Impax Laboratories RX
FDA Approved Drugs

Impax Laboratories 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 113
  • Latest Approval Date Jun 28, 2022
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
283
View
Unclassified
10
View
Discontinued
160
View
RX
113
View
Company Overview

Company

Impax Laboratories RX

Country

U.S.A

Website

Visit Website

Email

inquiries@impaxlabs.com

Social Profiles

Company Snapshot

Impax Laboratories RX

30831 Huntwood Ave.Hayward, CA 94544

U.S.A

www.impaxlabs.com/ inquiries@impaxlabs.com View on Map
FDA Approved Drug Records ( 113 records )
2009
14 May
RX Application: 78441

Drug Name

ACARBOSE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-05-14

78441 / 1

Active Ingredient

ACARBOSE

Application Number

78441

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-05-14

Regulatory Status

RX

2009
14 May
RX Application: 78441

Drug Name

ACARBOSE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2009-05-14

78441 / 2

Active Ingredient

ACARBOSE

Application Number

78441

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2009-05-14

Regulatory Status

RX

2009
14 May
RX Application: 78441

Drug Name

ACARBOSE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2009-05-14

78441 / 3

Active Ingredient

ACARBOSE

Application Number

78441

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2009-05-14

Regulatory Status

RX

2015
23 Dec
RX Application: 202552

Drug Name

ACITRETIN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2015-12-23

202552 / 1

Active Ingredient

ACITRETIN

Application Number

202552

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2015-12-23

Regulatory Status

RX

2015
23 Dec
RX Application: 202552

Drug Name

ACITRETIN

Product Number

2

Dosage Form

-

Strength

17.5MG

Approval Date

2015-12-23

202552 / 2

Active Ingredient

ACITRETIN

Application Number

202552

Product Number

2

Dosage Form

-

Strength

17.5MG

Approval Date

2015-12-23

Regulatory Status

RX

2015
23 Dec
RX Application: 202552

Drug Name

ACITRETIN

Product Number

3

Dosage Form

-

Strength

22.5MG

Approval Date

2015-12-23

202552 / 3

Active Ingredient

ACITRETIN

Application Number

202552

Product Number

3

Dosage Form

-

Strength

22.5MG

Approval Date

2015-12-23

Regulatory Status

RX

2015
23 Dec
RX Application: 202552

Drug Name

ACITRETIN

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2015-12-23

202552 / 4

Active Ingredient

ACITRETIN

Application Number

202552

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2015-12-23

Regulatory Status

RX

2005
18 Apr
RX Application: 76910

Drug Name

ANAGRELIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2005-04-18

76910 / 1

Active Ingredient

ANAGRELIDE HYDROCHLORIDE

Application Number

76910

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2005-04-18

Regulatory Status

RX

2005
18 Apr
RX Application: 76910

Drug Name

ANAGRELIDE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2005-04-18

76910 / 2

Active Ingredient

ANAGRELIDE HYDROCHLORIDE

Application Number

76910

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2005-04-18

Regulatory Status

RX

2012
31 Jul
RX Application: 78404

Drug Name

BUDESONIDE

Product Number

1

Dosage Form

-

Strength

0.25MG/2ML

Approval Date

2012-07-31

78404 / 1

Active Ingredient

BUDESONIDE

Application Number

78404

Product Number

1

Dosage Form

-

Strength

0.25MG/2ML

Approval Date

2012-07-31

Regulatory Status

RX

2012
31 Jul
RX Application: 78404

Drug Name

BUDESONIDE

Product Number

2

Dosage Form

-

Strength

0.5MG/2ML

Approval Date

2012-07-31

78404 / 2

Active Ingredient

BUDESONIDE

Application Number

78404

Product Number

2

Dosage Form

-

Strength

0.5MG/2ML

Approval Date

2012-07-31

Regulatory Status

RX

2004
28 Jan
RX Application: 75913

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2004-01-28

75913 / 1

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

75913

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2004-01-28

Regulatory Status

RX

2004
22 Mar
RX Application: 75913

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2004-03-22

75913 / 2

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

75913

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2004-03-22

Regulatory Status

RX

2004
27 May
RX Application: 75914

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2004-05-27

75914 / 1

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

75914

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2004-05-27

Regulatory Status

RX

2001
28 Mar
RX Application: 74253

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2001-03-28

74253 / 1

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

74253

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2001-03-28

Regulatory Status

RX

2001
28 Mar
RX Application: 74253

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2001-03-28

74253 / 2

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

74253

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2001-03-28

Regulatory Status

RX

2002
13 Mar
RX Application: 74253

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2002-03-13

74253 / 3

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

74253

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2002-03-13

Regulatory Status

RX

2004
14 May
RX Application: 76521

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

1

Dosage Form

-

Strength

25MG;100MG

Approval Date

2004-05-14

76521 / 1

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

76521

Product Number

1

Dosage Form

-

Strength

25MG;100MG

Approval Date

2004-05-14

Regulatory Status

RX

2004
14 May
RX Application: 76521

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

2

Dosage Form

-

Strength

50MG;200MG

Approval Date

2004-05-14

76521 / 2

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

76521

Product Number

2

Dosage Form

-

Strength

50MG;200MG

Approval Date

2004-05-14

Regulatory Status

RX

2018
07 May
RX Application: 204717

Drug Name

CARVEDILOL PHOSPHATE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-05-07

204717 / 1

Active Ingredient

CARVEDILOL PHOSPHATE

Application Number

204717

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-05-07

Regulatory Status

RX

2018
07 May
RX Application: 204717

Drug Name

CARVEDILOL PHOSPHATE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2018-05-07

204717 / 2

Active Ingredient

CARVEDILOL PHOSPHATE

Application Number

204717

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2018-05-07

Regulatory Status

RX

2018
07 May
RX Application: 204717

Drug Name

CARVEDILOL PHOSPHATE

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2018-05-07

204717 / 3

Active Ingredient

CARVEDILOL PHOSPHATE

Application Number

204717

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2018-05-07

Regulatory Status

RX

2018
07 May
RX Application: 204717

Drug Name

CARVEDILOL PHOSPHATE

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

2018-05-07

204717 / 4

Active Ingredient

CARVEDILOL PHOSPHATE

Application Number

204717

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

2018-05-07

Regulatory Status

RX

2003
29 Aug
RX Application: 40516

Drug Name

CHLOROQUINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2003-08-29

40516 / 1

Active Ingredient

CHLOROQUINE PHOSPHATE

Application Number

40516

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2003-08-29

Regulatory Status

RX

1982
01 Jan
RX Application: 80880

Drug Name

CHLOROQUINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

80880 / 1

Active Ingredient

CHLOROQUINE PHOSPHATE

Application Number

80880

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

RX

2009
27 Aug
RX Application: 78099

Drug Name

CLONIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2009-08-27

78099 / 1

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

78099

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2009-08-27

Regulatory Status

RX

2009
27 Aug
RX Application: 78099

Drug Name

CLONIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

0.2MG

Approval Date

2009-08-27

78099 / 2

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

78099

Product Number

2

Dosage Form

-

Strength

0.2MG

Approval Date

2009-08-27

Regulatory Status

RX

2009
27 Aug
RX Application: 78099

Drug Name

CLONIDINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

0.3MG

Approval Date

2009-08-27

78099 / 3

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

78099

Product Number

3

Dosage Form

-

Strength

0.3MG

Approval Date

2009-08-27

Regulatory Status

RX

2018
16 May
RX Application: 91600

Drug Name

COLESEVELAM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

625MG

Approval Date

2018-05-16

91600 / 1

Active Ingredient

COLESEVELAM HYDROCHLORIDE

Application Number

91600

Product Number

1

Dosage Form

-

Strength

625MG

Approval Date

2018-05-16

Regulatory Status

RX

2006
24 Oct
RX Application: 77510

Drug Name

COLESTIPOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2006-10-24

77510 / 1

Active Ingredient

COLESTIPOL HYDROCHLORIDE

Application Number

77510

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2006-10-24

Regulatory Status

RX

2005
01 Mar
RX Application: 76856

Drug Name

DANTROLENE SODIUM

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2005-03-01

76856 / 1

Active Ingredient

DANTROLENE SODIUM

Application Number

76856

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2005-03-01

Regulatory Status

RX

2005
01 Mar
RX Application: 76856

Drug Name

DANTROLENE SODIUM

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2005-03-01

76856 / 2

Active Ingredient

DANTROLENE SODIUM

Application Number

76856

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2005-03-01

Regulatory Status

RX

2005
01 Mar
RX Application: 76856

Drug Name

DANTROLENE SODIUM

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2005-03-01

76856 / 3

Active Ingredient

DANTROLENE SODIUM

Application Number

76856

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2005-03-01

Regulatory Status

RX

1982
01 Jan
RX Application: 17078

Drug Name

DEXEDRINE SPANSULE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

17078 / 1

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

17078

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 17078

Drug Name

DEXEDRINE SPANSULE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

17078 / 2

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

17078

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 17078

Drug Name

DEXEDRINE SPANSULE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

17078 / 3

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

17078

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

Regulatory Status

RX

2015
05 Aug
RX Application: 79108

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-08-05

79108 / 1

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

79108

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-08-05

Regulatory Status

RX

2015
05 Aug
RX Application: 79108

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2015-08-05

79108 / 2

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

79108

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2015-08-05

Regulatory Status

RX

2014
19 May
RX Application: 79108

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2014-05-19

79108 / 3

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

79108

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2014-05-19

Regulatory Status

RX

2015
21 Dec
RX Application: 79108

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2015-12-21

79108 / 4

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

79108

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2015-12-21

Regulatory Status

RX

2013
21 Nov
RX Application: 79108

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

2013-11-21

79108 / 5

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

79108

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

2013-11-21

Regulatory Status

RX

2017
05 Jul
RX Application: 203614

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2017-07-05

203614 / 1

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

203614

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2017-07-05

Regulatory Status

RX

2017
05 Jul
RX Application: 203614

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

35MG

Approval Date

2017-07-05

203614 / 2

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

203614

Product Number

2

Dosage Form

-

Strength

35MG

Approval Date

2017-07-05

Regulatory Status

RX

2016
16 Feb
RX Application: 76852

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

2016-02-16

76852 / 1

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

76852

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2016-02-16

Regulatory Status

RX

2016
16 Feb
RX Application: 76852

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

2016-02-16

76852 / 2

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

76852

Product Number

2

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2016-02-16

Regulatory Status

RX

2016
16 Feb
RX Application: 76852

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

2016-02-16

76852 / 3

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

76852

Product Number

3

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2016-02-16

Regulatory Status

RX

2016
16 Feb
RX Application: 76852

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

4

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2016-02-16

76852 / 4

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

76852

Product Number

4

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2016-02-16

Regulatory Status

RX

2016
16 Feb
RX Application: 76852

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

2016-02-16

76852 / 5

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

76852

Product Number

5

Dosage Form

-

Strength

6.25MG;6.25MG;6.25MG;6.25MG

Approval Date

2016-02-16

Regulatory Status

RX

2016
16 Feb
RX Application: 76852

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

2016-02-16

76852 / 6

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

76852

Product Number

6

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2016-02-16

Regulatory Status

RX

2007
18 Jul
RX Application: 40782

Drug Name

DIPYRIDAMOLE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2007-07-18

40782 / 1

Active Ingredient

DIPYRIDAMOLE

Application Number

40782

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2007-07-18

Regulatory Status

RX

2007
18 Jul
RX Application: 40782

Drug Name

DIPYRIDAMOLE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2007-07-18

40782 / 2

Active Ingredient

DIPYRIDAMOLE

Application Number

40782

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2007-07-18

Regulatory Status

RX

2007
18 Jul
RX Application: 40782

Drug Name

DIPYRIDAMOLE

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2007-07-18

40782 / 3

Active Ingredient

DIPYRIDAMOLE

Application Number

40782

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2007-07-18

Regulatory Status

RX

1995
04 Jan
RX Application: 73580

Drug Name

EMVERM

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1995-01-04

73580 / 1

Active Ingredient

MEBENDAZOLE

Application Number

73580

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1995-01-04

Regulatory Status

RX

2007
09 Aug
RX Application: 65331

Drug Name

EPIRUBICIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/25ML (2MG/ML)

Approval Date

2007-08-09

65331 / 1

Active Ingredient

EPIRUBICIN HYDROCHLORIDE

Application Number

65331

Product Number

1

Dosage Form

-

Strength

50MG/25ML (2MG/ML)

Approval Date

2007-08-09

Regulatory Status

RX

2007
09 Aug
RX Application: 65331

Drug Name

EPIRUBICIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2007-08-09

65331 / 2

Active Ingredient

EPIRUBICIN HYDROCHLORIDE

Application Number

65331

Product Number

2

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2007-08-09

Regulatory Status

RX

2008
26 Mar
RX Application: 76509

Drug Name

FENOFIBRATE

Product Number

1

Dosage Form

-

Strength

54MG

Approval Date

2008-03-26

76509 / 1

Active Ingredient

FENOFIBRATE

Application Number

76509

Product Number

1

Dosage Form

-

Strength

54MG

Approval Date

2008-03-26

Regulatory Status

RX

2008
26 Mar
RX Application: 76509

Drug Name

FENOFIBRATE

Product Number

2

Dosage Form

-

Strength

160MG

Approval Date

2008-03-26

76509 / 2

Active Ingredient

FENOFIBRATE

Application Number

76509

Product Number

2

Dosage Form

-

Strength

160MG

Approval Date

2008-03-26

Regulatory Status

RX

2016
07 Sep
RX Application: 200264

Drug Name

FENOFIBRIC ACID

Product Number

1

Dosage Form

-

Strength

EQ 45MG FENOFIBRIC ACID

Approval Date

2016-09-07

200264 / 1

Active Ingredient

CHOLINE FENOFIBRATE

Application Number

200264

Product Number

1

Dosage Form

-

Strength

EQ 45MG FENOFIBRIC ACID

Approval Date

2016-09-07

Regulatory Status

RX

2016
07 Sep
RX Application: 200264

Drug Name

FENOFIBRIC ACID

Product Number

2

Dosage Form

-

Strength

EQ 135MG FENOFIBRIC ACID

Approval Date

2016-09-07

200264 / 2

Active Ingredient

CHOLINE FENOFIBRATE

Application Number

200264

Product Number

2

Dosage Form

-

Strength

EQ 135MG FENOFIBRIC ACID

Approval Date

2016-09-07

Regulatory Status

RX

2002
18 Mar
RX Application: 40431

Drug Name

FLUDROCORTISONE ACETATE

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2002-03-18

40431 / 1

Active Ingredient

FLUDROCORTISONE ACETATE

Application Number

40431

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2002-03-18

Regulatory Status

RX

2007
01 Jun
RX Application: 78207

Drug Name

GEMFIBROZIL

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2007-06-01

78207 / 1

Active Ingredient

GEMFIBROZIL

Application Number

78207

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2007-06-01

Regulatory Status

RX

2015
30 Sep
RX Application: 206079

Drug Name

GLYBURIDE

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

2015-09-30

206079 / 1

Active Ingredient

GLYBURIDE

Application Number

206079

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

2015-09-30

Regulatory Status

RX

2015
30 Sep
RX Application: 206079

Drug Name

GLYBURIDE

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2015-09-30

206079 / 2

Active Ingredient

GLYBURIDE

Application Number

206079

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2015-09-30

Regulatory Status

RX

2015
30 Sep
RX Application: 206079

Drug Name

GLYBURIDE

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2015-09-30

206079 / 3

Active Ingredient

GLYBURIDE

Application Number

206079

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2015-09-30

Regulatory Status

RX

2007
30 Mar
RX Application: 40646

Drug Name

HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-03-30

40646 / 1

Active Ingredient

HYDROCORTISONE

Application Number

40646

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-03-30

Regulatory Status

RX

2007
30 Mar
RX Application: 40646

Drug Name

HYDROCORTISONE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-03-30

40646 / 2

Active Ingredient

HYDROCORTISONE

Application Number

40646

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-03-30

Regulatory Status

RX

2007
30 Mar
RX Application: 40646

Drug Name

HYDROCORTISONE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2007-03-30

40646 / 3

Active Ingredient

HYDROCORTISONE

Application Number

40646

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2007-03-30

Regulatory Status

RX

1996
15 Jul
RX Application: 40156

Drug Name

HYDROXYZINE PAMOATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG HYDROCHLORIDE

Approval Date

1996-07-15

40156 / 1

Active Ingredient

HYDROXYZINE PAMOATE

Application Number

40156

Product Number

1

Dosage Form

-

Strength

EQ 25MG HYDROCHLORIDE

Approval Date

1996-07-15

Regulatory Status

RX

1996
15 Jul
RX Application: 40156

Drug Name

HYDROXYZINE PAMOATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG HYDROCHLORIDE

Approval Date

1996-07-15

40156 / 2

Active Ingredient

HYDROXYZINE PAMOATE

Application Number

40156

Product Number

2

Dosage Form

-

Strength

EQ 50MG HYDROCHLORIDE

Approval Date

1996-07-15

Regulatory Status

RX

2013
15 Jul
RX Application: 200828

Drug Name

LAMOTRIGINE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2013-07-15

200828 / 1

Active Ingredient

LAMOTRIGINE

Application Number

200828

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2013-07-15

Regulatory Status

RX

2013
15 Jul
RX Application: 200828

Drug Name

LAMOTRIGINE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2013-07-15

200828 / 2

Active Ingredient

LAMOTRIGINE

Application Number

200828

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2013-07-15

Regulatory Status

RX

2013
15 Jul
RX Application: 200828

Drug Name

LAMOTRIGINE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2013-07-15

200828 / 3

Active Ingredient

LAMOTRIGINE

Application Number

200828

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2013-07-15

Regulatory Status

RX

2013
15 Jul
RX Application: 200828

Drug Name

LAMOTRIGINE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2013-07-15

200828 / 4

Active Ingredient

LAMOTRIGINE

Application Number

200828

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2013-07-15

Regulatory Status

RX

2008
09 Apr
RX Application: 77756

Drug Name

LEVALBUTEROL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.021% BASE

Approval Date

2008-04-09

77756 / 1

Active Ingredient

LEVALBUTEROL HYDROCHLORIDE

Application Number

77756

Product Number

1

Dosage Form

-

Strength

EQ 0.021% BASE

Approval Date

2008-04-09

Regulatory Status

RX

2008
09 Apr
RX Application: 77756

Drug Name

LEVALBUTEROL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 0.042% BASE

Approval Date

2008-04-09

77756 / 2

Active Ingredient

LEVALBUTEROL HYDROCHLORIDE

Application Number

77756

Product Number

2

Dosage Form

-

Strength

EQ 0.042% BASE

Approval Date

2008-04-09

Regulatory Status

RX

2008
09 Apr
RX Application: 77756

Drug Name

LEVALBUTEROL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 0.0103% BASE

Approval Date

2008-04-09

77756 / 3

Active Ingredient

LEVALBUTEROL HYDROCHLORIDE

Application Number

77756

Product Number

3

Dosage Form

-

Strength

EQ 0.0103% BASE

Approval Date

2008-04-09

Regulatory Status

RX

2016
28 Jul
RX Application: 205105

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2016-07-28

205105 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

205105

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2016-07-28

Regulatory Status

RX

2016
28 Jul
RX Application: 205105

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2016-07-28

205105 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

205105

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2016-07-28

Regulatory Status

RX

2016
28 Jul
RX Application: 205105

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2016-07-28

205105 / 3

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

205105

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2016-07-28

Regulatory Status

RX

2016
28 Jul
RX Application: 205105

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2016-07-28

205105 / 4

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

205105

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2016-07-28

Regulatory Status

RX

2016
28 Jul
RX Application: 205105

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2016-07-28

205105 / 5

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

205105

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2016-07-28

Regulatory Status

RX

2016
28 Jul
RX Application: 205105

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2016-07-28

205105 / 6

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

205105

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2016-07-28

Regulatory Status

RX

1982
01 Jan
RX Application: 80767

Drug Name

METHYLTESTOSTERONE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

80767 / 2

Active Ingredient

METHYLTESTOSTERONE

Application Number

80767

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

RX

2015
21 Sep
RX Application: 204851

Drug Name

METHYLTESTOSTERONE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2015-09-21

204851 / 1

Active Ingredient

METHYLTESTOSTERONE

Application Number

204851

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2015-09-21

Regulatory Status

RX

1999
23 Mar
RX Application: 65005

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1999-03-23

65005 / 1

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

65005

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1999-03-23

Regulatory Status

RX

1999
23 Mar
RX Application: 65005

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1999-03-23

65005 / 2

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

65005

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1999-03-23

Regulatory Status

RX

2001
18 Apr
RX Application: 65005

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2001-04-18

65005 / 3

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

65005

Product Number

3

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2001-04-18

Regulatory Status

RX

1993
28 Jan
RX Application: 73652

Drug Name

NITROFURANTOIN

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1993-01-28

73652 / 1

Active Ingredient

NITROFURANTOIN, MACROCRYSTALLINE

Application Number

73652

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1993-01-28

Regulatory Status

RX

1993
28 Jan
RX Application: 73671

Drug Name

NITROFURANTOIN

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1993-01-28

73671 / 1

Active Ingredient

NITROFURANTOIN, MACROCRYSTALLINE

Application Number

73671

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1993-01-28

Regulatory Status

RX

2007
22 Oct
RX Application: 75785

Drug Name

OMEPRAZOLE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2007-10-22

75785 / 1

Active Ingredient

OMEPRAZOLE

Application Number

75785

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2007-10-22

Regulatory Status

RX

2007
22 Oct
RX Application: 75785

Drug Name

OMEPRAZOLE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2007-10-22

75785 / 2

Active Ingredient

OMEPRAZOLE

Application Number

75785

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2007-10-22

Regulatory Status

RX

2009
21 Jan
RX Application: 75785

Drug Name

OMEPRAZOLE

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2009-01-21

75785 / 3

Active Ingredient

OMEPRAZOLE

Application Number

75785

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2009-01-21

Regulatory Status

RX

2010
14 Jun
RX Application: 79087

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2010-06-14

79087 / 1

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

79087

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2010-06-14

Regulatory Status

RX

2010
21 Dec
RX Application: 79087

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2010-12-21

79087 / 2

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

79087

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2010-12-21

Regulatory Status

RX

2010
14 Jun
RX Application: 79087

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2010-06-14

79087 / 3

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

79087

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2010-06-14

Regulatory Status

RX

2010
21 Dec
RX Application: 79087

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2010-12-21

79087 / 4

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

79087

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2010-12-21

Regulatory Status

RX

2010
14 Jun
RX Application: 79087

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2010-06-14

79087 / 5

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

79087

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2010-06-14

Regulatory Status

RX

2010
22 Jul
RX Application: 79087

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2010-07-22

79087 / 6

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

79087

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2010-07-22

Regulatory Status

RX

2010
14 Jun
RX Application: 79087

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

7

Dosage Form

-

Strength

40MG

Approval Date

2010-06-14

79087 / 7

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

79087

Product Number

7

Dosage Form

-

Strength

40MG

Approval Date

2010-06-14

Regulatory Status

RX

2006
31 Mar
RX Application: 77248

Drug Name

PILOCARPINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2006-03-31

77248 / 1

Active Ingredient

PILOCARPINE HYDROCHLORIDE

Application Number

77248

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2006-03-31

Regulatory Status

RX

2006
31 Mar
RX Application: 77248

Drug Name

PILOCARPINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2006-03-31

77248 / 2

Active Ingredient

PILOCARPINE HYDROCHLORIDE

Application Number

77248

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2006-03-31

Regulatory Status

RX

1988
06 Apr
RX Application: 71972

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1988-04-06

71972 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

71972

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1988-04-06

Regulatory Status

RX

1988
06 Apr
RX Application: 71972

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

1988-04-06

71972 / 2

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

71972

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

1988-04-06

Regulatory Status

RX

1988
06 Apr
RX Application: 71972

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

1988-04-06

71972 / 3

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

71972

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

1988-04-06

Regulatory Status

RX

1988
06 Apr
RX Application: 71976

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

1988-04-06

71976 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

71976

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

1988-04-06

Regulatory Status

RX

1986
13 May
RX Application: 71976

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

1986-05-13

71976 / 2

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

71976

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

1986-05-13

Regulatory Status

RX

2003
24 Apr
RX Application: 40502

Drug Name

PYRIDOSTIGMINE BROMIDE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2003-04-24

40502 / 1

Active Ingredient

PYRIDOSTIGMINE BROMIDE

Application Number

40502

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2003-04-24

Regulatory Status

RX

2022
28 Jun
RX Application: 40502

Drug Name

PYRIDOSTIGMINE BROMIDE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2022-06-28

40502 / 2

Active Ingredient

PYRIDOSTIGMINE BROMIDE

Application Number

40502

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2022-06-28

Regulatory Status

RX

2003
29 Jan
RX Application: 76173

Drug Name

RILUZOLE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2003-01-29

76173 / 1

Active Ingredient

RILUZOLE

Application Number

76173

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2003-01-29

Regulatory Status

RX

2002
30 Aug
RX Application: 76132

Drug Name

RIMANTADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2002-08-30

76132 / 1

Active Ingredient

RIMANTADINE HYDROCHLORIDE

Application Number

76132

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2002-08-30

Regulatory Status

RX

2010
02 Mar
RX Application: 90377

Drug Name

TAMSULOSIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.4MG

Approval Date

2010-03-02

90377 / 1

Active Ingredient

TAMSULOSIN HYDROCHLORIDE

Application Number

90377

Product Number

1

Dosage Form

-

Strength

0.4MG

Approval Date

2010-03-02

Regulatory Status

RX

2001
26 Jun
RX Application: 75877

Drug Name

TERBUTALINE SULFATE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2001-06-26

75877 / 1

Active Ingredient

TERBUTALINE SULFATE

Application Number

75877

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2001-06-26

Regulatory Status

RX

2001
26 Jun
RX Application: 75877

Drug Name

TERBUTALINE SULFATE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2001-06-26

75877 / 2

Active Ingredient

TERBUTALINE SULFATE

Application Number

75877

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2001-06-26

Regulatory Status

RX

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Drug Status Breakdown
113 total
  • RX
Official Source

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

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FDA Approved Drug Record Details Preview

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

Drug Name

ACARBOSE

Application Number

78441

Product Number

1

Active Ingredient

ACARBOSE

Dosage Form

-

Strength

25MG

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

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