Novitium Pharma LLC RX
FDA Approved Drugs

Novitium Pharma LLC RX

FDA Approved Drugs Database

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

RX
  • Total Records 173
  • Latest Approval Date Aug 12, 2026
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
206
View
Discontinued
33
View
RX
173
View
Company Overview

Company

Novitium Pharma LLC RX

Country

U.S.A

Website

Visit Website

Email

info@novitiumpharma.com

Social Profiles

Company Snapshot

Novitium Pharma LLC RX

70 Lake Drive East Windsor, NJ 08520

U.S.A

novitiumpharma.com/ info@novitiumpharma.com View on Map
FDA Approved Drug Records ( 173 records )
2019
17 Oct
RX Application: 210588

Drug Name

ACETAZOLAMIDE

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2019-10-17

210588 / 1

Active Ingredient

ACETAZOLAMIDE

Application Number

210588

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2019-10-17

Regulatory Status

RX

2019
17 Oct
RX Application: 210588

Drug Name

ACETAZOLAMIDE

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2019-10-17

210588 / 2

Active Ingredient

ACETAZOLAMIDE

Application Number

210588

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2019-10-17

Regulatory Status

RX

2020
10 Jul
RX Application: 212252

Drug Name

ACYCLOVIR

Product Number

1

Dosage Form

-

Strength

200MG/5ML

Approval Date

2020-07-10

212252 / 1

Active Ingredient

ACYCLOVIR

Application Number

212252

Product Number

1

Dosage Form

-

Strength

200MG/5ML

Approval Date

2020-07-10

Regulatory Status

RX

2023
11 May
RX Application: 214512

Drug Name

ALENDRONATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 70MG BASE/75ML

Approval Date

2023-05-11

214512 / 1

Active Ingredient

ALENDRONATE SODIUM

Application Number

214512

Product Number

1

Dosage Form

-

Strength

EQ 70MG BASE/75ML

Approval Date

2023-05-11

Regulatory Status

RX

1993
19 Oct
RX Application: 74174

Drug Name

ALPRAZOLAM

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

1993-10-19

74174 / 1

Active Ingredient

ALPRAZOLAM

Application Number

74174

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

1993-10-19

Regulatory Status

RX

1993
19 Oct
RX Application: 74174

Drug Name

ALPRAZOLAM

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

1993-10-19

74174 / 2

Active Ingredient

ALPRAZOLAM

Application Number

74174

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

1993-10-19

Regulatory Status

RX

1993
19 Oct
RX Application: 74174

Drug Name

ALPRAZOLAM

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

1993-10-19

74174 / 3

Active Ingredient

ALPRAZOLAM

Application Number

74174

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

1993-10-19

Regulatory Status

RX

1993
19 Oct
RX Application: 74174

Drug Name

ALPRAZOLAM

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

1993-10-19

74174 / 4

Active Ingredient

ALPRAZOLAM

Application Number

74174

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

1993-10-19

Regulatory Status

RX

2005
18 Apr
RX Application: 76811

Drug Name

ANAGRELIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2005-04-18

76811 / 1

Active Ingredient

ANAGRELIDE HYDROCHLORIDE

Application Number

76811

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2005-04-18

Regulatory Status

RX

2005
18 Apr
RX Application: 76811

Drug Name

ANAGRELIDE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2005-04-18

76811 / 2

Active Ingredient

ANAGRELIDE HYDROCHLORIDE

Application Number

76811

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2005-04-18

Regulatory Status

RX

2021
25 Oct
RX Application: 215560

Drug Name

ATENOLOL AND CHLORTHALIDONE

Product Number

1

Dosage Form

-

Strength

50MG;25MG

Approval Date

2021-10-25

215560 / 1

Active Ingredient

ATENOLOL; CHLORTHALIDONE

Application Number

215560

Product Number

1

Dosage Form

-

Strength

50MG;25MG

Approval Date

2021-10-25

Regulatory Status

RX

2021
25 Oct
RX Application: 215560

Drug Name

ATENOLOL AND CHLORTHALIDONE

Product Number

2

Dosage Form

-

Strength

100MG;25MG

Approval Date

2021-10-25

215560 / 2

Active Ingredient

ATENOLOL; CHLORTHALIDONE

Application Number

215560

Product Number

2

Dosage Form

-

Strength

100MG;25MG

Approval Date

2021-10-25

Regulatory Status

RX

2007
28 Dec
RX Application: 77807

Drug Name

BALSALAZIDE DISODIUM

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

2007-12-28

77807 / 1

Active Ingredient

BALSALAZIDE DISODIUM

Application Number

77807

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

2007-12-28

Regulatory Status

RX

2021
23 Nov
RX Application: 214864

Drug Name

BETAINE

Product Number

1

Dosage Form

-

Strength

1GM/SCOOPFUL

Approval Date

2021-11-23

214864 / 1

Active Ingredient

BETAINE

Application Number

214864

Product Number

1

Dosage Form

-

Strength

1GM/SCOOPFUL

Approval Date

2021-11-23

Regulatory Status

RX

2021
29 Oct
RX Application: 215563

Drug Name

BISOPROLOL FUMARATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2021-10-29

215563 / 1

Active Ingredient

BISOPROLOL FUMARATE

Application Number

215563

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2021-10-29

Regulatory Status

RX

2021
29 Oct
RX Application: 215563

Drug Name

BISOPROLOL FUMARATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2021-10-29

215563 / 2

Active Ingredient

BISOPROLOL FUMARATE

Application Number

215563

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2021-10-29

Regulatory Status

RX

2021
04 Nov
RX Application: 215562

Drug Name

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

2.5MG;6.25MG

Approval Date

2021-11-04

215562 / 1

Active Ingredient

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Application Number

215562

Product Number

1

Dosage Form

-

Strength

2.5MG;6.25MG

Approval Date

2021-11-04

Regulatory Status

RX

2021
04 Nov
RX Application: 215562

Drug Name

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

2021-11-04

215562 / 2

Active Ingredient

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Application Number

215562

Product Number

2

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

2021-11-04

Regulatory Status

RX

2021
04 Nov
RX Application: 215562

Drug Name

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

10MG;6.25MG

Approval Date

2021-11-04

215562 / 3

Active Ingredient

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Application Number

215562

Product Number

3

Dosage Form

-

Strength

10MG;6.25MG

Approval Date

2021-11-04

Regulatory Status

RX

2022
06 Oct
RX Application: 214277

Drug Name

CARBAMAZEPINE

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2022-10-06

214277 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

214277

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2022-10-06

Regulatory Status

RX

2021
13 Oct
RX Application: 213729

Drug Name

CARGLUMIC ACID

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2021-10-13

213729 / 1

Active Ingredient

CARGLUMIC ACID

Application Number

213729

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2021-10-13

Regulatory Status

RX

2019
27 Nov
RX Application: 212253

Drug Name

CHLORZOXAZONE

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

2019-11-27

212253 / 1

Active Ingredient

CHLORZOXAZONE

Application Number

212253

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

2019-11-27

Regulatory Status

RX

2019
27 Nov
RX Application: 212253

Drug Name

CHLORZOXAZONE

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2019-11-27

212253 / 2

Active Ingredient

CHLORZOXAZONE

Application Number

212253

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2019-11-27

Regulatory Status

RX

2019
12 Sep
RX Application: 212254

Drug Name

CHLORZOXAZONE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2019-09-12

212254 / 1

Active Ingredient

CHLORZOXAZONE

Application Number

212254

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2019-09-12

Regulatory Status

RX

2013
10 Jun
RX Application: 202710

Drug Name

CLARITHROMYCIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2013-06-10

202710 / 1

Active Ingredient

CLARITHROMYCIN

Application Number

202710

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2013-06-10

Regulatory Status

RX

2013
10 Jun
RX Application: 202710

Drug Name

CLARITHROMYCIN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2013-06-10

202710 / 2

Active Ingredient

CLARITHROMYCIN

Application Number

202710

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2013-06-10

Regulatory Status

RX

2025
17 Oct
RX Application: 219781

Drug Name

CLOMIPHENE CITRATE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2025-10-17

219781 / 1

Active Ingredient

CLOMIPHENE CITRATE

Application Number

219781

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2025-10-17

Regulatory Status

RX

2022
16 Jun
RX Application: 213730

Drug Name

CLORAZEPATE DIPOTASSIUM

Product Number

1

Dosage Form

-

Strength

3.75MG

Approval Date

2022-06-16

213730 / 1

Active Ingredient

CLORAZEPATE DIPOTASSIUM

Application Number

213730

Product Number

1

Dosage Form

-

Strength

3.75MG

Approval Date

2022-06-16

Regulatory Status

RX

2022
16 Jun
RX Application: 213730

Drug Name

CLORAZEPATE DIPOTASSIUM

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2022-06-16

213730 / 2

Active Ingredient

CLORAZEPATE DIPOTASSIUM

Application Number

213730

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2022-06-16

Regulatory Status

RX

2022
16 Dec
RX Application: 213730

Drug Name

CLORAZEPATE DIPOTASSIUM

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2022-12-16

213730 / 3

Active Ingredient

CLORAZEPATE DIPOTASSIUM

Application Number

213730

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2022-12-16

Regulatory Status

RX

2019
14 Feb
RX Application: 209815

Drug Name

CLOTRIMAZOLE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2019-02-14

209815 / 1

Active Ingredient

CLOTRIMAZOLE

Application Number

209815

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2019-02-14

Regulatory Status

RX

2016
01 Dec
RX Application: 206505

Drug Name

DAPSONE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2016-12-01

206505 / 1

Active Ingredient

DAPSONE

Application Number

206505

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2016-12-01

Regulatory Status

RX

2016
01 Dec
RX Application: 206505

Drug Name

DAPSONE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2016-12-01

206505 / 2

Active Ingredient

DAPSONE

Application Number

206505

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2016-12-01

Regulatory Status

RX

2022
08 Aug
RX Application: 215604

Drug Name

DEXAMETHASONE

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

2022-08-08

215604 / 1

Active Ingredient

DEXAMETHASONE

Application Number

215604

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

2022-08-08

Regulatory Status

RX

2022
08 Aug
RX Application: 215604

Drug Name

DEXAMETHASONE

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2022-08-08

215604 / 2

Active Ingredient

DEXAMETHASONE

Application Number

215604

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2022-08-08

Regulatory Status

RX

2022
08 Aug
RX Application: 215604

Drug Name

DEXAMETHASONE

Product Number

3

Dosage Form

-

Strength

6MG

Approval Date

2022-08-08

215604 / 3

Active Ingredient

DEXAMETHASONE

Application Number

215604

Product Number

3

Dosage Form

-

Strength

6MG

Approval Date

2022-08-08

Regulatory Status

RX

2023
05 Oct
RX Application: 215604

Drug Name

DEXAMETHASONE

Product Number

4

Dosage Form

-

Strength

0.5MG

Approval Date

2023-10-05

215604 / 4

Active Ingredient

DEXAMETHASONE

Application Number

215604

Product Number

4

Dosage Form

-

Strength

0.5MG

Approval Date

2023-10-05

Regulatory Status

RX

2023
05 Oct
RX Application: 215604

Drug Name

DEXAMETHASONE

Product Number

5

Dosage Form

-

Strength

0.75MG

Approval Date

2023-10-05

215604 / 5

Active Ingredient

DEXAMETHASONE

Application Number

215604

Product Number

5

Dosage Form

-

Strength

0.75MG

Approval Date

2023-10-05

Regulatory Status

RX

2023
09 May
RX Application: 217696

Drug Name

DEXAMETHASONE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2023-05-09

217696 / 1

Active Ingredient

DEXAMETHASONE

Application Number

217696

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2023-05-09

Regulatory Status

RX

2020
08 Jul
RX Application: 210799

Drug Name

DIAZOXIDE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2020-07-08

210799 / 1

Active Ingredient

DIAZOXIDE

Application Number

210799

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2020-07-08

Regulatory Status

RX

2021
23 Apr
RX Application: 214721

Drug Name

DICYCLOMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/5ML

Approval Date

2021-04-23

214721 / 1

Active Ingredient

DICYCLOMINE HYDROCHLORIDE

Application Number

214721

Product Number

1

Dosage Form

-

Strength

10MG/5ML

Approval Date

2021-04-23

Regulatory Status

RX

2021
22 Nov
RX Application: 215307

Drug Name

DIGOXIN

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2021-11-22

215307 / 1

Active Ingredient

DIGOXIN

Application Number

215307

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2021-11-22

Regulatory Status

RX

2021
22 Nov
RX Application: 215307

Drug Name

DIGOXIN

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2021-11-22

215307 / 2

Active Ingredient

DIGOXIN

Application Number

215307

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2021-11-22

Regulatory Status

RX

2022
25 Aug
RX Application: 215307

Drug Name

DIGOXIN

Product Number

3

Dosage Form

-

Strength

0.0625MG

Approval Date

2022-08-25

215307 / 3

Active Ingredient

DIGOXIN

Application Number

215307

Product Number

3

Dosage Form

-

Strength

0.0625MG

Approval Date

2022-08-25

Regulatory Status

RX

2011
31 May
RX Application: 90551

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-05-31

90551 / 1

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

90551

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-05-31

Regulatory Status

RX

2011
31 May
RX Application: 90551

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-05-31

90551 / 2

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

90551

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-05-31

Regulatory Status

RX

1997
03 Jul
RX Application: 74826

Drug Name

ESTAZOLAM

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1997-07-03

74826 / 1

Active Ingredient

ESTAZOLAM

Application Number

74826

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1997-07-03

Regulatory Status

RX

1997
03 Jul
RX Application: 74826

Drug Name

ESTAZOLAM

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

1997-07-03

74826 / 2

Active Ingredient

ESTAZOLAM

Application Number

74826

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

1997-07-03

Regulatory Status

RX

2023
06 Sep
RX Application: 217334

Drug Name

ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2023-09-06

217334 / 1

Active Ingredient

ESTRADIOL

Application Number

217334

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2023-09-06

Regulatory Status

RX

2023
06 Sep
RX Application: 217334

Drug Name

ESTRADIOL

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2023-09-06

217334 / 2

Active Ingredient

ESTRADIOL

Application Number

217334

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2023-09-06

Regulatory Status

RX

2023
06 Sep
RX Application: 217334

Drug Name

ESTRADIOL

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2023-09-06

217334 / 3

Active Ingredient

ESTRADIOL

Application Number

217334

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2023-09-06

Regulatory Status

RX

2023
24 Aug
RX Application: 217610

Drug Name

ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.1% (0.25GM/PACKET)

Approval Date

2023-08-24

217610 / 1

Active Ingredient

ESTRADIOL

Application Number

217610

Product Number

1

Dosage Form

-

Strength

0.1% (0.25GM/PACKET)

Approval Date

2023-08-24

Regulatory Status

RX

2023
24 Aug
RX Application: 217610

Drug Name

ESTRADIOL

Product Number

2

Dosage Form

-

Strength

0.1% (0.5GM/PACKET)

Approval Date

2023-08-24

217610 / 2

Active Ingredient

ESTRADIOL

Application Number

217610

Product Number

2

Dosage Form

-

Strength

0.1% (0.5GM/PACKET)

Approval Date

2023-08-24

Regulatory Status

RX

2023
24 Aug
RX Application: 217610

Drug Name

ESTRADIOL

Product Number

3

Dosage Form

-

Strength

0.1% (0.75GM/PACKET)

Approval Date

2023-08-24

217610 / 3

Active Ingredient

ESTRADIOL

Application Number

217610

Product Number

3

Dosage Form

-

Strength

0.1% (0.75GM/PACKET)

Approval Date

2023-08-24

Regulatory Status

RX

2023
24 Aug
RX Application: 217610

Drug Name

ESTRADIOL

Product Number

4

Dosage Form

-

Strength

0.1% (1GM/PACKET)

Approval Date

2023-08-24

217610 / 4

Active Ingredient

ESTRADIOL

Application Number

217610

Product Number

4

Dosage Form

-

Strength

0.1% (1GM/PACKET)

Approval Date

2023-08-24

Regulatory Status

RX

2023
24 Aug
RX Application: 217610

Drug Name

ESTRADIOL

Product Number

5

Dosage Form

-

Strength

0.1% (1.25GM/PACKET)

Approval Date

2023-08-24

217610 / 5

Active Ingredient

ESTRADIOL

Application Number

217610

Product Number

5

Dosage Form

-

Strength

0.1% (1.25GM/PACKET)

Approval Date

2023-08-24

Regulatory Status

RX

2024
23 Oct
RX Application: 217882

Drug Name

ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.06% (1.25GM/ACTIVATION)

Approval Date

2024-10-23

217882 / 1

Active Ingredient

ESTRADIOL

Application Number

217882

Product Number

1

Dosage Form

-

Strength

0.06% (1.25GM/ACTIVATION)

Approval Date

2024-10-23

Regulatory Status

RX

2014
30 May
RX Application: 201995

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

40MG/5ML

Approval Date

2014-05-30

201995 / 1

Active Ingredient

FAMOTIDINE

Application Number

201995

Product Number

1

Dosage Form

-

Strength

40MG/5ML

Approval Date

2014-05-30

Regulatory Status

RX

2021
20 Apr
RX Application: 215043

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

40MG/5ML

Approval Date

2021-04-20

215043 / 1

Active Ingredient

FAMOTIDINE

Application Number

215043

Product Number

1

Dosage Form

-

Strength

40MG/5ML

Approval Date

2021-04-20

Regulatory Status

RX

2019
31 May
RX Application: 211333

Drug Name

FELBAMATE

Product Number

1

Dosage Form

-

Strength

600MG/5ML

Approval Date

2019-05-31

211333 / 1

Active Ingredient

FELBAMATE

Application Number

211333

Product Number

1

Dosage Form

-

Strength

600MG/5ML

Approval Date

2019-05-31

Regulatory Status

RX

2025
19 Mar
RX Application: 218499

Drug Name

FINASTERIDE AND TADALAFIL

Product Number

1

Dosage Form

-

Strength

5MG;5MG

Approval Date

2025-03-19

218499 / 1

Active Ingredient

FINASTERIDE; TADALAFIL

Application Number

218499

Product Number

1

Dosage Form

-

Strength

5MG;5MG

Approval Date

2025-03-19

Regulatory Status

RX

2022
31 May
RX Application: 215279

Drug Name

FLUDROCORTISONE ACETATE

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2022-05-31

215279 / 1

Active Ingredient

FLUDROCORTISONE ACETATE

Application Number

215279

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2022-05-31

Regulatory Status

RX

2022
09 Nov
RX Application: 216448

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/5ML

Approval Date

2022-11-09

216448 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

216448

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/5ML

Approval Date

2022-11-09

Regulatory Status

RX

2021
01 Mar
RX Application: 214674

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2021-03-01

214674 / 1

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

214674

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2021-03-01

Regulatory Status

RX

2021
01 Mar
RX Application: 214674

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2021-03-01

214674 / 2

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

214674

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2021-03-01

Regulatory Status

RX

2021
01 Mar
RX Application: 214674

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2021-03-01

214674 / 3

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

214674

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2021-03-01

Regulatory Status

RX

2021
01 Mar
RX Application: 214674

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2021-03-01

214674 / 4

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

214674

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2021-03-01

Regulatory Status

RX

2026
12 Aug
RX Application: 210426

Drug Name

FOSFOMYCIN TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

EQ 3GM BASE/PACKET

Approval Date

2026-08-12

210426 / 1

Active Ingredient

FOSFOMYCIN TROMETHAMINE

Application Number

210426

Product Number

1

Dosage Form

-

Strength

EQ 3GM BASE/PACKET

Approval Date

2026-08-12

Regulatory Status

RX

2025
02 May
RX Application: 217881

Drug Name

HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2025-05-02

217881 / 1

Active Ingredient

HYDROCORTISONE

Application Number

217881

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2025-05-02

Regulatory Status

RX

2025
02 May
RX Application: 217881

Drug Name

HYDROCORTISONE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2025-05-02

217881 / 2

Active Ingredient

HYDROCORTISONE

Application Number

217881

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2025-05-02

Regulatory Status

RX

2025
02 May
RX Application: 217881

Drug Name

HYDROCORTISONE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2025-05-02

217881 / 3

Active Ingredient

HYDROCORTISONE

Application Number

217881

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2025-05-02

Regulatory Status

RX

2025
16 Dec
RX Application: 219648

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/5ML

Approval Date

2025-12-16

219648 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

219648

Product Number

1

Dosage Form

-

Strength

10MG/5ML

Approval Date

2025-12-16

Regulatory Status

RX

2024
12 Jan
RX Application: 217883

Drug Name

INDOMETHACIN

Product Number

1

Dosage Form

-

Strength

25MG/5ML

Approval Date

2024-01-12

217883 / 1

Active Ingredient

INDOMETHACIN

Application Number

217883

Product Number

1

Dosage Form

-

Strength

25MG/5ML

Approval Date

2024-01-12

Regulatory Status

RX

2025
28 Jan
RX Application: 219141

Drug Name

INZIRQO

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2025-01-28

219141 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

219141

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2025-01-28

Regulatory Status

RX

2024
16 Sep
RX Application: 218498

Drug Name

KETOCONAZOLE

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2024-09-16

218498 / 1

Active Ingredient

KETOCONAZOLE

Application Number

218498

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2024-09-16

Regulatory Status

RX

2025
03 Jul
RX Application: 219129

Drug Name

KETOCONAZOLE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2025-07-03

219129 / 1

Active Ingredient

KETOCONAZOLE

Application Number

219129

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2025-07-03

Regulatory Status

RX

2024
08 Jul
RX Application: 215647

Drug Name

L-GLUTAMINE

Product Number

1

Dosage Form

-

Strength

5GM/PACKET

Approval Date

2024-07-08

215647 / 1

Active Ingredient

L-GLUTAMINE

Application Number

215647

Product Number

1

Dosage Form

-

Strength

5GM/PACKET

Approval Date

2024-07-08

Regulatory Status

RX

2022
26 Aug
RX Application: 216151

Drug Name

LACOSAMIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2022-08-26

216151 / 1

Active Ingredient

LACOSAMIDE

Application Number

216151

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2022-08-26

Regulatory Status

RX

2019
14 Aug
RX Application: 211676

Drug Name

LEVOCARNITINE

Product Number

1

Dosage Form

-

Strength

1GM/10ML

Approval Date

2019-08-14

211676 / 1

Active Ingredient

LEVOCARNITINE

Application Number

211676

Product Number

1

Dosage Form

-

Strength

1GM/10ML

Approval Date

2019-08-14

Regulatory Status

RX

2022
09 Dec
RX Application: 216384

Drug Name

LEVOCARNITINE

Product Number

1

Dosage Form

-

Strength

330MG

Approval Date

2022-12-09

216384 / 1

Active Ingredient

LEVOCARNITINE

Application Number

216384

Product Number

1

Dosage Form

-

Strength

330MG

Approval Date

2022-12-09

Regulatory Status

RX

2019
14 Aug
RX Application: 211676

Drug Name

LEVOCARNITINE SF

Product Number

2

Dosage Form

-

Strength

1GM/10ML

Approval Date

2019-08-14

211676 / 2

Active Ingredient

LEVOCARNITINE

Application Number

211676

Product Number

2

Dosage Form

-

Strength

1GM/10ML

Approval Date

2019-08-14

Regulatory Status

RX

2011
20 Jun
RX Application: 91678

Drug Name

LEVOFLOXACIN

Product Number

1

Dosage Form

-

Strength

250MG/10ML

Approval Date

2011-06-20

91678 / 1

Active Ingredient

LEVOFLOXACIN

Application Number

91678

Product Number

1

Dosage Form

-

Strength

250MG/10ML

Approval Date

2011-06-20

Regulatory Status

RX

2020
01 Jul
RX Application: 213479

Drug Name

LEVORPHANOL TARTRATE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2020-07-01

213479 / 1

Active Ingredient

LEVORPHANOL TARTRATE

Application Number

213479

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2020-07-01

Regulatory Status

RX

2021
12 Jan
RX Application: 213479

Drug Name

LEVORPHANOL TARTRATE

Product Number

2

Dosage Form

-

Strength

3MG

Approval Date

2021-01-12

213479 / 2

Active Ingredient

LEVORPHANOL TARTRATE

Application Number

213479

Product Number

2

Dosage Form

-

Strength

3MG

Approval Date

2021-01-12

Regulatory Status

RX

2021
20 Jul
RX Application: 213479

Drug Name

LEVORPHANOL TARTRATE

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2021-07-20

213479 / 3

Active Ingredient

LEVORPHANOL TARTRATE

Application Number

213479

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2021-07-20

Regulatory Status

RX

2022
23 Mar
RX Application: 216250

Drug Name

LIDOCAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

2022-03-23

216250 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

216250

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

2022-03-23

Regulatory Status

RX

2025
22 Oct
RX Application: 219917

Drug Name

LOFEXIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.18MG BASE

Approval Date

2025-10-22

219917 / 1

Active Ingredient

LOFEXIDINE HYDROCHLORIDE

Application Number

219917

Product Number

1

Dosage Form

-

Strength

EQ 0.18MG BASE

Approval Date

2025-10-22

Regulatory Status

RX

2006
16 Feb
RX Application: 77404

Drug Name

MEGESTROL ACETATE

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2006-02-16

77404 / 1

Active Ingredient

MEGESTROL ACETATE

Application Number

77404

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2006-02-16

Regulatory Status

RX

2009
13 May
RX Application: 77928

Drug Name

MELOXICAM

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2009-05-13

77928 / 1

Active Ingredient

MELOXICAM

Application Number

77928

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2009-05-13

Regulatory Status

RX

2009
13 May
RX Application: 77928

Drug Name

MELOXICAM

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2009-05-13

77928 / 2

Active Ingredient

MELOXICAM

Application Number

77928

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2009-05-13

Regulatory Status

RX

2021
09 Mar
RX Application: 211398

Drug Name

MELOXICAM

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2021-03-09

211398 / 1

Active Ingredient

MELOXICAM

Application Number

211398

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2021-03-09

Regulatory Status

RX

2021
09 Mar
RX Application: 211398

Drug Name

MELOXICAM

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2021-03-09

211398 / 2

Active Ingredient

MELOXICAM

Application Number

211398

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2021-03-09

Regulatory Status

RX

2025
16 Apr
RX Application: 215269

Drug Name

MESALAMINE

Product Number

1

Dosage Form

-

Strength

4GM/60ML

Approval Date

2025-04-16

215269 / 1

Active Ingredient

MESALAMINE

Application Number

215269

Product Number

1

Dosage Form

-

Strength

4GM/60ML

Approval Date

2025-04-16

Regulatory Status

RX

2023
01 May
RX Application: 217213

Drug Name

METHSUXIMIDE

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2023-05-01

217213 / 1

Active Ingredient

METHSUXIMIDE

Application Number

217213

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2023-05-01

Regulatory Status

RX

2022
18 Feb
RX Application: 215270

Drug Name

METHYLTESTOSTERONE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2022-02-18

215270 / 1

Active Ingredient

METHYLTESTOSTERONE

Application Number

215270

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2022-02-18

Regulatory Status

RX

2016
25 May
RX Application: 208162

Drug Name

METRONIDAZOLE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2016-05-25

208162 / 1

Active Ingredient

METRONIDAZOLE

Application Number

208162

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2016-05-25

Regulatory Status

RX

2016
25 May
RX Application: 208162

Drug Name

METRONIDAZOLE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2016-05-25

208162 / 2

Active Ingredient

METRONIDAZOLE

Application Number

208162

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2016-05-25

Regulatory Status

RX

2026
02 Feb
RX Application: 219919

Drug Name

MIRTAZAPINE

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2026-02-02

219919 / 1

Active Ingredient

MIRTAZAPINE

Application Number

219919

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2026-02-02

Regulatory Status

RX

2026
02 Feb
RX Application: 219919

Drug Name

MIRTAZAPINE

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2026-02-02

219919 / 2

Active Ingredient

MIRTAZAPINE

Application Number

219919

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2026-02-02

Regulatory Status

RX

2026
02 Feb
RX Application: 219919

Drug Name

MIRTAZAPINE

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2026-02-02

219919 / 3

Active Ingredient

MIRTAZAPINE

Application Number

219919

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2026-02-02

Regulatory Status

RX

2026
02 Feb
RX Application: 219919

Drug Name

MIRTAZAPINE

Product Number

4

Dosage Form

-

Strength

45MG

Approval Date

2026-02-02

219919 / 4

Active Ingredient

MIRTAZAPINE

Application Number

219919

Product Number

4

Dosage Form

-

Strength

45MG

Approval Date

2026-02-02

Regulatory Status

RX

2025
07 Jan
RX Application: 219118

Drug Name

NABUMETONE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2025-01-07

219118 / 1

Active Ingredient

NABUMETONE

Application Number

219118

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2025-01-07

Regulatory Status

RX

2025
07 Jan
RX Application: 219118

Drug Name

NABUMETONE

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2025-01-07

219118 / 2

Active Ingredient

NABUMETONE

Application Number

219118

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2025-01-07

Regulatory Status

RX

2021
10 Mar
RX Application: 211910

Drug Name

NAPROXEN

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

2021-03-10

211910 / 1

Active Ingredient

NAPROXEN

Application Number

211910

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

2021-03-10

Regulatory Status

RX

2024
12 Jun
RX Application: 218497

Drug Name

NAPROXEN

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

2024-06-12

218497 / 1

Active Ingredient

NAPROXEN

Application Number

218497

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

2024-06-12

Regulatory Status

RX

2024
12 Jun
RX Application: 218497

Drug Name

NAPROXEN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2024-06-12

218497 / 2

Active Ingredient

NAPROXEN

Application Number

218497

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2024-06-12

Regulatory Status

RX

2019
26 Aug
RX Application: 211041

Drug Name

NITISINONE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2019-08-26

211041 / 1

Active Ingredient

NITISINONE

Application Number

211041

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2019-08-26

Regulatory Status

RX

2019
26 Aug
RX Application: 211041

Drug Name

NITISINONE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2019-08-26

211041 / 2

Active Ingredient

NITISINONE

Application Number

211041

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2019-08-26

Regulatory Status

RX

2019
26 Aug
RX Application: 211041

Drug Name

NITISINONE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2019-08-26

211041 / 3

Active Ingredient

NITISINONE

Application Number

211041

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2019-08-26

Regulatory Status

RX

2023
14 Apr
RX Application: 216385

Drug Name

NITROFURANTOIN

Product Number

1

Dosage Form

-

Strength

25MG/5ML

Approval Date

2023-04-14

216385 / 1

Active Ingredient

NITROFURANTOIN

Application Number

216385

Product Number

1

Dosage Form

-

Strength

25MG/5ML

Approval Date

2023-04-14

Regulatory Status

RX

2025
10 Dec
RX Application: 219161

Drug Name

OMEPRAZOLE AND SODIUM BICARBONATE

Product Number

1

Dosage Form

-

Strength

20MG/PACKET;1.68GM/PACKET

Approval Date

2025-12-10

219161 / 1

Active Ingredient

OMEPRAZOLE; SODIUM BICARBONATE

Application Number

219161

Product Number

1

Dosage Form

-

Strength

20MG/PACKET;1.68GM/PACKET

Approval Date

2025-12-10

Regulatory Status

RX

2025
10 Dec
RX Application: 219161

Drug Name

OMEPRAZOLE AND SODIUM BICARBONATE

Product Number

2

Dosage Form

-

Strength

40MG/PACKET;1.68GM/PACKET

Approval Date

2025-12-10

219161 / 2

Active Ingredient

OMEPRAZOLE; SODIUM BICARBONATE

Application Number

219161

Product Number

2

Dosage Form

-

Strength

40MG/PACKET;1.68GM/PACKET

Approval Date

2025-12-10

Regulatory Status

RX

2017
23 Oct
RX Application: 209823

Drug Name

OXYBUTYNIN CHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2017-10-23

209823 / 1

Active Ingredient

OXYBUTYNIN CHLORIDE

Application Number

209823

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2017-10-23

Regulatory Status

RX

2021
03 Sep
RX Application: 215003

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/5ML

Approval Date

2021-09-03

215003 / 1

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

215003

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/5ML

Approval Date

2021-09-03

Regulatory Status

RX

2022
19 Jul
RX Application: 215042

Drug Name

PHENOXYBENZAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2022-07-19

215042 / 1

Active Ingredient

PHENOXYBENZAMINE HYDROCHLORIDE

Application Number

215042

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2022-07-19

Regulatory Status

RX

2026
13 Apr
RX Application: 219897

Drug Name

PIMOZIDE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2026-04-13

219897 / 1

Active Ingredient

PIMOZIDE

Application Number

219897

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2026-04-13

Regulatory Status

RX

2026
13 Apr
RX Application: 219897

Drug Name

PIMOZIDE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2026-04-13

219897 / 2

Active Ingredient

PIMOZIDE

Application Number

219897

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2026-04-13

Regulatory Status

RX

2026
21 Jul
RX Application: 218495

Drug Name

PITOLISANT HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 4.45MG BASE

Approval Date

2026-07-21

218495 / 1

Active Ingredient

PITOLISANT HYDROCHLORIDE

Application Number

218495

Product Number

1

Dosage Form

-

Strength

EQ 4.45MG BASE

Approval Date

2026-07-21

Regulatory Status

RX

2026
21 Jul
RX Application: 218495

Drug Name

PITOLISANT HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 17.8MG BASE

Approval Date

2026-07-21

218495 / 2

Active Ingredient

PITOLISANT HYDROCHLORIDE

Application Number

218495

Product Number

2

Dosage Form

-

Strength

EQ 17.8MG BASE

Approval Date

2026-07-21

Regulatory Status

RX

2023
12 Jul
RX Application: 212816

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

20MEQ

Approval Date

2023-07-12

212816 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

212816

Product Number

1

Dosage Form

-

Strength

20MEQ

Approval Date

2023-07-12

Regulatory Status

RX

2018
03 Oct
RX Application: 210971

Drug Name

PRAZOSIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2018-10-03

210971 / 1

Active Ingredient

PRAZOSIN HYDROCHLORIDE

Application Number

210971

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2018-10-03

Regulatory Status

RX

2018
03 Oct
RX Application: 210971

Drug Name

PRAZOSIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2018-10-03

210971 / 2

Active Ingredient

PRAZOSIN HYDROCHLORIDE

Application Number

210971

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2018-10-03

Regulatory Status

RX

2018
03 Oct
RX Application: 210971

Drug Name

PRAZOSIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2018-10-03

210971 / 3

Active Ingredient

PRAZOSIN HYDROCHLORIDE

Application Number

210971

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2018-10-03

Regulatory Status

RX

2019
15 Nov
RX Application: 211575

Drug Name

PREDNISONE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2019-11-15

211575 / 1

Active Ingredient

PREDNISONE

Application Number

211575

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2019-11-15

Regulatory Status

RX

2019
15 Nov
RX Application: 211575

Drug Name

PREDNISONE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2019-11-15

211575 / 2

Active Ingredient

PREDNISONE

Application Number

211575

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2019-11-15

Regulatory Status

RX

2019
15 Nov
RX Application: 211575

Drug Name

PREDNISONE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2019-11-15

211575 / 3

Active Ingredient

PREDNISONE

Application Number

211575

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2019-11-15

Regulatory Status

RX

2019
15 Nov
RX Application: 211575

Drug Name

PREDNISONE

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2019-11-15

211575 / 4

Active Ingredient

PREDNISONE

Application Number

211575

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2019-11-15

Regulatory Status

RX

2019
15 Nov
RX Application: 211575

Drug Name

PREDNISONE

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2019-11-15

211575 / 5

Active Ingredient

PREDNISONE

Application Number

211575

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2019-11-15

Regulatory Status

RX

2021
06 Jul
RX Application: 215246

Drug Name

PREDNISONE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2021-07-06

215246 / 1

Active Ingredient

PREDNISONE

Application Number

215246

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2021-07-06

Regulatory Status

RX

2022
13 Jun
RX Application: 216202

Drug Name

PROCHLORPERAZINE MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2022-06-13

216202 / 1

Active Ingredient

PROCHLORPERAZINE MALEATE

Application Number

216202

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2022-06-13

Regulatory Status

RX

2022
13 Jun
RX Application: 216202

Drug Name

PROCHLORPERAZINE MALEATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2022-06-13

216202 / 2

Active Ingredient

PROCHLORPERAZINE MALEATE

Application Number

216202

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2022-06-13

Regulatory Status

RX

2024
26 Dec
RX Application: 218492

Drug Name

PRUCALOPRIDE SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2024-12-26

218492 / 1

Active Ingredient

PRUCALOPRIDE SUCCINATE

Application Number

218492

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2024-12-26

Regulatory Status

RX

2024
26 Dec
RX Application: 218492

Drug Name

PRUCALOPRIDE SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2024-12-26

218492 / 2

Active Ingredient

PRUCALOPRIDE SUCCINATE

Application Number

218492

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2024-12-26

Regulatory Status

RX

1982
01 Jan
RX Application: 80157

Drug Name

PYRAZINAMIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

80157 / 1

Active Ingredient

PYRAZINAMIDE

Application Number

80157

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

RX

2019
08 Mar
RX Application: 211694

Drug Name

PYRIDOSTIGMINE BROMIDE

Product Number

1

Dosage Form

-

Strength

60MG/5ML

Approval Date

2019-03-08

211694 / 1

Active Ingredient

PYRIDOSTIGMINE BROMIDE

Application Number

211694

Product Number

1

Dosage Form

-

Strength

60MG/5ML

Approval Date

2019-03-08

Regulatory Status

RX

2021
17 Dec
RX Application: 215041

Drug Name

RIFABUTIN

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2021-12-17

215041 / 1

Active Ingredient

RIFABUTIN

Application Number

215041

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2021-12-17

Regulatory Status

RX

2026
29 Jun
RX Application: 219918

Drug Name

RIFAMPIN

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2026-06-29

219918 / 1

Active Ingredient

RIFAMPIN

Application Number

219918

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2026-06-29

Regulatory Status

RX

2026
29 Jun
RX Application: 219918

Drug Name

RIFAMPIN

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2026-06-29

219918 / 2

Active Ingredient

RIFAMPIN

Application Number

219918

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2026-06-29

Regulatory Status

RX

2008
09 Oct
RX Application: 78871

Drug Name

RISPERIDONE

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2008-10-09

78871 / 1

Active Ingredient

RISPERIDONE

Application Number

78871

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2008-10-09

Regulatory Status

RX

2008
09 Oct
RX Application: 78871

Drug Name

RISPERIDONE

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2008-10-09

78871 / 2

Active Ingredient

RISPERIDONE

Application Number

78871

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2008-10-09

Regulatory Status

RX

2008
09 Oct
RX Application: 78871

Drug Name

RISPERIDONE

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2008-10-09

78871 / 3

Active Ingredient

RISPERIDONE

Application Number

78871

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2008-10-09

Regulatory Status

RX

2008
09 Oct
RX Application: 78871

Drug Name

RISPERIDONE

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2008-10-09

78871 / 4

Active Ingredient

RISPERIDONE

Application Number

78871

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2008-10-09

Regulatory Status

RX

2008
09 Oct
RX Application: 78871

Drug Name

RISPERIDONE

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2008-10-09

78871 / 5

Active Ingredient

RISPERIDONE

Application Number

78871

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2008-10-09

Regulatory Status

RX

2008
09 Oct
RX Application: 78871

Drug Name

RISPERIDONE

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2008-10-09

78871 / 6

Active Ingredient

RISPERIDONE

Application Number

78871

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2008-10-09

Regulatory Status

RX

1998
30 Nov
RX Application: 75352

Drug Name

SELEGILINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1998-11-30

75352 / 1

Active Ingredient

SELEGILINE HYDROCHLORIDE

Application Number

75352

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1998-11-30

Regulatory Status

RX

2026
20 Jan
RX Application: 219714

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2026-01-20

219714 / 1

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

219714

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2026-01-20

Regulatory Status

RX

2026
20 Jan
RX Application: 219714

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2026-01-20

219714 / 2

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

219714

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2026-01-20

Regulatory Status

RX

2019
31 May
RX Application: 212260

Drug Name

SILDENAFIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2019-05-31

212260 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

212260

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2019-05-31

Regulatory Status

RX

2023
29 Aug
RX Application: 216383

Drug Name

SILDENAFIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2023-08-29

216383 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

216383

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2023-08-29

Regulatory Status

RX

2023
29 Aug
RX Application: 216383

Drug Name

SILDENAFIL CITRATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2023-08-29

216383 / 2

Active Ingredient

SILDENAFIL CITRATE

Application Number

216383

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2023-08-29

Regulatory Status

RX

2023
29 Aug
RX Application: 216383

Drug Name

SILDENAFIL CITRATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2023-08-29

216383 / 3

Active Ingredient

SILDENAFIL CITRATE

Application Number

216383

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2023-08-29

Regulatory Status

RX

2019
28 Jan
RX Application: 211040

Drug Name

SIROLIMUS

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2019-01-28

211040 / 1

Active Ingredient

SIROLIMUS

Application Number

211040

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2019-01-28

Regulatory Status

RX

2019
26 Sep
RX Application: 212214

Drug Name

SOLIFENACIN SUCCINATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-09-26

212214 / 1

Active Ingredient

SOLIFENACIN SUCCINATE

Application Number

212214

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-09-26

Regulatory Status

RX

2019
26 Sep
RX Application: 212214

Drug Name

SOLIFENACIN SUCCINATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-09-26

212214 / 2

Active Ingredient

SOLIFENACIN SUCCINATE

Application Number

212214

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-09-26

Regulatory Status

RX

2022
14 Jan
RX Application: 214581

Drug Name

SOVUNA

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2022-01-14

214581 / 1

Active Ingredient

HYDROXYCHLOROQUINE SULFATE

Application Number

214581

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2022-01-14

Regulatory Status

RX

2022
14 Jan
RX Application: 214581

Drug Name

SOVUNA

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2022-01-14

214581 / 2

Active Ingredient

HYDROXYCHLOROQUINE SULFATE

Application Number

214581

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2022-01-14

Regulatory Status

RX

2022
08 Feb
RX Application: 214330

Drug Name

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Product Number

1

Dosage Form

-

Strength

200MG/5ML;40MG/5ML

Approval Date

2022-02-08

214330 / 1

Active Ingredient

SULFAMETHOXAZOLE; TRIMETHOPRIM

Application Number

214330

Product Number

1

Dosage Form

-

Strength

200MG/5ML;40MG/5ML

Approval Date

2022-02-08

Regulatory Status

RX

2023
03 Mar
RX Application: 215949

Drug Name

TADALAFIL

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2023-03-03

215949 / 1

Active Ingredient

TADALAFIL

Application Number

215949

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2023-03-03

Regulatory Status

RX

2023
03 Mar
RX Application: 215949

Drug Name

TADALAFIL

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2023-03-03

215949 / 2

Active Ingredient

TADALAFIL

Application Number

215949

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2023-03-03

Regulatory Status

RX

2023
03 Mar
RX Application: 215949

Drug Name

TADALAFIL

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2023-03-03

215949 / 3

Active Ingredient

TADALAFIL

Application Number

215949

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2023-03-03

Regulatory Status

RX

2026
26 Jan
RX Application: 219119

Drug Name

TAPENTADOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/ML

Approval Date

2026-01-26

219119 / 1

Active Ingredient

TAPENTADOL HYDROCHLORIDE

Application Number

219119

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/ML

Approval Date

2026-01-26

Regulatory Status

RX

2020
03 Mar
RX Application: 212635

Drug Name

TETRACYCLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2020-03-03

212635 / 1

Active Ingredient

TETRACYCLINE HYDROCHLORIDE

Application Number

212635

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2020-03-03

Regulatory Status

RX

2020
03 Mar
RX Application: 212635

Drug Name

TETRACYCLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2020-03-03

212635 / 2

Active Ingredient

TETRACYCLINE HYDROCHLORIDE

Application Number

212635

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2020-03-03

Regulatory Status

RX

2019
05 Apr
RX Application: 211642

Drug Name

THIOTHIXENE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2019-04-05

211642 / 1

Active Ingredient

THIOTHIXENE

Application Number

211642

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2019-04-05

Regulatory Status

RX

2019
05 Apr
RX Application: 211642

Drug Name

THIOTHIXENE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2019-04-05

211642 / 2

Active Ingredient

THIOTHIXENE

Application Number

211642

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2019-04-05

Regulatory Status

RX

2019
05 Apr
RX Application: 211642

Drug Name

THIOTHIXENE

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2019-04-05

211642 / 3

Active Ingredient

THIOTHIXENE

Application Number

211642

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2019-04-05

Regulatory Status

RX

2019
05 Apr
RX Application: 211642

Drug Name

THIOTHIXENE

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2019-04-05

211642 / 4

Active Ingredient

THIOTHIXENE

Application Number

211642

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2019-04-05

Regulatory Status

RX

2026
26 Jun
RX Application: 219647

Drug Name

TRAMADOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

2026-06-26

219647 / 1

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

219647

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

2026-06-26

Regulatory Status

RX

2018
17 Apr
RX Application: 206856

Drug Name

TRANYLCYPROMINE SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2018-04-17

206856 / 1

Active Ingredient

TRANYLCYPROMINE SULFATE

Application Number

206856

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2018-04-17

Regulatory Status

RX

1998
24 Dec
RX Application: 40254

Drug Name

TRIHEXYPHENIDYL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1998-12-24

40254 / 1

Active Ingredient

TRIHEXYPHENIDYL HYDROCHLORIDE

Application Number

40254

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1998-12-24

Regulatory Status

RX

1998
24 Dec
RX Application: 40254

Drug Name

TRIHEXYPHENIDYL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1998-12-24

40254 / 2

Active Ingredient

TRIHEXYPHENIDYL HYDROCHLORIDE

Application Number

40254

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1998-12-24

Regulatory Status

RX

2022
28 Oct
RX Application: 216393

Drug Name

TRIMETHOPRIM

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2022-10-28

216393 / 1

Active Ingredient

TRIMETHOPRIM

Application Number

216393

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2022-10-28

Regulatory Status

RX

2021
02 Nov
RX Application: 214102

Drug Name

VALSARTAN

Product Number

1

Dosage Form

-

Strength

4MG/ML

Approval Date

2021-11-02

214102 / 1

Active Ingredient

VALSARTAN

Application Number

214102

Product Number

1

Dosage Form

-

Strength

4MG/ML

Approval Date

2021-11-02

Regulatory Status

RX

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Drug Status Breakdown
173 total
  • RX
Official Source

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

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

ACETAZOLAMIDE

Application Number

210588

Product Number

1

Active Ingredient

ACETAZOLAMIDE

Dosage Form

-

Strength

125MG

FDA Approved Drug Data

Approved drug product information

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