Mankind Pharma
FDA Approved Drugs

Mankind Pharma

FDA Approved Drugs Database

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

RX Discontinued Unclassified
  • Total Records 143
  • Latest Approval Date Jul 31, 2026
  • Data Source FDA
  • First Approval Date Apr 16, 2001
All
143
View
Unclassified
11
View
Discontinued
15
View
RX
117
View
Company Overview

Company

Mankind Pharma

Country

India

Website

Visit Website

Email

contact@mankindpharma.com

Social Profiles

Company Snapshot

Mankind Pharma

208, Okhla Industrial Estate, Phase III, New Delhi - 110020

India

www.mankindpharma.com/ contact@mankindpharma.com View on Map
FDA Approved Drug Records ( 143 records )
2020
07 Oct
RX Application: 214282

Drug Name

ACETAZOLAMIDE

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2020-10-07

214282 / 1

Active Ingredient

ACETAZOLAMIDE

Application Number

214282

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2020-10-07

Regulatory Status

RX

2020
07 Oct
RX Application: 214282

Drug Name

ACETAZOLAMIDE

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2020-10-07

214282 / 2

Active Ingredient

ACETAZOLAMIDE

Application Number

214282

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2020-10-07

Regulatory Status

RX

2020
09 Sep
RX Application: 213614

Drug Name

ALOSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2020-09-09

213614 / 1

Active Ingredient

ALOSETRON HYDROCHLORIDE

Application Number

213614

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2020-09-09

Regulatory Status

RX

2020
09 Sep
RX Application: 213614

Drug Name

ALOSETRON HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2020-09-09

213614 / 2

Active Ingredient

ALOSETRON HYDROCHLORIDE

Application Number

213614

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2020-09-09

Regulatory Status

RX

2021
19 Feb
RX Application: 213999

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2021-02-19

213999 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

213999

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2021-02-19

Regulatory Status

RX

2021
19 Feb
RX Application: 213999

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2021-02-19

213999 / 2

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

213999

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2021-02-19

Regulatory Status

RX

2021
19 Feb
RX Application: 213999

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2021-02-19

213999 / 3

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

213999

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2021-02-19

Regulatory Status

RX

2021
19 Feb
RX Application: 213999

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

2021-02-19

213999 / 4

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

213999

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

2021-02-19

Regulatory Status

RX

2021
19 Feb
RX Application: 213999

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

2021-02-19

213999 / 5

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

213999

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

2021-02-19

Regulatory Status

RX

2021
19 Feb
RX Application: 213999

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

150MG

Approval Date

2021-02-19

213999 / 6

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

213999

Product Number

6

Dosage Form

-

Strength

150MG

Approval Date

2021-02-19

Regulatory Status

RX

2024
07 Feb
RX Application: 211734

Drug Name

APREMILAST

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2024-02-07

211734 / 1

Active Ingredient

APREMILAST

Application Number

211734

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2024-02-07

Regulatory Status

RX

2024
07 Feb
RX Application: 211734

Drug Name

APREMILAST

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2024-02-07

211734 / 2

Active Ingredient

APREMILAST

Application Number

211734

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2024-02-07

Regulatory Status

RX

2024
07 Feb
RX Application: 211734

Drug Name

APREMILAST

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2024-02-07

211734 / 3

Active Ingredient

APREMILAST

Application Number

211734

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2024-02-07

Regulatory Status

RX

2022
15 Nov
RX Application: 216128

Drug Name

ARFORMOTEROL TARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 0.015MG BASE/2ML

Approval Date

2022-11-15

216128 / 1

Active Ingredient

ARFORMOTEROL TARTRATE

Application Number

216128

Product Number

1

Dosage Form

-

Strength

EQ 0.015MG BASE/2ML

Approval Date

2022-11-15

Regulatory Status

RX

2024
05 Jan
RX Application: 217081

Drug Name

ATORVASTATIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2024-01-05

217081 / 1

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

217081

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2024-01-05

Regulatory Status

RX

2024
05 Jan
RX Application: 217081

Drug Name

ATORVASTATIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2024-01-05

217081 / 2

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

217081

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2024-01-05

Regulatory Status

RX

2024
05 Jan
RX Application: 217081

Drug Name

ATORVASTATIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2024-01-05

217081 / 3

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

217081

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2024-01-05

Regulatory Status

RX

2024
05 Jan
RX Application: 217081

Drug Name

ATORVASTATIN CALCIUM

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2024-01-05

217081 / 4

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

217081

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2024-01-05

Regulatory Status

RX

2024
08 Jan
RX Application: 218148

Drug Name

ATROPINE SULFATE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2024-01-08

218148 / 1

Active Ingredient

ATROPINE SULFATE

Application Number

218148

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2024-01-08

Regulatory Status

RX

2022
25 Jan
RX Application: 215885

Drug Name

BACLOFEN

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2022-01-25

215885 / 1

Active Ingredient

BACLOFEN

Application Number

215885

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2022-01-25

Regulatory Status

RX

2022
25 Jan
RX Application: 215885

Drug Name

BACLOFEN

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2022-01-25

215885 / 2

Active Ingredient

BACLOFEN

Application Number

215885

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2022-01-25

Regulatory Status

RX

2022
25 Jan
RX Application: 215885

Drug Name

BACLOFEN

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2022-01-25

215885 / 3

Active Ingredient

BACLOFEN

Application Number

215885

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2022-01-25

Regulatory Status

RX

2025
17 Mar
RX Application: 218196

Drug Name

BIMATOPROST

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

2025-03-17

218196 / 1

Active Ingredient

BIMATOPROST

Application Number

218196

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

2025-03-17

Regulatory Status

RX

2026
16 Apr
RX Application: 220398

Drug Name

BRIMONIDINE TARTRATE

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2026-04-16

220398 / 1

Active Ingredient

BRIMONIDINE TARTRATE

Application Number

220398

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2026-04-16

Regulatory Status

RX

2025
03 Apr
RX Application: 219291

Drug Name

BUMETANIDE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2025-04-03

219291 / 1

Active Ingredient

BUMETANIDE

Application Number

219291

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2025-04-03

Regulatory Status

RX

2025
03 Apr
RX Application: 219291

Drug Name

BUMETANIDE

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2025-04-03

219291 / 2

Active Ingredient

BUMETANIDE

Application Number

219291

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2025-04-03

Regulatory Status

RX

2025
03 Apr
RX Application: 219291

Drug Name

BUMETANIDE

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2025-04-03

219291 / 3

Active Ingredient

BUMETANIDE

Application Number

219291

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2025-04-03

Regulatory Status

RX

2022
04 Aug
RX Application: 215587

Drug Name

CHLORTHALIDONE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2022-08-04

215587 / 1

Active Ingredient

CHLORTHALIDONE

Application Number

215587

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2022-08-04

Regulatory Status

RX

2022
04 Aug
RX Application: 215587

Drug Name

CHLORTHALIDONE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2022-08-04

215587 / 2

Active Ingredient

CHLORTHALIDONE

Application Number

215587

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2022-08-04

Regulatory Status

RX

2019
08 Apr
RX Application: 211767

Drug Name

CLOMIPRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2019-04-08

211767 / 1

Active Ingredient

CLOMIPRAMINE HYDROCHLORIDE

Application Number

211767

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2019-04-08

Regulatory Status

RX

2019
08 Apr
RX Application: 211767

Drug Name

CLOMIPRAMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2019-04-08

211767 / 2

Active Ingredient

CLOMIPRAMINE HYDROCHLORIDE

Application Number

211767

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2019-04-08

Regulatory Status

RX

2019
08 Apr
RX Application: 211767

Drug Name

CLOMIPRAMINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2019-04-08

211767 / 3

Active Ingredient

CLOMIPRAMINE HYDROCHLORIDE

Application Number

211767

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2019-04-08

Regulatory Status

RX

2024
10 Jul
RX Application: 217839

Drug Name

CYANOCOBALAMIN

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2024-07-10

217839 / 1

Active Ingredient

CYANOCOBALAMIN

Application Number

217839

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2024-07-10

Regulatory Status

RX

2025
12 Aug
RX Application: 217358

Drug Name

DIVALPROEX SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 125MG VALPROIC ACID

Approval Date

2025-08-12

217358 / 1

Active Ingredient

DIVALPROEX SODIUM

Application Number

217358

Product Number

1

Dosage Form

-

Strength

EQ 125MG VALPROIC ACID

Approval Date

2025-08-12

Regulatory Status

RX

2022
09 Feb
RX Application: 215710

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2022-02-09

215710 / 1

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

215710

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2022-02-09

Regulatory Status

RX

2022
09 Feb
RX Application: 215710

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2022-02-09

215710 / 2

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

215710

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2022-02-09

Regulatory Status

RX

2022
09 Feb
RX Application: 215710

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2022-02-09

215710 / 3

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

215710

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2022-02-09

Regulatory Status

RX

2022
09 Feb
RX Application: 215710

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2022-02-09

215710 / 4

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

215710

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2022-02-09

Regulatory Status

RX

2022
09 Feb
RX Application: 215710

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2022-02-09

215710 / 5

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

215710

Product Number

5

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2022-02-09

Regulatory Status

RX

2022
14 Apr
RX Application: 216129

Drug Name

EPHEDRINE SULFATE

Product Number

1

Dosage Form

-

Strength

50MG/ML (50MG/ML)

Approval Date

2022-04-14

216129 / 1

Active Ingredient

EPHEDRINE SULFATE

Application Number

216129

Product Number

1

Dosage Form

-

Strength

50MG/ML (50MG/ML)

Approval Date

2022-04-14

Regulatory Status

RX

2026
02 Jan
Discontinued Application: 219773

Drug Name

EXTENDED PHENYTOIN SODIUM

Product Number

1

Dosage Form

-

Strength

100MG EXTENDED

Approval Date

2026-01-02

219773 / 1

Active Ingredient

PHENYTOIN SODIUM

Application Number

219773

Product Number

1

Dosage Form

-

Strength

100MG EXTENDED

Approval Date

2026-01-02

Regulatory Status

Discontinued

2001
16 Apr
RX Application: 75302

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2001-04-16

75302 / 1

Active Ingredient

FAMOTIDINE

Application Number

75302

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2001-04-16

Regulatory Status

RX

2001
16 Apr
RX Application: 75302

Drug Name

FAMOTIDINE

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2001-04-16

75302 / 2

Active Ingredient

FAMOTIDINE

Application Number

75302

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2001-04-16

Regulatory Status

RX

2020
12 Jun
RX Application: 213864

Drug Name

FENOFIBRATE

Product Number

1

Dosage Form

-

Strength

54MG

Approval Date

2020-06-12

213864 / 1

Active Ingredient

FENOFIBRATE

Application Number

213864

Product Number

1

Dosage Form

-

Strength

54MG

Approval Date

2020-06-12

Regulatory Status

RX

2020
12 Jun
RX Application: 213864

Drug Name

FENOFIBRATE

Product Number

2

Dosage Form

-

Strength

160MG

Approval Date

2020-06-12

213864 / 2

Active Ingredient

FENOFIBRATE

Application Number

213864

Product Number

2

Dosage Form

-

Strength

160MG

Approval Date

2020-06-12

Regulatory Status

RX

2023
22 Mar
RX Application: 215883

Drug Name

FORMOTEROL FUMARATE

Product Number

1

Dosage Form

-

Strength

0.02MG/2ML

Approval Date

2023-03-22

215883 / 1

Active Ingredient

FORMOTEROL FUMARATE

Application Number

215883

Product Number

1

Dosage Form

-

Strength

0.02MG/2ML

Approval Date

2023-03-22

Regulatory Status

RX

2022
16 Dec
RX Application: 216860

Drug Name

FUROSEMIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2022-12-16

216860 / 1

Active Ingredient

FUROSEMIDE

Application Number

216860

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2022-12-16

Regulatory Status

RX

2023
27 Feb
Discontinued Application: 217354

Drug Name

GLYCOPYRROLATE

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2023-02-27

217354 / 1

Active Ingredient

GLYCOPYRROLATE

Application Number

217354

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2023-02-27

Regulatory Status

Discontinued

2024
11 Apr
RX Application: 216918

Drug Name

HALOPERIDOL

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2024-04-11

216918 / 1

Active Ingredient

HALOPERIDOL

Application Number

216918

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2024-04-11

Regulatory Status

RX

2024
11 Apr
RX Application: 216918

Drug Name

HALOPERIDOL

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2024-04-11

216918 / 2

Active Ingredient

HALOPERIDOL

Application Number

216918

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2024-04-11

Regulatory Status

RX

2024
11 Apr
RX Application: 216918

Drug Name

HALOPERIDOL

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2024-04-11

216918 / 3

Active Ingredient

HALOPERIDOL

Application Number

216918

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2024-04-11

Regulatory Status

RX

2024
11 Apr
RX Application: 216918

Drug Name

HALOPERIDOL

Product Number

4

Dosage Form

-

Strength

5MG

Approval Date

2024-04-11

216918 / 4

Active Ingredient

HALOPERIDOL

Application Number

216918

Product Number

4

Dosage Form

-

Strength

5MG

Approval Date

2024-04-11

Regulatory Status

RX

2024
11 Apr
RX Application: 216918

Drug Name

HALOPERIDOL

Product Number

5

Dosage Form

-

Strength

10MG

Approval Date

2024-04-11

216918 / 5

Active Ingredient

HALOPERIDOL

Application Number

216918

Product Number

5

Dosage Form

-

Strength

10MG

Approval Date

2024-04-11

Regulatory Status

RX

2024
11 Apr
RX Application: 216918

Drug Name

HALOPERIDOL

Product Number

6

Dosage Form

-

Strength

20MG

Approval Date

2024-04-11

216918 / 6

Active Ingredient

HALOPERIDOL

Application Number

216918

Product Number

6

Dosage Form

-

Strength

20MG

Approval Date

2024-04-11

Regulatory Status

RX

2023
23 May
RX Application: 216730

Drug Name

HALOPERIDOL DECANOATE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

2023-05-23

216730 / 1

Active Ingredient

HALOPERIDOL DECANOATE

Application Number

216730

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

2023-05-23

Regulatory Status

RX

2023
23 May
RX Application: 216730

Drug Name

HALOPERIDOL DECANOATE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

2023-05-23

216730 / 2

Active Ingredient

HALOPERIDOL DECANOATE

Application Number

216730

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

2023-05-23

Regulatory Status

RX

2025
17 Dec
Discontinued Application: 220360

Drug Name

LATANOPROST

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2025-12-17

220360 / 1

Active Ingredient

LATANOPROST

Application Number

220360

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2025-12-17

Regulatory Status

Discontinued

2024
21 Oct
Discontinued Application: 218770

Drug Name

LEVALBUTEROL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.0103% BASE

Approval Date

2024-10-21

218770 / 1

Active Ingredient

LEVALBUTEROL HYDROCHLORIDE

Application Number

218770

Product Number

1

Dosage Form

-

Strength

EQ 0.0103% BASE

Approval Date

2024-10-21

Regulatory Status

Discontinued

2024
21 Oct
Discontinued Application: 218770

Drug Name

LEVALBUTEROL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 0.021% BASE

Approval Date

2024-10-21

218770 / 2

Active Ingredient

LEVALBUTEROL HYDROCHLORIDE

Application Number

218770

Product Number

2

Dosage Form

-

Strength

EQ 0.021% BASE

Approval Date

2024-10-21

Regulatory Status

Discontinued

2024
21 Oct
Discontinued Application: 218770

Drug Name

LEVALBUTEROL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 0.042% BASE

Approval Date

2024-10-21

218770 / 3

Active Ingredient

LEVALBUTEROL HYDROCHLORIDE

Application Number

218770

Product Number

3

Dosage Form

-

Strength

EQ 0.042% BASE

Approval Date

2024-10-21

Regulatory Status

Discontinued

2023
16 Jun
RX Application: 217692

Drug Name

LIDOCAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2023-06-16

217692 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

217692

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2023-06-16

Regulatory Status

RX

2023
16 Jun
RX Application: 217692

Drug Name

LIDOCAINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

2023-06-16

217692 / 2

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

217692

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

2023-06-16

Regulatory Status

RX

2023
29 Nov
RX Application: 217692

Drug Name

LIDOCAINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

1%

Approval Date

2023-11-29

217692 / 3

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

217692

Product Number

3

Dosage Form

-

Strength

1%

Approval Date

2023-11-29

Regulatory Status

RX

2023
11 Jul
RX Application: 217693

Drug Name

LIDOCAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2023-07-11

217693 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

217693

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2023-07-11

Regulatory Status

RX

2023
11 Jul
RX Application: 217693

Drug Name

LIDOCAINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

2023-07-11

217693 / 2

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

217693

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

2023-07-11

Regulatory Status

RX

2023
01 Nov
RX Application: 217271

Drug Name

MIDODRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2023-11-01

217271 / 1

Active Ingredient

MIDODRINE HYDROCHLORIDE

Application Number

217271

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2023-11-01

Regulatory Status

RX

2023
01 Nov
RX Application: 217271

Drug Name

MIDODRINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2023-11-01

217271 / 2

Active Ingredient

MIDODRINE HYDROCHLORIDE

Application Number

217271

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2023-11-01

Regulatory Status

RX

2023
01 Nov
RX Application: 217271

Drug Name

MIDODRINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2023-11-01

217271 / 3

Active Ingredient

MIDODRINE HYDROCHLORIDE

Application Number

217271

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2023-11-01

Regulatory Status

RX

2025
27 Jan
RX Application: 217988

Drug Name

MOXIFLOXACIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2025-01-27

217988 / 1

Active Ingredient

MOXIFLOXACIN HYDROCHLORIDE

Application Number

217988

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2025-01-27

Regulatory Status

RX

2024
29 Feb
RX Application: 218404

Drug Name

NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

2024-02-29

218404 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

218404

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

2024-02-29

Regulatory Status

RX

2022
14 Nov
RX Application: 216172

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2022-11-14

216172 / 1

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

216172

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2022-11-14

Regulatory Status

RX

2022
14 Nov
RX Application: 216172

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2022-11-14

216172 / 2

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

216172

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2022-11-14

Regulatory Status

RX

2022
14 Nov
RX Application: 216172

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2022-11-14

216172 / 3

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

216172

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2022-11-14

Regulatory Status

RX

2022
14 Nov
RX Application: 216172

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2022-11-14

216172 / 4

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

216172

Product Number

4

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2022-11-14

Regulatory Status

RX

2009
17 Nov
RX Application: 90671

Drug Name

NICARDIPINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG/10ML (2.5MG/ML)

Approval Date

2009-11-17

90671 / 1

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

90671

Product Number

1

Dosage Form

-

Strength

25MG/10ML (2.5MG/ML)

Approval Date

2009-11-17

Regulatory Status

RX

2023
21 Mar
RX Application: 217272

Drug Name

NITROFURANTOIN

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2023-03-21

217272 / 1

Active Ingredient

NITROFURANTOIN, MACROCRYSTALLINE

Application Number

217272

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2023-03-21

Regulatory Status

RX

2023
21 Mar
RX Application: 217272

Drug Name

NITROFURANTOIN

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2023-03-21

217272 / 2

Active Ingredient

NITROFURANTOIN, MACROCRYSTALLINE

Application Number

217272

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2023-03-21

Regulatory Status

RX

2023
21 Mar
RX Application: 217272

Drug Name

NITROFURANTOIN

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2023-03-21

217272 / 3

Active Ingredient

NITROFURANTOIN, MACROCRYSTALLINE

Application Number

217272

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2023-03-21

Regulatory Status

RX

2023
11 Jul
RX Application: 217357

Drug Name

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

Product Number

1

Dosage Form

-

Strength

75MG;25MG

Approval Date

2023-07-11

217357 / 1

Active Ingredient

NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

Application Number

217357

Product Number

1

Dosage Form

-

Strength

75MG;25MG

Approval Date

2023-07-11

Regulatory Status

RX

2023
05 Dec
RX Application: 217970

Drug Name

NITROGLYCERIN

Product Number

1

Dosage Form

-

Strength

0.3MG

Approval Date

2023-12-05

217970 / 1

Active Ingredient

NITROGLYCERIN

Application Number

217970

Product Number

1

Dosage Form

-

Strength

0.3MG

Approval Date

2023-12-05

Regulatory Status

RX

2023
05 Dec
RX Application: 217970

Drug Name

NITROGLYCERIN

Product Number

2

Dosage Form

-

Strength

0.4MG

Approval Date

2023-12-05

217970 / 2

Active Ingredient

NITROGLYCERIN

Application Number

217970

Product Number

2

Dosage Form

-

Strength

0.4MG

Approval Date

2023-12-05

Regulatory Status

RX

2023
05 Dec
RX Application: 217970

Drug Name

NITROGLYCERIN

Product Number

3

Dosage Form

-

Strength

0.6MG

Approval Date

2023-12-05

217970 / 3

Active Ingredient

NITROGLYCERIN

Application Number

217970

Product Number

3

Dosage Form

-

Strength

0.6MG

Approval Date

2023-12-05

Regulatory Status

RX

2022
23 Nov
RX Application: 215886

Drug Name

OFLOXACIN

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2022-11-23

215886 / 1

Active Ingredient

OFLOXACIN

Application Number

215886

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2022-11-23

Regulatory Status

RX

2022
14 Jul
RX Application: 216130

Drug Name

OFLOXACIN

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2022-07-14

216130 / 1

Active Ingredient

OFLOXACIN

Application Number

216130

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2022-07-14

Regulatory Status

RX

2021
15 Nov
RX Application: 215458

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

2021-11-15

215458 / 1

Active Ingredient

OMEGA-3-ACID ETHYL ESTERS

Application Number

215458

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2021-11-15

Regulatory Status

RX

2022
26 Jul
RX Application: 215880

Drug Name

PANTOPRAZOLE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2022-07-26

215880 / 1

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

215880

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2022-07-26

Regulatory Status

RX

2024
25 Apr
Discontinued Application: 215880

Drug Name

PANTOPRAZOLE SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2024-04-25

215880 / 2

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

215880

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2024-04-25

Regulatory Status

Discontinued

2023
11 Jan
RX Application: 216496

Drug Name

PHENYLEPHRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

2023-01-11

216496 / 1

Active Ingredient

PHENYLEPHRINE HYDROCHLORIDE

Application Number

216496

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

2023-01-11

Regulatory Status

RX

2022
29 Sep
RX Application: 216859

Drug Name

PHENYLEPHRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5%

Approval Date

2022-09-29

216859 / 1

Active Ingredient

PHENYLEPHRINE HYDROCHLORIDE

Application Number

216859

Product Number

1

Dosage Form

-

Strength

2.5%

Approval Date

2022-09-29

Regulatory Status

RX

2022
30 Aug
RX Application: 217069

Drug Name

PHENYLEPHRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML (10MG/ML)

Approval Date

2022-08-30

217069 / 1

Active Ingredient

PHENYLEPHRINE HYDROCHLORIDE

Application Number

217069

Product Number

1

Dosage Form

-

Strength

10MG/ML (10MG/ML)

Approval Date

2022-08-30

Regulatory Status

RX

2022
30 Aug
RX Application: 217069

Drug Name

PHENYLEPHRINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2022-08-30

217069 / 2

Active Ingredient

PHENYLEPHRINE HYDROCHLORIDE

Application Number

217069

Product Number

2

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2022-08-30

Regulatory Status

RX

2022
30 Aug
RX Application: 217069

Drug Name

PHENYLEPHRINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2022-08-30

217069 / 3

Active Ingredient

PHENYLEPHRINE HYDROCHLORIDE

Application Number

217069

Product Number

3

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2022-08-30

Regulatory Status

RX

2022
30 Dec
RX Application: 215697

Drug Name

PRAZOSIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2022-12-30

215697 / 1

Active Ingredient

PRAZOSIN HYDROCHLORIDE

Application Number

215697

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2022-12-30

Regulatory Status

RX

2022
30 Dec
RX Application: 215697

Drug Name

PRAZOSIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2022-12-30

215697 / 2

Active Ingredient

PRAZOSIN HYDROCHLORIDE

Application Number

215697

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2022-12-30

Regulatory Status

RX

2022
30 Dec
RX Application: 215697

Drug Name

PRAZOSIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2022-12-30

215697 / 3

Active Ingredient

PRAZOSIN HYDROCHLORIDE

Application Number

215697

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2022-12-30

Regulatory Status

RX

2025
21 May
RX Application: 219136

Drug Name

PROPARACAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2025-05-21

219136 / 1

Active Ingredient

PROPARACAINE HYDROCHLORIDE

Application Number

219136

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2025-05-21

Regulatory Status

RX

2026
27 Jan
RX Application: 216663

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2026-01-27

216663 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

216663

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2026-01-27

Regulatory Status

RX

2026
27 Jan
RX Application: 216663

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2026-01-27

216663 / 2

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

216663

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2026-01-27

Regulatory Status

RX

2026
27 Jan
RX Application: 216663

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2026-01-27

216663 / 3

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

216663

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2026-01-27

Regulatory Status

RX

2026
27 Jan
RX Application: 216663

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

60MG

Approval Date

2026-01-27

216663 / 4

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

216663

Product Number

4

Dosage Form

-

Strength

60MG

Approval Date

2026-01-27

Regulatory Status

RX

2026
27 Jan
RX Application: 216663

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

80MG

Approval Date

2026-01-27

216663 / 5

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

216663

Product Number

5

Dosage Form

-

Strength

80MG

Approval Date

2026-01-27

Regulatory Status

RX

2020
12 Feb
RX Application: 212284

Drug Name

RANOLAZINE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2020-02-12

212284 / 1

Active Ingredient

RANOLAZINE

Application Number

212284

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2020-02-12

Regulatory Status

RX

2020
12 Feb
RX Application: 212284

Drug Name

RANOLAZINE

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2020-02-12

212284 / 2

Active Ingredient

RANOLAZINE

Application Number

212284

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2020-02-12

Regulatory Status

RX

-
Unclassified Application: 218089

Drug Name

REVEFENACIN

Product Number

1

Dosage Form

-

Strength

175MCG/3ML

Approval Date

-

218089 / 1

Active Ingredient

REVEFENACIN

Application Number

218089

Product Number

1

Dosage Form

-

Strength

175MCG/3ML

Approval Date

-

Regulatory Status

Unclassified

2026
01 Jul
RX Application: 220874

Drug Name

RIVAROXABAN

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2026-07-01

220874 / 1

Active Ingredient

RIVAROXABAN

Application Number

220874

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2026-07-01

Regulatory Status

RX

2026
01 Jul
RX Application: 220874

Drug Name

RIVAROXABAN

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2026-07-01

220874 / 2

Active Ingredient

RIVAROXABAN

Application Number

220874

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2026-07-01

Regulatory Status

RX

2026
01 Jul
RX Application: 220874

Drug Name

RIVAROXABAN

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2026-07-01

220874 / 3

Active Ingredient

RIVAROXABAN

Application Number

220874

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2026-07-01

Regulatory Status

RX

2026
01 Jul
RX Application: 220874

Drug Name

RIVAROXABAN

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2026-07-01

220874 / 4

Active Ingredient

RIVAROXABAN

Application Number

220874

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2026-07-01

Regulatory Status

RX

2025
29 May
RX Application: 219674

Drug Name

ROCURONIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2025-05-29

219674 / 1

Active Ingredient

ROCURONIUM BROMIDE

Application Number

219674

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2025-05-29

Regulatory Status

RX

2025
29 May
RX Application: 219674

Drug Name

ROCURONIUM BROMIDE

Product Number

2

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2025-05-29

219674 / 2

Active Ingredient

ROCURONIUM BROMIDE

Application Number

219674

Product Number

2

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2025-05-29

Regulatory Status

RX

2025
16 May
Discontinued Application: 206603

Drug Name

ROSUVASTATIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2025-05-16

206603 / 1

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

206603

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2025-05-16

Regulatory Status

Discontinued

2025
16 May
Discontinued Application: 206603

Drug Name

ROSUVASTATIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2025-05-16

206603 / 2

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

206603

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2025-05-16

Regulatory Status

Discontinued

2025
16 May
Discontinued Application: 206603

Drug Name

ROSUVASTATIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2025-05-16

206603 / 3

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

206603

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2025-05-16

Regulatory Status

Discontinued

2025
16 May
Discontinued Application: 206603

Drug Name

ROSUVASTATIN CALCIUM

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2025-05-16

206603 / 4

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

206603

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2025-05-16

Regulatory Status

Discontinued

-
Unclassified Application: 216919

Drug Name

SITAGLIPTIN

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

-

216919 / 1

Active Ingredient

SITAGLIPTIN PHOSPHATE

Application Number

216919

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 216919

Drug Name

SITAGLIPTIN

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

-

216919 / 2

Active Ingredient

SITAGLIPTIN PHOSPHATE

Application Number

216919

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 216919

Drug Name

SITAGLIPTIN

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

-

216919 / 3

Active Ingredient

SITAGLIPTIN PHOSPHATE

Application Number

216919

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 218971

Drug Name

SITAGLIPTIN AND METFORMIN HCL

Product Number

1

Dosage Form

-

Strength

1000MG ER TABLET

Approval Date

-

218971 / 1

Active Ingredient

SITAGLIPTIN, METFORMIN HYDROCHLORIDE

Application Number

218971

Product Number

1

Dosage Form

-

Strength

1000MG ER TABLET

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 218971

Drug Name

SITAGLIPTIN AND METFORMIN HCL

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE TABLET

Approval Date

-

218971 / 2

Active Ingredient

SITAGLIPTIN, METFORMIN HYDROCHLORIDE

Application Number

218971

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE TABLET

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 218971

Drug Name

SITAGLIPTIN AND METFORMIN HCL

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

-

218971 / 3

Active Ingredient

SITAGLIPTIN, METFORMIN HYDROCHLORIDE

Application Number

218971

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 218971

Drug Name

SITAGLIPTIN AND METFORMIN HCL

Product Number

4

Dosage Form

-

Strength

50MG

Approval Date

-

218971 / 4

Active Ingredient

SITAGLIPTIN, METFORMIN HYDROCHLORIDE

Application Number

218971

Product Number

4

Dosage Form

-

Strength

50MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 218971

Drug Name

SITAGLIPTIN AND METFORMIN HCL

Product Number

5

Dosage Form

-

Strength

1000MG

Approval Date

-

218971 / 5

Active Ingredient

SITAGLIPTIN, METFORMIN HYDROCHLORIDE

Application Number

218971

Product Number

5

Dosage Form

-

Strength

1000MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 218405

Drug Name

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

-

218405 / 2

Active Ingredient

SITAGLIPTIN, METFORMIN HYDROCHLORIDE

Application Number

218405

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 218405

Drug Name

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

-

218405 / 3

Active Ingredient

SITAGLIPTIN, METFORMIN HYDROCHLORIDE

Application Number

218405

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

-

Regulatory Status

Unclassified

2023
02 Feb
Discontinued Application: 216127

Drug Name

SUCCINYLCHOLINE CHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2023-02-02

216127 / 1

Active Ingredient

SUCCINYLCHOLINE CHLORIDE

Application Number

216127

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2023-02-02

Regulatory Status

Discontinued

2026
28 Jul
RX Application: 214230

Drug Name

SUGAMMADEX SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/2ML (EQ 100MG BASE/ML)

Approval Date

2026-07-28

214230 / 1

Active Ingredient

SUGAMMADEX SODIUM

Application Number

214230

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/2ML (EQ 100MG BASE/ML)

Approval Date

2026-07-28

Regulatory Status

RX

2026
28 Jul
RX Application: 214230

Drug Name

SUGAMMADEX SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/5ML (EQ 100MG BASE/ML)

Approval Date

2026-07-28

214230 / 2

Active Ingredient

SUGAMMADEX SODIUM

Application Number

214230

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/5ML (EQ 100MG BASE/ML)

Approval Date

2026-07-28

Regulatory Status

RX

2024
15 Oct
RX Application: 218157

Drug Name

TELMISARTAN

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2024-10-15

218157 / 1

Active Ingredient

TELMISARTAN

Application Number

218157

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2024-10-15

Regulatory Status

RX

2024
15 Oct
RX Application: 218157

Drug Name

TELMISARTAN

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2024-10-15

218157 / 2

Active Ingredient

TELMISARTAN

Application Number

218157

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2024-10-15

Regulatory Status

RX

2024
15 Oct
RX Application: 218157

Drug Name

TELMISARTAN

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

2024-10-15

218157 / 3

Active Ingredient

TELMISARTAN

Application Number

218157

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

2024-10-15

Regulatory Status

RX

2025
03 Mar
Discontinued Application: 218406

Drug Name

TELMISARTAN AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;40MG

Approval Date

2025-03-03

218406 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; TELMISARTAN

Application Number

218406

Product Number

1

Dosage Form

-

Strength

12.5MG;40MG

Approval Date

2025-03-03

Regulatory Status

Discontinued

2025
03 Mar
Discontinued Application: 218406

Drug Name

TELMISARTAN AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;80MG

Approval Date

2025-03-03

218406 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; TELMISARTAN

Application Number

218406

Product Number

2

Dosage Form

-

Strength

12.5MG;80MG

Approval Date

2025-03-03

Regulatory Status

Discontinued

2025
03 Mar
Discontinued Application: 218406

Drug Name

TELMISARTAN AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;80MG

Approval Date

2025-03-03

218406 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; TELMISARTAN

Application Number

218406

Product Number

3

Dosage Form

-

Strength

25MG;80MG

Approval Date

2025-03-03

Regulatory Status

Discontinued

2026
31 Jul
RX Application: 220513

Drug Name

THIAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2026-07-31

220513 / 1

Active Ingredient

THIAMINE HYDROCHLORIDE

Application Number

220513

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2026-07-31

Regulatory Status

RX

2026
06 Feb
RX Application: 217679

Drug Name

TICAGRELOR

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2026-02-06

217679 / 1

Active Ingredient

TICAGRELOR

Application Number

217679

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2026-02-06

Regulatory Status

RX

2026
06 Feb
RX Application: 217679

Drug Name

TICAGRELOR

Product Number

2

Dosage Form

-

Strength

90MG

Approval Date

2026-02-06

217679 / 2

Active Ingredient

TICAGRELOR

Application Number

217679

Product Number

2

Dosage Form

-

Strength

90MG

Approval Date

2026-02-06

Regulatory Status

RX

2009
28 Sep
RX Application: 78771

Drug Name

TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 0.25% BASE

Approval Date

2009-09-28

78771 / 1

Active Ingredient

TIMOLOL MALEATE

Application Number

78771

Product Number

1

Dosage Form

-

Strength

EQ 0.25% BASE

Approval Date

2009-09-28

Regulatory Status

RX

2009
28 Sep
RX Application: 78771

Drug Name

TIMOLOL MALEATE

Product Number

2

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2009-09-28

78771 / 2

Active Ingredient

TIMOLOL MALEATE

Application Number

78771

Product Number

2

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2009-09-28

Regulatory Status

RX

2023
30 Jun
RX Application: 214478

Drug Name

TOBRAMYCIN

Product Number

1

Dosage Form

-

Strength

300MG/5ML

Approval Date

2023-06-30

214478 / 1

Active Ingredient

TOBRAMYCIN

Application Number

214478

Product Number

1

Dosage Form

-

Strength

300MG/5ML

Approval Date

2023-06-30

Regulatory Status

RX

2022
22 Sep
RX Application: 216725

Drug Name

TOBRAMYCIN

Product Number

1

Dosage Form

-

Strength

300MG/4ML

Approval Date

2022-09-22

216725 / 1

Active Ingredient

TOBRAMYCIN

Application Number

216725

Product Number

1

Dosage Form

-

Strength

300MG/4ML

Approval Date

2022-09-22

Regulatory Status

RX

2023
01 Aug
RX Application: 214255

Drug Name

VARENICLINE TARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2023-08-01

214255 / 1

Active Ingredient

VARENICLINE TARTRATE

Application Number

214255

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2023-08-01

Regulatory Status

RX

2023
01 Aug
RX Application: 214255

Drug Name

VARENICLINE TARTRATE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2023-08-01

214255 / 2

Active Ingredient

VARENICLINE TARTRATE

Application Number

214255

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2023-08-01

Regulatory Status

RX

2022
15 Jun
RX Application: 214653

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

2022-06-15

214653 / 1

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

214653

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

2022-06-15

Regulatory Status

RX

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Drug Status Breakdown
143 total
  • RX
  • Discontinued
  • Unclassified
Official Source

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

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

ACETAZOLAMIDE

Application Number

214282

Product Number

1

Active Ingredient

ACETAZOLAMIDE

Dosage Form

-

Strength

125MG

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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