ANI Pharmaceuticals Inc RX
FDA Approved Drugs

ANI Pharmaceuticals Inc 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 116
  • Latest Approval Date Mar 27, 2026
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
450
View
Unclassified
1
View
Discontinued
331
View
OTC
2
View
RX
116
View
Company Overview

Company

ANI Pharmaceuticals Inc RX

Country

U.S.A

Website

Visit Website

Email

rob.schrepfer@anipharmaceuticals.com

Social Profiles

Company Snapshot

ANI Pharmaceuticals Inc RX

210 Main Street West Baudette, MN 56623

U.S.A

www.anipharmaceuticals.com/ rob.schrepfer@anipharmaceuticals.com View on Map
FDA Approved Drug Records ( 116 records )
1995
18 Oct
RX Application: 74007

Drug Name

ACEBUTOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

1995-10-18

74007 / 1

Active Ingredient

ACEBUTOLOL HYDROCHLORIDE

Application Number

74007

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

1995-10-18

Regulatory Status

RX

1995
18 Oct
RX Application: 74007

Drug Name

ACEBUTOLOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

1995-10-18

74007 / 2

Active Ingredient

ACEBUTOLOL HYDROCHLORIDE

Application Number

74007

Product Number

2

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

1995-10-18

Regulatory Status

RX

1995
27 Dec
RX Application: 20541

Drug Name

ARIMIDEX

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1995-12-27

20541 / 1

Active Ingredient

ANASTROZOLE

Application Number

20541

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1995-12-27

Regulatory Status

RX

1998
04 Jun
RX Application: 20838

Drug Name

ATACAND

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1998-06-04

20838 / 1

Active Ingredient

CANDESARTAN CILEXETIL

Application Number

20838

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1998-06-04

Regulatory Status

RX

1998
04 Jun
RX Application: 20838

Drug Name

ATACAND

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

1998-06-04

20838 / 2

Active Ingredient

CANDESARTAN CILEXETIL

Application Number

20838

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

1998-06-04

Regulatory Status

RX

1998
04 Jun
RX Application: 20838

Drug Name

ATACAND

Product Number

3

Dosage Form

-

Strength

16MG

Approval Date

1998-06-04

20838 / 3

Active Ingredient

CANDESARTAN CILEXETIL

Application Number

20838

Product Number

3

Dosage Form

-

Strength

16MG

Approval Date

1998-06-04

Regulatory Status

RX

1998
04 Jun
RX Application: 20838

Drug Name

ATACAND

Product Number

4

Dosage Form

-

Strength

32MG

Approval Date

1998-06-04

20838 / 4

Active Ingredient

CANDESARTAN CILEXETIL

Application Number

20838

Product Number

4

Dosage Form

-

Strength

32MG

Approval Date

1998-06-04

Regulatory Status

RX

2000
05 Sep
RX Application: 21093

Drug Name

ATACAND HCT

Product Number

1

Dosage Form

-

Strength

16MG;12.5MG

Approval Date

2000-09-05

21093 / 1

Active Ingredient

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Application Number

21093

Product Number

1

Dosage Form

-

Strength

16MG;12.5MG

Approval Date

2000-09-05

Regulatory Status

RX

2000
05 Sep
RX Application: 21093

Drug Name

ATACAND HCT

Product Number

2

Dosage Form

-

Strength

32MG;12.5MG

Approval Date

2000-09-05

21093 / 2

Active Ingredient

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Application Number

21093

Product Number

2

Dosage Form

-

Strength

32MG;12.5MG

Approval Date

2000-09-05

Regulatory Status

RX

2008
16 May
RX Application: 21093

Drug Name

ATACAND HCT

Product Number

3

Dosage Form

-

Strength

32MG;25MG

Approval Date

2008-05-16

21093 / 3

Active Ingredient

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Application Number

21093

Product Number

3

Dosage Form

-

Strength

32MG;25MG

Approval Date

2008-05-16

Regulatory Status

RX

2023
08 Jun
RX Application: 217252

Drug Name

BACLOFEN

Product Number

1

Dosage Form

-

Strength

25MG/5ML

Approval Date

2023-06-08

217252 / 1

Active Ingredient

BACLOFEN

Application Number

217252

Product Number

1

Dosage Form

-

Strength

25MG/5ML

Approval Date

2023-06-08

Regulatory Status

RX

2004
11 Feb
RX Application: 76333

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2004-02-11

76333 / 1

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

76333

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2004-02-11

Regulatory Status

RX

2004
11 Feb
RX Application: 76333

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2004-02-11

76333 / 2

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

76333

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2004-02-11

Regulatory Status

RX

2004
11 Feb
RX Application: 76333

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2004-02-11

76333 / 3

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

76333

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2004-02-11

Regulatory Status

RX

2004
11 Feb
RX Application: 76333

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2004-02-11

76333 / 4

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

76333

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2004-02-11

Regulatory Status

RX

2004
11 Feb
RX Application: 76342

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

2004-02-11

76342 / 1

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

76342

Product Number

1

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

2004-02-11

Regulatory Status

RX

2004
11 Feb
RX Application: 76342

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2004-02-11

76342 / 2

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

76342

Product Number

2

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2004-02-11

Regulatory Status

RX

2004
11 Feb
RX Application: 76342

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2004-02-11

76342 / 3

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

76342

Product Number

3

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2004-02-11

Regulatory Status

RX

2004
11 Feb
RX Application: 76342

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

4

Dosage Form

-

Strength

20MG;25MG

Approval Date

2004-02-11

76342 / 4

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

76342

Product Number

4

Dosage Form

-

Strength

20MG;25MG

Approval Date

2004-02-11

Regulatory Status

RX

2018
08 May
RX Application: 209861

Drug Name

BEXAROTENE

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2018-05-08

209861 / 1

Active Ingredient

BEXAROTENE

Application Number

209861

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2018-05-08

Regulatory Status

RX

1982
01 Jan
RX Application: 17849

Drug Name

BRETHINE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1982-01-01

17849 / 1

Active Ingredient

TERBUTALINE SULFATE

Application Number

17849

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 17849

Drug Name

BRETHINE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

17849 / 2

Active Ingredient

TERBUTALINE SULFATE

Application Number

17849

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

RX

2011
20 May
RX Application: 76697

Drug Name

CARBAMAZEPINE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2011-05-20

76697 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

76697

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2011-05-20

Regulatory Status

RX

2011
20 May
RX Application: 76697

Drug Name

CARBAMAZEPINE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2011-05-20

76697 / 2

Active Ingredient

CARBAMAZEPINE

Application Number

76697

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2011-05-20

Regulatory Status

RX

2011
20 May
RX Application: 76697

Drug Name

CARBAMAZEPINE

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2011-05-20

76697 / 3

Active Ingredient

CARBAMAZEPINE

Application Number

76697

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2011-05-20

Regulatory Status

RX

1995
04 Oct
RX Application: 20498

Drug Name

CASODEX

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1995-10-04

20498 / 1

Active Ingredient

BICALUTAMIDE

Application Number

20498

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1995-10-04

Regulatory Status

RX

2023
10 Mar
RX Application: 216517

Drug Name

COLESTIPOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2023-03-10

216517 / 1

Active Ingredient

COLESTIPOL HYDROCHLORIDE

Application Number

216517

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2023-03-10

Regulatory Status

RX

1982
01 Jan
RX Application: 16199

Drug Name

CORTENEMA

Product Number

1

Dosage Form

-

Strength

100MG/60ML

Approval Date

1982-01-01

16199 / 1

Active Ingredient

HYDROCORTISONE

Application Number

16199

Product Number

1

Dosage Form

-

Strength

100MG/60ML

Approval Date

1982-01-01

Regulatory Status

RX

2019
22 Jan
RX Application: 205401

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2019-01-22

205401 / 1

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

205401

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2019-01-22

Regulatory Status

RX

2019
22 Jan
RX Application: 205401

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

2

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2019-01-22

205401 / 2

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

205401

Product Number

2

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2019-01-22

Regulatory Status

RX

2019
22 Jan
RX Application: 205401

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

3

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2019-01-22

205401 / 3

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

205401

Product Number

3

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2019-01-22

Regulatory Status

RX

2019
22 Jan
RX Application: 205401

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

4

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2019-01-22

205401 / 4

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

205401

Product Number

4

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2019-01-22

Regulatory Status

RX

2019
22 Jan
RX Application: 205401

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

5

Dosage Form

-

Strength

6.25MG;6.25MG;6.25MG;6.25MG

Approval Date

2019-01-22

205401 / 5

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

205401

Product Number

5

Dosage Form

-

Strength

6.25MG;6.25MG;6.25MG;6.25MG

Approval Date

2019-01-22

Regulatory Status

RX

2019
22 Jan
RX Application: 205401

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

6

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2019-01-22

205401 / 6

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

205401

Product Number

6

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2019-01-22

Regulatory Status

RX

1982
01 Jan
RX Application: 86727

Drug Name

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Product Number

1

Dosage Form

-

Strength

0.025MG;2.5MG

Approval Date

1982-01-01

86727 / 1

Active Ingredient

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

Application Number

86727

Product Number

1

Dosage Form

-

Strength

0.025MG;2.5MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 62055

Drug Name

ERYTHROMYCIN ETHYLSUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/5ML

Approval Date

1982-01-01

62055 / 1

Active Ingredient

ERYTHROMYCIN ETHYLSUCCINATE

Application Number

62055

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

RX

2018
02 Nov
RX Application: 62055

Drug Name

ERYTHROMYCIN ETHYLSUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 400MG BASE/5ML

Approval Date

2018-11-02

62055 / 2

Active Ingredient

ERYTHROMYCIN ETHYLSUCCINATE

Application Number

62055

Product Number

2

Dosage Form

-

Strength

EQ 400MG BASE/5ML

Approval Date

2018-11-02

Regulatory Status

RX

2018
02 Nov
RX Application: 62055

Drug Name

ERYTHROMYCIN ETHYLSUCCINATE

Product Number

3

Dosage Form

-

Strength

EQ 200MG BASE/5ML

Approval Date

2018-11-02

62055 / 3

Active Ingredient

ERYTHROMYCIN ETHYLSUCCINATE

Application Number

62055

Product Number

3

Dosage Form

-

Strength

EQ 200MG BASE/5ML

Approval Date

2018-11-02

Regulatory Status

RX

1999
16 Sep
RX Application: 75126

Drug Name

ETODOLAC

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1999-09-16

75126 / 1

Active Ingredient

ETODOLAC

Application Number

75126

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1999-09-16

Regulatory Status

RX

1999
16 Sep
RX Application: 75126

Drug Name

ETODOLAC

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1999-09-16

75126 / 2

Active Ingredient

ETODOLAC

Application Number

75126

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1999-09-16

Regulatory Status

RX

2015
04 Nov
RX Application: 202284

Drug Name

FELBAMATE

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2015-11-04

202284 / 1

Active Ingredient

FELBAMATE

Application Number

202284

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2015-11-04

Regulatory Status

RX

2015
04 Nov
RX Application: 202284

Drug Name

FELBAMATE

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

2015-11-04

202284 / 2

Active Ingredient

FELBAMATE

Application Number

202284

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

2015-11-04

Regulatory Status

RX

2018
30 Apr
RX Application: 209504

Drug Name

FENOFIBRATE (MICRONIZED)

Product Number

1

Dosage Form

-

Strength

67MG

Approval Date

2018-04-30

209504 / 1

Active Ingredient

FENOFIBRATE

Application Number

209504

Product Number

1

Dosage Form

-

Strength

67MG

Approval Date

2018-04-30

Regulatory Status

RX

2018
30 Apr
RX Application: 209504

Drug Name

FENOFIBRATE (MICRONIZED)

Product Number

2

Dosage Form

-

Strength

134MG

Approval Date

2018-04-30

209504 / 2

Active Ingredient

FENOFIBRATE

Application Number

209504

Product Number

2

Dosage Form

-

Strength

134MG

Approval Date

2018-04-30

Regulatory Status

RX

2018
30 Apr
RX Application: 209504

Drug Name

FENOFIBRATE (MICRONIZED)

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2018-04-30

209504 / 3

Active Ingredient

FENOFIBRATE

Application Number

209504

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2018-04-30

Regulatory Status

RX

2002
28 Oct
RX Application: 75882

Drug Name

FLECAINIDE ACETATE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2002-10-28

75882 / 1

Active Ingredient

FLECAINIDE ACETATE

Application Number

75882

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2002-10-28

Regulatory Status

RX

2002
28 Oct
RX Application: 75882

Drug Name

FLECAINIDE ACETATE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2002-10-28

75882 / 2

Active Ingredient

FLECAINIDE ACETATE

Application Number

75882

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2002-10-28

Regulatory Status

RX

2002
28 Oct
RX Application: 75882

Drug Name

FLECAINIDE ACETATE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2002-10-28

75882 / 3

Active Ingredient

FLECAINIDE ACETATE

Application Number

75882

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2002-10-28

Regulatory Status

RX

2011
07 Mar
RX Application: 78423

Drug Name

FLUCONAZOLE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2011-03-07

78423 / 1

Active Ingredient

FLUCONAZOLE

Application Number

78423

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2011-03-07

Regulatory Status

RX

2011
07 Mar
RX Application: 78423

Drug Name

FLUCONAZOLE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2011-03-07

78423 / 2

Active Ingredient

FLUCONAZOLE

Application Number

78423

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2011-03-07

Regulatory Status

RX

2011
07 Mar
RX Application: 78423

Drug Name

FLUCONAZOLE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2011-03-07

78423 / 3

Active Ingredient

FLUCONAZOLE

Application Number

78423

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2011-03-07

Regulatory Status

RX

2011
07 Mar
RX Application: 78423

Drug Name

FLUCONAZOLE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2011-03-07

78423 / 4

Active Ingredient

FLUCONAZOLE

Application Number

78423

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2011-03-07

Regulatory Status

RX

1995
31 Aug
RX Application: 74497

Drug Name

GLIPIZIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1995-08-31

74497 / 1

Active Ingredient

GLIPIZIDE

Application Number

74497

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1995-08-31

Regulatory Status

RX

1995
31 Aug
RX Application: 74497

Drug Name

GLIPIZIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1995-08-31

74497 / 2

Active Ingredient

GLIPIZIDE

Application Number

74497

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1995-08-31

Regulatory Status

RX

1995
27 Jul
RX Application: 74299

Drug Name

INDAPAMIDE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1995-07-27

74299 / 1

Active Ingredient

INDAPAMIDE

Application Number

74299

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1995-07-27

Regulatory Status

RX

1996
29 Apr
RX Application: 74299

Drug Name

INDAPAMIDE

Product Number

2

Dosage Form

-

Strength

1.25MG

Approval Date

1996-04-29

74299 / 2

Active Ingredient

INDAPAMIDE

Application Number

74299

Product Number

2

Dosage Form

-

Strength

1.25MG

Approval Date

1996-04-29

Regulatory Status

RX

1983
19 Apr
RX Application: 18553

Drug Name

INDERAL LA

Product Number

1

Dosage Form

-

Strength

160MG

Approval Date

1983-04-19

18553 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

18553

Product Number

1

Dosage Form

-

Strength

160MG

Approval Date

1983-04-19

Regulatory Status

RX

1983
19 Apr
RX Application: 18553

Drug Name

INDERAL LA

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

1983-04-19

18553 / 2

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

18553

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

1983-04-19

Regulatory Status

RX

1983
19 Apr
RX Application: 18553

Drug Name

INDERAL LA

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

1983-04-19

18553 / 3

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

18553

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

1983-04-19

Regulatory Status

RX

1987
18 Mar
RX Application: 18553

Drug Name

INDERAL LA

Product Number

4

Dosage Form

-

Strength

60MG

Approval Date

1987-03-18

18553 / 4

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

18553

Product Number

4

Dosage Form

-

Strength

60MG

Approval Date

1987-03-18

Regulatory Status

RX

2003
12 Mar
RX Application: 21438

Drug Name

INNOPRAN XL

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

2003-03-12

21438 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

21438

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

2003-03-12

Regulatory Status

RX

2003
12 Mar
RX Application: 21438

Drug Name

INNOPRAN XL

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2003-03-12

21438 / 2

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

21438

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2003-03-12

Regulatory Status

RX

1998
27 Nov
RX Application: 75147

Drug Name

ISOSORBIDE MONONITRATE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1998-11-27

75147 / 1

Active Ingredient

ISOSORBIDE MONONITRATE

Application Number

75147

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1998-11-27

Regulatory Status

RX

2026
27 Mar
RX Application: 75147

Drug Name

ISOSORBIDE MONONITRATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2026-03-27

75147 / 2

Active Ingredient

ISOSORBIDE MONONITRATE

Application Number

75147

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2026-03-27

Regulatory Status

RX

2007
17 Sep
RX Application: 40028

Drug Name

KIONEX

Product Number

1

Dosage Form

-

Strength

15GM/60ML

Approval Date

2007-09-17

40028 / 1

Active Ingredient

SODIUM POLYSTYRENE SULFONATE

Application Number

40028

Product Number

1

Dosage Form

-

Strength

15GM/60ML

Approval Date

2007-09-17

Regulatory Status

RX

1998
06 Feb
RX Application: 40029

Drug Name

KIONEX

Product Number

1

Dosage Form

-

Strength

454GM/BOT

Approval Date

1998-02-06

40029 / 1

Active Ingredient

SODIUM POLYSTYRENE SULFONATE

Application Number

40029

Product Number

1

Dosage Form

-

Strength

454GM/BOT

Approval Date

1998-02-06

Regulatory Status

RX

1982
01 Jan
RX Application: 18027

Drug Name

LITHOBID

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

18027 / 1

Active Ingredient

LITHIUM CARBONATE

Application Number

18027

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

Regulatory Status

RX

2006
13 Dec
RX Application: 77396

Drug Name

LORAZEPAM

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2006-12-13

77396 / 1

Active Ingredient

LORAZEPAM

Application Number

77396

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2006-12-13

Regulatory Status

RX

2006
13 Dec
RX Application: 77396

Drug Name

LORAZEPAM

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2006-12-13

77396 / 2

Active Ingredient

LORAZEPAM

Application Number

77396

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2006-12-13

Regulatory Status

RX

2006
13 Dec
RX Application: 77396

Drug Name

LORAZEPAM

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2006-12-13

77396 / 3

Active Ingredient

LORAZEPAM

Application Number

77396

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2006-12-13

Regulatory Status

RX

2007
20 Dec
RX Application: 21519

Drug Name

LUVOX

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2007-12-20

21519 / 1

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

21519

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2007-12-20

Regulatory Status

RX

2007
20 Dec
RX Application: 21519

Drug Name

LUVOX

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2007-12-20

21519 / 2

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

21519

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2007-12-20

Regulatory Status

RX

2007
20 Dec
RX Application: 21519

Drug Name

LUVOX

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2007-12-20

21519 / 3

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

21519

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2007-12-20

Regulatory Status

RX

2023
15 Dec
RX Application: 208237

Drug Name

MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG;21MG

Approval Date

2023-12-15

208237 / 1

Active Ingredient

DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

Application Number

208237

Product Number

1

Dosage Form

-

Strength

10MG;21MG

Approval Date

2023-12-15

Regulatory Status

RX

1993
30 Jun
RX Application: 40001

Drug Name

METHAZOLAMIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1993-06-30

40001 / 1

Active Ingredient

METHAZOLAMIDE

Application Number

40001

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1993-06-30

Regulatory Status

RX

1993
30 Jun
RX Application: 40001

Drug Name

METHAZOLAMIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1993-06-30

40001 / 2

Active Ingredient

METHAZOLAMIDE

Application Number

40001

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1993-06-30

Regulatory Status

RX

1993
25 Jun
RX Application: 71402

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/5ML

Approval Date

1993-06-25

71402 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

71402

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/5ML

Approval Date

1993-06-25

Regulatory Status

RX

1996
16 May
RX Application: 74450

Drug Name

MEXILETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

1996-05-16

74450 / 1

Active Ingredient

MEXILETINE HYDROCHLORIDE

Application Number

74450

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

1996-05-16

Regulatory Status

RX

1996
16 May
RX Application: 74450

Drug Name

MEXILETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1996-05-16

74450 / 2

Active Ingredient

MEXILETINE HYDROCHLORIDE

Application Number

74450

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1996-05-16

Regulatory Status

RX

1996
16 May
RX Application: 74450

Drug Name

MEXILETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

250MG

Approval Date

1996-05-16

74450 / 3

Active Ingredient

MEXILETINE HYDROCHLORIDE

Application Number

74450

Product Number

3

Dosage Form

-

Strength

250MG

Approval Date

1996-05-16

Regulatory Status

RX

2018
17 Apr
RX Application: 208342

Drug Name

MIGLUSTAT

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2018-04-17

208342 / 1

Active Ingredient

MIGLUSTAT

Application Number

208342

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2018-04-17

Regulatory Status

RX

2002
10 Jul
RX Application: 76095

Drug Name

MISOPROSTOL

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2002-07-10

76095 / 1

Active Ingredient

MISOPROSTOL

Application Number

76095

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2002-07-10

Regulatory Status

RX

2002
10 Jul
RX Application: 76095

Drug Name

MISOPROSTOL

Product Number

2

Dosage Form

-

Strength

0.2MG

Approval Date

2002-07-10

76095 / 2

Active Ingredient

MISOPROSTOL

Application Number

76095

Product Number

2

Dosage Form

-

Strength

0.2MG

Approval Date

2002-07-10

Regulatory Status

RX

2015
16 Apr
RX Application: 203659

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2015-04-16

203659 / 1

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

203659

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2015-04-16

Regulatory Status

RX

2015
16 Apr
RX Application: 203659

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2015-04-16

203659 / 2

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

203659

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2015-04-16

Regulatory Status

RX

2015
16 Apr
RX Application: 203659

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2015-04-16

203659 / 3

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

203659

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2015-04-16

Regulatory Status

RX

2015
16 Apr
RX Application: 203659

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2015-04-16

203659 / 4

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

203659

Product Number

4

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2015-04-16

Regulatory Status

RX

1996
28 Oct
RX Application: 74670

Drug Name

NICARDIPINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1996-10-28

74670 / 1

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

74670

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1996-10-28

Regulatory Status

RX

1996
28 Oct
RX Application: 74670

Drug Name

NICARDIPINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

1996-10-28

74670 / 2

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

74670

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

1996-10-28

Regulatory Status

RX

2016
15 Jul
RX Application: 207631

Drug Name

NILUTAMIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2016-07-15

207631 / 1

Active Ingredient

NILUTAMIDE

Application Number

207631

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2016-07-15

Regulatory Status

RX

2025
03 Feb
RX Application: 214844

Drug Name

NITAZOXANIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2025-02-03

214844 / 1

Active Ingredient

NITAZOXANIDE

Application Number

214844

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2025-02-03

Regulatory Status

RX

2007
11 Dec
RX Application: 78005

Drug Name

OXCARBAZEPINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2007-12-11

78005 / 1

Active Ingredient

OXCARBAZEPINE

Application Number

78005

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2007-12-11

Regulatory Status

RX

2007
11 Dec
RX Application: 78005

Drug Name

OXCARBAZEPINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2007-12-11

78005 / 2

Active Ingredient

OXCARBAZEPINE

Application Number

78005

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2007-12-11

Regulatory Status

RX

2007
11 Dec
RX Application: 78005

Drug Name

OXCARBAZEPINE

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2007-12-11

78005 / 3

Active Ingredient

OXCARBAZEPINE

Application Number

78005

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2007-12-11

Regulatory Status

RX

2015
01 Jun
RX Application: 204979

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2015-06-01

204979 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

204979

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2015-06-01

Regulatory Status

RX

2016
31 Mar
RX Application: 205177

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2016-03-31

205177 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

205177

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2016-03-31

Regulatory Status

RX

1997
09 Jul
RX Application: 74878

Drug Name

PENTOXIFYLLINE

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1997-07-09

74878 / 1

Active Ingredient

PENTOXIFYLLINE

Application Number

74878

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1997-07-09

Regulatory Status

RX

1993
29 Mar
RX Application: 73609

Drug Name

PINDOLOL

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1993-03-29

73609 / 1

Active Ingredient

PINDOLOL

Application Number

73609

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1993-03-29

Regulatory Status

RX

1993
29 Mar
RX Application: 73609

Drug Name

PINDOLOL

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1993-03-29

73609 / 2

Active Ingredient

PINDOLOL

Application Number

73609

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1993-03-29

Regulatory Status

RX

2020
14 Jan
RX Application: 212779

Drug Name

POTASSIUM CITRATE

Product Number

1

Dosage Form

-

Strength

10MEQ

Approval Date

2020-01-14

212779 / 1

Active Ingredient

POTASSIUM CITRATE

Application Number

212779

Product Number

1

Dosage Form

-

Strength

10MEQ

Approval Date

2020-01-14

Regulatory Status

RX

2020
14 Jan
RX Application: 212779

Drug Name

POTASSIUM CITRATE

Product Number

2

Dosage Form

-

Strength

15MEQ

Approval Date

2020-01-14

212779 / 2

Active Ingredient

POTASSIUM CITRATE

Application Number

212779

Product Number

2

Dosage Form

-

Strength

15MEQ

Approval Date

2020-01-14

Regulatory Status

RX

1984
02 Apr
RX Application: 11265

Drug Name

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

15MG/5ML;6.25MG/5ML

Approval Date

1984-04-02

11265 / 2

Active Ingredient

DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE

Application Number

11265

Product Number

2

Dosage Form

-

Strength

15MG/5ML;6.25MG/5ML

Approval Date

1984-04-02

Regulatory Status

RX

2004
23 Apr
RX Application: 76550

Drug Name

PROPAFENONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2004-04-23

76550 / 1

Active Ingredient

PROPAFENONE HYDROCHLORIDE

Application Number

76550

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2004-04-23

Regulatory Status

RX

2004
23 Apr
RX Application: 76550

Drug Name

PROPAFENONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

225MG

Approval Date

2004-04-23

76550 / 2

Active Ingredient

PROPAFENONE HYDROCHLORIDE

Application Number

76550

Product Number

2

Dosage Form

-

Strength

225MG

Approval Date

2004-04-23

Regulatory Status

RX

2004
23 Apr
RX Application: 76550

Drug Name

PROPAFENONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2004-04-23

76550 / 3

Active Ingredient

PROPAFENONE HYDROCHLORIDE

Application Number

76550

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2004-04-23

Regulatory Status

RX

1982
01 Jan
RX Application: 8975

Drug Name

PURIFIED CORTROPHIN GEL

Product Number

2

Dosage Form

-

Strength

80 UNITS/ML

Approval Date

1982-01-01

8975 / 2

Active Ingredient

CORTICOTROPIN

Application Number

8975

Product Number

2

Dosage Form

-

Strength

80 UNITS/ML

Approval Date

1982-01-01

Regulatory Status

RX

2003
08 Oct
RX Application: 40512

Drug Name

PYRIDOSTIGMINE BROMIDE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2003-10-08

40512 / 1

Active Ingredient

PYRIDOSTIGMINE BROMIDE

Application Number

40512

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2003-10-08

Regulatory Status

RX

1982
01 Jan
RX Application: 17854

Drug Name

REGLAN

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1982-01-01

17854 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

17854

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1982-01-01

Regulatory Status

RX

1987
05 May
RX Application: 17854

Drug Name

REGLAN

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1987-05-05

17854 / 2

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

17854

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1987-05-05

Regulatory Status

RX

2009
30 Jan
RX Application: 76440

Drug Name

RISPERIDONE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2009-01-30

76440 / 1

Active Ingredient

RISPERIDONE

Application Number

76440

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2009-01-30

Regulatory Status

RX

2016
25 Jul
RX Application: 203256

Drug Name

TRANEXAMIC ACID

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

2016-07-25

203256 / 1

Active Ingredient

TRANEXAMIC ACID

Application Number

203256

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

2016-07-25

Regulatory Status

RX

1992
25 Aug
RX Application: 73178

Drug Name

VALPROIC ACID

Product Number

1

Dosage Form

-

Strength

250MG/5ML

Approval Date

1992-08-25

73178 / 1

Active Ingredient

VALPROIC ACID

Application Number

73178

Product Number

1

Dosage Form

-

Strength

250MG/5ML

Approval Date

1992-08-25

Regulatory Status

RX

1986
15 Apr
RX Application: 50606

Drug Name

VANCOCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE

Approval Date

1986-04-15

50606 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

50606

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE

Approval Date

1986-04-15

Regulatory Status

RX

1986
15 Apr
RX Application: 50606

Drug Name

VANCOCIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1986-04-15

50606 / 2

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

50606

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1986-04-15

Regulatory Status

RX

1983
13 Jul
RX Application: 61667

Drug Name

VANCOCIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1983-07-13

61667 / 2

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

61667

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1983-07-13

Regulatory Status

RX

2006
31 Oct
RX Application: 21902

Drug Name

VEREGEN

Product Number

1

Dosage Form

-

Strength

15%

Approval Date

2006-10-31

21902 / 1

Active Ingredient

SINECATECHINS

Application Number

21902

Product Number

1

Dosage Form

-

Strength

15%

Approval Date

2006-10-31

Regulatory Status

RX

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Drug Status Breakdown
116 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

ACEBUTOLOL HYDROCHLORIDE

Application Number

74007

Product Number

1

Active Ingredient

ACEBUTOLOL HYDROCHLORIDE

Dosage Form

-

Strength

EQ 200MG BASE

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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