drug Name

ARIPIPRAZOLE

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2016-09-29

206383 / 5

Active Ingredient

ARIPIPRAZOLE

Application Number

206383

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2016-09-29

Regulatory Status

RX

2016
29 Sep
RX Application: 206383

Drug Name

ARIPIPRAZOLE

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2016-09-29

206383 / 6

Active Ingredient

ARIPIPRAZOLE

Application Number

206383

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2016-09-29

Regulatory Status

RX

2018
18 Apr
RX Application: 207240

Drug Name

ARIPIPRAZOLE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-04-18

207240 / 1

Active Ingredient

ARIPIPRAZOLE

Application Number

207240

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-04-18

Regulatory Status

RX

2018
18 Apr
RX Application: 207240

Drug Name

ARIPIPRAZOLE

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2018-04-18

207240 / 2

Active Ingredient

ARIPIPRAZOLE

Application Number

207240

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2018-04-18

Regulatory Status

RX

2016
19 May
RX Application: 205519

Drug Name

ATORVASTATIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2016-05-19

205519 / 1

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

205519

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2016-05-19

Regulatory Status

RX

2016
19 May
RX Application: 205519

Drug Name

ATORVASTATIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2016-05-19

205519 / 2

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

205519

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2016-05-19

Regulatory Status

RX

2016
19 May
RX Application: 205519

Drug Name

ATORVASTATIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2016-05-19

205519 / 3

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

205519

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2016-05-19

Regulatory Status

RX

2016
19 May
RX Application: 205519

Drug Name

ATORVASTATIN CALCIUM

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2016-05-19

205519 / 4

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

205519

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2016-05-19

Regulatory Status

RX

2019
23 Aug
Discontinued Application: 210032

Drug Name

AZELASTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.2055MG/SPRAY

Approval Date

2019-08-23

210032 / 1

Active Ingredient

AZELASTINE HYDROCHLORIDE

Application Number

210032

Product Number

1

Dosage Form

-

Strength

0.2055MG/SPRAY

Approval Date

2019-08-23

Regulatory Status

Discontinued

1995
30 Jan
Discontinued Application: 64028

Drug Name

BACITRACIN ZINC AND POLYMYXIN B SULFATE

Product Number

1

Dosage Form

-

Strength

500 UNITS/GM;10,000 UNITS/GM

Approval Date

1995-01-30

64028 / 1

Active Ingredient

BACITRACIN ZINC; POLYMYXIN B SULFATE

Application Number

64028

Product Number

1

Dosage Form

-

Strength

500 UNITS/GM;10,000 UNITS/GM

Approval Date

1995-01-30

Regulatory Status

Discontinued

2026
01 Jul
RX Application: 219952

Drug Name

BRIVARACETAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2026-07-01

219952 / 1

Active Ingredient

BRIVARACETAM

Application Number

219952

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2026-07-01

Regulatory Status

RX

2026
01 Jul
RX Application: 219952

Drug Name

BRIVARACETAM

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2026-07-01

219952 / 2

Active Ingredient

BRIVARACETAM

Application Number

219952

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2026-07-01

Regulatory Status

RX

2026
01 Jul
RX Application: 219952

Drug Name

BRIVARACETAM

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2026-07-01

219952 / 3

Active Ingredient

BRIVARACETAM

Application Number

219952

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2026-07-01

Regulatory Status

RX

2026
01 Jul
RX Application: 219952

Drug Name

BRIVARACETAM

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

2026-07-01

219952 / 4

Active Ingredient

BRIVARACETAM

Application Number

219952

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

2026-07-01

Regulatory Status

RX

2026
01 Jul
RX Application: 219952

Drug Name

BRIVARACETAM

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

2026-07-01

219952 / 5

Active Ingredient

BRIVARACETAM

Application Number

219952

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

2026-07-01

Regulatory Status

RX

2016
01 Mar
RX Application: 205794

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2016-03-01

205794 / 1

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

205794

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2016-03-01

Regulatory Status

RX

2016
01 Mar
RX Application: 205794

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2016-03-01

205794 / 2

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

205794

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2016-03-01

Regulatory Status

RX

2016
01 Mar
RX Application: 205794

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2016-03-01

205794 / 3

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

205794

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2016-03-01

Regulatory Status

RX

2016
17 Aug
RX Application: 206122

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2016-08-17

206122 / 1

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

206122

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2016-08-17

Regulatory Status

RX

2017
12 Apr
RX Application: 207479

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2017-04-12

207479 / 1

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

207479

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2017-04-12

Regulatory Status

RX

2017
12 Apr
RX Application: 207479

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2017-04-12

207479 / 2

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

207479

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2017-04-12

Regulatory Status

RX

2021
05 Oct
RX Application: 214091

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

1

Dosage Form

-

Strength

25MG;100MG

Approval Date

2021-10-05

214091 / 1

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

214091

Product Number

1

Dosage Form

-

Strength

25MG;100MG

Approval Date

2021-10-05

Regulatory Status

RX

2021
05 Oct
RX Application: 214091

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

2

Dosage Form

-

Strength

50MG;200MG

Approval Date

2021-10-05

214091 / 2

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

214091

Product Number

2

Dosage Form

-

Strength

50MG;200MG

Approval Date

2021-10-05

Regulatory Status

RX

2021
07 May
RX Application: 214092

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

1

Dosage Form

-

Strength

10MG;100MG

Approval Date

2021-05-07

214092 / 1

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

214092

Product Number

1

Dosage Form

-

Strength

10MG;100MG

Approval Date

2021-05-07

Regulatory Status

RX

2021
07 May
RX Application: 214092

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

2

Dosage Form

-

Strength

25MG;100MG

Approval Date

2021-05-07

214092 / 2

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

214092

Product Number

2

Dosage Form

-

Strength

25MG;100MG

Approval Date

2021-05-07

Regulatory Status

RX

2021
07 May
RX Application: 214092

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

3

Dosage Form

-

Strength

25MG;250MG

Approval Date

2021-05-07

214092 / 3

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

214092

Product Number

3

Dosage Form

-

Strength

25MG;250MG

Approval Date

2021-05-07

Regulatory Status

RX

2014
27 Jan
RX Application: 203374

Drug Name

CARISOPRODOL

Product Number

1

Dosage Form

-

Strength

350MG

Approval Date

2014-01-27

203374 / 1

Active Ingredient

CARISOPRODOL

Application Number

203374

Product Number

1

Dosage Form

-

Strength

350MG

Approval Date

2014-01-27

Regulatory Status

RX

2007
05 Sep
Discontinued Application: 77316

Drug Name

CARVEDILOL

Product Number

1

Dosage Form

-

Strength

3.125MG

Approval Date

2007-09-05

77316 / 1

Active Ingredient

CARVEDILOL

Application Number

77316

Product Number

1

Dosage Form

-

Strength

3.125MG

Approval Date

2007-09-05

Regulatory Status

Discontinued

2007
05 Sep
Discontinued Application: 77316

Drug Name

CARVEDILOL

Product Number

2

Dosage Form

-

Strength

6.25MG

Approval Date

2007-09-05

77316 / 2

Active Ingredient

CARVEDILOL

Application Number

77316

Product Number

2

Dosage Form

-

Strength

6.25MG

Approval Date

2007-09-05

Regulatory Status

Discontinued

2007
05 Sep
Discontinued Application: 77316

Drug Name

CARVEDILOL

Product Number

3

Dosage Form

-

Strength

12.5MG

Approval Date

2007-09-05

77316 / 3

Active Ingredient

CARVEDILOL

Application Number

77316

Product Number

3

Dosage Form

-

Strength

12.5MG

Approval Date

2007-09-05

Regulatory Status

Discontinued

2007
05 Sep
Discontinued Application: 77316

Drug Name

CARVEDILOL

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2007-09-05

77316 / 4

Active Ingredient

CARVEDILOL

Application Number

77316

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2007-09-05

Regulatory Status

Discontinued

2020
03 Dec
RX Application: 205129

Drug Name

CELECOXIB

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2020-12-03

205129 / 1

Active Ingredient

CELECOXIB

Application Number

205129

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2020-12-03

Regulatory Status

RX

2020
03 Dec
RX Application: 205129

Drug Name

CELECOXIB

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2020-12-03

205129 / 2

Active Ingredient

CELECOXIB

Application Number

205129

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2020-12-03

Regulatory Status

RX

2020
03 Dec
RX Application: 205129

Drug Name

CELECOXIB

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2020-12-03

205129 / 3

Active Ingredient

CELECOXIB

Application Number

205129

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2020-12-03

Regulatory Status

RX

2020
03 Dec
RX Application: 205129

Drug Name

CELECOXIB

Product Number

4

Dosage Form

-

Strength

400MG

Approval Date

2020-12-03

205129 / 4

Active Ingredient

CELECOXIB

Application Number

205129

Product Number

4

Dosage Form

-

Strength

400MG

Approval Date

2020-12-03

Regulatory Status

RX

1996
07 May
Discontinued Application: 74356

Drug Name

CHLORHEXIDINE GLUCONATE

Product Number

1

Dosage Form

-

Strength

0.12%

Approval Date

1996-05-07

74356 / 1

Active Ingredient

CHLORHEXIDINE GLUCONATE

Application Number

74356

Product Number

1

Dosage Form

-

Strength

0.12%

Approval Date

1996-05-07

Regulatory Status

Discontinued

2017
28 Apr
Discontinued Application: 207218

Drug Name

CLOBETASOL PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2017-04-28

207218 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

207218

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2017-04-28

Regulatory Status

Discontinued

2014
15 Sep
RX Application: 204165

Drug Name

CLOPIDOGREL BISULFATE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2014-09-15

204165 / 1

Active Ingredient

CLOPIDOGREL BISULFATE

Application Number

204165

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2014-09-15

Regulatory Status

RX

2014
15 Sep
RX Application: 204165

Drug Name

CLOPIDOGREL BISULFATE

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2014-09-15

204165 / 2

Active Ingredient

CLOPIDOGREL BISULFATE

Application Number

204165

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2014-09-15

Regulatory Status

RX

2023
16 Oct
RX Application: 216569

Drug Name

CLOTRIMAZOLE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2023-10-16

216569 / 1

Active Ingredient

CLOTRIMAZOLE

Application Number

216569

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2023-10-16

Regulatory Status

RX

1998
29 Apr
Discontinued Application: 74706

Drug Name

CROMOLYN SODIUM

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

1998-04-29

74706 / 1

Active Ingredient

CROMOLYN SODIUM

Application Number

74706

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

1998-04-29

Regulatory Status

Discontinued

2015
09 Dec
Discontinued Application: 205937

Drug Name

CYCLOPENTOLATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2015-12-09

205937 / 1

Active Ingredient

CYCLOPENTOLATE HYDROCHLORIDE

Application Number

205937

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2015-12-09

Regulatory Status

Discontinued

-
Unclassified Application: 219408

Drug Name

DAPAGLIFLOZIN

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

-

219408 / 1

Active Ingredient

DAPAGLIFLOZIN

Application Number

219408

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 219408

Drug Name

DAPAGLIFLOZIN

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

-

219408 / 2

Active Ingredient

DAPAGLIFLOZIN

Application Number

219408

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

-

Regulatory Status

Unclassified

2015
12 Jun
RX Application: 203234

Drug Name

DESOXIMETASONE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2015-06-12

203234 / 1

Active Ingredient

DESOXIMETASONE

Application Number

203234

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2015-06-12

Regulatory Status

RX

2017
06 Jan
RX Application: 203787

Drug Name

DESOXIMETASONE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2017-01-06

203787 / 1

Active Ingredient

DESOXIMETASONE

Application Number

203787

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2017-01-06

Regulatory Status

RX

2008
17 Apr
Discontinued Application: 77845

Drug Name

DICLOFENAC SODIUM

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2008-04-17

77845 / 1

Active Ingredient

DICLOFENAC SODIUM

Application Number

77845

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2008-04-17

Regulatory Status

Discontinued

2015
24 Jul
Discontinued Application: 206572

Drug Name

DIFLORASONE DIACETATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2015-07-24

206572 / 1

Active Ingredient

DIFLORASONE DIACETATE

Application Number

206572

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2015-07-24

Regulatory Status

Discontinued

2023
06 Apr
RX Application: 216327

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2023-04-06

216327 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

216327

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2023-04-06

Regulatory Status

RX

2023
06 Apr
RX Application: 216327

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2023-04-06

216327 / 2

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

216327

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2023-04-06

Regulatory Status

RX

2023
06 Apr
RX Application: 216327

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

2023-04-06

216327 / 3

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

216327

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

2023-04-06

Regulatory Status

RX

2023
06 Apr
RX Application: 216327

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

300MG

Approval Date

2023-04-06

216327 / 4

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

216327

Product Number

4

Dosage Form

-

Strength

300MG

Approval Date

2023-04-06

Regulatory Status

RX

2023
06 Apr
RX Application: 216327

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

360MG

Approval Date

2023-04-06

216327 / 5

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

216327

Product Number

5

Dosage Form

-

Strength

360MG

Approval Date

2023-04-06

Regulatory Status

RX

2023
06 Apr
RX Application: 216327

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

420MG

Approval Date

2023-04-06

216327 / 6

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

216327

Product Number

6

Dosage Form

-

Strength

420MG

Approval Date

2023-04-06

Regulatory Status

RX

2022
23 Sep
RX Application: 216521

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2022-09-23

216521 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

216521

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2022-09-23

Regulatory Status

RX

2022
23 Sep
RX Application: 216521

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2022-09-23

216521 / 2

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

216521

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2022-09-23

Regulatory Status

RX

2022
23 Sep
RX Application: 216521

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

90MG

Approval Date

2022-09-23

216521 / 3

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

216521

Product Number

3

Dosage Form

-

Strength

90MG

Approval Date

2022-09-23

Regulatory Status

RX

2022
23 Sep
RX Application: 216521

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

120MG

Approval Date

2022-09-23

216521 / 4

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

216521

Product Number

4

Dosage Form

-

Strength

120MG

Approval Date

2022-09-23

Regulatory Status

RX

1990
28 Sep
Discontinued Application: 72416

Drug Name

DIPHENHYDRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

12.5MG/5ML

Approval Date

1990-09-28

72416 / 1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Application Number

72416

Product Number

1

Dosage Form

-

Strength

12.5MG/5ML

Approval Date

1990-09-28

Regulatory Status

Discontinued

2009
04 Aug
RX Application: 78705

Drug Name

DIVALPROEX SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

2009-08-04

78705 / 1

Active Ingredient

DIVALPROEX SODIUM

Application Number

78705

Product Number

1

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

2009-08-04

Regulatory Status

RX

2009
10 Feb
RX Application: 78705

Drug Name

DIVALPROEX SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

2009-02-10

78705 / 2

Active Ingredient

DIVALPROEX SODIUM

Application Number

78705

Product Number

2

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

2009-02-10

Regulatory Status

RX

2014
29 Oct
RX Application: 203907

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2014-10-29

203907 / 1

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

203907

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2014-10-29

Regulatory Status

RX

2014
29 Oct
RX Application: 203907

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2014-10-29

203907 / 2

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

203907

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2014-10-29

Regulatory Status

RX

2021
18 Feb
RX Application: 214017

Drug Name

DROXIDOPA

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2021-02-18

214017 / 1

Active Ingredient

DROXIDOPA

Application Number

214017

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2021-02-18

Regulatory Status

RX

2021
18 Feb
RX Application: 214017

Drug Name

DROXIDOPA

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2021-02-18

214017 / 2

Active Ingredient

DROXIDOPA

Application Number

214017

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2021-02-18

Regulatory Status

RX

2021
18 Feb
RX Application: 214017

Drug Name

DROXIDOPA

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2021-02-18

214017 / 3

Active Ingredient

DROXIDOPA

Application Number

214017

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2021-02-18

Regulatory Status

RX

2019
27 Aug
RX Application: 211232

Drug Name

ETHACRYNIC ACID

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2019-08-27

211232 / 1

Active Ingredient

ETHACRYNIC ACID

Application Number

211232

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2019-08-27

Regulatory Status

RX

2020
23 Oct
RX Application: 210673

Drug Name

EZETIMIBE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2020-10-23

210673 / 1

Active Ingredient

EZETIMIBE

Application Number

210673

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2020-10-23

Regulatory Status

RX

2024
10 Dec
Discontinued Application: 211663

Drug Name

EZETIMIBE AND SIMVASTATIN

Product Number

1

Dosage Form

-

Strength

10MG;10MG

Approval Date

2024-12-10

211663 / 1

Active Ingredient

EZETIMIBE; SIMVASTATIN

Application Number

211663

Product Number

1

Dosage Form

-

Strength

10MG;10MG

Approval Date

2024-12-10

Regulatory Status

Discontinued

2024
10 Dec
Discontinued Application: 211663

Drug Name

EZETIMIBE AND SIMVASTATIN

Product Number

2

Dosage Form

-

Strength

10MG;20MG

Approval Date

2024-12-10

211663 / 2

Active Ingredient

EZETIMIBE; SIMVASTATIN

Application Number

211663

Product Number

2

Dosage Form

-

Strength

10MG;20MG

Approval Date

2024-12-10

Regulatory Status

Discontinued

2024
10 Dec
Discontinued Application: 211663

Drug Name

EZETIMIBE AND SIMVASTATIN

Product Number

3

Dosage Form

-

Strength

10MG;40MG

Approval Date

2024-12-10

211663 / 3

Active Ingredient

EZETIMIBE; SIMVASTATIN

Application Number

211663

Product Number

3

Dosage Form

-

Strength

10MG;40MG

Approval Date

2024-12-10

Regulatory Status

Discontinued

2024
10 Dec
Discontinued Application: 211663

Drug Name

EZETIMIBE AND SIMVASTATIN

Product Number

4

Dosage Form

-

Strength

10MG;80MG

Approval Date

2024-12-10

211663 / 4

Active Ingredient

EZETIMIBE; SIMVASTATIN

Application Number

211663

Product Number

4

Dosage Form

-

Strength

10MG;80MG

Approval Date

2024-12-10

Regulatory Status

Discontinued

2015
16 Sep
OTC Application: 204507

Drug Name

FEXOFENADINE HYDROCHLORIDE ALLERGY

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2015-09-16

204507 / 2

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

204507

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2015-09-16

Regulatory Status

OTC

2015
16 Sep
OTC Application: 204507

Drug Name

FEXOFENADINE HYDROCHLORIDE ALLERGY

Product Number

3

Dosage Form

-

Strength

180MG

Approval Date

2015-09-16

204507 / 3

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

204507

Product Number

3

Dosage Form

-

Strength

180MG

Approval Date

2015-09-16

Regulatory Status

OTC

2015
16 Sep
OTC Application: 204507

Drug Name

FEXOFENADINE HYDROCHLORIDE HIVES

Product Number

4

Dosage Form

-

Strength

60MG

Approval Date

2015-09-16

204507 / 4

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

204507

Product Number

4

Dosage Form

-

Strength

60MG

Approval Date

2015-09-16

Regulatory Status

OTC

2015
16 Sep
OTC Application: 204507

Drug Name

FEXOFENADINE HYDROCHLORIDE HIVES

Product Number

5

Dosage Form

-

Strength

180MG

Approval Date

2015-09-16

204507 / 5

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

204507

Product Number

5

Dosage Form

-

Strength

180MG

Approval Date

2015-09-16

Regulatory Status

OTC

2015
25 Jun
Discontinued Application: 91514

Drug Name

FLUOCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

2015-06-25

91514 / 1

Active Ingredient

FLUOCINOLONE ACETONIDE

Application Number

91514

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

2015-06-25

Regulatory Status

Discontinued

2016
09 Sep
Discontinued Application: 202705

Drug Name

FLUOCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

2016-09-09

202705 / 1

Active Ingredient

FLUOCINOLONE ACETONIDE

Application Number

202705

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

2016-09-09

Regulatory Status

Discontinued

2019
18 Mar
RX Application: 207554

Drug Name

FLUOCINONIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2019-03-18

207554 / 1

Active Ingredient

FLUOCINONIDE

Application Number

207554

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2019-03-18

Regulatory Status

RX

2002
27 Jun
RX Application: 75525

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/5ML

Approval Date

2002-06-27

75525 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

75525

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/5ML

Approval Date

2002-06-27

Regulatory Status

RX

2015
16 Mar
RX Application: 204597

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2015-03-16

204597 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

204597

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2015-03-16

Regulatory Status

RX

2015
16 Mar
RX Application: 204597

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2015-03-16

204597 / 2

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

204597

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2015-03-16

Regulatory Status

RX

2015
16 Mar
RX Application: 204597

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2015-03-16

204597 / 3

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

204597

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2015-03-16

Regulatory Status

RX

2019
20 Mar
RX Application: 210935

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2019-03-20

210935 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

210935

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2019-03-20

Regulatory Status

RX

2019
20 Mar
RX Application: 210935

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2019-03-20

210935 / 2

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

210935

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2019-03-20

Regulatory Status

RX

2019
10 Jan
RX Application: 211282

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2019-01-10

211282 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

211282

Product Number

1

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2019-01-10

Regulatory Status

RX

2016
04 Feb
RX Application: 205101

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2016-02-04

205101 / 1

Active Ingredient

GABAPENTIN

Application Number

205101

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2016-02-04

Regulatory Status

RX

2016
04 Feb
RX Application: 205101

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

2016-02-04

205101 / 2

Active Ingredient

GABAPENTIN

Application Number

205101

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

2016-02-04

Regulatory Status

RX

2025
19 Sep
RX Application: 218491

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2025-09-19

218491 / 1

Active Ingredient

GABAPENTIN

Application Number

218491

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2025-09-19

Regulatory Status

RX

2025
19 Sep
RX Application: 218491

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

2025-09-19

218491 / 2

Active Ingredient

GABAPENTIN

Application Number

218491

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

2025-09-19

Regulatory Status

RX

1995
31 Aug
Discontinued Application: 64093

Drug Name

GENTAMICIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 0.3% BASE

Approval Date

1995-08-31

64093 / 1

Active Ingredient

GENTAMICIN SULFATE

Application Number

64093

Product Number

1

Dosage Form

-

Strength

EQ 0.3% BASE

Approval Date

1995-08-31

Regulatory Status

Discontinued

2024
07 Oct
RX Application: 216297

Drug Name

GLYCOPYRROLATE

Product Number

1

Dosage Form

-

Strength

1MG/5ML

Approval Date

2024-10-07

216297 / 1

Active Ingredient

GLYCOPYRROLATE

Application Number

216297

Product Number

1

Dosage Form

-

Strength

1MG/5ML

Approval Date

2024-10-07

Regulatory Status

RX

2017
26 May
RX Application: 205236

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2017-05-26

205236 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

205236

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2017-05-26

Regulatory Status

RX

2017
26 May
RX Application: 205236

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2017-05-26

205236 / 2

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

205236

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2017-05-26

Regulatory Status

RX

2017
26 May
RX Application: 205236

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2017-05-26

205236 / 3

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

205236

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2017-05-26

Regulatory Status

RX

2017
26 May
RX Application: 205236

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2017-05-26

205236 / 4

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

205236

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2017-05-26

Regulatory Status

RX

2014
23 Jul
RX Application: 203018

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2014-07-23

203018 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

203018

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2014-07-23

Regulatory Status

RX

2014
23 Jul
RX Application: 203018

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2014-07-23

203018 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

203018

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2014-07-23

Regulatory Status

RX

2019
14 Jan
RX Application: 203561

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2019-01-14

203561 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

203561

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2019-01-14

Regulatory Status

RX

2015
07 Dec
RX Application: 204774

Drug Name

IRBESARTAN

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2015-12-07

204774 / 1

Active Ingredient

IRBESARTAN

Application Number

204774

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2015-12-07

Regulatory Status

RX

2015
07 Dec
RX Application: 204774

Drug Name

IRBESARTAN

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2015-12-07

204774 / 2

Active Ingredient

IRBESARTAN

Application Number

204774

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2015-12-07

Regulatory Status

RX

2015
07 Dec
RX Application: 204774

Drug Name

IRBESARTAN

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2015-12-07

204774 / 3

Active Ingredient

IRBESARTAN

Application Number

204774

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2015-12-07

Regulatory Status

RX

2022
17 Mar
RX Application: 205237

Drug Name

LACOSAMIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2022-03-17

205237 / 1

Active Ingredient

LACOSAMIDE

Application Number

205237

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2022-03-17

Regulatory Status

RX

2022
17 Mar
RX Application: 205237

Drug Name

LACOSAMIDE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2022-03-17

205237 / 2

Active Ingredient

LACOSAMIDE

Application Number

205237

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2022-03-17

Regulatory Status

RX

2022
17 Mar
RX Application: 205237

Drug Name

LACOSAMIDE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2022-03-17

205237 / 3

Active Ingredient

LACOSAMIDE

Application Number

205237

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2022-03-17

Regulatory Status

RX

2022
17 Mar
RX Application: 205237

Drug Name

LACOSAMIDE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2022-03-17

205237 / 4

Active Ingredient

LACOSAMIDE

Application Number

205237

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2022-03-17

Regulatory Status

RX

2013
04 Jan
RX Application: 202498

Drug Name

LAMOTRIGINE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2013-01-04

202498 / 1

Active Ingredient

LAMOTRIGINE

Application Number

202498

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2013-01-04

Regulatory Status

RX

2013
04 Jan
RX Application: 202498

Drug Name

LAMOTRIGINE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2013-01-04

202498 / 2

Active Ingredient

LAMOTRIGINE

Application Number

202498

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2013-01-04

Regulatory Status

RX

2013
04 Jan
RX Application: 202498

Drug Name

LAMOTRIGINE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2013-01-04

202498 / 3

Active Ingredient

LAMOTRIGINE

Application Number

202498

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2013-01-04

Regulatory Status

RX

2013
04 Jan
RX Application: 202498

Drug Name

LAMOTRIGINE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2013-01-04

202498 / 4

Active Ingredient

LAMOTRIGINE

Application Number

202498

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2013-01-04

Regulatory Status

RX

2013
04 Jan
RX Application: 202498

Drug Name

LAMOTRIGINE

Product Number

5

Dosage Form

-

Strength

300MG

Approval Date

2013-01-04

202498 / 5

Active Ingredient

LAMOTRIGINE

Application Number

202498

Product Number

5

Dosage Form

-

Strength

300MG

Approval Date

2013-01-04

Regulatory Status

RX

2016
17 Jun
RX Application: 206382

Drug Name

LAMOTRIGINE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2016-06-17

206382 / 1

Active Ingredient

LAMOTRIGINE

Application Number

206382

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2016-06-17

Regulatory Status

RX

2016
17 Jun
RX Application: 206382

Drug Name

LAMOTRIGINE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2016-06-17

206382 / 2

Active Ingredient

LAMOTRIGINE

Application Number

206382

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2016-06-17

Regulatory Status

RX

2016
17 Jun
RX Application: 206382

Drug Name

LAMOTRIGINE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2016-06-17

206382 / 3

Active Ingredient

LAMOTRIGINE

Application Number

206382

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2016-06-17

Regulatory Status

RX

2016
17 Jun
RX Application: 206382

Drug Name

LAMOTRIGINE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2016-06-17

206382 / 4

Active Ingredient

LAMOTRIGINE

Application Number

206382

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2016-06-17

Regulatory Status

RX

2020
27 Nov
RX Application: 205130

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2020-11-27

205130 / 1

Active Ingredient

LEVETIRACETAM

Application Number

205130

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2020-11-27

Regulatory Status

RX

2020
27 Nov
RX Application: 205130

Drug Name

LEVETIRACETAM

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2020-11-27

205130 / 2

Active Ingredient

LEVETIRACETAM

Application Number

205130

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2020-11-27

Regulatory Status

RX

2021
11 Jun
RX Application: 215069

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

2021-06-11

215069 / 1

Active Ingredient

LEVETIRACETAM

Application Number

215069

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

2021-06-11

Regulatory Status

RX

2021
11 Jun
RX Application: 215069

Drug Name

LEVETIRACETAM

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2021-06-11

215069 / 2

Active Ingredient

LEVETIRACETAM

Application Number

215069

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2021-06-11

Regulatory Status

RX

2022
27 May
RX Application: 215069

Drug Name

LEVETIRACETAM

Product Number

3

Dosage Form

-

Strength

250MG

Approval Date

2022-05-27

215069 / 3

Active Ingredient

LEVETIRACETAM

Application Number

215069

Product Number

3

Dosage Form

-

Strength

250MG

Approval Date

2022-05-27

Regulatory Status

RX

2022
27 May
RX Application: 215069

Drug Name

LEVETIRACETAM

Product Number

4

Dosage Form

-

Strength

500MG

Approval Date

2022-05-27

215069 / 4

Active Ingredient

LEVETIRACETAM

Application Number

215069

Product Number

4

Dosage Form

-

Strength

500MG

Approval Date

2022-05-27

Regulatory Status

RX

2021
10 Nov
RX Application: 212533

Drug Name

LEVOCARNITINE

Product Number

1

Dosage Form

-

Strength

1GM/10ML

Approval Date

2021-11-10

212533 / 1

Active Ingredient

LEVOCARNITINE

Application Number

212533

Product Number

1

Dosage Form

-

Strength

1GM/10ML

Approval Date

2021-11-10

Regulatory Status

RX

2014
09 Sep
RX Application: 203646

Drug Name

LEVOCETIRIZINE DIHYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2014-09-09

203646 / 1

Active Ingredient

LEVOCETIRIZINE DIHYDROCHLORIDE

Application Number

203646

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2014-09-09

Regulatory Status

RX

2010
20 Dec
Discontinued Application: 90268

Drug Name

LEVOFLOXACIN

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2010-12-20

90268 / 1

Active Ingredient

LEVOFLOXACIN

Application Number

90268

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2010-12-20

Regulatory Status

Discontinued

2021
04 Mar
RX Application: 208920

Drug Name

LISINOPRIL

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2021-03-04

208920 / 1

Active Ingredient

LISINOPRIL

Application Number

208920

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2021-03-04

Regulatory Status

RX

2021
04 Mar
RX Application: 208920

Drug Name

LISINOPRIL

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2021-03-04

208920 / 2

Active Ingredient

LISINOPRIL

Application Number

208920

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2021-03-04

Regulatory Status

RX

2021
04 Mar
RX Application: 208920

Drug Name

LISINOPRIL

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2021-03-04

208920 / 3

Active Ingredient

LISINOPRIL

Application Number

208920

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2021-03-04

Regulatory Status

RX

2020
15 Sep
RX Application: 212041

Drug Name

LISINOPRIL

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2020-09-15

212041 / 1

Active Ingredient

LISINOPRIL

Application Number

212041

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2020-09-15

Regulatory Status

RX

2020
15 Sep
RX Application: 212041

Drug Name

LISINOPRIL

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2020-09-15

212041 / 2

Active Ingredient

LISINOPRIL

Application Number

212041

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2020-09-15

Regulatory Status

RX

2020
15 Sep
RX Application: 212041

Drug Name

LISINOPRIL

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2020-09-15

212041 / 3

Active Ingredient

LISINOPRIL

Application Number

212041

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2020-09-15

Regulatory Status

RX

2024
18 Mar
RX Application: 217183

Drug Name

LITHIUM CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 300MG CARBONATE/5ML

Approval Date

2024-03-18

217183 / 1

Active Ingredient

LITHIUM CITRATE

Application Number

217183

Product Number

1

Dosage Form

-

Strength

EQ 300MG CARBONATE/5ML

Approval Date

2024-03-18

Regulatory Status

RX

1989
22 May
RX Application: 84092

Drug Name

MECLIZINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

1989-05-22

84092 / 3

Active Ingredient

MECLIZINE HYDROCHLORIDE

Application Number

84092

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

1989-05-22

Regulatory Status

RX

2017
31 Aug
RX Application: 207466

Drug Name

METAXALONE

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

2017-08-31

207466 / 1

Active Ingredient

METAXALONE

Application Number

207466

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

2017-08-31

Regulatory Status

RX

2020
13 Mar
RX Application: 207466

Drug Name

METAXALONE

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

2020-03-13

207466 / 2

Active Ingredient

METAXALONE

Application Number

207466

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

2020-03-13

Regulatory Status

RX

2013
11 Sep
RX Application: 203769

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2013-09-11

203769 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

203769

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2013-09-11

Regulatory Status

RX

2013
11 Sep
RX Application: 203769

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

850MG

Approval Date

2013-09-11

203769 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

203769

Product Number

2

Dosage Form

-

Strength

850MG

Approval Date

2013-09-11

Regulatory Status

RX

2013
11 Sep
RX Application: 203769

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

2013-09-11

203769 / 3

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

203769

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

2013-09-11

Regulatory Status

RX

2026
09 Feb
RX Application: 203769

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

625MG

Approval Date

2026-02-09

203769 / 4

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

203769

Product Number

4

Dosage Form

-

Strength

625MG

Approval Date

2026-02-09

Regulatory Status

RX

2026
09 Feb
RX Application: 203769

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

750MG

Approval Date

2026-02-09

203769 / 5

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

203769

Product Number

5

Dosage Form

-

Strength

750MG

Approval Date

2026-02-09

Regulatory Status

RX

2021
16 Apr
RX Application: 213334

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2021-04-16

213334 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

213334

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2021-04-16

Regulatory Status

RX

2021
16 Apr
RX Application: 213334

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2021-04-16

213334 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

213334

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2021-04-16

Regulatory Status

RX

2022
22 Feb
RX Application: 214629

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2022-02-22

214629 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

214629

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2022-02-22

Regulatory Status

RX

2022
22 Feb
RX Application: 214629

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2022-02-22

214629 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

214629

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2022-02-22

Regulatory Status

RX

2020
05 Feb
RX Application: 208955

Drug Name

METOPROLOL TARTRATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2020-02-05

208955 / 1

Active Ingredient

METOPROLOL TARTRATE

Application Number

208955

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2020-02-05

Regulatory Status

RX

2020
05 Feb
RX Application: 208955

Drug Name

METOPROLOL TARTRATE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2020-02-05

208955 / 2

Active Ingredient

METOPROLOL TARTRATE

Application Number

208955

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2020-02-05

Regulatory Status

RX

2020
05 Feb
RX Application: 208955

Drug Name

METOPROLOL TARTRATE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2020-02-05

208955 / 3

Active Ingredient

METOPROLOL TARTRATE

Application Number

208955

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2020-02-05

Regulatory Status

RX

2024
31 Dec
RX Application: 216750

Drug Name

METRONIDAZOLE

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

2024-12-31

216750 / 1

Active Ingredient

METRONIDAZOLE

Application Number

216750

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

2024-12-31

Regulatory Status

RX

2008
24 Sep
RX Application: 78420

Drug Name

NABUMETONE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2008-09-24

78420 / 1

Active Ingredient

NABUMETONE

Application Number

78420

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2008-09-24

Regulatory Status

RX

2008
24 Sep
RX Application: 78420

Drug Name

NABUMETONE

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2008-09-24

78420 / 2

Active Ingredient

NABUMETONE

Application Number

78420

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2008-09-24

Regulatory Status

RX

2020
21 Feb
RX Application: 212517

Drug Name

NAPROXEN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2020-02-21

212517 / 1

Active Ingredient

NAPROXEN

Application Number

212517

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2020-02-21

Regulatory Status

RX

2020
21 Feb
RX Application: 212517

Drug Name

NAPROXEN

Product Number

2

Dosage Form

-

Strength

375MG

Approval Date

2020-02-21

212517 / 2

Active Ingredient

NAPROXEN

Application Number

212517

Product Number

2

Dosage Form

-

Strength

375MG

Approval Date

2020-02-21

Regulatory Status

RX

2020
21 Feb
RX Application: 212517

Drug Name

NAPROXEN

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2020-02-21

212517 / 3

Active Ingredient

NAPROXEN

Application Number

212517

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2020-02-21

Regulatory Status

RX

2023
11 Oct
RX Application: 217738

Drug Name

NAPROXEN AND ESOMEPRAZOLE MAGNESIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE;375MG

Approval Date

2023-10-11

217738 / 1

Active Ingredient

ESOMEPRAZOLE MAGNESIUM; NAPROXEN

Application Number

217738

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE;375MG

Approval Date

2023-10-11

Regulatory Status

RX

2023
11 Oct
RX Application: 217738

Drug Name

NAPROXEN AND ESOMEPRAZOLE MAGNESIUM

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE;500MG

Approval Date

2023-10-11

217738 / 2

Active Ingredient

ESOMEPRAZOLE MAGNESIUM; NAPROXEN

Application Number

217738

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE;500MG

Approval Date

2023-10-11

Regulatory Status

RX

2019
30 Oct
RX Application: 212199

Drug Name

NAPROXEN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2019-10-30

212199 / 1

Active Ingredient

NAPROXEN SODIUM

Application Number

212199

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2019-10-30

Regulatory Status

RX

2019
30 Oct
RX Application: 212199

Drug Name

NAPROXEN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2019-10-30

212199 / 2

Active Ingredient

NAPROXEN SODIUM

Application Number

212199

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2019-10-30

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 83244

Drug Name

NEMBUTAL

Product Number

1

Dosage Form

-

Strength

18.2MG/5ML

Approval Date

1982-01-01

83244 / 1

Active Ingredient

PENTOBARBITAL

Application Number

83244

Product Number

1

Dosage Form

-

Strength

18.2MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
25 Jan
Discontinued Application: 83247

Drug Name

NEMBUTAL

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1982-01-25

83247 / 1

Active Ingredient

PENTOBARBITAL SODIUM

Application Number

83247

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1982-01-25

Regulatory Status

Discontinued

1982
25 Jan
Discontinued Application: 83247

Drug Name

NEMBUTAL

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

1982-01-25

83247 / 2

Active Ingredient

PENTOBARBITAL SODIUM

Application Number

83247

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

1982-01-25

Regulatory Status

Discontinued

1982
25 Jan
Discontinued Application: 83247

Drug Name

NEMBUTAL

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

1982-01-25

83247 / 3

Active Ingredient

PENTOBARBITAL SODIUM

Application Number

83247

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

1982-01-25

Regulatory Status

Discontinued

1982
25 Jan
Discontinued Application: 83247

Drug Name

NEMBUTAL

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

1982-01-25

83247 / 4

Active Ingredient

PENTOBARBITAL SODIUM

Application Number

83247

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

1982-01-25

Regulatory Status

Discontinued

2004
06 Feb
Discontinued Application: 65088

Drug Name

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC

Product Number

1

Dosage Form

-

Strength

400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM

Approval Date

2004-02-06

65088 / 1

Active Ingredient

BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

65088

Product Number

1

Dosage Form

-

Strength

400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM

Approval Date

2004-02-06

Regulatory Status

Discontinued

2005
28 Oct
RX Application: 65187

Drug Name

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN

Product Number

1

Dosage Form

-

Strength

0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML

Approval Date

2005-10-28

65187 / 1

Active Ingredient

GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

65187

Product Number

1

Dosage Form

-

Strength

0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML

Approval Date

2005-10-28

Regulatory Status

RX

2006
01 May
RX Application: 65219

Drug Name

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Approval Date

2006-05-01

65219 / 1

Active Ingredient

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

65219

Product Number

1

Dosage Form

-

Strength

1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Approval Date

2006-05-01

Regulatory Status

RX

2012
25 Jul
Discontinued Application: 65213

Drug Name

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

Approval Date

2012-07-25

65213 / 1

Active Ingredient

BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

65213

Product Number

1

Dosage Form

-

Strength

400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

Approval Date

2012-07-25

Regulatory Status

Discontinued

1991
27 Dec
RX Application: 62832

Drug Name

NYSTATIN

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/ML

Approval Date

1991-12-27

62832 / 1

Active Ingredient

NYSTATIN

Application Number

62832

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/ML

Approval Date

1991-12-27

Regulatory Status

RX

2018
29 Jun
RX Application: 208130

Drug Name

OLMESARTAN MEDOXOMIL

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2018-06-29

208130 / 1

Active Ingredient

OLMESARTAN MEDOXOMIL

Application Number

208130

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2018-06-29

Regulatory Status

RX

2018
29 Jun
RX Application: 208130

Drug Name

OLMESARTAN MEDOXOMIL

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2018-06-29

208130 / 2

Active Ingredient

OLMESARTAN MEDOXOMIL

Application Number

208130

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2018-06-29

Regulatory Status

RX

2018
29 Jun
RX Application: 208130

Drug Name

OLMESARTAN MEDOXOMIL

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2018-06-29

208130 / 3

Active Ingredient

OLMESARTAN MEDOXOMIL

Application Number

208130

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2018-06-29

Regulatory Status

RX

2026
31 Mar
RX Application: 208465

Drug Name

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;20MG

Approval Date

2026-03-31

208465 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

208465

Product Number

1

Dosage Form

-

Strength

12.5MG;20MG

Approval Date

2026-03-31

Regulatory Status

RX

2026
31 Mar
RX Application: 208465

Drug Name

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;40MG

Approval Date

2026-03-31

208465 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

208465

Product Number

2

Dosage Form

-

Strength

12.5MG;40MG

Approval Date

2026-03-31

Regulatory Status

RX

2026
31 Mar
RX Application: 208465

Drug Name

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;40MG

Approval Date

2026-03-31

208465 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

208465

Product Number

3

Dosage Form

-

Strength

25MG;40MG

Approval Date

2026-03-31

Regulatory Status

RX

2017
10 Jan
Discontinued Application: 204532

Drug Name

OLOPATADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

2017-01-10

204532 / 1

Active Ingredient

OLOPATADINE HYDROCHLORIDE

Application Number

204532

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

2017-01-10

Regulatory Status

Discontinued

2017
05 Dec
Discontinued Application: 204723

Drug Name

OLOPATADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.2% BASE

Approval Date

2017-12-05

204723 / 1

Active Ingredient

OLOPATADINE HYDROCHLORIDE

Application Number

204723

Product Number

1

Dosage Form

-

Strength

EQ 0.2% BASE

Approval Date

2017-12-05

Regulatory Status

Discontinued

2016
06 Dec
RX Application: 207476

Drug Name

OMEPRAZOLE AND SODIUM BICARBONATE

Product Number

1

Dosage Form

-

Strength

20MG;1.1GM

Approval Date

2016-12-06

207476 / 1

Active Ingredient

OMEPRAZOLE; SODIUM BICARBONATE

Application Number

207476

Product Number

1

Dosage Form

-

Strength

20MG;1.1GM

Approval Date

2016-12-06

Regulatory Status

RX

2016
06 Dec
RX Application: 207476

Drug Name

OMEPRAZOLE AND SODIUM BICARBONATE

Product Number

2

Dosage Form

-

Strength

40MG;1.1GM

Approval Date

2016-12-06

207476 / 2

Active Ingredient

OMEPRAZOLE; SODIUM BICARBONATE

Application Number

207476

Product Number

2

Dosage Form

-

Strength

40MG;1.1GM

Approval Date

2016-12-06

Regulatory Status

RX

2023
28 Jul
RX Application: 213329

Drug Name

PHYTONADIONE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2023-07-28

213329 / 1

Active Ingredient

PHYTONADIONE

Application Number

213329

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2023-07-28

Regulatory Status

RX

2022
01 Aug
RX Application: 212077

Drug Name

PIRFENIDONE

Product Number

1

Dosage Form

-

Strength

267MG

Approval Date

2022-08-01

212077 / 1

Active Ingredient

PIRFENIDONE

Application Number

212077

Product Number

1

Dosage Form

-

Strength

267MG

Approval Date

2022-08-01

Regulatory Status

RX

2022
01 Aug
RX Application: 212078

Drug Name

PIRFENIDONE

Product Number

1

Dosage Form

-

Strength

267MG

Approval Date

2022-08-01

212078 / 1

Active Ingredient

PIRFENIDONE

Application Number

212078

Product Number

1

Dosage Form

-

Strength

267MG

Approval Date

2022-08-01

Regulatory Status

RX

2022
01 Aug
RX Application: 212078

Drug Name

PIRFENIDONE

Product Number

2

Dosage Form

-

Strength

801MG

Approval Date

2022-08-01

212078 / 2

Active Ingredient

PIRFENIDONE

Application Number

212078

Product Number

2

Dosage Form

-

Strength

801MG

Approval Date

2022-08-01

Regulatory Status

RX

2021
21 May
RX Application: 211648

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

20MEQ/15ML

Approval Date

2021-05-21

211648 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

211648

Product Number

1

Dosage Form

-

Strength

20MEQ/15ML

Approval Date

2021-05-21

Regulatory Status

RX

2021
21 May
RX Application: 211648

Drug Name

POTASSIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

40MEQ/15ML

Approval Date

2021-05-21

211648 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

211648

Product Number

2

Dosage Form

-

Strength

40MEQ/15ML

Approval Date

2021-05-21

Regulatory Status

RX

2014
28 Oct
RX Application: 203855

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2014-10-28

203855 / 1

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

203855

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2014-10-28

Regulatory Status

RX

2014
28 Oct
RX Application: 203855

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2014-10-28

203855 / 2

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

203855

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2014-10-28

Regulatory Status

RX

2014
28 Oct
RX Application: 203855

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

2014-10-28

203855 / 3

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

203855

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

2014-10-28

Regulatory Status

RX

2014
28 Oct
RX Application: 203855

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

0.75MG

Approval Date

2014-10-28

203855 / 4

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

203855

Product Number

4

Dosage Form

-

Strength

0.75MG

Approval Date

2014-10-28

Regulatory Status

RX

2014
28 Oct
RX Application: 203855

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

1MG

Approval Date

2014-10-28

203855 / 5

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

203855

Product Number

5

Dosage Form

-

Strength

1MG

Approval Date

2014-10-28

Regulatory Status

RX

2014
28 Oct
RX Application: 203855

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

1.5MG

Approval Date

2014-10-28

203855 / 6

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

203855

Product Number

6

Dosage Form

-

Strength

1.5MG

Approval Date

2014-10-28

Regulatory Status

RX

2019
19 Jul
RX Application: 208677

Drug Name

PREGABALIN

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2019-07-19

208677 / 1

Active Ingredient

PREGABALIN

Application Number

208677

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 208677

Drug Name

PREGABALIN

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2019-07-19

208677 / 2

Active Ingredient

PREGABALIN

Application Number

208677

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 208677

Drug Name

PREGABALIN

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2019-07-19

208677 / 3

Active Ingredient

PREGABALIN

Application Number

208677

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 208677

Drug Name

PREGABALIN

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2019-07-19

208677 / 4

Active Ingredient

PREGABALIN

Application Number

208677

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 208677

Drug Name

PREGABALIN

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2019-07-19

208677 / 5

Active Ingredient

PREGABALIN

Application Number

208677

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 208677

Drug Name

PREGABALIN

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

2019-07-19

208677 / 6

Active Ingredient

PREGABALIN

Application Number

208677

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 208677

Drug Name

PREGABALIN

Product Number

7

Dosage Form

-

Strength

225MG

Approval Date

2019-07-19

208677 / 7

Active Ingredient

PREGABALIN

Application Number

208677

Product Number

7

Dosage Form

-

Strength

225MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 208677

Drug Name

PREGABALIN

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

2019-07-19

208677 / 8

Active Ingredient

PREGABALIN

Application Number

208677

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

2019-07-19

Regulatory Status

RX

2022
14 Sep
Discontinued Application: 215675

Drug Name

PREGABALIN

Product Number

1

Dosage Form

-

Strength

82.5MG

Approval Date

2022-09-14

215675 / 1

Active Ingredient

PREGABALIN

Application Number

215675

Product Number

1

Dosage Form

-

Strength

82.5MG

Approval Date

2022-09-14

Regulatory Status

Discontinued

2022
14 Sep
Discontinued Application: 215675

Drug Name

PREGABALIN

Product Number

2

Dosage Form

-

Strength

165MG

Approval Date

2022-09-14

215675 / 2

Active Ingredient

PREGABALIN

Application Number

215675

Product Number

2

Dosage Form

-

Strength

165MG

Approval Date

2022-09-14

Regulatory Status

Discontinued

2022
14 Sep
Discontinued Application: 215675

Drug Name

PREGABALIN

Product Number

3

Dosage Form

-

Strength

330MG

Approval Date

2022-09-14

215675 / 3

Active Ingredient

PREGABALIN

Application Number

215675

Product Number

3

Dosage Form

-

Strength

330MG

Approval Date

2022-09-14

Regulatory Status

Discontinued

2012
27 Mar
RX Application: 90960

Drug Name

QUETIAPINE FUMARATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2012-03-27

90960 / 1

Active Ingredient

QUETIAPINE FUMARATE

Application Number

90960

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2012-03-27

Regulatory Status

RX

2012
27 Mar
RX Application: 90960

Drug Name

QUETIAPINE FUMARATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2012-03-27

90960 / 2

Active Ingredient

QUETIAPINE FUMARATE

Application Number

90960

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2012-03-27

Regulatory Status

RX

2012
27 Mar
RX Application: 90960

Drug Name

QUETIAPINE FUMARATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2012-03-27

90960 / 3

Active Ingredient

QUETIAPINE FUMARATE

Application Number

90960

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2012-03-27

Regulatory Status

RX

2012
27 Mar
RX Application: 90960

Drug Name

QUETIAPINE FUMARATE

Product Number

4

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2012-03-27

90960 / 4

Active Ingredient

QUETIAPINE FUMARATE

Application Number

90960

Product Number

4

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2012-03-27

Regulatory Status

RX

2012
27 Mar
RX Application: 90960

Drug Name

QUETIAPINE FUMARATE

Product Number

5

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2012-03-27

90960 / 5

Active Ingredient

QUETIAPINE FUMARATE

Application Number

90960

Product Number

5

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2012-03-27

Regulatory Status

RX

2012
27 Mar
RX Application: 90960

Drug Name

QUETIAPINE FUMARATE

Product Number

6

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2012-03-27

90960 / 6

Active Ingredient

QUETIAPINE FUMARATE

Application Number

90960

Product Number

6

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2012-03-27

Regulatory Status

RX

2017
29 Nov
RX Application: 209635

Drug Name

QUETIAPINE FUMARATE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2017-11-29

209635 / 1

Active Ingredient

QUETIAPINE FUMARATE

Application Number

209635

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2017-11-29

Regulatory Status

RX

2017
29 Nov
RX Application: 209635

Drug Name

QUETIAPINE FUMARATE

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2017-11-29

209635 / 2

Active Ingredient

QUETIAPINE FUMARATE

Application Number

209635

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2017-11-29

Regulatory Status

RX

2017
29 Nov
RX Application: 209635

Drug Name

QUETIAPINE FUMARATE

Product Number

3

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2017-11-29

209635 / 3

Active Ingredient

QUETIAPINE FUMARATE

Application Number

209635

Product Number

3

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2017-11-29

Regulatory Status

RX

2017
29 Nov
RX Application: 209635

Drug Name

QUETIAPINE FUMARATE

Product Number

4

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2017-11-29

209635 / 4

Active Ingredient

QUETIAPINE FUMARATE

Application Number

209635

Product Number

4

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2017-11-29

Regulatory Status

RX

2018
16 Nov
RX Application: 209635

Drug Name

QUETIAPINE FUMARATE

Product Number

5

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2018-11-16

209635 / 5

Active Ingredient

QUETIAPINE FUMARATE

Application Number

209635

Product Number

5

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2018-11-16

Regulatory Status

RX

2016
12 Oct
RX Application: 206384

Drug Name

RALOXIFENE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2016-10-12

206384 / 1

Active Ingredient

RALOXIFENE HYDROCHLORIDE

Application Number

206384

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2016-10-12

Regulatory Status

RX

2019
04 Jun
RX Application: 211829

Drug Name

RANOLAZINE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2019-06-04

211829 / 1

Active Ingredient

RANOLAZINE

Application Number

211829

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2019-06-04

Regulatory Status

RX

2019
04 Jun
RX Application: 211829

Drug Name

RANOLAZINE

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2019-06-04

211829 / 2

Active Ingredient

RANOLAZINE

Application Number

211829

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2019-06-04

Regulatory Status

RX

2016
18 Feb
RX Application: 204989

Drug Name

RELGAABI

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2016-02-18

204989 / 1

Active Ingredient

GABAPENTIN

Application Number

204989

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2016-02-18

Regulatory Status

RX

2016
18 Feb
RX Application: 204989

Drug Name

RELGAABI

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2016-02-18

204989 / 2

Active Ingredient

GABAPENTIN

Application Number

204989

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2016-02-18

Regulatory Status

RX

2016
18 Feb
RX Application: 204989

Drug Name

RELGAABI

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2016-02-18

204989 / 3

Active Ingredient

GABAPENTIN

Application Number

204989

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2016-02-18

Regulatory Status

RX

2026
06 Mar
RX Application: 204989

Drug Name

RELGAABI

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2026-03-06

204989 / 4

Active Ingredient

GABAPENTIN

Application Number

204989

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2026-03-06

Regulatory Status

RX

2025
31 Jul
RX Application: 218117

Drug Name

RIVAROXABAN

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2025-07-31

218117 / 1

Active Ingredient

RIVAROXABAN

Application Number

218117

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2025-07-31

Regulatory Status

RX

2025
31 Jul
RX Application: 218117

Drug Name

RIVAROXABAN

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2025-07-31

218117 / 2

Active Ingredient

RIVAROXABAN

Application Number

218117

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2025-07-31

Regulatory Status

RX

2025
31 Jul
RX Application: 218117

Drug Name

RIVAROXABAN

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2025-07-31

218117 / 3

Active Ingredient

RIVAROXABAN

Application Number

218117

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2025-07-31

Regulatory Status

RX

2025
31 Jul
RX Application: 218117

Drug Name

RIVAROXABAN

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2025-07-31

218117 / 4

Active Ingredient

RIVAROXABAN

Application Number

218117

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2025-07-31

Regulatory Status

RX

2019
24 Apr
RX Application: 206381

Drug Name

ROSUVASTATIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2019-04-24

206381 / 1

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

206381

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2019-04-24

Regulatory Status

RX

2019
24 Apr
RX Application: 206381

Drug Name

ROSUVASTATIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2019-04-24

206381 / 2

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

206381

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2019-04-24

Regulatory Status

RX

2019
24 Apr
RX Application: 206381

Drug Name

ROSUVASTATIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2019-04-24

206381 / 3

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

206381

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2019-04-24

Regulatory Status

RX

2019
24 Apr
RX Application: 206381

Drug Name

ROSUVASTATIN CALCIUM

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2019-04-24

206381 / 4

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

206381

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2019-04-24

Regulatory Status

RX

2016
16 May
RX Application: 205095

Drug Name

RUFINAMIDE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2016-05-16

205095 / 1

Active Ingredient

RUFINAMIDE

Application Number

205095

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2016-05-16

Regulatory Status

RX

2016
16 May
RX Application: 205095

Drug Name

RUFINAMIDE

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

2016-05-16

205095 / 2

Active Ingredient

RUFINAMIDE

Application Number

205095

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

2016-05-16

Regulatory Status

RX

2007
30 Apr
RX Application: 76442

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2007-04-30

76442 / 1

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

76442

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2007-04-30

Regulatory Status

RX

2007
30 Apr
RX Application: 76442

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2007-04-30

76442 / 2

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

76442

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2007-04-30

Regulatory Status

RX

2007
30 Apr
RX Application: 76442

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2007-04-30

76442 / 3

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

76442

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2007-04-30

Regulatory Status

RX

-
Unclassified Application: 216337

Drug Name

SITAGLIPTIN

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

-

216337 / 1

Active Ingredient

SITAGLIPTIN

Application Number

216337

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 216337

Drug Name

SITAGLIPTIN

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

-

216337 / 2

Active Ingredient

SITAGLIPTIN

Application Number

216337

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 216337

Drug Name

SITAGLIPTIN

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

-

216337 / 3

Active Ingredient

SITAGLIPTIN

Application Number

216337

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

2019
20 May
RX Application: 211657

Drug Name

SOLIFENACIN SUCCINATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-05-20

211657 / 1

Active Ingredient

SOLIFENACIN SUCCINATE

Application Number

211657

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-05-20

Regulatory Status

RX

2019
20 May
RX Application: 211657

Drug Name

SOLIFENACIN SUCCINATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-05-20

211657 / 2

Active Ingredient

SOLIFENACIN SUCCINATE

Application Number

211657

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-05-20

Regulatory Status

RX

2010
27 Apr
RX Application: 78938

Drug Name

TAMSULOSIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.4MG

Approval Date

2010-04-27

78938 / 1

Active Ingredient

TAMSULOSIN HYDROCHLORIDE

Application Number

78938

Product Number

1

Dosage Form

-

Strength

0.4MG

Approval Date

2010-04-27

Regulatory Status

RX

2025
28 Oct
RX Application: 218962

Drug Name

TICAGRELOR

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2025-10-28

218962 / 1

Active Ingredient

TICAGRELOR

Application Number

218962

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2025-10-28

Regulatory Status

RX

2025
28 Oct
RX Application: 218962

Drug Name

TICAGRELOR

Product Number

2

Dosage Form

-

Strength

90MG

Approval Date

2025-10-28

218962 / 2

Active Ingredient

TICAGRELOR

Application Number

218962

Product Number

2

Dosage Form

-

Strength

90MG

Approval Date

2025-10-28

Regulatory Status

RX

2026
25 Jun
RX Application: 220972

Drug Name

TOFACITINIB CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 11MG BASE

Approval Date

2026-06-25

220972 / 1

Active Ingredient

TOFACITINIB CITRATE

Application Number

220972

Product Number

1

Dosage Form

-

Strength

EQ 11MG BASE

Approval Date

2026-06-25

Regulatory Status

RX

2016
11 Aug
Discontinued Application: 206312

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2016-08-11

206312 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

206312

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2016-08-11

Regulatory Status

Discontinued

2016
07 Dec
RX Application: 207094

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.147MG/GM

Approval Date

2016-12-07

207094 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

207094

Product Number

1

Dosage Form

-

Strength

0.147MG/GM

Approval Date

2016-12-07

Regulatory Status

RX

2021
27 Oct
RX Application: 204038

Drug Name

VALSARTAN

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2021-10-27

204038 / 1

Active Ingredient

VALSARTAN

Application Number

204038

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2021-10-27

Regulatory Status

RX

2021
27 Oct
RX Application: 204038

Drug Name

VALSARTAN

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2021-10-27

204038 / 2

Active Ingredient

VALSARTAN

Application Number

204038

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2021-10-27

Regulatory Status

RX

2021
27 Oct
RX Application: 204038

Drug Name

VALSARTAN

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2021-10-27

204038 / 3

Active Ingredient

VALSARTAN

Application Number

204038

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2021-10-27

Regulatory Status

RX

2021
27 Oct
RX Application: 204038

Drug Name

VALSARTAN

Product Number

4

Dosage Form

-

Strength

320MG

Approval Date

2021-10-27

204038 / 4

Active Ingredient

VALSARTAN

Application Number

204038

Product Number

4

Dosage Form

-

Strength

320MG

Approval Date

2021-10-27

Regulatory Status

RX

2026
23 Apr
RX Application: 204687

Drug Name

VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;80MG

Approval Date

2026-04-23

204687 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

204687

Product Number

1

Dosage Form

-

Strength

12.5MG;80MG

Approval Date

2026-04-23

Regulatory Status

RX

2026
23 Apr
RX Application: 204687

Drug Name

VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;160MG

Approval Date

2026-04-23

204687 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

204687

Product Number

2

Dosage Form

-

Strength

12.5MG;160MG

Approval Date

2026-04-23

Regulatory Status

RX

2026
23 Apr
RX Application: 204687

Drug Name

VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

12.5MG;320MG

Approval Date

2026-04-23

204687 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

204687

Product Number

3

Dosage Form

-

Strength

12.5MG;320MG

Approval Date

2026-04-23

Regulatory Status

RX

2026
23 Apr
RX Application: 204687

Drug Name

VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

4

Dosage Form

-

Strength

25MG;160MG

Approval Date

2026-04-23

204687 / 4

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

204687

Product Number

4

Dosage Form

-

Strength

25MG;160MG

Approval Date

2026-04-23

Regulatory Status

RX

2026
23 Apr
RX Application: 204687

Drug Name

VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

5

Dosage Form

-

Strength

25MG;320MG

Approval Date

2026-04-23

204687 / 5

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

204687

Product Number

5

Dosage Form

-

Strength

25MG;320MG

Approval Date

2026-04-23

Regulatory Status

RX

2011
14 Apr
RX Application: 78865

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2011-04-14

78865 / 1

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

78865

Product Number

1

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2011-04-14

Regulatory Status

RX

2011
14 Apr
RX Application: 78865

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2011-04-14

78865 / 2

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

78865

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2011-04-14

Regulatory Status

RX

2011
14 Apr
RX Application: 78865

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2011-04-14

78865 / 3

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

78865

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2011-04-14

Regulatory Status

RX

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

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

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

ACETIC ACID

Application Number

40607

Product Number

1

Active Ingredient

ACETIC ACID, GLACIAL

Dosage Form

-

Strength

2%

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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