Apotex Fermentation Inc.
FDA Approved Drugs

Apotex Fermentation 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 OTC Unclassified
  • Total Records 558
  • Latest Approval Date Jul 14, 2026
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
558
View
Unclassified
9
View
Discontinued
263
View
OTC
8
View
RX
278
View
Company Overview

Company

Apotex Fermentation Inc.

Country

Canada

Website

Visit Website

Email

services@apoferm.com

Social Profiles

Company Snapshot

Apotex Fermentation Inc.

50 Scurfield BoulevardWinnipeg, ManitobaCanada R3Y 1G4

Canada

www.apoferm.com/ services@apoferm.com View on Map
FDA Approved Drug Records ( 558 records )
2018
31 Oct
RX Application: 208453

Drug Name

ABIRATERONE ACETATE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2018-10-31

208453 / 1

Active Ingredient

ABIRATERONE ACETATE

Application Number

208453

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2018-10-31

Regulatory Status

RX

2004
23 Jan
RX Application: 21539

Drug Name

ACETADOTE

Product Number

1

Dosage Form

-

Strength

6GM/30ML (200MG/ML)

Approval Date

2004-01-23

21539 / 1

Active Ingredient

ACETYLCYSTEINE

Application Number

21539

Product Number

1

Dosage Form

-

Strength

6GM/30ML (200MG/ML)

Approval Date

2004-01-23

Regulatory Status

RX

2023
18 Apr
RX Application: 205746

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

Approval Date

2023-04-18

205746 / 1

Active Ingredient

ACETAMINOPHEN

Application Number

205746

Product Number

1

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

Approval Date

2023-04-18

Regulatory Status

RX

2005
28 Sep
RX Application: 75677

Drug Name

ACYCLOVIR

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2005-09-28

75677 / 1

Active Ingredient

ACYCLOVIR

Application Number

75677

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2005-09-28

Regulatory Status

RX

2005
29 Sep
RX Application: 77309

Drug Name

ACYCLOVIR

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2005-09-29

77309 / 1

Active Ingredient

ACYCLOVIR

Application Number

77309

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2005-09-29

Regulatory Status

RX

2005
29 Sep
RX Application: 77309

Drug Name

ACYCLOVIR

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

2005-09-29

77309 / 2

Active Ingredient

ACYCLOVIR

Application Number

77309

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

2005-09-29

Regulatory Status

RX

2019
06 Sep
Discontinued Application: 210774

Drug Name

ACYCLOVIR

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2019-09-06

210774 / 1

Active Ingredient

ACYCLOVIR

Application Number

210774

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2019-09-06

Regulatory Status

Discontinued

2018
06 Jul
RX Application: 205459

Drug Name

ADEFOVIR DIPIVOXIL

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-07-06

205459 / 1

Active Ingredient

ADEFOVIR DIPIVOXIL

Application Number

205459

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-07-06

Regulatory Status

RX

2026
14 Jul
RX Application: 210725

Drug Name

AFATINIB DIMALEATE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2026-07-14

210725 / 1

Active Ingredient

AFATINIB DIMALEATE

Application Number

210725

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2026-07-14

Regulatory Status

RX

2026
14 Jul
RX Application: 210725

Drug Name

AFATINIB DIMALEATE

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2026-07-14

210725 / 2

Active Ingredient

AFATINIB DIMALEATE

Application Number

210725

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2026-07-14

Regulatory Status

RX

2026
14 Jul
RX Application: 210725

Drug Name

AFATINIB DIMALEATE

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2026-07-14

210725 / 3

Active Ingredient

AFATINIB DIMALEATE

Application Number

210725

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2026-07-14

Regulatory Status

RX

2008
04 Aug
Discontinued Application: 77982

Drug Name

ALENDRONATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2008-08-04

77982 / 1

Active Ingredient

ALENDRONATE SODIUM

Application Number

77982

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2008-08-04

Regulatory Status

Discontinued

2008
04 Aug
Discontinued Application: 77982

Drug Name

ALENDRONATE SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2008-08-04

77982 / 2

Active Ingredient

ALENDRONATE SODIUM

Application Number

77982

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2008-08-04

Regulatory Status

Discontinued

2008
04 Aug
Discontinued Application: 77982

Drug Name

ALENDRONATE SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 35MG BASE

Approval Date

2008-08-04

77982 / 3

Active Ingredient

ALENDRONATE SODIUM

Application Number

77982

Product Number

3

Dosage Form

-

Strength

EQ 35MG BASE

Approval Date

2008-08-04

Regulatory Status

Discontinued

2008
04 Aug
Discontinued Application: 77982

Drug Name

ALENDRONATE SODIUM

Product Number

4

Dosage Form

-

Strength

EQ 70MG BASE

Approval Date

2008-08-04

77982 / 4

Active Ingredient

ALENDRONATE SODIUM

Application Number

77982

Product Number

4

Dosage Form

-

Strength

EQ 70MG BASE

Approval Date

2008-08-04

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 14691

Drug Name

ALKERAN

Product Number

2

Dosage Form

-

Strength

2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

14691 / 2

Active Ingredient

MELPHALAN

Application Number

14691

Product Number

2

Dosage Form

-

Strength

2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1992
18 Nov
Discontinued Application: 20207

Drug Name

ALKERAN

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-11-18

20207 / 1

Active Ingredient

MELPHALAN HYDROCHLORIDE

Application Number

20207

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-11-18

Regulatory Status

Discontinued

2022
19 May
RX Application: 210701

Drug Name

AMBRISENTAN

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2022-05-19

210701 / 1

Active Ingredient

AMBRISENTAN

Application Number

210701

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2022-05-19

Regulatory Status

RX

2022
19 May
RX Application: 210701

Drug Name

AMBRISENTAN

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2022-05-19

210701 / 2

Active Ingredient

AMBRISENTAN

Application Number

210701

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2022-05-19

Regulatory Status

RX

2019
18 Nov
RX Application: 205199

Drug Name

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;EQ 10MG BASE

Approval Date

2019-11-18

205199 / 1

Active Ingredient

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Application Number

205199

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;EQ 10MG BASE

Approval Date

2019-11-18

Regulatory Status

RX

2019
18 Nov
RX Application: 205199

Drug Name

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;EQ 20MG BASE

Approval Date

2019-11-18

205199 / 2

Active Ingredient

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Application Number

205199

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;EQ 20MG BASE

Approval Date

2019-11-18

Regulatory Status

RX

2019
18 Nov
RX Application: 205199

Drug Name

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE;EQ 40MG BASE

Approval Date

2019-11-18

205199 / 3

Active Ingredient

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Application Number

205199

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE;EQ 40MG BASE

Approval Date

2019-11-18

Regulatory Status

RX

2019
18 Nov
RX Application: 205199

Drug Name

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM

Product Number

4

Dosage Form

-

Strength

EQ 5MG BASE;EQ 80MG BASE

Approval Date

2019-11-18

205199 / 4

Active Ingredient

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Application Number

205199

Product Number

4

Dosage Form

-

Strength

EQ 5MG BASE;EQ 80MG BASE

Approval Date

2019-11-18

Regulatory Status

RX

2019
18 Nov
RX Application: 205199

Drug Name

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM

Product Number

5

Dosage Form

-

Strength

EQ 10MG BASE;EQ 10MG BASE

Approval Date

2019-11-18

205199 / 5

Active Ingredient

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Application Number

205199

Product Number

5

Dosage Form

-

Strength

EQ 10MG BASE;EQ 10MG BASE

Approval Date

2019-11-18

Regulatory Status

RX

2019
18 Nov
RX Application: 205199

Drug Name

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM

Product Number

6

Dosage Form

-

Strength

EQ 10MG BASE;EQ 20MG BASE

Approval Date

2019-11-18

205199 / 6

Active Ingredient

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Application Number

205199

Product Number

6

Dosage Form

-

Strength

EQ 10MG BASE;EQ 20MG BASE

Approval Date

2019-11-18

Regulatory Status

RX

2019
18 Nov
RX Application: 205199

Drug Name

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM

Product Number

7

Dosage Form

-

Strength

EQ 10MG BASE;EQ 40MG BASE

Approval Date

2019-11-18

205199 / 7

Active Ingredient

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Application Number

205199

Product Number

7

Dosage Form

-

Strength

EQ 10MG BASE;EQ 40MG BASE

Approval Date

2019-11-18

Regulatory Status

RX

2019
18 Nov
RX Application: 205199

Drug Name

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM

Product Number

8

Dosage Form

-

Strength

EQ 10MG BASE;EQ 80MG BASE

Approval Date

2019-11-18

205199 / 8

Active Ingredient

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Application Number

205199

Product Number

8

Dosage Form

-

Strength

EQ 10MG BASE;EQ 80MG BASE

Approval Date

2019-11-18

Regulatory Status

RX

2024
16 Feb
Discontinued Application: 210091

Drug Name

APIXABAN

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2024-02-16

210091 / 1

Active Ingredient

APIXABAN

Application Number

210091

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2024-02-16

Regulatory Status

Discontinued

2024
16 Feb
Discontinued Application: 210091

Drug Name

APIXABAN

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2024-02-16

210091 / 2

Active Ingredient

APIXABAN

Application Number

210091

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2024-02-16

Regulatory Status

Discontinued

2015
24 Jul
Discontinued Application: 78583

Drug Name

ARIPIPRAZOLE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2015-07-24

78583 / 1

Active Ingredient

ARIPIPRAZOLE

Application Number

78583

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2015-07-24

Regulatory Status

Discontinued

2015
24 Jul
Discontinued Application: 78583

Drug Name

ARIPIPRAZOLE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2015-07-24

78583 / 2

Active Ingredient

ARIPIPRAZOLE

Application Number

78583

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2015-07-24

Regulatory Status

Discontinued

2015
24 Jul
Discontinued Application: 78583

Drug Name

ARIPIPRAZOLE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2015-07-24

78583 / 3

Active Ingredient

ARIPIPRAZOLE

Application Number

78583

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2015-07-24

Regulatory Status

Discontinued

2015
24 Jul
Discontinued Application: 78583

Drug Name

ARIPIPRAZOLE

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2015-07-24

78583 / 4

Active Ingredient

ARIPIPRAZOLE

Application Number

78583

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2015-07-24

Regulatory Status

Discontinued

2015
24 Jul
Discontinued Application: 78583

Drug Name

ARIPIPRAZOLE

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2015-07-24

78583 / 5

Active Ingredient

ARIPIPRAZOLE

Application Number

78583

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2015-07-24

Regulatory Status

Discontinued

2015
24 Jul
Discontinued Application: 78583

Drug Name

ARIPIPRAZOLE

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2015-07-24

78583 / 6

Active Ingredient

ARIPIPRAZOLE

Application Number

78583

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2015-07-24

Regulatory Status

Discontinued

2015
30 Sep
RX Application: 204094

Drug Name

ARIPIPRAZOLE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2015-09-30

204094 / 1

Active Ingredient

ARIPIPRAZOLE

Application Number

204094

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2015-09-30

Regulatory Status

RX

2017
30 May
RX Application: 78983

Drug Name

ATOMOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2017-05-30

78983 / 1

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

78983

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2017-05-30

Regulatory Status

RX

2017
30 May
RX Application: 78983

Drug Name

ATOMOXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 18MG BASE

Approval Date

2017-05-30

78983 / 2

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

78983

Product Number

2

Dosage Form

-

Strength

EQ 18MG BASE

Approval Date

2017-05-30

Regulatory Status

RX

2017
30 May
RX Application: 78983

Drug Name

ATOMOXETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2017-05-30

78983 / 3

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

78983

Product Number

3

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2017-05-30

Regulatory Status

RX

2017
30 May
RX Application: 78983

Drug Name

ATOMOXETINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2017-05-30

78983 / 4

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

78983

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2017-05-30

Regulatory Status

RX

2017
30 May
RX Application: 78983

Drug Name

ATOMOXETINE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2017-05-30

78983 / 5

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

78983

Product Number

5

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2017-05-30

Regulatory Status

RX

2017
30 May
RX Application: 78983

Drug Name

ATOMOXETINE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2017-05-30

78983 / 6

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

78983

Product Number

6

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2017-05-30

Regulatory Status

RX

2017
30 May
RX Application: 78983

Drug Name

ATOMOXETINE HYDROCHLORIDE

Product Number

7

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2017-05-30

78983 / 7

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

78983

Product Number

7

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2017-05-30

Regulatory Status

RX

2021
02 Sep
RX Application: 214969

Drug Name

ATORVASTATIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2021-09-02

214969 / 1

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

214969

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2021-09-02

Regulatory Status

RX

2021
02 Sep
RX Application: 214969

Drug Name

ATORVASTATIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2021-09-02

214969 / 2

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

214969

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2021-09-02

Regulatory Status

RX

2021
02 Sep
RX Application: 214969

Drug Name

ATORVASTATIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2021-09-02

214969 / 3

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

214969

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2021-09-02

Regulatory Status

RX

2021
02 Sep
RX Application: 214969

Drug Name

ATORVASTATIN CALCIUM

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2021-09-02

214969 / 4

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

214969

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2021-09-02

Regulatory Status

RX

2017
11 Oct
Discontinued Application: 209750

Drug Name

ATOVAQUONE

Product Number

1

Dosage Form

-

Strength

750MG/5ML

Approval Date

2017-10-11

209750 / 1

Active Ingredient

ATOVAQUONE

Application Number

209750

Product Number

1

Dosage Form

-

Strength

750MG/5ML

Approval Date

2017-10-11

Regulatory Status

Discontinued

2021
26 Nov
RX Application: 215624

Drug Name

ATROPINE SULFATE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2021-11-26

215624 / 1

Active Ingredient

ATROPINE SULFATE

Application Number

215624

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2021-11-26

Regulatory Status

RX

2025
30 Oct
Discontinued Application: 211650

Drug Name

AXITINIB

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2025-10-30

211650 / 1

Active Ingredient

AXITINIB

Application Number

211650

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2025-10-30

Regulatory Status

Discontinued

2025
30 Oct
Discontinued Application: 211650

Drug Name

AXITINIB

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2025-10-30

211650 / 2

Active Ingredient

AXITINIB

Application Number

211650

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2025-10-30

Regulatory Status

Discontinued

2009
03 Aug
RX Application: 78621

Drug Name

AZELASTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2009-08-03

78621 / 1

Active Ingredient

AZELASTINE HYDROCHLORIDE

Application Number

78621

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2009-08-03

Regulatory Status

RX

2024
29 May
OTC Application: 216421

Drug Name

AZELASTINE HYDROCHLORIDE ALLERGY

Product Number

1

Dosage Form

-

Strength

0.2055MG/SPRAY

Approval Date

2024-05-29

216421 / 1

Active Ingredient

AZELASTINE HYDROCHLORIDE

Application Number

216421

Product Number

1

Dosage Form

-

Strength

0.2055MG/SPRAY

Approval Date

2024-05-29

Regulatory Status

OTC

2017
28 Apr
RX Application: 207712

Drug Name

AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.137MG/SPRAY;0.05MG/SPRAY

Approval Date

2017-04-28

207712 / 1

Active Ingredient

AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

Application Number

207712

Product Number

1

Dosage Form

-

Strength

0.137MG/SPRAY;0.05MG/SPRAY

Approval Date

2017-04-28

Regulatory Status

RX

2024
29 May
OTC Application: 216421

Drug Name

AZELASTINE HYDROCHLORIDE CHILDRENS ALLERGY

Product Number

2

Dosage Form

-

Strength

0.2055MG/SPRAY

Approval Date

2024-05-29

216421 / 2

Active Ingredient

AZELASTINE HYDROCHLORIDE

Application Number

216421

Product Number

2

Dosage Form

-

Strength

0.2055MG/SPRAY

Approval Date

2024-05-29

Regulatory Status

OTC

2011
13 Jul
Discontinued Application: 65507

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2011-07-13

65507 / 1

Active Ingredient

AZITHROMYCIN

Application Number

65507

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2011-07-13

Regulatory Status

Discontinued

2011
13 Jul
Discontinued Application: 65508

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 600MG BASE

Approval Date

2011-07-13

65508 / 1

Active Ingredient

AZITHROMYCIN

Application Number

65508

Product Number

1

Dosage Form

-

Strength

EQ 600MG BASE

Approval Date

2011-07-13

Regulatory Status

Discontinued

2011
13 Jul
Discontinued Application: 65509

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2011-07-13

65509 / 1

Active Ingredient

AZITHROMYCIN

Application Number

65509

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2011-07-13

Regulatory Status

Discontinued

2007
28 Dec
RX Application: 77883

Drug Name

BALSALAZIDE DISODIUM

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

2007-12-28

77883 / 1

Active Ingredient

BALSALAZIDE DISODIUM

Application Number

77883

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

2007-12-28

Regulatory Status

RX

2014
21 Aug
Discontinued Application: 78794

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

2014-08-21

78794 / 1

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

78794

Product Number

1

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

2014-08-21

Regulatory Status

Discontinued

2014
21 Aug
Discontinued Application: 78794

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2014-08-21

78794 / 2

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

78794

Product Number

2

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2014-08-21

Regulatory Status

Discontinued

2014
21 Aug
Discontinued Application: 78794

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2014-08-21

78794 / 3

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

78794

Product Number

3

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2014-08-21

Regulatory Status

Discontinued

2014
21 Aug
Discontinued Application: 78794

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

4

Dosage Form

-

Strength

20MG;25MG

Approval Date

2014-08-21

78794 / 4

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

78794

Product Number

4

Dosage Form

-

Strength

20MG;25MG

Approval Date

2014-08-21

Regulatory Status

Discontinued

2023
05 Jun
Discontinued Application: 204230

Drug Name

BENDAMUSTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG/VIAL

Approval Date

2023-06-05

204230 / 1

Active Ingredient

BENDAMUSTINE HYDROCHLORIDE

Application Number

204230

Product Number

1

Dosage Form

-

Strength

25MG/VIAL

Approval Date

2023-06-05

Regulatory Status

Discontinued

2023
05 Jun
Discontinued Application: 204230

Drug Name

BENDAMUSTINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2023-06-05

204230 / 2

Active Ingredient

BENDAMUSTINE HYDROCHLORIDE

Application Number

204230

Product Number

2

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2023-06-05

Regulatory Status

Discontinued

2022
07 Dec
RX Application: 215033

Drug Name

BENDAMUSTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/4ML (25MG/ML)

Approval Date

2022-12-07

215033 / 1

Active Ingredient

BENDAMUSTINE HYDROCHLORIDE

Application Number

215033

Product Number

1

Dosage Form

-

Strength

100MG/4ML (25MG/ML)

Approval Date

2022-12-07

Regulatory Status

RX

2019
05 Mar
Discontinued Application: 206066

Drug Name

BEPOTASTINE BESILATE

Product Number

1

Dosage Form

-

Strength

1.5%

Approval Date

2019-03-05

206066 / 1

Active Ingredient

BEPOTASTINE BESILATE

Application Number

206066

Product Number

1

Dosage Form

-

Strength

1.5%

Approval Date

2019-03-05

Regulatory Status

Discontinued

2015
21 May
Discontinued Application: 200274

Drug Name

BICALUTAMIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2015-05-21

200274 / 1

Active Ingredient

BICALUTAMIDE

Application Number

200274

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2015-05-21

Regulatory Status

Discontinued

2015
20 Jul
RX Application: 90449

Drug Name

BIMATOPROST

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

2015-07-20

90449 / 1

Active Ingredient

BIMATOPROST

Application Number

90449

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

2015-07-20

Regulatory Status

RX

2014
01 Dec
Discontinued Application: 201894

Drug Name

BIMATOPROST

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

2014-12-01

201894 / 1

Active Ingredient

BIMATOPROST

Application Number

201894

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

2014-12-01

Regulatory Status

Discontinued

2017
06 Jul
Discontinued Application: 204876

Drug Name

BIVALIRUDIN

Product Number

1

Dosage Form

-

Strength

250MG/VIAL

Approval Date

2017-07-06

204876 / 1

Active Ingredient

BIVALIRUDIN

Application Number

204876

Product Number

1

Dosage Form

-

Strength

250MG/VIAL

Approval Date

2017-07-06

Regulatory Status

Discontinued

2022
02 May
RX Application: 205533

Drug Name

BORTEZOMIB

Product Number

1

Dosage Form

-

Strength

3.5MG/VIAL

Approval Date

2022-05-02

205533 / 1

Active Ingredient

BORTEZOMIB

Application Number

205533

Product Number

1

Dosage Form

-

Strength

3.5MG/VIAL

Approval Date

2022-05-02

Regulatory Status

RX

2025
24 Feb
Discontinued Application: 213731

Drug Name

BREXPIPRAZOLE

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2025-02-24

213731 / 1

Active Ingredient

BREXPIPRAZOLE

Application Number

213731

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2025-02-24

Regulatory Status

Discontinued

2025
24 Feb
Discontinued Application: 213731

Drug Name

BREXPIPRAZOLE

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2025-02-24

213731 / 2

Active Ingredient

BREXPIPRAZOLE

Application Number

213731

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2025-02-24

Regulatory Status

Discontinued

2025
24 Feb
Discontinued Application: 213731

Drug Name

BREXPIPRAZOLE

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2025-02-24

213731 / 3

Active Ingredient

BREXPIPRAZOLE

Application Number

213731

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2025-02-24

Regulatory Status

Discontinued

2025
24 Feb
Discontinued Application: 213731

Drug Name

BREXPIPRAZOLE

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2025-02-24

213731 / 4

Active Ingredient

BREXPIPRAZOLE

Application Number

213731

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2025-02-24

Regulatory Status

Discontinued

2025
24 Feb
Discontinued Application: 213731

Drug Name

BREXPIPRAZOLE

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2025-02-24

213731 / 5

Active Ingredient

BREXPIPRAZOLE

Application Number

213731

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2025-02-24

Regulatory Status

Discontinued

2022
31 Jan
RX Application: 78479

Drug Name

BRIMONIDINE TARTRATE

Product Number

1

Dosage Form

-

Strength

0.15%

Approval Date

2022-01-31

78479 / 1

Active Ingredient

BRIMONIDINE TARTRATE

Application Number

78479

Product Number

1

Dosage Form

-

Strength

0.15%

Approval Date

2022-01-31

Regulatory Status

RX

2022
21 Dec
RX Application: 78480

Drug Name

BRIMONIDINE TARTRATE

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2022-12-21

78480 / 1

Active Ingredient

BRIMONIDINE TARTRATE

Application Number

78480

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2022-12-21

Regulatory Status

RX

2022
20 Apr
RX Application: 91442

Drug Name

BRIMONIDINE TARTRATE AND TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

0.2%;EQ 0.5% BASE

Approval Date

2022-04-20

91442 / 1

Active Ingredient

BRIMONIDINE TARTRATE; TIMOLOL MALEATE

Application Number

91442

Product Number

1

Dosage Form

-

Strength

0.2%;EQ 0.5% BASE

Approval Date

2022-04-20

Regulatory Status

RX

2026
23 Feb
RX Application: 214875

Drug Name

BRIVARACETAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2026-02-23

214875 / 1

Active Ingredient

BRIVARACETAM

Application Number

214875

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2026-02-23

Regulatory Status

RX

2026
23 Feb
RX Application: 214875

Drug Name

BRIVARACETAM

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2026-02-23

214875 / 2

Active Ingredient

BRIVARACETAM

Application Number

214875

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2026-02-23

Regulatory Status

RX

2026
23 Feb
RX Application: 214875

Drug Name

BRIVARACETAM

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2026-02-23

214875 / 3

Active Ingredient

BRIVARACETAM

Application Number

214875

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2026-02-23

Regulatory Status

RX

2026
23 Feb
RX Application: 214875

Drug Name

BRIVARACETAM

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

2026-02-23

214875 / 4

Active Ingredient

BRIVARACETAM

Application Number

214875

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

2026-02-23

Regulatory Status

RX

2026
23 Feb
RX Application: 214875

Drug Name

BRIVARACETAM

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

2026-02-23

214875 / 5

Active Ingredient

BRIVARACETAM

Application Number

214875

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

2026-02-23

Regulatory Status

RX

2014
19 Jun
Discontinued Application: 202435

Drug Name

BROMFENAC SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 0.09% ACID

Approval Date

2014-06-19

202435 / 1

Active Ingredient

BROMFENAC SODIUM

Application Number

202435

Product Number

1

Dosage Form

-

Strength

EQ 0.09% ACID

Approval Date

2014-06-19

Regulatory Status

Discontinued

2014
23 Jun
Discontinued Application: 202620

Drug Name

BROMFENAC SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 0.09% ACID

Approval Date

2014-06-23

202620 / 1

Active Ingredient

BROMFENAC SODIUM

Application Number

202620

Product Number

1

Dosage Form

-

Strength

EQ 0.09% ACID

Approval Date

2014-06-23

Regulatory Status

Discontinued

2024
08 Jul
RX Application: 207334

Drug Name

BROMFENAC SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 0.07% ACID

Approval Date

2024-07-08

207334 / 1

Active Ingredient

BROMFENAC SODIUM

Application Number

207334

Product Number

1

Dosage Form

-

Strength

EQ 0.07% ACID

Approval Date

2024-07-08

Regulatory Status

RX

-
Unclassified Application: 78949

Drug Name

BUDESONIDE

Product Number

1

Dosage Form

-

Strength

0.032MG/INH

Approval Date

-

78949 / 1

Active Ingredient

BUDESONIDE

Application Number

78949

Product Number

1

Dosage Form

-

Strength

0.032MG/INH

Approval Date

-

Regulatory Status

Unclassified

2015
20 Nov
OTC Application: 78949

Drug Name

BUDESONIDE

Product Number

2

Dosage Form

-

Strength

0.032MG/SPRAY

Approval Date

2015-11-20

78949 / 2

Active Ingredient

BUDESONIDE

Application Number

78949

Product Number

2

Dosage Form

-

Strength

0.032MG/SPRAY

Approval Date

2015-11-20

Regulatory Status

OTC

2006
17 Jan
RX Application: 76143

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2006-01-17

76143 / 1

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

76143

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2006-01-17

Regulatory Status

RX

2006
17 Jan
RX Application: 76143

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2006-01-17

76143 / 2

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

76143

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2006-01-17

Regulatory Status

RX

2019
07 May
Discontinued Application: 210448

Drug Name

BUSULFAN

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2019-05-07

210448 / 1

Active Ingredient

BUSULFAN

Application Number

210448

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2019-05-07

Regulatory Status

Discontinued

2002
04 Dec
RX Application: 75499

Drug Name

BUTORPHANOL TARTRATE

Product Number

1

Dosage Form

-

Strength

1MG/SPRAY

Approval Date

2002-12-04

75499 / 1

Active Ingredient

BUTORPHANOL TARTRATE

Application Number

75499

Product Number

1

Dosage Form

-

Strength

1MG/SPRAY

Approval Date

2002-12-04

Regulatory Status

RX

2023
10 Feb
Discontinued Application: 207736

Drug Name

CABAZITAXEL

Product Number

1

Dosage Form

-

Strength

60MG/1.5ML (40MG/ML)

Approval Date

2023-02-10

207736 / 1

Active Ingredient

CABAZITAXEL

Application Number

207736

Product Number

1

Dosage Form

-

Strength

60MG/1.5ML (40MG/ML)

Approval Date

2023-02-10

Regulatory Status

Discontinued

2013
08 Mar
Discontinued Application: 201503

Drug Name

CABERGOLINE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2013-03-08

201503 / 1

Active Ingredient

CABERGOLINE

Application Number

201503

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2013-03-08

Regulatory Status

Discontinued

2009
11 Jun
Discontinued Application: 22348

Drug Name

CALDOLOR

Product Number

1

Dosage Form

-

Strength

400MG/4ML (100MG/ML)

Approval Date

2009-06-11

22348 / 1

Active Ingredient

IBUPROFEN

Application Number

22348

Product Number

1

Dosage Form

-

Strength

400MG/4ML (100MG/ML)

Approval Date

2009-06-11

Regulatory Status

Discontinued

2009
11 Jun
RX Application: 22348

Drug Name

CALDOLOR

Product Number

2

Dosage Form

-

Strength

800MG/8ML (100MG/ML)

Approval Date

2009-06-11

22348 / 2

Active Ingredient

IBUPROFEN

Application Number

22348

Product Number

2

Dosage Form

-

Strength

800MG/8ML (100MG/ML)

Approval Date

2009-06-11

Regulatory Status

RX

2019
25 Jan
RX Application: 22348

Drug Name

CALDOLOR

Product Number

3

Dosage Form

-

Strength

800MG/200ML (4MG/ML)

Approval Date

2019-01-25

22348 / 3

Active Ingredient

IBUPROFEN

Application Number

22348

Product Number

3

Dosage Form

-

Strength

800MG/200ML (4MG/ML)

Approval Date

2019-01-25

Regulatory Status

RX

2026
14 Apr
RX Application: 210449

Drug Name

CANAGLIFLOZIN

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2026-04-14

210449 / 1

Active Ingredient

CANAGLIFLOZIN

Application Number

210449

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2026-04-14

Regulatory Status

RX

2026
14 Apr
RX Application: 210449

Drug Name

CANAGLIFLOZIN

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2026-04-14

210449 / 2

Active Ingredient

CANAGLIFLOZIN

Application Number

210449

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2026-04-14

Regulatory Status

RX

2014
10 Jan
Discontinued Application: 202079

Drug Name

CANDESARTAN CILEXETIL

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2014-01-10

202079 / 1

Active Ingredient

CANDESARTAN CILEXETIL

Application Number

202079

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2014-01-10

Regulatory Status

Discontinued

2014
10 Jan
Discontinued Application: 202079

Drug Name

CANDESARTAN CILEXETIL

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

2014-01-10

202079 / 2

Active Ingredient

CANDESARTAN CILEXETIL

Application Number

202079

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

2014-01-10

Regulatory Status

Discontinued

2014
10 Jan
Discontinued Application: 202079

Drug Name

CANDESARTAN CILEXETIL

Product Number

3

Dosage Form

-

Strength

16MG

Approval Date

2014-01-10

202079 / 3

Active Ingredient

CANDESARTAN CILEXETIL

Application Number

202079

Product Number

3

Dosage Form

-

Strength

16MG

Approval Date

2014-01-10

Regulatory Status

Discontinued

2014
10 Jan
Discontinued Application: 202079

Drug Name

CANDESARTAN CILEXETIL

Product Number

4

Dosage Form

-

Strength

32MG

Approval Date

2014-01-10

202079 / 4

Active Ingredient

CANDESARTAN CILEXETIL

Application Number

202079

Product Number

4

Dosage Form

-

Strength

32MG

Approval Date

2014-01-10

Regulatory Status

Discontinued

2002
27 Feb
RX Application: 75948

Drug Name

CARBAMAZEPINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2002-02-27

75948 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

75948

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2002-02-27

Regulatory Status

RX

2024
08 Mar
Discontinued Application: 213159

Drug Name

CARBAMAZEPINE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2024-03-08

213159 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

213159

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2024-03-08

Regulatory Status

Discontinued

2024
08 Mar
Discontinued Application: 213159

Drug Name

CARBAMAZEPINE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2024-03-08

213159 / 2

Active Ingredient

CARBAMAZEPINE

Application Number

213159

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2024-03-08

Regulatory Status

Discontinued

2024
08 Mar
Discontinued Application: 213159

Drug Name

CARBAMAZEPINE

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2024-03-08

213159 / 3

Active Ingredient

CARBAMAZEPINE

Application Number

213159

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2024-03-08

Regulatory Status

Discontinued

2004
16 Jun
Discontinued Application: 76212

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

1

Dosage Form

-

Strength

25MG;100MG

Approval Date

2004-06-16

76212 / 1

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

76212

Product Number

1

Dosage Form

-

Strength

25MG;100MG

Approval Date

2004-06-16

Regulatory Status

Discontinued

2004
16 Jun
Discontinued Application: 76212

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

2

Dosage Form

-

Strength

50MG;200MG

Approval Date

2004-06-16

76212 / 2

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

76212

Product Number

2

Dosage Form

-

Strength

50MG;200MG

Approval Date

2004-06-16

Regulatory Status

Discontinued

2020
16 Mar
Discontinued Application: 209425

Drug Name

CARFILZOMIB

Product Number

1

Dosage Form

-

Strength

60MG/VIAL

Approval Date

2020-03-16

209425 / 1

Active Ingredient

CARFILZOMIB

Application Number

209425

Product Number

1

Dosage Form

-

Strength

60MG/VIAL

Approval Date

2020-03-16

Regulatory Status

Discontinued

2020
20 Mar
Discontinued Application: 211185

Drug Name

CARFILZOMIB

Product Number

1

Dosage Form

-

Strength

30MG/VIAL

Approval Date

2020-03-20

211185 / 1

Active Ingredient

CARFILZOMIB

Application Number

211185

Product Number

1

Dosage Form

-

Strength

30MG/VIAL

Approval Date

2020-03-20

Regulatory Status

Discontinued

2021
21 Sep
RX Application: 208075

Drug Name

CEFTAROLINE FOSAMIL

Product Number

1

Dosage Form

-

Strength

400MG/VIAL

Approval Date

2021-09-21

208075 / 1

Active Ingredient

CEFTAROLINE FOSAMIL

Application Number

208075

Product Number

1

Dosage Form

-

Strength

400MG/VIAL

Approval Date

2021-09-21

Regulatory Status

RX

2021
21 Sep
RX Application: 208075

Drug Name

CEFTAROLINE FOSAMIL

Product Number

2

Dosage Form

-

Strength

600MG/VIAL

Approval Date

2021-09-21

208075 / 2

Active Ingredient

CEFTAROLINE FOSAMIL

Application Number

208075

Product Number

2

Dosage Form

-

Strength

600MG/VIAL

Approval Date

2021-09-21

Regulatory Status

RX

2006
12 May
RX Application: 65180

Drug Name

CEFTRIAXONE

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2006-05-12

65180 / 1

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65180

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2006-05-12

Regulatory Status

RX

2002
02 Oct
Discontinued Application: 65069

Drug Name

CEFUROXIME AXETIL

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2002-10-02

65069 / 1

Active Ingredient

CEFUROXIME AXETIL

Application Number

65069

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2002-10-02

Regulatory Status

Discontinued

2002
02 Oct
Discontinued Application: 65069

Drug Name

CEFUROXIME AXETIL

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2002-10-02

65069 / 2

Active Ingredient

CEFUROXIME AXETIL

Application Number

65069

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2002-10-02

Regulatory Status

Discontinued

2015
02 Jun
RX Application: 204197

Drug Name

CELECOXIB

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2015-06-02

204197 / 1

Active Ingredient

CELECOXIB

Application Number

204197

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2015-06-02

Regulatory Status

RX

2015
02 Jun
RX Application: 204197

Drug Name

CELECOXIB

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2015-06-02

204197 / 2

Active Ingredient

CELECOXIB

Application Number

204197

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2015-06-02

Regulatory Status

RX

2015
02 Jun
RX Application: 204197

Drug Name

CELECOXIB

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2015-06-02

204197 / 3

Active Ingredient

CELECOXIB

Application Number

204197

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2015-06-02

Regulatory Status

RX

2016
12 Aug
Discontinued Application: 207235

Drug Name

CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2016-08-12

207235 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

207235

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2016-08-12

Regulatory Status

Discontinued

2004
10 Dec
RX Application: 77030

Drug Name

CILOSTAZOL

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-12-10

77030 / 1

Active Ingredient

CILOSTAZOL

Application Number

77030

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-12-10

Regulatory Status

RX

2004
10 Dec
RX Application: 77030

Drug Name

CILOSTAZOL

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2004-12-10

77030 / 2

Active Ingredient

CILOSTAZOL

Application Number

77030

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2004-12-10

Regulatory Status

RX

1998
19 Jun
Discontinued Application: 74948

Drug Name

CIMETIDINE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1998-06-19

74948 / 1

Active Ingredient

CIMETIDINE

Application Number

74948

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1998-06-19

Regulatory Status

Discontinued

2002
26 Jul
Discontinued Application: 74948

Drug Name

CIMETIDINE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2002-07-26

74948 / 2

Active Ingredient

CIMETIDINE

Application Number

74948

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2002-07-26

Regulatory Status

Discontinued

2004
24 Nov
Discontinued Application: 77046

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2004-11-24

77046 / 1

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

77046

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2004-11-24

Regulatory Status

Discontinued

2004
24 Nov
Discontinued Application: 77046

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2004-11-24

77046 / 2

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

77046

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2004-11-24

Regulatory Status

Discontinued

2004
24 Nov
Discontinued Application: 77046

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2004-11-24

77046 / 3

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

77046

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2004-11-24

Regulatory Status

Discontinued

2025
24 Nov
RX Application: 218425

Drug Name

CLADRIBINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2025-11-24

218425 / 1

Active Ingredient

CLADRIBINE

Application Number

218425

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2025-11-24

Regulatory Status

RX

2020
09 Jun
Discontinued Application: 209853

Drug Name

CLOBAZAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2020-06-09

209853 / 1

Active Ingredient

CLOBAZAM

Application Number

209853

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2020-06-09

Regulatory Status

Discontinued

2020
09 Jun
Discontinued Application: 209853

Drug Name

CLOBAZAM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2020-06-09

209853 / 2

Active Ingredient

CLOBAZAM

Application Number

209853

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2020-06-09

Regulatory Status

Discontinued

2018
17 Apr
Discontinued Application: 210446

Drug Name

CLOBETASOL PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2018-04-17

210446 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

210446

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2018-04-17

Regulatory Status

Discontinued

2024
19 Aug
Discontinued Application: 218745

Drug Name

CUPRIC SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 0.4MG COPPER/ML

Approval Date

2024-08-19

218745 / 1

Active Ingredient

CUPRIC SULFATE

Application Number

218745

Product Number

1

Dosage Form

-

Strength

EQ 0.4MG COPPER/ML

Approval Date

2024-08-19

Regulatory Status

Discontinued

2018
24 Jul
Discontinued Application: 206703

Drug Name

CYCLOBENZAPRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2018-07-24

206703 / 1

Active Ingredient

CYCLOBENZAPRINE HYDROCHLORIDE

Application Number

206703

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2018-07-24

Regulatory Status

Discontinued

2018
24 Jul
Discontinued Application: 206703

Drug Name

CYCLOBENZAPRINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2018-07-24

206703 / 2

Active Ingredient

CYCLOBENZAPRINE HYDROCHLORIDE

Application Number

206703

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2018-07-24

Regulatory Status

Discontinued

2002
09 May
RX Application: 65040

Drug Name

CYCLOSPORINE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2002-05-09

65040 / 1

Active Ingredient

CYCLOSPORINE

Application Number

65040

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2002-05-09

Regulatory Status

RX

2002
09 May
RX Application: 65040

Drug Name

CYCLOSPORINE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2002-05-09

65040 / 2

Active Ingredient

CYCLOSPORINE

Application Number

65040

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2002-05-09

Regulatory Status

RX

2023
12 Jan
Discontinued Application: 207606

Drug Name

CYCLOSPORINE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2023-01-12

207606 / 1

Active Ingredient

CYCLOSPORINE

Application Number

207606

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2023-01-12

Regulatory Status

Discontinued

2019
10 Jul
RX Application: 210721

Drug Name

CYCLOSPORINE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2019-07-10

210721 / 1

Active Ingredient

CYCLOSPORINE

Application Number

210721

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2019-07-10

Regulatory Status

RX

2019
10 Jul
RX Application: 210721

Drug Name

CYCLOSPORINE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2019-07-10

210721 / 2

Active Ingredient

CYCLOSPORINE

Application Number

210721

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2019-07-10

Regulatory Status

RX

2019
10 Jul
RX Application: 210721

Drug Name

CYCLOSPORINE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2019-07-10

210721 / 3

Active Ingredient

CYCLOSPORINE

Application Number

210721

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2019-07-10

Regulatory Status

RX

2023
15 Dec
RX Application: 208070

Drug Name

DABIGATRAN ETEXILATE MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2023-12-15

208070 / 1

Active Ingredient

DABIGATRAN ETEXILATE MESYLATE

Application Number

208070

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2023-12-15

Regulatory Status

RX

2023
15 Dec
RX Application: 208070

Drug Name

DABIGATRAN ETEXILATE MESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 110MG BASE

Approval Date

2023-12-15

208070 / 2

Active Ingredient

DABIGATRAN ETEXILATE MESYLATE

Application Number

208070

Product Number

2

Dosage Form

-

Strength

EQ 110MG BASE

Approval Date

2023-12-15

Regulatory Status

RX

2023
15 Dec
RX Application: 208070

Drug Name

DABIGATRAN ETEXILATE MESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2023-12-15

208070 / 3

Active Ingredient

DABIGATRAN ETEXILATE MESYLATE

Application Number

208070

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2023-12-15

Regulatory Status

RX

2016
10 Jun
RX Application: 202103

Drug Name

DASATINIB

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2016-06-10

202103 / 1

Active Ingredient

DASATINIB

Application Number

202103

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2016-06-10

Regulatory Status

RX

2016
10 Jun
RX Application: 202103

Drug Name

DASATINIB

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2016-06-10

202103 / 2

Active Ingredient

DASATINIB

Application Number

202103

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2016-06-10

Regulatory Status

RX

2016
10 Jun
RX Application: 202103

Drug Name

DASATINIB

Product Number

3

Dosage Form

-

Strength

70MG

Approval Date

2016-06-10

202103 / 3

Active Ingredient

DASATINIB

Application Number

202103

Product Number

3

Dosage Form

-

Strength

70MG

Approval Date

2016-06-10

Regulatory Status

RX

2016
10 Jun
RX Application: 202103

Drug Name

DASATINIB

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2016-06-10

202103 / 4

Active Ingredient

DASATINIB

Application Number

202103

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2016-06-10

Regulatory Status

RX

2021
23 Nov
RX Application: 203180

Drug Name

DASATINIB

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

2021-11-23

203180 / 1

Active Ingredient

DASATINIB

Application Number

203180

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

2021-11-23

Regulatory Status

RX

2021
23 Nov
RX Application: 203180

Drug Name

DASATINIB

Product Number

2

Dosage Form

-

Strength

140MG

Approval Date

2021-11-23

203180 / 2

Active Ingredient

DASATINIB

Application Number

203180

Product Number

2

Dosage Form

-

Strength

140MG

Approval Date

2021-11-23

Regulatory Status

RX

2006
07 Mar
RX Application: 77414

Drug Name

DESMOPRESSIN ACETATE

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2006-03-07

77414 / 1

Active Ingredient

DESMOPRESSIN ACETATE

Application Number

77414

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2006-03-07

Regulatory Status

RX

2006
07 Mar
RX Application: 77414

Drug Name

DESMOPRESSIN ACETATE

Product Number

2

Dosage Form

-

Strength

0.2MG

Approval Date

2006-03-07

77414 / 2

Active Ingredient

DESMOPRESSIN ACETATE

Application Number

77414

Product Number

2

Dosage Form

-

Strength

0.2MG

Approval Date

2006-03-07

Regulatory Status

RX

2005
27 Jan
RX Application: 76703

Drug Name

DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)

Product Number

1

Dosage Form

-

Strength

0.01MG/SPRAY

Approval Date

2005-01-27

76703 / 1

Active Ingredient

DESMOPRESSIN ACETATE

Application Number

76703

Product Number

1

Dosage Form

-

Strength

0.01MG/SPRAY

Approval Date

2005-01-27

Regulatory Status

RX

2023
23 Aug
RX Application: 217695

Drug Name

DEXAMETHASONE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2023-08-23

217695 / 1

Active Ingredient

DEXAMETHASONE

Application Number

217695

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2023-08-23

Regulatory Status

RX

2023
23 Aug
RX Application: 217695

Drug Name

DEXAMETHASONE

Product Number

2

Dosage Form

-

Strength

0.75MG

Approval Date

2023-08-23

217695 / 2

Active Ingredient

DEXAMETHASONE

Application Number

217695

Product Number

2

Dosage Form

-

Strength

0.75MG

Approval Date

2023-08-23

Regulatory Status

RX

2023
23 Aug
RX Application: 217695

Drug Name

DEXAMETHASONE

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2023-08-23

217695 / 3

Active Ingredient

DEXAMETHASONE

Application Number

217695

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2023-08-23

Regulatory Status

RX

2023
23 Aug
RX Application: 217695

Drug Name

DEXAMETHASONE

Product Number

4

Dosage Form

-

Strength

1.5MG

Approval Date

2023-08-23

217695 / 4

Active Ingredient

DEXAMETHASONE

Application Number

217695

Product Number

4

Dosage Form

-

Strength

1.5MG

Approval Date

2023-08-23

Regulatory Status

RX

2023
23 Aug
RX Application: 217695

Drug Name

DEXAMETHASONE

Product Number

5

Dosage Form

-

Strength

2MG

Approval Date

2023-08-23

217695 / 5

Active Ingredient

DEXAMETHASONE

Application Number

217695

Product Number

5

Dosage Form

-

Strength

2MG

Approval Date

2023-08-23

Regulatory Status

RX

2023
23 Aug
RX Application: 217695

Drug Name

DEXAMETHASONE

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2023-08-23

217695 / 6

Active Ingredient

DEXAMETHASONE

Application Number

217695

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2023-08-23

Regulatory Status

RX

2023
23 Aug
RX Application: 217695

Drug Name

DEXAMETHASONE

Product Number

7

Dosage Form

-

Strength

6MG

Approval Date

2023-08-23

217695 / 7

Active Ingredient

DEXAMETHASONE

Application Number

217695

Product Number

7

Dosage Form

-

Strength

6MG

Approval Date

2023-08-23

Regulatory Status

RX

2014
27 May
Discontinued Application: 202027

Drug Name

DICLOFENAC SODIUM

Product Number

1

Dosage Form

-

Strength

1.5%

Approval Date

2014-05-27

202027 / 1

Active Ingredient

DICLOFENAC SODIUM

Application Number

202027

Product Number

1

Dosage Form

-

Strength

1.5%

Approval Date

2014-05-27

Regulatory Status

Discontinued

2022
06 May
RX Application: 207714

Drug Name

DICLOFENAC SODIUM

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2022-05-06

207714 / 1

Active Ingredient

DICLOFENAC SODIUM

Application Number

207714

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2022-05-06

Regulatory Status

RX

2004
20 May
Discontinued Application: 76151

Drug Name

DILT-CD

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2004-05-20

76151 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

76151

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2004-05-20

Regulatory Status

Discontinued

2004
20 May
Discontinued Application: 76151

Drug Name

DILT-CD

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2004-05-20

76151 / 2

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

76151

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2004-05-20

Regulatory Status

Discontinued

2004
20 May
Discontinued Application: 76151

Drug Name

DILT-CD

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

2004-05-20

76151 / 3

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

76151

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

2004-05-20

Regulatory Status

Discontinued

2004
20 May
Discontinued Application: 76151

Drug Name

DILT-CD

Product Number

4

Dosage Form

-

Strength

300MG

Approval Date

2004-05-20

76151 / 4

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

76151

Product Number

4

Dosage Form

-

Strength

300MG

Approval Date

2004-05-20

Regulatory Status

Discontinued

1998
06 Aug
RX Application: 74943

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

240MG

Approval Date

1998-08-06

74943 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

74943

Product Number

1

Dosage Form

-

Strength

240MG

Approval Date

1998-08-06

Regulatory Status

RX

2000
19 Dec
RX Application: 74943

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2000-12-19

74943 / 2

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

74943

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2000-12-19

Regulatory Status

RX

2000
19 Dec
RX Application: 74943

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

2000-12-19

74943 / 3

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

74943

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

2000-12-19

Regulatory Status

RX

2006
01 Feb
Discontinued Application: 76395

Drug Name

DILTZAC

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2006-02-01

76395 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

76395

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2006-02-01

Regulatory Status

Discontinued

2006
01 Feb
Discontinued Application: 76395

Drug Name

DILTZAC

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2006-02-01

76395 / 2

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

76395

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2006-02-01

Regulatory Status

Discontinued

2006
01 Feb
Discontinued Application: 76395

Drug Name

DILTZAC

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

2006-02-01

76395 / 3

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

76395

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

2006-02-01

Regulatory Status

Discontinued

2006
01 Feb
Discontinued Application: 76395

Drug Name

DILTZAC

Product Number

4

Dosage Form

-

Strength

300MG

Approval Date

2006-02-01

76395 / 4

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

76395

Product Number

4

Dosage Form

-

Strength

300MG

Approval Date

2006-02-01

Regulatory Status

Discontinued

2006
01 Feb
Discontinued Application: 76395

Drug Name

DILTZAC

Product Number

5

Dosage Form

-

Strength

360MG

Approval Date

2006-02-01

76395 / 5

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

76395

Product Number

5

Dosage Form

-

Strength

360MG

Approval Date

2006-02-01

Regulatory Status

Discontinued

2008
29 Jul
Discontinued Application: 77615

Drug Name

DIVALPROEX SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

2008-07-29

77615 / 1

Active Ingredient

DIVALPROEX SODIUM

Application Number

77615

Product Number

1

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

2008-07-29

Regulatory Status

Discontinued

2008
29 Jul
Discontinued Application: 77615

Drug Name

DIVALPROEX SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

2008-07-29

77615 / 2

Active Ingredient

DIVALPROEX SODIUM

Application Number

77615

Product Number

2

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

2008-07-29

Regulatory Status

Discontinued

2008
29 Jul
Discontinued Application: 77615

Drug Name

DIVALPROEX SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 125MG VALPROIC ACID

Approval Date

2008-07-29

77615 / 3

Active Ingredient

DIVALPROEX SODIUM

Application Number

77615

Product Number

3

Dosage Form

-

Strength

EQ 125MG VALPROIC ACID

Approval Date

2008-07-29

Regulatory Status

Discontinued

2011
02 Jun
Discontinued Application: 78841

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-06-02

78841 / 1

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

78841

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-06-02

Regulatory Status

Discontinued

2011
02 Jun
Discontinued Application: 78841

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-06-02

78841 / 2

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

78841

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-06-02

Regulatory Status

Discontinued

2000
18 Oct
RX Application: 75580

Drug Name

DOXAZOSIN MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2000-10-18

75580 / 1

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

75580

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2000-10-18

Regulatory Status

RX

2000
18 Oct
RX Application: 75580

Drug Name

DOXAZOSIN MESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2000-10-18

75580 / 2

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

75580

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2000-10-18

Regulatory Status

RX

2000
18 Oct
RX Application: 75580

Drug Name

DOXAZOSIN MESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2000-10-18

75580 / 3

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

75580

Product Number

3

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2000-10-18

Regulatory Status

RX

2000
18 Oct
RX Application: 75580

Drug Name

DOXAZOSIN MESYLATE

Product Number

4

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2000-10-18

75580 / 4

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

75580

Product Number

4

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2000-10-18

Regulatory Status

RX

2024
11 Jul
RX Application: 217170

Drug Name

DOXYCYCLINE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2024-07-11

217170 / 1

Active Ingredient

DOXYCYCLINE

Application Number

217170

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2024-07-11

Regulatory Status

RX

2019
15 Apr
Discontinued Application: 209243

Drug Name

DOXYCYCLINE HYCLATE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2019-04-15

209243 / 1

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

209243

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2019-04-15

Regulatory Status

Discontinued

2019
15 Apr
Discontinued Application: 209243

Drug Name

DOXYCYCLINE HYCLATE

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2019-04-15

209243 / 2

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

209243

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2019-04-15

Regulatory Status

Discontinued

2016
21 Sep
Discontinued Application: 205876

Drug Name

DROSPIRENONE AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

3MG;0.03MG

Approval Date

2016-09-21

205876 / 1

Active Ingredient

DROSPIRENONE; ETHINYL ESTRADIOL

Application Number

205876

Product Number

1

Dosage Form

-

Strength

3MG;0.03MG

Approval Date

2016-09-21

Regulatory Status

Discontinued

2014
11 Jun
Discontinued Application: 202045

Drug Name

DULOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2014-06-11

202045 / 1

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

202045

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2014-06-11

Regulatory Status

Discontinued

2014
11 Jun
Discontinued Application: 202045

Drug Name

DULOXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2014-06-11

202045 / 2

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

202045

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2014-06-11

Regulatory Status

Discontinued

2014
11 Jun
Discontinued Application: 202045

Drug Name

DULOXETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2014-06-11

202045 / 3

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

202045

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2014-06-11

Regulatory Status

Discontinued

2015
24 Nov
Discontinued Application: 204292

Drug Name

DUTASTERIDE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2015-11-24

204292 / 1

Active Ingredient

DUTASTERIDE

Application Number

204292

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2015-11-24

Regulatory Status

Discontinued

2024
10 Jul
Discontinued Application: 212425

Drug Name

ELIGLUSTAT TARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 84MG BASE

Approval Date

2024-07-10

212425 / 1

Active Ingredient

ELIGLUSTAT TARTRATE

Application Number

212425

Product Number

1

Dosage Form

-

Strength

EQ 84MG BASE

Approval Date

2024-07-10

Regulatory Status

Discontinued

2024
17 May
Discontinued Application: 214053

Drug Name

EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE

Product Number

1

Dosage Form

-

Strength

120MG;EQ 15MG BASE

Approval Date

2024-05-17

214053 / 1

Active Ingredient

EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Application Number

214053

Product Number

1

Dosage Form

-

Strength

120MG;EQ 15MG BASE

Approval Date

2024-05-17

Regulatory Status

Discontinued

2024
17 May
Discontinued Application: 214053

Drug Name

EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE

Product Number

2

Dosage Form

-

Strength

200MG;EQ 25MG BASE

Approval Date

2024-05-17

214053 / 2

Active Ingredient

EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Application Number

214053

Product Number

2

Dosage Form

-

Strength

200MG;EQ 25MG BASE

Approval Date

2024-05-17

Regulatory Status

Discontinued

2021
16 Jun
Discontinued Application: 208740

Drug Name

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Product Number

1

Dosage Form

-

Strength

200MG;300MG

Approval Date

2021-06-16

208740 / 1

Active Ingredient

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Application Number

208740

Product Number

1

Dosage Form

-

Strength

200MG;300MG

Approval Date

2021-06-16

Regulatory Status

Discontinued

2026
30 Jan
Discontinued Application: 214095

Drug Name

EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE

Product Number

1

Dosage Form

-

Strength

200MG;EQ 25MG BASE;EQ 25MG BASE

Approval Date

2026-01-30

214095 / 1

Active Ingredient

EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE

Application Number

214095

Product Number

1

Dosage Form

-

Strength

200MG;EQ 25MG BASE;EQ 25MG BASE

Approval Date

2026-01-30

Regulatory Status

Discontinued

2022
22 Apr
Discontinued Application: 209645

Drug Name

ENZALUTAMIDE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2022-04-22

209645 / 1

Active Ingredient

ENZALUTAMIDE

Application Number

209645

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2022-04-22

Regulatory Status

Discontinued

2011
31 Oct
Discontinued Application: 90919

Drug Name

EPINASTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2011-10-31

90919 / 1

Active Ingredient

EPINASTINE HYDROCHLORIDE

Application Number

90919

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2011-10-31

Regulatory Status

Discontinued

2019
05 Nov
Discontinued Application: 208396

Drug Name

ERLOTINIB HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2019-11-05

208396 / 1

Active Ingredient

ERLOTINIB HYDROCHLORIDE

Application Number

208396

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2019-11-05

Regulatory Status

Discontinued

2019
05 Nov
Discontinued Application: 208396

Drug Name

ERLOTINIB HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2019-11-05

208396 / 2

Active Ingredient

ERLOTINIB HYDROCHLORIDE

Application Number

208396

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2019-11-05

Regulatory Status

Discontinued

2019
05 Nov
Discontinued Application: 208396

Drug Name

ERLOTINIB HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2019-11-05

208396 / 3

Active Ingredient

ERLOTINIB HYDROCHLORIDE

Application Number

208396

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2019-11-05

Regulatory Status

Discontinued

2023
07 Dec
RX Application: 211236

Drug Name

ESLICARBAZEPINE ACETATE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2023-12-07

211236 / 1

Active Ingredient

ESLICARBAZEPINE ACETATE

Application Number

211236

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2023-12-07

Regulatory Status

RX

2023
07 Dec
RX Application: 211236

Drug Name

ESLICARBAZEPINE ACETATE

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

2023-12-07

211236 / 2

Active Ingredient

ESLICARBAZEPINE ACETATE

Application Number

211236

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

2023-12-07

Regulatory Status

RX

2023
07 Dec
RX Application: 211236

Drug Name

ESLICARBAZEPINE ACETATE

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2023-12-07

211236 / 3

Active Ingredient

ESLICARBAZEPINE ACETATE

Application Number

211236

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2023-12-07

Regulatory Status

RX

2023
07 Dec
RX Application: 211236

Drug Name

ESLICARBAZEPINE ACETATE

Product Number

4

Dosage Form

-

Strength

800MG

Approval Date

2023-12-07

211236 / 4

Active Ingredient

ESLICARBAZEPINE ACETATE

Application Number

211236

Product Number

4

Dosage Form

-

Strength

800MG

Approval Date

2023-12-07

Regulatory Status

RX

2000
28 Jul
RX Application: 75419

Drug Name

ETODOLAC

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2000-07-28

75419 / 1

Active Ingredient

ETODOLAC

Application Number

75419

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2000-07-28

Regulatory Status

RX

2000
28 Jul
RX Application: 75419

Drug Name

ETODOLAC

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2000-07-28

75419 / 2

Active Ingredient

ETODOLAC

Application Number

75419

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2000-07-28

Regulatory Status

RX

2002
03 Dec
RX Application: 76004

Drug Name

ETODOLAC

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2002-12-03

76004 / 1

Active Ingredient

ETODOLAC

Application Number

76004

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2002-12-03

Regulatory Status

RX

2002
03 Dec
RX Application: 76004

Drug Name

ETODOLAC

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2002-12-03

76004 / 2

Active Ingredient

ETODOLAC

Application Number

76004

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2002-12-03

Regulatory Status

RX

2026
01 May
RX Application: 220837

Drug Name

EVDI

Product Number

1

Dosage Form

-

Strength

1MG/20ML (0.05MG/ML)

Approval Date

2026-05-01

220837 / 1

Active Ingredient

TRABECTEDIN

Application Number

220837

Product Number

1

Dosage Form

-

Strength

1MG/20ML (0.05MG/ML)

Approval Date

2026-05-01

Regulatory Status

RX

2026
12 May
RX Application: 218488

Drug Name

EVEROLIMUS

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2026-05-12

218488 / 1

Active Ingredient

EVEROLIMUS

Application Number

218488

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2026-05-12

Regulatory Status

RX

2026
12 May
RX Application: 218488

Drug Name

EVEROLIMUS

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2026-05-12

218488 / 2

Active Ingredient

EVEROLIMUS

Application Number

218488

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2026-05-12

Regulatory Status

RX

2026
12 May
RX Application: 218488

Drug Name

EVEROLIMUS

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

2026-05-12

218488 / 3

Active Ingredient

EVEROLIMUS

Application Number

218488

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

2026-05-12

Regulatory Status

RX

2026
12 May
RX Application: 218488

Drug Name

EVEROLIMUS

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2026-05-12

218488 / 4

Active Ingredient

EVEROLIMUS

Application Number

218488

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2026-05-12

Regulatory Status

RX

2017
12 Jun
Discontinued Application: 208332

Drug Name

EZETIMIBE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2017-06-12

208332 / 1

Active Ingredient

EZETIMIBE

Application Number

208332

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2017-06-12

Regulatory Status

Discontinued

2011
22 Jul
Discontinued Application: 91480

Drug Name

FAMCICLOVIR

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2011-07-22

91480 / 1

Active Ingredient

FAMCICLOVIR

Application Number

91480

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2011-07-22

Regulatory Status

Discontinued

2011
22 Jul
Discontinued Application: 91480

Drug Name

FAMCICLOVIR

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2011-07-22

91480 / 2

Active Ingredient

FAMCICLOVIR

Application Number

91480

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2011-07-22

Regulatory Status

Discontinued

2011
22 Jul
Discontinued Application: 91480

Drug Name

FAMCICLOVIR

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2011-07-22

91480 / 3

Active Ingredient

FAMCICLOVIR

Application Number

91480

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2011-07-22

Regulatory Status

Discontinued

2002
12 Mar
Discontinued Application: 75610

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2002-03-12

75610 / 1

Active Ingredient

FAMOTIDINE

Application Number

75610

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2002-03-12

Regulatory Status

Discontinued

2001
23 Jul
Discontinued Application: 75611

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2001-07-23

75611 / 1

Active Ingredient

FAMOTIDINE

Application Number

75611

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2001-07-23

Regulatory Status

Discontinued

2001
23 Jul
Discontinued Application: 75611

Drug Name

FAMOTIDINE

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2001-07-23

75611 / 2

Active Ingredient

FAMOTIDINE

Application Number

75611

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2001-07-23

Regulatory Status

Discontinued

2013
26 Jul
RX Application: 202252

Drug Name

FENOFIBRATE (MICRONIZED)

Product Number

1

Dosage Form

-

Strength

43MG

Approval Date

2013-07-26

202252 / 1

Active Ingredient

FENOFIBRATE

Application Number

202252

Product Number

1

Dosage Form

-

Strength

43MG

Approval Date

2013-07-26

Regulatory Status

RX

2013
26 Jul
RX Application: 202252

Drug Name

FENOFIBRATE (MICRONIZED)

Product Number

2

Dosage Form

-

Strength

130MG

Approval Date

2013-07-26

202252 / 2

Active Ingredient

FENOFIBRATE

Application Number

202252

Product Number

2

Dosage Form

-

Strength

130MG

Approval Date

2013-07-26

Regulatory Status

RX

2026
02 Feb
RX Application: 219559

Drug Name

FIDAXOMICIN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2026-02-02

219559 / 1

Active Ingredient

FIDAXOMICIN

Application Number

219559

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2026-02-02

Regulatory Status

RX

2020
18 Dec
RX Application: 207993

Drug Name

FINGOLIMOD HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2020-12-18

207993 / 1

Active Ingredient

FINGOLIMOD HYDROCHLORIDE

Application Number

207993

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2020-12-18

Regulatory Status

RX

2007
09 Aug
Discontinued Application: 77436

Drug Name

FLUNISOLIDE

Product Number

1

Dosage Form

-

Strength

0.029MG/SPRAY

Approval Date

2007-08-09

77436 / 1

Active Ingredient

FLUNISOLIDE

Application Number

77436

Product Number

1

Dosage Form

-

Strength

0.029MG/SPRAY

Approval Date

2007-08-09

Regulatory Status

Discontinued

2022
15 Jul
Discontinued Application: 216649

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2022-07-15

216649 / 1

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

216649

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2022-07-15

Regulatory Status

Discontinued

2022
15 Jul
Discontinued Application: 216649

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2022-07-15

216649 / 2

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

216649

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2022-07-15

Regulatory Status

Discontinued

2022
15 Jul
Discontinued Application: 216649

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2022-07-15

216649 / 3

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

216649

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2022-07-15

Regulatory Status

Discontinued

2022
15 Jul
Discontinued Application: 216649

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2022-07-15

216649 / 4

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

216649

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2022-07-15

Regulatory Status

Discontinued

2007
12 Sep
RX Application: 77538

Drug Name

FLUTICASONE PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2007-09-12

77538 / 1

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

77538

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2007-09-12

Regulatory Status

RX

2016
29 Feb
OTC Application: 208150

Drug Name

FLUTICASONE PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2016-02-29

208150 / 1

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

208150

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2016-02-29

Regulatory Status

OTC

2001
07 May
RX Application: 75902

Drug Name

FLUVOXAMINE MALEATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2001-05-07

75902 / 1

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

75902

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2001-05-07

Regulatory Status

RX

2001
07 May
RX Application: 75902

Drug Name

FLUVOXAMINE MALEATE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2001-05-07

75902 / 2

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

75902

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2001-05-07

Regulatory Status

RX

2001
07 May
RX Application: 75902

Drug Name

FLUVOXAMINE MALEATE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2001-05-07

75902 / 3

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

75902

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2001-05-07

Regulatory Status

RX

2019
05 Sep
Discontinued Application: 205020

Drug Name

FOSAPREPITANT DIMEGLUMINE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/VIAL

Approval Date

2019-09-05

205020 / 1

Active Ingredient

FOSAPREPITANT DIMEGLUMINE

Application Number

205020

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/VIAL

Approval Date

2019-09-05

Regulatory Status

Discontinued

2005
17 May
Discontinued Application: 76906

Drug Name

FOSINOPRIL SODIUM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2005-05-17

76906 / 1

Active Ingredient

FOSINOPRIL SODIUM

Application Number

76906

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2005-05-17

Regulatory Status

Discontinued

2005
17 May
Discontinued Application: 76906

Drug Name

FOSINOPRIL SODIUM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2005-05-17

76906 / 2

Active Ingredient

FOSINOPRIL SODIUM

Application Number

76906

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2005-05-17

Regulatory Status

Discontinued

2005
17 May
Discontinued Application: 76906

Drug Name

FOSINOPRIL SODIUM

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2005-05-17

76906 / 3

Active Ingredient

FOSINOPRIL SODIUM

Application Number

76906

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2005-05-17

Regulatory Status

Discontinued

2021
11 Jun
Discontinued Application: 211730

Drug Name

FULVESTRANT

Product Number

1

Dosage Form

-

Strength

250MG/5ML (50MG/ML)

Approval Date

2021-06-11

211730 / 1

Active Ingredient

FULVESTRANT

Application Number

211730

Product Number

1

Dosage Form

-

Strength

250MG/5ML (50MG/ML)

Approval Date

2021-06-11

Regulatory Status

Discontinued

2007
22 Mar
RX Application: 77941

Drug Name

FUROSEMIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2007-03-22

77941 / 1

Active Ingredient

FUROSEMIDE

Application Number

77941

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2007-03-22

Regulatory Status

RX

2006
10 Oct
Discontinued Application: 77894

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2006-10-10

77894 / 1

Active Ingredient

GABAPENTIN

Application Number

77894

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2006-10-10

Regulatory Status

Discontinued

2006
10 Oct
Discontinued Application: 77894

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2006-10-10

77894 / 2

Active Ingredient

GABAPENTIN

Application Number

77894

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2006-10-10

Regulatory Status

Discontinued

2006
10 Oct
Discontinued Application: 77894

Drug Name

GABAPENTIN

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2006-10-10

77894 / 3

Active Ingredient

GABAPENTIN

Application Number

77894

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2006-10-10

Regulatory Status

Discontinued

2022
23 Sep
Discontinued Application: 209532

Drug Name

GEFITINIB

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2022-09-23

209532 / 1

Active Ingredient

GEFITINIB

Application Number

209532

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2022-09-23

Regulatory Status

Discontinued

2017
23 May
Discontinued Application: 206776

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

200MG/5.26ML (38MG/ML)

Approval Date

2017-05-23

206776 / 1

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

206776

Product Number

1

Dosage Form

-

Strength

200MG/5.26ML (38MG/ML)

Approval Date

2017-05-23

Regulatory Status

Discontinued

2017
23 May
Discontinued Application: 206776

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

1GM/26.3ML (38MG/ML)

Approval Date

2017-05-23

206776 / 2

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

206776

Product Number

2

Dosage Form

-

Strength

1GM/26.3ML (38MG/ML)

Approval Date

2017-05-23

Regulatory Status

Discontinued

2017
23 May
Discontinued Application: 206776

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

2GM/52.6ML (38MG/ML)

Approval Date

2017-05-23

206776 / 3

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

206776

Product Number

3

Dosage Form

-

Strength

2GM/52.6ML (38MG/ML)

Approval Date

2017-05-23

Regulatory Status

Discontinued

1998
20 Jul
Discontinued Application: 75034

Drug Name

GEMFIBROZIL

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

1998-07-20

75034 / 1

Active Ingredient

GEMFIBROZIL

Application Number

75034

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

1998-07-20

Regulatory Status

Discontinued

2001
13 Jun
RX Application: 75795

Drug Name

GLIPIZIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2001-06-13

75795 / 1

Active Ingredient

GLIPIZIDE

Application Number

75795

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2001-06-13

Regulatory Status

RX

2001
13 Jun
RX Application: 75795

Drug Name

GLIPIZIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2001-06-13

75795 / 2

Active Ingredient

GLIPIZIDE

Application Number

75795

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2001-06-13

Regulatory Status

RX

2019
29 Oct
Discontinued Application: 210246

Drug Name

GLYCOPYRROLATE

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2019-10-29

210246 / 1

Active Ingredient

GLYCOPYRROLATE

Application Number

210246

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2019-10-29

Regulatory Status

Discontinued

2018
25 Jul
RX Application: 205430

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2018-07-25

205430 / 1

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

205430

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2018-07-25

Regulatory Status

RX

2018
25 Jul
RX Application: 205430

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2018-07-25

205430 / 2

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

205430

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2018-07-25

Regulatory Status

RX

2018
25 Jul
RX Application: 205430

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2018-07-25

205430 / 3

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

205430

Product Number

3

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2018-07-25

Regulatory Status

RX

2018
25 Jul
RX Application: 205430

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2018-07-25

205430 / 4

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

205430

Product Number

4

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2018-07-25

Regulatory Status

RX

2007
03 Oct
Discontinued Application: 40774

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2007-10-03

40774 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

40774

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2007-10-03

Regulatory Status

Discontinued

2007
03 Oct
Discontinued Application: 40774

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2007-10-03

40774 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

40774

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2007-10-03

Regulatory Status

Discontinued

2008
16 May
Discontinued Application: 78389

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2008-05-16

78389 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

78389

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2008-05-16

Regulatory Status

Discontinued

2026
05 Feb
RX Application: 219856

Drug Name

HYDROCORTISONE SODIUM SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2026-02-05

219856 / 1

Active Ingredient

HYDROCORTISONE SODIUM SUCCINATE

Application Number

219856

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2026-02-05

Regulatory Status

RX

2015
16 Oct
RX Application: 204222

Drug Name

IBANDRONATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 3MG BASE/3ML

Approval Date

2015-10-16

204222 / 1

Active Ingredient

IBANDRONATE SODIUM

Application Number

204222

Product Number

1

Dosage Form

-

Strength

EQ 3MG BASE/3ML

Approval Date

2015-10-16

Regulatory Status

RX

2021
30 Jun
RX Application: 209437

Drug Name

ICOSAPENT ETHYL

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2021-06-30

209437 / 1

Active Ingredient

ICOSAPENT ETHYL

Application Number

209437

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2021-06-30

Regulatory Status

RX

2016
05 Aug
RX Application: 79179

Drug Name

IMATINIB MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2016-08-05

79179 / 1

Active Ingredient

IMATINIB MESYLATE

Application Number

79179

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2016-08-05

Regulatory Status

RX

2016
05 Aug
RX Application: 79179

Drug Name

IMATINIB MESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2016-08-05

79179 / 2

Active Ingredient

IMATINIB MESYLATE

Application Number

79179

Product Number

2

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2016-08-05

Regulatory Status

RX

2019
02 Aug
Discontinued Application: 208481

Drug Name

ITRACONAZOLE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2019-08-02

208481 / 1

Active Ingredient

ITRACONAZOLE

Application Number

208481

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2019-08-02

Regulatory Status

Discontinued

2023
18 Aug
RX Application: 217110

Drug Name

IVRA

Product Number

1

Dosage Form

-

Strength

EQ 90MG BASE/ML (EQ 90MG BASE/ML)

Approval Date

2023-08-18

217110 / 1

Active Ingredient

MELPHALAN HYDROCHLORIDE

Application Number

217110

Product Number

1

Dosage Form

-

Strength

EQ 90MG BASE/ML (EQ 90MG BASE/ML)

Approval Date

2023-08-18

Regulatory Status

RX

2009
05 Nov
RX Application: 76109

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2009-11-05

76109 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

76109

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2009-11-05

Regulatory Status

RX

2009
05 Nov
Discontinued Application: 77308

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

0.4%

Approval Date

2009-11-05

77308 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

77308

Product Number

1

Dosage Form

-

Strength

0.4%

Approval Date

2009-11-05

Regulatory Status

Discontinued

2007
27 Mar
RX Application: 77942

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

15MG/ML

Approval Date

2007-03-27

77942 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

77942

Product Number

1

Dosage Form

-

Strength

15MG/ML

Approval Date

2007-03-27

Regulatory Status

RX

2007
27 Mar
RX Application: 77942

Drug Name

KETOROLAC TROMETHAMINE

Product Number

2

Dosage Form

-

Strength

30MG/ML

Approval Date

2007-03-27

77942 / 2

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

77942

Product Number

2

Dosage Form

-

Strength

30MG/ML

Approval Date

2007-03-27

Regulatory Status

RX

2022
26 Sep
Discontinued Application: 206355

Drug Name

LACOSAMIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2022-09-26

206355 / 1

Active Ingredient

LACOSAMIDE

Application Number

206355

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2022-09-26

Regulatory Status

Discontinued

2022
23 Sep
Discontinued Application: 214567

Drug Name

LACOSAMIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2022-09-23

214567 / 1

Active Ingredient

LACOSAMIDE

Application Number

214567

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2022-09-23

Regulatory Status

Discontinued

2022
23 Sep
Discontinued Application: 214567

Drug Name

LACOSAMIDE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2022-09-23

214567 / 2

Active Ingredient

LACOSAMIDE

Application Number

214567

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2022-09-23

Regulatory Status

Discontinued

2022
23 Sep
Discontinued Application: 214567

Drug Name

LACOSAMIDE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2022-09-23

214567 / 3

Active Ingredient

LACOSAMIDE

Application Number

214567

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2022-09-23

Regulatory Status

Discontinued

2022
23 Sep
Discontinued Application: 214567

Drug Name

LACOSAMIDE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2022-09-23

214567 / 4

Active Ingredient

LACOSAMIDE

Application Number

214567

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2022-09-23

Regulatory Status

Discontinued

2023
13 Nov
RX Application: 216670

Drug Name

LACOSAMIDE

Product Number

1

Dosage Form

-

Strength

200MG/20ML (10MG/ML)

Approval Date

2023-11-13

216670 / 1

Active Ingredient

LACOSAMIDE

Application Number

216670

Product Number

1

Dosage Form

-

Strength

200MG/20ML (10MG/ML)

Approval Date

2023-11-13

Regulatory Status

RX

1997
10 Dec
RX Application: 74712

Drug Name

LACTULOSE

Product Number

1

Dosage Form

-

Strength

10GM/PACKET

Approval Date

1997-12-10

74712 / 1

Active Ingredient

LACTULOSE

Application Number

74712

Product Number

1

Dosage Form

-

Strength

10GM/PACKET

Approval Date

1997-12-10

Regulatory Status

RX

1997
10 Dec
RX Application: 74712

Drug Name

LACTULOSE

Product Number

2

Dosage Form

-

Strength

20GM/PACKET

Approval Date

1997-12-10

74712 / 2

Active Ingredient

LACTULOSE

Application Number

74712

Product Number

2

Dosage Form

-

Strength

20GM/PACKET

Approval Date

1997-12-10

Regulatory Status

RX

2011
02 Dec
RX Application: 91606

Drug Name

LAMIVUDINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2011-12-02

91606 / 1

Active Ingredient

LAMIVUDINE

Application Number

91606

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2011-12-02

Regulatory Status

RX

2011
02 Dec
RX Application: 91606

Drug Name

LAMIVUDINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2011-12-02

91606 / 2

Active Ingredient

LAMIVUDINE

Application Number

91606

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2011-12-02

Regulatory Status

RX

2014
02 Jan
RX Application: 202941

Drug Name

LAMIVUDINE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2014-01-02

202941 / 1

Active Ingredient

LAMIVUDINE

Application Number

202941

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2014-01-02

Regulatory Status

RX

2012
14 Sep
RX Application: 202176

Drug Name

LANSOPRAZOLE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2012-09-14

202176 / 1

Active Ingredient

LANSOPRAZOLE

Application Number

202176

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2012-09-14

Regulatory Status

RX

2012
14 Sep
RX Application: 202176

Drug Name

LANSOPRAZOLE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2012-09-14

202176 / 2

Active Ingredient

LANSOPRAZOLE

Application Number

202176

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2012-09-14

Regulatory Status

RX

2005
13 Sep
RX Application: 77090

Drug Name

LEFLUNOMIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2005-09-13

77090 / 1

Active Ingredient

LEFLUNOMIDE

Application Number

77090

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2005-09-13

Regulatory Status

RX

2005
13 Sep
RX Application: 77090

Drug Name

LEFLUNOMIDE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2005-09-13

77090 / 2

Active Ingredient

LEFLUNOMIDE

Application Number

77090

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2005-09-13

Regulatory Status

RX

2022
30 Aug
RX Application: 211022

Drug Name

LENALIDOMIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2022-08-30

211022 / 1

Active Ingredient

LENALIDOMIDE

Application Number

211022

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2022-08-30

Regulatory Status

RX

2022
30 Aug
RX Application: 211022

Drug Name

LENALIDOMIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2022-08-30

211022 / 2

Active Ingredient

LENALIDOMIDE

Application Number

211022

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2022-08-30

Regulatory Status

RX

2022
30 Aug
RX Application: 211022

Drug Name

LENALIDOMIDE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2022-08-30

211022 / 3

Active Ingredient

LENALIDOMIDE

Application Number

211022

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2022-08-30

Regulatory Status

RX

2022
30 Aug
RX Application: 211022

Drug Name

LENALIDOMIDE

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2022-08-30

211022 / 4

Active Ingredient

LENALIDOMIDE

Application Number

211022

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2022-08-30

Regulatory Status

RX

2023
07 Mar
RX Application: 211022

Drug Name

LENALIDOMIDE

Product Number

5

Dosage Form

-

Strength

2.5MG

Approval Date

2023-03-07

211022 / 5

Active Ingredient

LENALIDOMIDE

Application Number

211022

Product Number

5

Dosage Form

-

Strength

2.5MG

Approval Date

2023-03-07

Regulatory Status

RX

2023
07 Mar
RX Application: 211022

Drug Name

LENALIDOMIDE

Product Number

6

Dosage Form

-

Strength

20MG

Approval Date

2023-03-07

211022 / 6

Active Ingredient

LENALIDOMIDE

Application Number

211022

Product Number

6

Dosage Form

-

Strength

20MG

Approval Date

2023-03-07

Regulatory Status

RX

2015
25 Feb
Discontinued Application: 202958

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2015-02-25

202958 / 1

Active Ingredient

LEVETIRACETAM

Application Number

202958

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2015-02-25

Regulatory Status

Discontinued

2014
21 Aug
Discontinued Application: 202915

Drug Name

LEVOCETIRIZINE DIHYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG/5ML

Approval Date

2014-08-21

202915 / 1

Active Ingredient

LEVOCETIRIZINE DIHYDROCHLORIDE

Application Number

202915

Product Number

1

Dosage Form

-

Strength

2.5MG/5ML

Approval Date

2014-08-21

Regulatory Status

Discontinued

2015
13 Feb
Discontinued Application: 203027

Drug Name

LEVOCETIRIZINE DIHYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-02-13

203027 / 1

Active Ingredient

LEVOCETIRIZINE DIHYDROCHLORIDE

Application Number

203027

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-02-13

Regulatory Status

Discontinued

2021
21 Apr
Discontinued Application: 211443

Drug Name

LEVOCETIRIZINE DIHYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2021-04-21

211443 / 1

Active Ingredient

LEVOCETIRIZINE DIHYDROCHLORIDE

Application Number

211443

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2021-04-21

Regulatory Status

Discontinued

2023
25 Aug
RX Application: 216944

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2023-08-25

216944 / 1

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

216944

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 216944

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2023-08-25

216944 / 2

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

216944

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 216944

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2023-08-25

216944 / 3

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

216944

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 216944

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2023-08-25

216944 / 4

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

216944

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 216944

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2023-08-25

216944 / 5

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

216944

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 216944

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2023-08-25

216944 / 6

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

216944

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 216944

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

7

Dosage Form

-

Strength

70MG

Approval Date

2023-08-25

216944 / 7

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

216944

Product Number

7

Dosage Form

-

Strength

70MG

Approval Date

2023-08-25

Regulatory Status

RX

2006
14 Feb
OTC Application: 76471

Drug Name

LORATADINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2006-02-14

76471 / 1

Active Ingredient

LORATADINE

Application Number

76471

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2006-02-14

Regulatory Status

OTC

2010
06 Oct
Discontinued Application: 90790

Drug Name

LOSARTAN POTASSIUM

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2010-10-06

90790 / 1

Active Ingredient

LOSARTAN POTASSIUM

Application Number

90790

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2010-10-06

Regulatory Status

Discontinued

2010
06 Oct
Discontinued Application: 90790

Drug Name

LOSARTAN POTASSIUM

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2010-10-06

90790 / 2

Active Ingredient

LOSARTAN POTASSIUM

Application Number

90790

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2010-10-06

Regulatory Status

Discontinued

2010
06 Oct
Discontinued Application: 90790

Drug Name

LOSARTAN POTASSIUM

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2010-10-06

90790 / 3

Active Ingredient

LOSARTAN POTASSIUM

Application Number

90790

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2010-10-06

Regulatory Status

Discontinued

2024
04 Jun
Discontinued Application: 218551

Drug Name

LOSARTAN POTASSIUM

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2024-06-04

218551 / 1

Active Ingredient

LOSARTAN POTASSIUM

Application Number

218551

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2024-06-04

Regulatory Status

Discontinued

2024
04 Jun
Discontinued Application: 218551

Drug Name

LOSARTAN POTASSIUM

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2024-06-04

218551 / 2

Active Ingredient

LOSARTAN POTASSIUM

Application Number

218551

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2024-06-04

Regulatory Status

Discontinued

2024
04 Jun
Discontinued Application: 218551

Drug Name

LOSARTAN POTASSIUM

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2024-06-04

218551 / 3

Active Ingredient

LOSARTAN POTASSIUM

Application Number

218551

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2024-06-04

Regulatory Status

Discontinued

2010
06 Oct
Discontinued Application: 90150

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;50MG

Approval Date

2010-10-06

90150 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

90150

Product Number

1

Dosage Form

-

Strength

12.5MG;50MG

Approval Date

2010-10-06

Regulatory Status

Discontinued

2010
11 Aug
Discontinued Application: 90150

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;100MG

Approval Date

2010-08-11

90150 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

90150

Product Number

2

Dosage Form

-

Strength

12.5MG;100MG

Approval Date

2010-08-11

Regulatory Status

Discontinued

2010
06 Oct
Discontinued Application: 90150

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;100MG

Approval Date

2010-10-06

90150 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

90150

Product Number

3

Dosage Form

-

Strength

25MG;100MG

Approval Date

2010-10-06

Regulatory Status

Discontinued

2024
09 Jan
RX Application: 211195

Drug Name

MACITENTAN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2024-01-09

211195 / 1

Active Ingredient

MACITENTAN

Application Number

211195

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2024-01-09

Regulatory Status

RX

2016
22 Nov
Discontinued Application: 206135

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

7MG

Approval Date

2016-11-22

206135 / 1

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

206135

Product Number

1

Dosage Form

-

Strength

7MG

Approval Date

2016-11-22

Regulatory Status

Discontinued

2016
22 Nov
Discontinued Application: 206135

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

14MG

Approval Date

2016-11-22

206135 / 2

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

206135

Product Number

2

Dosage Form

-

Strength

14MG

Approval Date

2016-11-22

Regulatory Status

Discontinued

2016
22 Nov
Discontinued Application: 206135

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

21MG

Approval Date

2016-11-22

206135 / 3

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

206135

Product Number

3

Dosage Form

-

Strength

21MG

Approval Date

2016-11-22

Regulatory Status

Discontinued

2016
22 Nov
Discontinued Application: 206135

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

28MG

Approval Date

2016-11-22

206135 / 4

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

206135

Product Number

4

Dosage Form

-

Strength

28MG

Approval Date

2016-11-22

Regulatory Status

Discontinued

2018
09 Feb
RX Application: 209955

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2018-02-09

209955 / 1

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

209955

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2018-02-09

Regulatory Status

RX

2002
23 Apr
Discontinued Application: 75984

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2002-04-23

75984 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

75984

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2002-04-23

Regulatory Status

Discontinued

2002
23 Apr
Discontinued Application: 75984

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

850MG

Approval Date

2002-04-23

75984 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

75984

Product Number

2

Dosage Form

-

Strength

850MG

Approval Date

2002-04-23

Regulatory Status

Discontinued

2002
23 Apr
Discontinued Application: 75984

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

2002-04-23

75984 / 3

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

75984

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

2002-04-23

Regulatory Status

Discontinued

2004
14 Dec
Discontinued Application: 76706

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2004-12-14

76706 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

76706

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2004-12-14

Regulatory Status

Discontinued

2005
29 Dec
Discontinued Application: 76706

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2005-12-29

76706 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

76706

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2005-12-29

Regulatory Status

Discontinued

2011
07 Dec
Discontinued Application: 90666

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2011-12-07

90666 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

90666

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2011-12-07

Regulatory Status

Discontinued

2011
07 Dec
Discontinued Application: 90666

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

850MG

Approval Date

2011-12-07

90666 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

90666

Product Number

2

Dosage Form

-

Strength

850MG

Approval Date

2011-12-07

Regulatory Status

Discontinued

2011
07 Dec
Discontinued Application: 90666

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

2011-12-07

90666 / 3

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

90666

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

2011-12-07

Regulatory Status

Discontinued

2021
13 Dec
Discontinued Application: 213356

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2021-12-13

213356 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

213356

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2021-12-13

Regulatory Status

Discontinued

2021
13 Dec
Discontinued Application: 213356

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2021-12-13

213356 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

213356

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2021-12-13

Regulatory Status

Discontinued

2020
05 Nov
Discontinued Application: 208366

Drug Name

MICAFUNGIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

2020-11-05

208366 / 1

Active Ingredient

MICAFUNGIN SODIUM

Application Number

208366

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

2020-11-05

Regulatory Status

Discontinued

2020
05 Nov
Discontinued Application: 208366

Drug Name

MICAFUNGIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2020-11-05

208366 / 2

Active Ingredient

MICAFUNGIN SODIUM

Application Number

208366

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2020-11-05

Regulatory Status

Discontinued

2006
12 Sep
RX Application: 77746

Drug Name

MIDODRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2006-09-12

77746 / 1

Active Ingredient

MIDODRINE HYDROCHLORIDE

Application Number

77746

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2006-09-12

Regulatory Status

RX

2006
12 Sep
RX Application: 77746

Drug Name

MIDODRINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2006-09-12

77746 / 2

Active Ingredient

MIDODRINE HYDROCHLORIDE

Application Number

77746

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2006-09-12

Regulatory Status

RX

2006
12 Sep
RX Application: 77746

Drug Name

MIDODRINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2006-09-12

77746 / 3

Active Ingredient

MIDODRINE HYDROCHLORIDE

Application Number

77746

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2006-09-12

Regulatory Status

RX

2025
02 Jan
Discontinued Application: 209434

Drug Name

MIRABEGRON

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2025-01-02

209434 / 1

Active Ingredient

MIRABEGRON

Application Number

209434

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2025-01-02

Regulatory Status

Discontinued

2025
02 Jan
Discontinued Application: 209434

Drug Name

MIRABEGRON

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2025-01-02

209434 / 2

Active Ingredient

MIRABEGRON

Application Number

209434

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2025-01-02

Regulatory Status

Discontinued

2007
22 Aug
RX Application: 77666

Drug Name

MIRTAZAPINE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2007-08-22

77666 / 1

Active Ingredient

MIRTAZAPINE

Application Number

77666

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2007-08-22

Regulatory Status

RX

2007
22 Aug
RX Application: 77666

Drug Name

MIRTAZAPINE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2007-08-22

77666 / 2

Active Ingredient

MIRTAZAPINE

Application Number

77666

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2007-08-22

Regulatory Status

RX

2007
22 Aug
RX Application: 77666

Drug Name

MIRTAZAPINE

Product Number

3

Dosage Form

-

Strength

45MG

Approval Date

2007-08-22

77666 / 3

Active Ingredient

MIRTAZAPINE

Application Number

77666

Product Number

3

Dosage Form

-

Strength

45MG

Approval Date

2007-08-22

Regulatory Status

RX

2014
03 Feb
RX Application: 77667

Drug Name

MODAFINIL

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2014-02-03

77667 / 1

Active Ingredient

MODAFINIL

Application Number

77667

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2014-02-03

Regulatory Status

RX

2014
03 Feb
RX Application: 77667

Drug Name

MODAFINIL

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2014-02-03

77667 / 2

Active Ingredient

MODAFINIL

Application Number

77667

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2014-02-03

Regulatory Status

RX

2016
22 Mar
RX Application: 91161

Drug Name

MOMETASONE FUROATE

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2016-03-22

91161 / 1

Active Ingredient

MOMETASONE FUROATE

Application Number

91161

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2016-03-22

Regulatory Status

RX

2024
23 Apr
Discontinued Application: 217438

Drug Name

MOMETASONE FUROATE

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2024-04-23

217438 / 1

Active Ingredient

MOMETASONE FUROATE

Application Number

217438

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2024-04-23

Regulatory Status

Discontinued

2012
03 Aug
Discontinued Application: 201294

Drug Name

MONTELUKAST SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-08-03

201294 / 1

Active Ingredient

MONTELUKAST SODIUM

Application Number

201294

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-08-03

Regulatory Status

Discontinued

2017
30 Jun
RX Application: 90080

Drug Name

MOXIFLOXACIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2017-06-30

90080 / 1

Active Ingredient

MOXIFLOXACIN HYDROCHLORIDE

Application Number

90080

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2017-06-30

Regulatory Status

RX

2026
09 Apr
RX Application: 210273

Drug Name

MULTIPLE VITAMINS INJECTION ADULT

Product Number

1

Dosage Form

-

Strength

2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML

Approval Date

2026-04-09

210273 / 1

Active Ingredient

ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K

Application Number

210273

Product Number

1

Dosage Form

-

Strength

2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML

Approval Date

2026-04-09

Regulatory Status

RX

2026
09 Apr
RX Application: 210672

Drug Name

MULTIPLE VITAMINS INJECTION ADULT

Product Number

1

Dosage Form

-

Strength

2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML

Approval Date

2026-04-09

210672 / 1

Active Ingredient

ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K

Application Number

210672

Product Number

1

Dosage Form

-

Strength

2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML

Approval Date

2026-04-09

Regulatory Status

RX

2026
21 Apr
RX Application: 210671

Drug Name

MULTIPLE VITAMINS INJECTION PEDIATRIC

Product Number

1

Dosage Form

-

Strength

80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL

Approval Date

2026-04-21

210671 / 1

Active Ingredient

ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K

Application Number

210671

Product Number

1

Dosage Form

-

Strength

80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL

Approval Date

2026-04-21

Regulatory Status

RX

2026
21 Apr
RX Application: 210456

Drug Name

MULTIPLE VITAMINS INJECTION PEDIATRIC (PHARMACY BULK PACKAGE)

Product Number

1

Dosage Form

-

Strength

80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL

Approval Date

2026-04-21

210456 / 1

Active Ingredient

ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K

Application Number

210456

Product Number

1

Dosage Form

-

Strength

80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL

Approval Date

2026-04-21

Regulatory Status

RX

2009
22 Apr
Discontinued Application: 90419

Drug Name

MYCOPHENOLATE MOFETIL

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2009-04-22

90419 / 1

Active Ingredient

MYCOPHENOLATE MOFETIL

Application Number

90419

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2009-04-22

Regulatory Status

Discontinued

2009
22 Apr
Discontinued Application: 90499

Drug Name

MYCOPHENOLATE MOFETIL

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2009-04-22

90499 / 1

Active Ingredient

MYCOPHENOLATE MOFETIL

Application Number

90499

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2009-04-22

Regulatory Status

Discontinued

2011
22 Apr
Discontinued Application: 91373

Drug Name

NARATRIPTAN

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2011-04-22

91373 / 1

Active Ingredient

NARATRIPTAN HYDROCHLORIDE

Application Number

91373

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2011-04-22

Regulatory Status

Discontinued

2011
22 Apr
Discontinued Application: 91373

Drug Name

NARATRIPTAN

Product Number

2

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2011-04-22

91373 / 2

Active Ingredient

NARATRIPTAN HYDROCHLORIDE

Application Number

91373

Product Number

2

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2011-04-22

Regulatory Status

Discontinued

2024
27 Feb
Discontinued Application: 209741

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2024-02-27

209741 / 1

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

209741

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2024-02-27

Regulatory Status

Discontinued

2024
27 Feb
Discontinued Application: 209741

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2024-02-27

209741 / 2

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

209741

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2024-02-27

Regulatory Status

Discontinued

2014
03 Apr
Discontinued Application: 205258

Drug Name

NEVIRAPINE

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2014-04-03

205258 / 1

Active Ingredient

NEVIRAPINE

Application Number

205258

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2014-04-03

Regulatory Status

Discontinued

2024
05 Jan
RX Application: 203640

Drug Name

NILOTINIB HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2024-01-05

203640 / 1

Active Ingredient

NILOTINIB HYDROCHLORIDE

Application Number

203640

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2024-01-05

Regulatory Status

RX

2024
05 Jan
RX Application: 203640

Drug Name

NILOTINIB HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2024-01-05

203640 / 2

Active Ingredient

NILOTINIB HYDROCHLORIDE

Application Number

203640

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2024-01-05

Regulatory Status

RX

2024
05 Jan
RX Application: 203640

Drug Name

NILOTINIB HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2024-01-05

203640 / 3

Active Ingredient

NILOTINIB HYDROCHLORIDE

Application Number

203640

Product Number

3

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2024-01-05

Regulatory Status

RX

2026
02 Apr
RX Application: 219227

Drug Name

NINTEDANIB ESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2026-04-02

219227 / 1

Active Ingredient

NINTEDANIB ESYLATE

Application Number

219227

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2026-04-02

Regulatory Status

RX

2026
02 Apr
RX Application: 219227

Drug Name

NINTEDANIB ESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2026-04-02

219227 / 2

Active Ingredient

NINTEDANIB ESYLATE

Application Number

219227

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2026-04-02

Regulatory Status

RX

2018
21 Mar
Discontinued Application: 208639

Drug Name

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG

Approval Date

2018-03-21

208639 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

208639

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG

Approval Date

2018-03-21

Regulatory Status

Discontinued

2023
30 May
Discontinued Application: 214862

Drug Name

OBETICHOLIC ACID

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2023-05-30

214862 / 1

Active Ingredient

OBETICHOLIC ACID

Application Number

214862

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2023-05-30

Regulatory Status

Discontinued

2023
30 May
Discontinued Application: 214862

Drug Name

OBETICHOLIC ACID

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2023-05-30

214862 / 2

Active Ingredient

OBETICHOLIC ACID

Application Number

214862

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2023-05-30

Regulatory Status

Discontinued

2015
07 Dec
OTC Application: 78350

Drug Name

OLOPATADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

2015-12-07

78350 / 1

Active Ingredient

OLOPATADINE HYDROCHLORIDE

Application Number

78350

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

2015-12-07

Regulatory Status

OTC

2017
05 Dec
OTC Application: 90918

Drug Name

OLOPATADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.2% BASE

Approval Date

2017-12-05

90918 / 1

Active Ingredient

OLOPATADINE HYDROCHLORIDE

Application Number

90918

Product Number

1

Dosage Form

-

Strength

EQ 0.2% BASE

Approval Date

2017-12-05

Regulatory Status

OTC

-
Unclassified Application: 209015

Drug Name

OLOPATADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.7% BASE

Approval Date

-

209015 / 1

Active Ingredient

OLOPATADINE HYDROCHLORIDE

Application Number

209015

Product Number

1

Dosage Form

-

Strength

EQ 0.7% BASE

Approval Date

-

Regulatory Status

Unclassified

2014
30 Sep
Discontinued Application: 90973

Drug Name

OMEGA-3-ACID ETHYL ESTERS

Product Number

1

Dosage Form

-

Strength

1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS

Approval Date

2014-09-30

90973 / 1

Active Ingredient

OMEGA-3-ACID ETHYL ESTERS

Application Number

90973

Product Number

1

Dosage Form

-

Strength

1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS

Approval Date

2014-09-30

Regulatory Status

Discontinued

2007
22 Oct
RX Application: 76048

Drug Name

OMEPRAZOLE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2007-10-22

76048 / 1

Active Ingredient

OMEPRAZOLE

Application Number

76048

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2007-10-22

Regulatory Status

RX

2007
22 Oct
RX Application: 76048

Drug Name

OMEPRAZOLE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2007-10-22

76048 / 2

Active Ingredient

OMEPRAZOLE

Application Number

76048

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2007-10-22

Regulatory Status

RX

2009
21 Jan
RX Application: 76048

Drug Name

OMEPRAZOLE

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2009-01-21

76048 / 3

Active Ingredient

OMEPRAZOLE

Application Number

76048

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2009-01-21

Regulatory Status

RX

2019
11 Feb
Discontinued Application: 210070

Drug Name

OMEPRAZOLE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2019-02-11

210070 / 1

Active Ingredient

OMEPRAZOLE

Application Number

210070

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2019-02-11

Regulatory Status

Discontinued

2007
25 Jun
Discontinued Application: 77306

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2007-06-25

77306 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77306

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2007-06-25

Regulatory Status

Discontinued

2007
25 Jun
Discontinued Application: 77306

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2007-06-25

77306 / 2

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77306

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2007-06-25

Regulatory Status

Discontinued

2023
13 Jul
RX Application: 213369

Drug Name

OXCARBAZEPINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2023-07-13

213369 / 1

Active Ingredient

OXCARBAZEPINE

Application Number

213369

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2023-07-13

Regulatory Status

RX

2023
13 Jul
RX Application: 213369

Drug Name

OXCARBAZEPINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2023-07-13

213369 / 2

Active Ingredient

OXCARBAZEPINE

Application Number

213369

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2023-07-13

Regulatory Status

RX

2023
13 Jul
RX Application: 213369

Drug Name

OXCARBAZEPINE

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2023-07-13

213369 / 3

Active Ingredient

OXCARBAZEPINE

Application Number

213369

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2023-07-13

Regulatory Status

RX

2026
26 Jan
Discontinued Application: 203279

Drug Name

PALIPERIDONE

Product Number

1

Dosage Form

-

Strength

3MG

Approval Date

2026-01-26

203279 / 1

Active Ingredient

PALIPERIDONE

Application Number

203279

Product Number

1

Dosage Form

-

Strength

3MG

Approval Date

2026-01-26

Regulatory Status

Discontinued

2026
26 Jan
Discontinued Application: 203279

Drug Name

PALIPERIDONE

Product Number

2

Dosage Form

-

Strength

6MG

Approval Date

2026-01-26

203279 / 2

Active Ingredient

PALIPERIDONE

Application Number

203279

Product Number

2

Dosage Form

-

Strength

6MG

Approval Date

2026-01-26

Regulatory Status

Discontinued

2026
26 Jan
Discontinued Application: 203279

Drug Name

PALIPERIDONE

Product Number

3

Dosage Form

-

Strength

9MG

Approval Date

2026-01-26

203279 / 3

Active Ingredient

PALIPERIDONE

Application Number

203279

Product Number

3

Dosage Form

-

Strength

9MG

Approval Date

2026-01-26

Regulatory Status

Discontinued

2011
19 Jan
RX Application: 91231

Drug Name

PANTOPRAZOLE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2011-01-19

91231 / 1

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

91231

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2011-01-19

Regulatory Status

RX

2011
19 Jan
RX Application: 91231

Drug Name

PANTOPRAZOLE SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2011-01-19

91231 / 2

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

91231

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2011-01-19

Regulatory Status

RX

2003
30 Jul
RX Application: 75356

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2003-07-30

75356 / 1

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

75356

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2003-07-30

Regulatory Status

RX

2003
30 Jul
RX Application: 75356

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2003-07-30

75356 / 2

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

75356

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2003-07-30

Regulatory Status

RX

2003
30 Jul
RX Application: 75356

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2003-07-30

75356 / 3

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

75356

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2003-07-30

Regulatory Status

RX

2003
30 Jul
RX Application: 75356

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2003-07-30

75356 / 4

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

75356

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2003-07-30

Regulatory Status

RX

1992
29 Dec
RX Application: 20031

Drug Name

PAXIL

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1992-12-29

20031 / 1

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

20031

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1992-12-29

Regulatory Status

RX

1992
29 Dec
RX Application: 20031

Drug Name

PAXIL

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

1992-12-29

20031 / 2

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

20031

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

1992-12-29

Regulatory Status

RX

1992
29 Dec
RX Application: 20031

Drug Name

PAXIL

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

1992-12-29

20031 / 3

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

20031

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

1992-12-29

Regulatory Status

RX

1992
29 Dec
Discontinued Application: 20031

Drug Name

PAXIL

Product Number

4

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1992-12-29

20031 / 4

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

20031

Product Number

4

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1992-12-29

Regulatory Status

Discontinued

1992
29 Dec
RX Application: 20031

Drug Name

PAXIL

Product Number

5

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

1992-12-29

20031 / 5

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

20031

Product Number

5

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

1992-12-29

Regulatory Status

RX

1997
25 Jun
Discontinued Application: 20710

Drug Name

PAXIL

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-06-25

20710 / 1

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

20710

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-06-25

Regulatory Status

Discontinued

1998
09 Oct
Discontinued Application: 20885

Drug Name

PAXIL

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1998-10-09

20885 / 1

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

20885

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1998-10-09

Regulatory Status

Discontinued

1998
09 Oct
Discontinued Application: 20885

Drug Name

PAXIL

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1998-10-09

20885 / 2

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

20885

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1998-10-09

Regulatory Status

Discontinued

1998
09 Oct
Discontinued Application: 20885

Drug Name

PAXIL

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1998-10-09

20885 / 3

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

20885

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1998-10-09

Regulatory Status

Discontinued

1998
09 Oct
Discontinued Application: 20885

Drug Name

PAXIL

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1998-10-09

20885 / 4

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

20885

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1998-10-09

Regulatory Status

Discontinued

1999
16 Feb
RX Application: 20936

Drug Name

PAXIL CR

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE

Approval Date

1999-02-16

20936 / 1

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

20936

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE

Approval Date

1999-02-16

Regulatory Status

RX

1999
16 Feb
RX Application: 20936

Drug Name

PAXIL CR

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

1999-02-16

20936 / 2

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

20936

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

1999-02-16

Regulatory Status

RX

2000
06 Dec
RX Application: 20936

Drug Name

PAXIL CR

Product Number

3

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2000-12-06

20936 / 3

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

20936

Product Number

3

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2000-12-06

Regulatory Status

RX

2023
19 Oct
RX Application: 217713

Drug Name

PAZOPANIB HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2023-10-19

217713 / 1

Active Ingredient

PAZOPANIB HYDROCHLORIDE

Application Number

217713

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2023-10-19

Regulatory Status

RX

2022
25 May
RX Application: 203774

Drug Name

PEMETREXED DISODIUM

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2022-05-25

203774 / 1

Active Ingredient

PEMETREXED DISODIUM

Application Number

203774

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2022-05-25

Regulatory Status

RX

2022
25 May
RX Application: 203774

Drug Name

PEMETREXED DISODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2022-05-25

203774 / 2

Active Ingredient

PEMETREXED DISODIUM

Application Number

203774

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2022-05-25

Regulatory Status

RX

2022
25 May
Discontinued Application: 209085

Drug Name

PEMETREXED DISODIUM

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2022-05-25

209085 / 1

Active Ingredient

PEMETREXED DISODIUM

Application Number

209085

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2022-05-25

Regulatory Status

Discontinued

2022
25 May
RX Application: 209851

Drug Name

PEMETREXED DISODIUM

Product Number

1

Dosage Form

-

Strength

EQ 750MG BASE/VIAL

Approval Date

2022-05-25

209851 / 1

Active Ingredient

PEMETREXED DISODIUM

Application Number

209851

Product Number

1

Dosage Form

-

Strength

EQ 750MG BASE/VIAL

Approval Date

2022-05-25

Regulatory Status

RX

2020
28 Apr
Discontinued Application: 213310

Drug Name

PENICILLAMINE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2020-04-28

213310 / 1

Active Ingredient

PENICILLAMINE

Application Number

213310

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2020-04-28

Regulatory Status

Discontinued

1999
09 Jun
RX Application: 75191

Drug Name

PENTOXIFYLLINE

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1999-06-09

75191 / 1

Active Ingredient

PENTOXIFYLLINE

Application Number

75191

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1999-06-09

Regulatory Status

RX

2010
30 Aug
Discontinued Application: 90463

Drug Name

PERINDOPRIL ERBUMINE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2010-08-30

90463 / 1

Active Ingredient

PERINDOPRIL ERBUMINE

Application Number

90463

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2010-08-30

Regulatory Status

Discontinued

2010
30 Aug
Discontinued Application: 90463

Drug Name

PERINDOPRIL ERBUMINE

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2010-08-30

90463 / 2

Active Ingredient

PERINDOPRIL ERBUMINE

Application Number

90463

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2010-08-30

Regulatory Status

Discontinued

2010
30 Aug
Discontinued Application: 90463

Drug Name

PERINDOPRIL ERBUMINE

Product Number

3

Dosage Form

-

Strength

8MG

Approval Date

2010-08-30

90463 / 3

Active Ingredient

PERINDOPRIL ERBUMINE

Application Number

90463

Product Number

3

Dosage Form

-

Strength

8MG

Approval Date

2010-08-30

Regulatory Status

Discontinued

2017
22 Mar
RX Application: 206996

Drug Name

PIPERACILLIN AND TAZOBACTAM

Product Number

1

Dosage Form

-

Strength

EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL

Approval Date

2017-03-22

206996 / 1

Active Ingredient

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Application Number

206996

Product Number

1

Dosage Form

-

Strength

EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL

Approval Date

2017-03-22

Regulatory Status

RX

2017
22 Mar
RX Application: 206996

Drug Name

PIPERACILLIN AND TAZOBACTAM

Product Number

2

Dosage Form

-

Strength

EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL

Approval Date

2017-03-22

206996 / 2

Active Ingredient

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Application Number

206996

Product Number

2

Dosage Form

-

Strength

EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL

Approval Date

2017-03-22

Regulatory Status

RX

2017
22 Mar
RX Application: 206996

Drug Name

PIPERACILLIN AND TAZOBACTAM

Product Number

3

Dosage Form

-

Strength

EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL

Approval Date

2017-03-22

206996 / 3

Active Ingredient

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Application Number

206996

Product Number

3

Dosage Form

-

Strength

EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL

Approval Date

2017-03-22

Regulatory Status

RX

2017
17 Mar
RX Application: 207146

Drug Name

PIPERACILLIN AND TAZOBACTAM

Product Number

1

Dosage Form

-

Strength

EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL

Approval Date

2017-03-17

207146 / 1

Active Ingredient

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Application Number

207146

Product Number

1

Dosage Form

-

Strength

EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL

Approval Date

2017-03-17

Regulatory Status

RX

2023
09 Jun
Discontinued Application: 212687

Drug Name

PIRFENIDONE

Product Number

1

Dosage Form

-

Strength

267MG

Approval Date

2023-06-09

212687 / 1

Active Ingredient

PIRFENIDONE

Application Number

212687

Product Number

1

Dosage Form

-

Strength

267MG

Approval Date

2023-06-09

Regulatory Status

Discontinued

2023
31 May
RX Application: 212709

Drug Name

PIRFENIDONE

Product Number

1

Dosage Form

-

Strength

267MG

Approval Date

2023-05-31

212709 / 1

Active Ingredient

PIRFENIDONE

Application Number

212709

Product Number

1

Dosage Form

-

Strength

267MG

Approval Date

2023-05-31

Regulatory Status

RX

2023
31 May
RX Application: 212709

Drug Name

PIRFENIDONE

Product Number

2

Dosage Form

-

Strength

801MG

Approval Date

2023-05-31

212709 / 2

Active Ingredient

PIRFENIDONE

Application Number

212709

Product Number

2

Dosage Form

-

Strength

801MG

Approval Date

2023-05-31

Regulatory Status

RX

2024
11 Jun
RX Application: 210164

Drug Name

POMALIDOMIDE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2024-06-11

210164 / 1

Active Ingredient

POMALIDOMIDE

Application Number

210164

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2024-06-11

Regulatory Status

RX

2024
11 Jun
RX Application: 210164

Drug Name

POMALIDOMIDE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2024-06-11

210164 / 2

Active Ingredient

POMALIDOMIDE

Application Number

210164

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2024-06-11

Regulatory Status

RX

2024
11 Jun
RX Application: 210164

Drug Name

POMALIDOMIDE

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2024-06-11

210164 / 3

Active Ingredient

POMALIDOMIDE

Application Number

210164

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2024-06-11

Regulatory Status

RX

2024
11 Jun
RX Application: 210164

Drug Name

POMALIDOMIDE

Product Number

4

Dosage Form

-

Strength

4MG

Approval Date

2024-06-11

210164 / 4

Active Ingredient

POMALIDOMIDE

Application Number

210164

Product Number

4

Dosage Form

-

Strength

4MG

Approval Date

2024-06-11

Regulatory Status

RX

2023
14 Jul
Discontinued Application: 215893

Drug Name

PONATINIB HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2023-07-14

215893 / 1

Active Ingredient

PONATINIB HYDROCHLORIDE

Application Number

215893

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2023-07-14

Regulatory Status

Discontinued

2023
14 Jul
Discontinued Application: 215893

Drug Name

PONATINIB HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2023-07-14

215893 / 2

Active Ingredient

PONATINIB HYDROCHLORIDE

Application Number

215893

Product Number

2

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2023-07-14

Regulatory Status

Discontinued

2026
29 Jun
RX Application: 213331

Drug Name

POSACONAZOLE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2026-06-29

213331 / 1

Active Ingredient

POSACONAZOLE

Application Number

213331

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2026-06-29

Regulatory Status

RX

2018
08 Aug
Discontinued Application: 211067

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

20MEQ/15ML

Approval Date

2018-08-08

211067 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

211067

Product Number

1

Dosage Form

-

Strength

20MEQ/15ML

Approval Date

2018-08-08

Regulatory Status

Discontinued

2018
08 Aug
Discontinued Application: 211067

Drug Name

POTASSIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

40MEQ/15ML

Approval Date

2018-08-08

211067 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

211067

Product Number

2

Dosage Form

-

Strength

40MEQ/15ML

Approval Date

2018-08-08

Regulatory Status

Discontinued

2006
23 Oct
RX Application: 76341

Drug Name

PRAVASTATIN SODIUM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2006-10-23

76341 / 1

Active Ingredient

PRAVASTATIN SODIUM

Application Number

76341

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2006-10-23

Regulatory Status

RX

2006
23 Oct
RX Application: 76341

Drug Name

PRAVASTATIN SODIUM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2006-10-23

76341 / 2

Active Ingredient

PRAVASTATIN SODIUM

Application Number

76341

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2006-10-23

Regulatory Status

RX

2006
23 Oct
RX Application: 76341

Drug Name

PRAVASTATIN SODIUM

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2006-10-23

76341 / 3

Active Ingredient

PRAVASTATIN SODIUM

Application Number

76341

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2006-10-23

Regulatory Status

RX

2007
28 Dec
RX Application: 76341

Drug Name

PRAVASTATIN SODIUM

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

2007-12-28

76341 / 4

Active Ingredient

PRAVASTATIN SODIUM

Application Number

76341

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

2007-12-28

Regulatory Status

RX

2021
07 Jul
Discontinued Application: 211685

Drug Name

PREGABALIN

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2021-07-07

211685 / 1

Active Ingredient

PREGABALIN

Application Number

211685

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2021-07-07

Regulatory Status

Discontinued

2021
07 Jul
Discontinued Application: 211685

Drug Name

PREGABALIN

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2021-07-07

211685 / 2

Active Ingredient

PREGABALIN

Application Number

211685

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2021-07-07

Regulatory Status

Discontinued

2021
07 Jul
Discontinued Application: 211685

Drug Name

PREGABALIN

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2021-07-07

211685 / 3

Active Ingredient

PREGABALIN

Application Number

211685

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2021-07-07

Regulatory Status

Discontinued

2021
07 Jul
Discontinued Application: 211685

Drug Name

PREGABALIN

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2021-07-07

211685 / 4

Active Ingredient

PREGABALIN

Application Number

211685

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2021-07-07

Regulatory Status

Discontinued

2021
07 Jul
Discontinued Application: 211685

Drug Name

PREGABALIN

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2021-07-07

211685 / 5

Active Ingredient

PREGABALIN

Application Number

211685

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2021-07-07

Regulatory Status

Discontinued

2021
07 Jul
Discontinued Application: 211685

Drug Name

PREGABALIN

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

2021-07-07

211685 / 6

Active Ingredient

PREGABALIN

Application Number

211685

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

2021-07-07

Regulatory Status

Discontinued

2021
07 Jul
Discontinued Application: 211685

Drug Name

PREGABALIN

Product Number

7

Dosage Form

-

Strength

225MG

Approval Date

2021-07-07

211685 / 7

Active Ingredient

PREGABALIN

Application Number

211685

Product Number

7

Dosage Form

-

Strength

225MG

Approval Date

2021-07-07

Regulatory Status

Discontinued

2021
07 Jul
Discontinued Application: 211685

Drug Name

PREGABALIN

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

2021-07-07

211685 / 8

Active Ingredient

PREGABALIN

Application Number

211685

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

2021-07-07

Regulatory Status

Discontinued

2021
13 Apr
Discontinued Application: 213313

Drug Name

PREGABALIN

Product Number

1

Dosage Form

-

Strength

165MG

Approval Date

2021-04-13

213313 / 1

Active Ingredient

PREGABALIN

Application Number

213313

Product Number

1

Dosage Form

-

Strength

165MG

Approval Date

2021-04-13

Regulatory Status

Discontinued

2021
13 Apr
Discontinued Application: 213313

Drug Name

PREGABALIN

Product Number

2

Dosage Form

-

Strength

330MG

Approval Date

2021-04-13

213313 / 2

Active Ingredient

PREGABALIN

Application Number

213313

Product Number

2

Dosage Form

-

Strength

330MG

Approval Date

2021-04-13

Regulatory Status

Discontinued

2025
24 Jun
RX Application: 218977

Drug Name

PRUCALOPRIDE SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2025-06-24

218977 / 1

Active Ingredient

PRUCALOPRIDE SUCCINATE

Application Number

218977

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2025-06-24

Regulatory Status

RX

2025
24 Jun
RX Application: 218977

Drug Name

PRUCALOPRIDE SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2025-06-24

218977 / 2

Active Ingredient

PRUCALOPRIDE SUCCINATE

Application Number

218977

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2025-06-24

Regulatory Status

RX

2013
12 Mar
Discontinued Application: 91524

Drug Name

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;EQ 10MG BASE

Approval Date

2013-03-12

91524 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE

Application Number

91524

Product Number

1

Dosage Form

-

Strength

12.5MG;EQ 10MG BASE

Approval Date

2013-03-12

Regulatory Status

Discontinued

2013
12 Mar
Discontinued Application: 91524

Drug Name

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;EQ 20MG BASE

Approval Date

2013-03-12

91524 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE

Application Number

91524

Product Number

2

Dosage Form

-

Strength

12.5MG;EQ 20MG BASE

Approval Date

2013-03-12

Regulatory Status

Discontinued

2013
12 Mar
Discontinued Application: 91524

Drug Name

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;EQ 20MG BASE

Approval Date

2013-03-12

91524 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE

Application Number

91524

Product Number

3

Dosage Form

-

Strength

25MG;EQ 20MG BASE

Approval Date

2013-03-12

Regulatory Status

Discontinued

2015
02 Dec
Discontinued Application: 91069

Drug Name

RAMIPRIL

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

2015-12-02

91069 / 1

Active Ingredient

RAMIPRIL

Application Number

91069

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

2015-12-02

Regulatory Status

Discontinued

2015
02 Dec
Discontinued Application: 91069

Drug Name

RAMIPRIL

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2015-12-02

91069 / 2

Active Ingredient

RAMIPRIL

Application Number

91069

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2015-12-02

Regulatory Status

Discontinued

2015
02 Dec
Discontinued Application: 91069

Drug Name

RAMIPRIL

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2015-12-02

91069 / 3

Active Ingredient

RAMIPRIL

Application Number

91069

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2015-12-02

Regulatory Status

Discontinued

2015
02 Dec
Discontinued Application: 91069

Drug Name

RAMIPRIL

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2015-12-02

91069 / 4

Active Ingredient

RAMIPRIL

Application Number

91069

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2015-12-02

Regulatory Status

Discontinued

1997
12 Sep
Discontinued Application: 74680

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1997-09-12

74680 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

74680

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1997-09-12

Regulatory Status

Discontinued

1997
12 Sep
Discontinued Application: 74680

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

1997-09-12

74680 / 2

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

74680

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

1997-09-12

Regulatory Status

Discontinued

2000
04 May
Discontinued Application: 75167

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2000-05-04

75167 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

75167

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2000-05-04

Regulatory Status

Discontinued

2022
11 Apr
RX Application: 207604

Drug Name

REGADENOSON

Product Number

1

Dosage Form

-

Strength

0.4MG/5ML (0.08MG/ML)

Approval Date

2022-04-11

207604 / 1

Active Ingredient

REGADENOSON

Application Number

207604

Product Number

1

Dosage Form

-

Strength

0.4MG/5ML (0.08MG/ML)

Approval Date

2022-04-11

Regulatory Status

RX

2013
18 Jun
Discontinued Application: 91300

Drug Name

RILUZOLE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2013-06-18

91300 / 1

Active Ingredient

RILUZOLE

Application Number

91300

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2013-06-18

Regulatory Status

Discontinued

-
Unclassified Application: 219399

Drug Name

RIMEGEPANT

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

-

219399 / 1

Active Ingredient

RIMEGEPANT

Application Number

219399

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

-

Regulatory Status

Unclassified

2015
30 Nov
RX Application: 90877

Drug Name

RISEDRONATE SODIUM

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

2015-11-30

90877 / 1

Active Ingredient

RISEDRONATE SODIUM

Application Number

90877

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

2015-11-30

Regulatory Status

RX

2014
10 Jun
RX Application: 90877

Drug Name

RISEDRONATE SODIUM

Product Number

2

Dosage Form

-

Strength

75MG

Approval Date

2014-06-10

90877 / 2

Active Ingredient

RISEDRONATE SODIUM

Application Number

90877

Product Number

2

Dosage Form

-

Strength

75MG

Approval Date

2014-06-10

Regulatory Status

RX

2014
10 Jun
RX Application: 90877

Drug Name

RISEDRONATE SODIUM

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2014-06-10

90877 / 3

Active Ingredient

RISEDRONATE SODIUM

Application Number

90877

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2014-06-10

Regulatory Status

RX

2025
14 Nov
Discontinued Application: 208579

Drug Name

RIVAROXABAN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2025-11-14

208579 / 1

Active Ingredient

RIVAROXABAN

Application Number

208579

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2025-11-14

Regulatory Status

Discontinued

2025
14 Nov
Discontinued Application: 208579

Drug Name

RIVAROXABAN

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2025-11-14

208579 / 2

Active Ingredient

RIVAROXABAN

Application Number

208579

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2025-11-14

Regulatory Status

Discontinued

2025
14 Nov
Discontinued Application: 208579

Drug Name

RIVAROXABAN

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2025-11-14

208579 / 3

Active Ingredient

RIVAROXABAN

Application Number

208579

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2025-11-14

Regulatory Status

Discontinued

2025
02 May
RX Application: 217810

Drug Name

RIVAROXABAN

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2025-05-02

217810 / 1

Active Ingredient

RIVAROXABAN

Application Number

217810

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2025-05-02

Regulatory Status

RX

2026
02 Mar
RX Application: 218427

Drug Name

RIVAROXABAN

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2026-03-02

218427 / 1

Active Ingredient

RIVAROXABAN

Application Number

218427

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2026-03-02

Regulatory Status

RX

2016
19 Jul
Discontinued Application: 79145

Drug Name

ROSUVASTATIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2016-07-19

79145 / 1

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

79145

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2016-07-19

Regulatory Status

Discontinued

2016
19 Jul
Discontinued Application: 79145

Drug Name

ROSUVASTATIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2016-07-19

79145 / 2

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

79145

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2016-07-19

Regulatory Status

Discontinued

2016
19 Jul
Discontinued Application: 79145

Drug Name

ROSUVASTATIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2016-07-19

79145 / 3

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

79145

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2016-07-19

Regulatory Status

Discontinued

2016
19 Jul
Discontinued Application: 79145

Drug Name

ROSUVASTATIN CALCIUM

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2016-07-19

79145 / 4

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

79145

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2016-07-19

Regulatory Status

Discontinued

-
Unclassified Application: 219660

Drug Name

Ruxolitinib

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

-

219660 / 2

Active Ingredient

Ruxolitinib

Application Number

219660

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 219660

Drug Name

Ruxolitinib

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

-

219660 / 3

Active Ingredient

Ruxolitinib

Application Number

219660

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 219660

Drug Name

Ruxolitinib

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

-

219660 / 4

Active Ingredient

Ruxolitinib

Application Number

219660

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

-

Regulatory Status

Unclassified

2008
12 Sep
RX Application: 22198

Drug Name

SANCUSO

Product Number

1

Dosage Form

-

Strength

3.1MG/24HR

Approval Date

2008-09-12

22198 / 1

Active Ingredient

GRANISETRON

Application Number

22198

Product Number

1

Dosage Form

-

Strength

3.1MG/24HR

Approval Date

2008-09-12

Regulatory Status

RX

1997
06 Jun
RX Application: 74871

Drug Name

SELEGILINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1997-06-06

74871 / 1

Active Ingredient

SELEGILINE HYDROCHLORIDE

Application Number

74871

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1997-06-06

Regulatory Status

RX

1998
04 Dec
RX Application: 75321

Drug Name

SELEGILINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1998-12-04

75321 / 1

Active Ingredient

SELEGILINE HYDROCHLORIDE

Application Number

75321

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1998-12-04

Regulatory Status

RX

-
Unclassified Application: 91378

Drug Name

SILDENAFIL CITRATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

-

91378 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

91378

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 91378

Drug Name

SILDENAFIL CITRATE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

-

91378 / 2

Active Ingredient

SILDENAFIL CITRATE

Application Number

91378

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 91378

Drug Name

SILDENAFIL CITRATE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

-

91378 / 3

Active Ingredient

SILDENAFIL CITRATE

Application Number

91378

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

2012
06 Nov
Discontinued Application: 91379

Drug Name

SILDENAFIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-11-06

91379 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

91379

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-11-06

Regulatory Status

Discontinued

2019
22 Oct
RX Application: 211406

Drug Name

SIROLIMUS

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2019-10-22

211406 / 1

Active Ingredient

SIROLIMUS

Application Number

211406

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2019-10-22

Regulatory Status

RX

2026
30 Apr
RX Application: 202426

Drug Name

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG;EQ 50MG BASE

Approval Date

2026-04-30

202426 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

Application Number

202426

Product Number

1

Dosage Form

-

Strength

500MG;EQ 50MG BASE

Approval Date

2026-04-30

Regulatory Status

RX

2026
30 Apr
RX Application: 202426

Drug Name

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

1GM;EQ 50MG BASE

Approval Date

2026-04-30

202426 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

Application Number

202426

Product Number

2

Dosage Form

-

Strength

1GM;EQ 50MG BASE

Approval Date

2026-04-30

Regulatory Status

RX

2026
20 Jan
RX Application: 202425

Drug Name

SITAGLIPTIN PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2026-01-20

202425 / 1

Active Ingredient

SITAGLIPTIN PHOSPHATE

Application Number

202425

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2026-01-20

Regulatory Status

RX

2026
20 Jan
RX Application: 202425

Drug Name

SITAGLIPTIN PHOSPHATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2026-01-20

202425 / 2

Active Ingredient

SITAGLIPTIN PHOSPHATE

Application Number

202425

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2026-01-20

Regulatory Status

RX

2026
20 Jan
RX Application: 202425

Drug Name

SITAGLIPTIN PHOSPHATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2026-01-20

202425 / 3

Active Ingredient

SITAGLIPTIN PHOSPHATE

Application Number

202425

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2026-01-20

Regulatory Status

RX

2025
27 Jan
Discontinued Application: 212228

Drug Name

SORAFENIB TOSYLATE

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2025-01-27

212228 / 1

Active Ingredient

SORAFENIB TOSYLATE

Application Number

212228

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2025-01-27

Regulatory Status

Discontinued

2002
26 Sep
RX Application: 76140

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

2002-09-26

76140 / 1

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

76140

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

2002-09-26

Regulatory Status

RX

2002
26 Sep
RX Application: 76140

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2002-09-26

76140 / 2

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

76140

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2002-09-26

Regulatory Status

RX

2002
26 Sep
RX Application: 76140

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2002-09-26

76140 / 3

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

76140

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2002-09-26

Regulatory Status

RX

2002
26 Sep
RX Application: 76140

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

240MG

Approval Date

2002-09-26

76140 / 4

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

76140

Product Number

4

Dosage Form

-

Strength

240MG

Approval Date

2002-09-26

Regulatory Status

RX

2003
27 Aug
RX Application: 76214

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

2003-08-27

76214 / 1

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

76214

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

2003-08-27

Regulatory Status

RX

2003
27 Aug
RX Application: 76214

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2003-08-27

76214 / 2

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

76214

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2003-08-27

Regulatory Status

RX

2003
27 Aug
RX Application: 76214

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2003-08-27

76214 / 3

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

76214

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2003-08-27

Regulatory Status

RX

2011
23 Sep
Discontinued Application: 90878

Drug Name

TAMOXIFEN CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2011-09-23

90878 / 1

Active Ingredient

TAMOXIFEN CITRATE

Application Number

90878

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2011-09-23

Regulatory Status

Discontinued

2011
23 Sep
Discontinued Application: 90878

Drug Name

TAMOXIFEN CITRATE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2011-09-23

90878 / 2

Active Ingredient

TAMOXIFEN CITRATE

Application Number

90878

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2011-09-23

Regulatory Status

Discontinued

2022
20 Dec
RX Application: 211607

Drug Name

TASIMELTEON

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2022-12-20

211607 / 1

Active Ingredient

TASIMELTEON

Application Number

211607

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2022-12-20

Regulatory Status

RX

2018
05 Jul
Discontinued Application: 204159

Drug Name

TEMOZOLOMIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2018-07-05

204159 / 1

Active Ingredient

TEMOZOLOMIDE

Application Number

204159

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2018-07-05

Regulatory Status

Discontinued

2018
05 Jul
Discontinued Application: 204159

Drug Name

TEMOZOLOMIDE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2018-07-05

204159 / 2

Active Ingredient

TEMOZOLOMIDE

Application Number

204159

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2018-07-05

Regulatory Status

Discontinued

2018
05 Jul
Discontinued Application: 204159

Drug Name

TEMOZOLOMIDE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2018-07-05

204159 / 3

Active Ingredient

TEMOZOLOMIDE

Application Number

204159

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2018-07-05

Regulatory Status

Discontinued

2018
05 Jul
Discontinued Application: 204159

Drug Name

TEMOZOLOMIDE

Product Number

4

Dosage Form

-

Strength

140MG

Approval Date

2018-07-05

204159 / 4

Active Ingredient

TEMOZOLOMIDE

Application Number

204159

Product Number

4

Dosage Form

-

Strength

140MG

Approval Date

2018-07-05

Regulatory Status

Discontinued

2018
05 Jul
Discontinued Application: 204159

Drug Name

TEMOZOLOMIDE

Product Number

5

Dosage Form

-

Strength

180MG

Approval Date

2018-07-05

204159 / 5

Active Ingredient

TEMOZOLOMIDE

Application Number

204159

Product Number

5

Dosage Form

-

Strength

180MG

Approval Date

2018-07-05

Regulatory Status

Discontinued

2018
05 Jul
Discontinued Application: 204159

Drug Name

TEMOZOLOMIDE

Product Number

6

Dosage Form

-

Strength

250MG

Approval Date

2018-07-05

204159 / 6

Active Ingredient

TEMOZOLOMIDE

Application Number

204159

Product Number

6

Dosage Form

-

Strength

250MG

Approval Date

2018-07-05

Regulatory Status

Discontinued

2024
21 Mar
Discontinued Application: 213867

Drug Name

TENOFOVIR ALAFENAMIDE FUMARATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2024-03-21

213867 / 1

Active Ingredient

TENOFOVIR ALAFENAMIDE FUMARATE

Application Number

213867

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2024-03-21

Regulatory Status

Discontinued

2018
02 Nov
Discontinued Application: 209601

Drug Name

TERIFLUNOMIDE

Product Number

1

Dosage Form

-

Strength

7MG

Approval Date

2018-11-02

209601 / 1

Active Ingredient

TERIFLUNOMIDE

Application Number

209601

Product Number

1

Dosage Form

-

Strength

7MG

Approval Date

2018-11-02

Regulatory Status

Discontinued

2018
02 Nov
Discontinued Application: 209601

Drug Name

TERIFLUNOMIDE

Product Number

2

Dosage Form

-

Strength

14MG

Approval Date

2018-11-02

209601 / 2

Active Ingredient

TERIFLUNOMIDE

Application Number

209601

Product Number

2

Dosage Form

-

Strength

14MG

Approval Date

2018-11-02

Regulatory Status

Discontinued

2023
16 Nov
RX Application: 211097

Drug Name

TERIPARATIDE

Product Number

1

Dosage Form

-

Strength

0.56MG/2.24ML (0.25MG/ML)

Approval Date

2023-11-16

211097 / 1

Active Ingredient

TERIPARATIDE

Application Number

211097

Product Number

1

Dosage Form

-

Strength

0.56MG/2.24ML (0.25MG/ML)

Approval Date

2023-11-16

Regulatory Status

RX

2020
25 Nov
Discontinued Application: 209181

Drug Name

TESTOSTERONE

Product Number

1

Dosage Form

-

Strength

30MG/1.5ML ACTUATION

Approval Date

2020-11-25

209181 / 1

Active Ingredient

TESTOSTERONE

Application Number

209181

Product Number

1

Dosage Form

-

Strength

30MG/1.5ML ACTUATION

Approval Date

2020-11-25

Regulatory Status

Discontinued

2020
17 Mar
RX Application: 206093

Drug Name

TETRABENAZINE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2020-03-17

206093 / 1

Active Ingredient

TETRABENAZINE

Application Number

206093

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2020-03-17

Regulatory Status

RX

2020
17 Mar
RX Application: 206093

Drug Name

TETRABENAZINE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2020-03-17

206093 / 2

Active Ingredient

TETRABENAZINE

Application Number

206093

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2020-03-17

Regulatory Status

RX

2025
01 May
RX Application: 208584

Drug Name

TICAGRELOR

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2025-05-01

208584 / 1

Active Ingredient

TICAGRELOR

Application Number

208584

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2025-05-01

Regulatory Status

RX

2025
28 Oct
RX Application: 208584

Drug Name

TICAGRELOR

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2025-10-28

208584 / 2

Active Ingredient

TICAGRELOR

Application Number

208584

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2025-10-28

Regulatory Status

RX

1999
01 Jul
Discontinued Application: 75089

Drug Name

TICLOPIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1999-07-01

75089 / 1

Active Ingredient

TICLOPIDINE HYDROCHLORIDE

Application Number

75089

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1999-07-01

Regulatory Status

Discontinued

2018
21 Dec
RX Application: 204439

Drug Name

TIGECYCLINE

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2018-12-21

204439 / 1

Active Ingredient

TIGECYCLINE

Application Number

204439

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2018-12-21

Regulatory Status

RX

2015
17 Apr
Discontinued Application: 204936

Drug Name

TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2015-04-17

204936 / 1

Active Ingredient

TIMOLOL MALEATE

Application Number

204936

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2015-04-17

Regulatory Status

Discontinued

2004
16 Jan
RX Application: 76533

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2004-01-16

76533 / 1

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

76533

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2004-01-16

Regulatory Status

RX

2004
16 Jan
RX Application: 76533

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2004-01-16

76533 / 2

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

76533

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2004-01-16

Regulatory Status

RX

2026
03 Jun
RX Application: 218096

Drug Name

TOFACITINIB CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2026-06-03

218096 / 1

Active Ingredient

TOFACITINIB CITRATE

Application Number

218096

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2026-06-03

Regulatory Status

RX

2026
03 Jun
RX Application: 218096

Drug Name

TOFACITINIB CITRATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2026-06-03

218096 / 2

Active Ingredient

TOFACITINIB CITRATE

Application Number

218096

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2026-06-03

Regulatory Status

RX

2026
03 Jun
RX Application: 220458

Drug Name

TOFACITINIB CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 11MG BASE

Approval Date

2026-06-03

220458 / 1

Active Ingredient

TOFACITINIB CITRATE

Application Number

220458

Product Number

1

Dosage Form

-

Strength

EQ 11MG BASE

Approval Date

2026-06-03

Regulatory Status

RX

2012
25 Sep
Discontinued Application: 200164

Drug Name

TOLTERODINE TARTRATE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2012-09-25

200164 / 1

Active Ingredient

TOLTERODINE TARTRATE

Application Number

200164

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2012-09-25

Regulatory Status

Discontinued

2012
25 Sep
Discontinued Application: 200164

Drug Name

TOLTERODINE TARTRATE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2012-09-25

200164 / 2

Active Ingredient

TOLTERODINE TARTRATE

Application Number

200164

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2012-09-25

Regulatory Status

Discontinued

2020
19 May
RX Application: 207605

Drug Name

TOLVAPTAN

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2020-05-19

207605 / 1

Active Ingredient

TOLVAPTAN

Application Number

207605

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2020-05-19

Regulatory Status

RX

2022
06 Sep
RX Application: 207605

Drug Name

TOLVAPTAN

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2022-09-06

207605 / 2

Active Ingredient

TOLVAPTAN

Application Number

207605

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2022-09-06

Regulatory Status

RX

2025
10 Nov
RX Application: 218381

Drug Name

TOLVAPTAN

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2025-11-10

218381 / 1

Active Ingredient

TOLVAPTAN

Application Number

218381

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2025-11-10

Regulatory Status

RX

2025
10 Nov
RX Application: 218381

Drug Name

TOLVAPTAN

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2025-11-10

218381 / 2

Active Ingredient

TOLVAPTAN

Application Number

218381

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2025-11-10

Regulatory Status

RX

2025
10 Nov
RX Application: 218381

Drug Name

TOLVAPTAN

Product Number

3

Dosage Form

-

Strength

45MG

Approval Date

2025-11-10

218381 / 3

Active Ingredient

TOLVAPTAN

Application Number

218381

Product Number

3

Dosage Form

-

Strength

45MG

Approval Date

2025-11-10

Regulatory Status

RX

2025
10 Nov
RX Application: 218381

Drug Name

TOLVAPTAN

Product Number

4

Dosage Form

-

Strength

60MG

Approval Date

2025-11-10

218381 / 4

Active Ingredient

TOLVAPTAN

Application Number

218381

Product Number

4

Dosage Form

-

Strength

60MG

Approval Date

2025-11-10

Regulatory Status

RX

2025
10 Nov
RX Application: 218381

Drug Name

TOLVAPTAN

Product Number

5

Dosage Form

-

Strength

90MG

Approval Date

2025-11-10

218381 / 5

Active Ingredient

TOLVAPTAN

Application Number

218381

Product Number

5

Dosage Form

-

Strength

90MG

Approval Date

2025-11-10

Regulatory Status

RX

2002
10 Jul
Discontinued Application: 75981

Drug Name

TRAMADOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2002-07-10

75981 / 1

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

75981

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2002-07-10

Regulatory Status

Discontinued

2014
27 Jan
Discontinued Application: 202286

Drug Name

TRANEXAMIC ACID

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

2014-01-27

202286 / 1

Active Ingredient

TRANEXAMIC ACID

Application Number

202286

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

2014-01-27

Regulatory Status

Discontinued

2020
14 Jan
RX Application: 209860

Drug Name

TRANEXAMIC ACID

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2020-01-14

209860 / 1

Active Ingredient

TRANEXAMIC ACID

Application Number

209860

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2020-01-14

Regulatory Status

RX

2015
10 Jul
RX Application: 203431

Drug Name

TRAVOPROST

Product Number

1

Dosage Form

-

Strength

0.004%

Approval Date

2015-07-10

203431 / 1

Active Ingredient

TRAVOPROST

Application Number

203431

Product Number

1

Dosage Form

-

Strength

0.004%

Approval Date

2015-07-10

Regulatory Status

RX

1987
25 Mar
RX Application: 71258

Drug Name

TRAZODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1987-03-25

71258 / 1

Active Ingredient

TRAZODONE HYDROCHLORIDE

Application Number

71258

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1987-03-25

Regulatory Status

RX

2023
19 Jan
OTC Application: 214615

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.055MG/SPRAY

Approval Date

2023-01-19

214615 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

214615

Product Number

1

Dosage Form

-

Strength

0.055MG/SPRAY

Approval Date

2023-01-19

Regulatory Status

OTC

2011
06 Dec
RX Application: 91513

Drug Name

TROSPIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2011-12-06

91513 / 1

Active Ingredient

TROSPIUM CHLORIDE

Application Number

91513

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2011-12-06

Regulatory Status

RX

2014
04 Apr
Discontinued Application: 90500

Drug Name

VALACYCLOVIR HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2014-04-04

90500 / 1

Active Ingredient

VALACYCLOVIR HYDROCHLORIDE

Application Number

90500

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2014-04-04

Regulatory Status

Discontinued

2014
04 Apr
Discontinued Application: 90500

Drug Name

VALACYCLOVIR HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

2014-04-04

90500 / 2

Active Ingredient

VALACYCLOVIR HYDROCHLORIDE

Application Number

90500

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

2014-04-04

Regulatory Status

Discontinued

2005
29 Dec
Discontinued Application: 21697

Drug Name

VAPRISOL

Product Number

1

Dosage Form

-

Strength

20MG/4ML (5MG/ML)

Approval Date

2005-12-29

21697 / 1

Active Ingredient

CONIVAPTAN HYDROCHLORIDE

Application Number

21697

Product Number

1

Dosage Form

-

Strength

20MG/4ML (5MG/ML)

Approval Date

2005-12-29

Regulatory Status

Discontinued

2008
08 Oct
RX Application: 21697

Drug Name

VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

20MG/100ML (0.2MG/ML)

Approval Date

2008-10-08

21697 / 2

Active Ingredient

CONIVAPTAN HYDROCHLORIDE

Application Number

21697

Product Number

2

Dosage Form

-

Strength

20MG/100ML (0.2MG/ML)

Approval Date

2008-10-08

Regulatory Status

RX

2023
25 Jan
RX Application: 201962

Drug Name

VARENICLINE TARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2023-01-25

201962 / 1

Active Ingredient

VARENICLINE TARTRATE

Application Number

201962

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2023-01-25

Regulatory Status

RX

2023
25 Jan
RX Application: 201962

Drug Name

VARENICLINE TARTRATE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2023-01-25

201962 / 2

Active Ingredient

VARENICLINE TARTRATE

Application Number

201962

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2023-01-25

Regulatory Status

RX

2012
20 Apr
Discontinued Application: 200878

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2012-04-20

200878 / 1

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

200878

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2012-04-20

Regulatory Status

Discontinued

2012
20 Apr
Discontinued Application: 200878

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2012-04-20

200878 / 2

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

200878

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2012-04-20

Regulatory Status

Discontinued

2012
20 Apr
Discontinued Application: 200878

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

2012-04-20

200878 / 3

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

200878

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

2012-04-20

Regulatory Status

Discontinued

2009
11 Sep
Discontinued Application: 22110

Drug Name

VIBATIV

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

2009-09-11

22110 / 1

Active Ingredient

TELAVANCIN HYDROCHLORIDE

Application Number

22110

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

2009-09-11

Regulatory Status

Discontinued

2009
11 Sep
RX Application: 22110

Drug Name

VIBATIV

Product Number

2

Dosage Form

-

Strength

EQ 750MG BASE/VIAL

Approval Date

2009-09-11

22110 / 2

Active Ingredient

TELAVANCIN HYDROCHLORIDE

Application Number

22110

Product Number

2

Dosage Form

-

Strength

EQ 750MG BASE/VIAL

Approval Date

2009-09-11

Regulatory Status

RX

2023
07 Jul
RX Application: 208228

Drug Name

VILAZODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2023-07-07

208228 / 1

Active Ingredient

VILAZODONE HYDROCHLORIDE

Application Number

208228

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2023-07-07

Regulatory Status

RX

2023
07 Jul
RX Application: 208228

Drug Name

VILAZODONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2023-07-07

208228 / 2

Active Ingredient

VILAZODONE HYDROCHLORIDE

Application Number

208228

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2023-07-07

Regulatory Status

RX

2023
07 Jul
RX Application: 208228

Drug Name

VILAZODONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2023-07-07

208228 / 3

Active Ingredient

VILAZODONE HYDROCHLORIDE

Application Number

208228

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2023-07-07

Regulatory Status

RX

2024
10 Jun
RX Application: 218059

Drug Name

ZINC SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE/5ML (EQ 5MG BASE/ML)

Approval Date

2024-06-10

218059 / 1

Active Ingredient

ZINC SULFATE

Application Number

218059

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE/5ML (EQ 5MG BASE/ML)

Approval Date

2024-06-10

Regulatory Status

RX

2024
28 Oct
RX Application: 218059

Drug Name

ZINC SULFATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE/10ML (EQ 1MG BASE/ML)

Approval Date

2024-10-28

218059 / 2

Active Ingredient

ZINC SULFATE

Application Number

218059

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE/10ML (EQ 1MG BASE/ML)

Approval Date

2024-10-28

Regulatory Status

RX

2012
02 Mar
RX Application: 77561

Drug Name

ZIPRASIDONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-03-02

77561 / 1

Active Ingredient

ZIPRASIDONE HYDROCHLORIDE

Application Number

77561

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-03-02

Regulatory Status

RX

2012
02 Mar
RX Application: 77561

Drug Name

ZIPRASIDONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2012-03-02

77561 / 2

Active Ingredient

ZIPRASIDONE HYDROCHLORIDE

Application Number

77561

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2012-03-02

Regulatory Status

RX

2012
02 Mar
RX Application: 77561

Drug Name

ZIPRASIDONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2012-03-02

77561 / 3

Active Ingredient

ZIPRASIDONE HYDROCHLORIDE

Application Number

77561

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2012-03-02

Regulatory Status

RX

2012
02 Mar
RX Application: 77561

Drug Name

ZIPRASIDONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2012-03-02

77561 / 4

Active Ingredient

ZIPRASIDONE HYDROCHLORIDE

Application Number

77561

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2012-03-02

Regulatory Status

RX

2015
24 Dec
Discontinued Application: 204367

Drug Name

ZOLEDRONIC ACID

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/100ML

Approval Date

2015-12-24

204367 / 1

Active Ingredient

ZOLEDRONIC ACID

Application Number

204367

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/100ML

Approval Date

2015-12-24

Regulatory Status

Discontinued

2013
10 Sep
Discontinued Application: 200266

Drug Name

ZOLPIDEM TARTRATE

Product Number

1

Dosage Form

-

Strength

6.25MG

Approval Date

2013-09-10

200266 / 1

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

200266

Product Number

1

Dosage Form

-

Strength

6.25MG

Approval Date

2013-09-10

Regulatory Status

Discontinued

2013
10 Sep
Discontinued Application: 200266

Drug Name

ZOLPIDEM TARTRATE

Product Number

2

Dosage Form

-

Strength

12.5MG

Approval Date

2013-09-10

200266 / 2

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

200266

Product Number

2

Dosage Form

-

Strength

12.5MG

Approval Date

2013-09-10

Regulatory Status

Discontinued

2005
22 Dec
Discontinued Application: 77642

Drug Name

ZONISAMIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2005-12-22

77642 / 1

Active Ingredient

ZONISAMIDE

Application Number

77642

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2005-12-22

Regulatory Status

Discontinued

2005
22 Dec
Discontinued Application: 77642

Drug Name

ZONISAMIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2005-12-22

77642 / 2

Active Ingredient

ZONISAMIDE

Application Number

77642

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2005-12-22

Regulatory Status

Discontinued

2005
22 Dec
Discontinued Application: 77642

Drug Name

ZONISAMIDE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2005-12-22

77642 / 3

Active Ingredient

ZONISAMIDE

Application Number

77642

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2005-12-22

Regulatory Status

Discontinued

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

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

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FDA Approved Drug Record Details Preview

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

Drug Name

ABIRATERONE ACETATE

Application Number

208453

Product Number

1

Active Ingredient

ABIRATERONE ACETATE

Dosage Form

-

Strength

250MG

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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