CorePharma, LLC
FDA Approved Drugs

CorePharma, LLC

FDA Approved Drugs Database

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

RX Discontinued Unclassified OTC
  • Total Records 73
  • Latest Approval Date Sep 17, 2024
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
73
View
Unclassified
6
View
Discontinued
10
View
OTC
1
View
RX
56
View
Company Overview

Company

CorePharma, LLC

Country

U.S.A

Website

Visit Website

Email

customer.service@corepharma.com

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Company Snapshot

CorePharma, LLC

215 Wood Avenue, Middlesex, NJ 08846

U.S.A

www.corepharma.com/ customer.service@corepharma.com View on Map
FDA Approved Drug Records ( 73 records )
2007
23 May
RX Application: 76719

Drug Name

AMLODIPINE BESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2007-05-23

76719 / 1

Active Ingredient

AMLODIPINE BESYLATE

Application Number

76719

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2007-05-23

Regulatory Status

RX

2007
23 May
RX Application: 76719

Drug Name

AMLODIPINE BESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2007-05-23

76719 / 2

Active Ingredient

AMLODIPINE BESYLATE

Application Number

76719

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2007-05-23

Regulatory Status

RX

2007
23 May
RX Application: 76719

Drug Name

AMLODIPINE BESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-05-23

76719 / 3

Active Ingredient

AMLODIPINE BESYLATE

Application Number

76719

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-05-23

Regulatory Status

RX

2019
25 Mar
RX Application: 201514

Drug Name

ARMODAFINIL

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2019-03-25

201514 / 1

Active Ingredient

ARMODAFINIL

Application Number

201514

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2019-03-25

Regulatory Status

RX

2019
25 Mar
RX Application: 201514

Drug Name

ARMODAFINIL

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2019-03-25

201514 / 2

Active Ingredient

ARMODAFINIL

Application Number

201514

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2019-03-25

Regulatory Status

RX

2019
25 Mar
RX Application: 201514

Drug Name

ARMODAFINIL

Product Number

3

Dosage Form

-

Strength

250MG

Approval Date

2019-03-25

201514 / 3

Active Ingredient

ARMODAFINIL

Application Number

201514

Product Number

3

Dosage Form

-

Strength

250MG

Approval Date

2019-03-25

Regulatory Status

RX

2006
08 Mar
RX Application: 77128

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2006-03-08

77128 / 1

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

77128

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2006-03-08

Regulatory Status

RX

2006
08 Mar
RX Application: 77128

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2006-03-08

77128 / 2

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

77128

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2006-03-08

Regulatory Status

RX

2006
08 Mar
RX Application: 77128

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2006-03-08

77128 / 3

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

77128

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2006-03-08

Regulatory Status

RX

2006
08 Mar
RX Application: 77128

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2006-03-08

77128 / 4

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

77128

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2006-03-08

Regulatory Status

RX

1998
28 Oct
RX Application: 74737

Drug Name

CAPTOPRIL

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

1998-10-28

74737 / 1

Active Ingredient

CAPTOPRIL

Application Number

74737

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

1998-10-28

Regulatory Status

RX

1998
28 Oct
RX Application: 74737

Drug Name

CAPTOPRIL

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1998-10-28

74737 / 2

Active Ingredient

CAPTOPRIL

Application Number

74737

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1998-10-28

Regulatory Status

RX

1998
28 Oct
RX Application: 74737

Drug Name

CAPTOPRIL

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1998-10-28

74737 / 3

Active Ingredient

CAPTOPRIL

Application Number

74737

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1998-10-28

Regulatory Status

RX

1998
28 Oct
RX Application: 74737

Drug Name

CAPTOPRIL

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

1998-10-28

74737 / 4

Active Ingredient

CAPTOPRIL

Application Number

74737

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

1998-10-28

Regulatory Status

RX

2022
29 Jul
RX Application: 215453

Drug Name

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

5MG;2.5MG

Approval Date

2022-07-29

215453 / 1

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE

Application Number

215453

Product Number

1

Dosage Form

-

Strength

5MG;2.5MG

Approval Date

2022-07-29

Regulatory Status

RX

2023
10 Apr
RX Application: 214702

Drug Name

CHLORZOXAZONE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2023-04-10

214702 / 1

Active Ingredient

CHLORZOXAZONE

Application Number

214702

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2023-04-10

Regulatory Status

RX

2022
20 Oct
RX Application: 214941

Drug Name

CHLORZOXAZONE

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

2022-10-20

214941 / 1

Active Ingredient

CHLORZOXAZONE

Application Number

214941

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

2022-10-20

Regulatory Status

RX

2022
20 Oct
RX Application: 214941

Drug Name

CHLORZOXAZONE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2022-10-20

214941 / 2

Active Ingredient

CHLORZOXAZONE

Application Number

214941

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2022-10-20

Regulatory Status

RX

2022
20 Oct
RX Application: 214941

Drug Name

CHLORZOXAZONE

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2022-10-20

214941 / 3

Active Ingredient

CHLORZOXAZONE

Application Number

214941

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2022-10-20

Regulatory Status

RX

2022
14 Jun
RX Application: 215566

Drug Name

CLORAZEPATE DIPOTASSIUM

Product Number

1

Dosage Form

-

Strength

3.75MG

Approval Date

2022-06-14

215566 / 1

Active Ingredient

CLORAZEPATE DIPOTASSIUM

Application Number

215566

Product Number

1

Dosage Form

-

Strength

3.75MG

Approval Date

2022-06-14

Regulatory Status

RX

2022
14 Jun
RX Application: 215566

Drug Name

CLORAZEPATE DIPOTASSIUM

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2022-06-14

215566 / 2

Active Ingredient

CLORAZEPATE DIPOTASSIUM

Application Number

215566

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2022-06-14

Regulatory Status

RX

2022
14 Jun
RX Application: 215566

Drug Name

CLORAZEPATE DIPOTASSIUM

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2022-06-14

215566 / 3

Active Ingredient

CLORAZEPATE DIPOTASSIUM

Application Number

215566

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2022-06-14

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 50261

Drug Name

DECLOMYCIN

Product Number

1

Dosage Form

-

Strength

75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

50261 / 1

Active Ingredient

DEMECLOCYCLINE HYDROCHLORIDE

Application Number

50261

Product Number

1

Dosage Form

-

Strength

75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50261

Drug Name

DECLOMYCIN

Product Number

2

Dosage Form

-

Strength

150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

50261 / 2

Active Ingredient

DEMECLOCYCLINE HYDROCHLORIDE

Application Number

50261

Product Number

2

Dosage Form

-

Strength

150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50261

Drug Name

DECLOMYCIN

Product Number

3

Dosage Form

-

Strength

300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

50261 / 3

Active Ingredient

DEMECLOCYCLINE HYDROCHLORIDE

Application Number

50261

Product Number

3

Dosage Form

-

Strength

300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

2024
17 Sep
RX Application: 218372

Drug Name

DEXAMETHASONE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2024-09-17

218372 / 1

Active Ingredient

DEXAMETHASONE

Application Number

218372

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2024-09-17

Regulatory Status

RX

2024
17 Sep
RX Application: 218372

Drug Name

DEXAMETHASONE

Product Number

2

Dosage Form

-

Strength

0.75MG

Approval Date

2024-09-17

218372 / 2

Active Ingredient

DEXAMETHASONE

Application Number

218372

Product Number

2

Dosage Form

-

Strength

0.75MG

Approval Date

2024-09-17

Regulatory Status

RX

2024
17 Sep
RX Application: 218372

Drug Name

DEXAMETHASONE

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2024-09-17

218372 / 3

Active Ingredient

DEXAMETHASONE

Application Number

218372

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2024-09-17

Regulatory Status

RX

2024
17 Sep
RX Application: 218372

Drug Name

DEXAMETHASONE

Product Number

4

Dosage Form

-

Strength

1.5MG

Approval Date

2024-09-17

218372 / 4

Active Ingredient

DEXAMETHASONE

Application Number

218372

Product Number

4

Dosage Form

-

Strength

1.5MG

Approval Date

2024-09-17

Regulatory Status

RX

2024
17 Sep
RX Application: 218372

Drug Name

DEXAMETHASONE

Product Number

5

Dosage Form

-

Strength

2MG

Approval Date

2024-09-17

218372 / 5

Active Ingredient

DEXAMETHASONE

Application Number

218372

Product Number

5

Dosage Form

-

Strength

2MG

Approval Date

2024-09-17

Regulatory Status

RX

2024
17 Sep
RX Application: 218372

Drug Name

DEXAMETHASONE

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2024-09-17

218372 / 6

Active Ingredient

DEXAMETHASONE

Application Number

218372

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2024-09-17

Regulatory Status

RX

2024
17 Sep
RX Application: 218372

Drug Name

DEXAMETHASONE

Product Number

7

Dosage Form

-

Strength

6MG

Approval Date

2024-09-17

218372 / 7

Active Ingredient

DEXAMETHASONE

Application Number

218372

Product Number

7

Dosage Form

-

Strength

6MG

Approval Date

2024-09-17

Regulatory Status

RX

2015
10 Nov
Discontinued Application: 206721

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

2015-11-10

206721 / 1

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

206721

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2015-11-10

Regulatory Status

Discontinued

2015
10 Nov
Discontinued Application: 206721

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

2

Dosage Form

-

Strength

1.875MG;1.875MG;1.875MG;1.875MG

Approval Date

2015-11-10

206721 / 2

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

206721

Product Number

2

Dosage Form

-

Strength

1.875MG;1.875MG;1.875MG;1.875MG

Approval Date

2015-11-10

Regulatory Status

Discontinued

2015
10 Nov
Discontinued Application: 206721

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

3

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2015-11-10

206721 / 3

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

206721

Product Number

3

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2015-11-10

Regulatory Status

Discontinued

2015
10 Nov
Discontinued Application: 206721

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

4

Dosage Form

-

Strength

3.125MG;3.125MG;3.125MG;3.125MG

Approval Date

2015-11-10

206721 / 4

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

206721

Product Number

4

Dosage Form

-

Strength

3.125MG;3.125MG;3.125MG;3.125MG

Approval Date

2015-11-10

Regulatory Status

Discontinued

2015
10 Nov
Discontinued Application: 206721

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

5

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2015-11-10

206721 / 5

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

206721

Product Number

5

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2015-11-10

Regulatory Status

Discontinued

2015
10 Nov
Discontinued Application: 206721

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

6

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2015-11-10

206721 / 6

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

206721

Product Number

6

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2015-11-10

Regulatory Status

Discontinued

2015
10 Nov
Discontinued Application: 206721

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

7

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2015-11-10

206721 / 7

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

206721

Product Number

7

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2015-11-10

Regulatory Status

Discontinued

-
Unclassified Application: 206304

Drug Name

DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

-

206304 / 1

Active Ingredient

DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE

Application Number

206304

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 206304

Drug Name

DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

-

206304 / 2

Active Ingredient

DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE

Application Number

206304

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 206304

Drug Name

DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

-

206304 / 3

Active Ingredient

DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE

Application Number

206304

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 206304

Drug Name

DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

-

206304 / 4

Active Ingredient

DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE

Application Number

206304

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 206304

Drug Name

DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE

Product Number

5

Dosage Form

-

Strength

25MG

Approval Date

-

206304 / 5

Active Ingredient

DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE

Application Number

206304

Product Number

5

Dosage Form

-

Strength

25MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 206304

Drug Name

DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

-

206304 / 6

Active Ingredient

DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE

Application Number

206304

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

-

Regulatory Status

Unclassified

2023
24 Mar
RX Application: 216639

Drug Name

DICYCLOMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2023-03-24

216639 / 1

Active Ingredient

DICYCLOMINE HYDROCHLORIDE

Application Number

216639

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2023-03-24

Regulatory Status

RX

2022
28 Nov
RX Application: 216760

Drug Name

DICYCLOMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2022-11-28

216760 / 1

Active Ingredient

DICYCLOMINE HYDROCHLORIDE

Application Number

216760

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2022-11-28

Regulatory Status

RX

2002
30 Sep
RX Application: 76102

Drug Name

LISINOPRIL

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2002-09-30

76102 / 1

Active Ingredient

LISINOPRIL

Application Number

76102

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2002-09-30

Regulatory Status

RX

2002
30 Sep
RX Application: 76102

Drug Name

LISINOPRIL

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2002-09-30

76102 / 2

Active Ingredient

LISINOPRIL

Application Number

76102

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2002-09-30

Regulatory Status

RX

2002
30 Sep
RX Application: 76102

Drug Name

LISINOPRIL

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2002-09-30

76102 / 3

Active Ingredient

LISINOPRIL

Application Number

76102

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2002-09-30

Regulatory Status

RX

2002
30 Sep
RX Application: 76102

Drug Name

LISINOPRIL

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2002-09-30

76102 / 4

Active Ingredient

LISINOPRIL

Application Number

76102

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2002-09-30

Regulatory Status

RX

2002
30 Sep
RX Application: 76102

Drug Name

LISINOPRIL

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

2002-09-30

76102 / 5

Active Ingredient

LISINOPRIL

Application Number

76102

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

2002-09-30

Regulatory Status

RX

2002
30 Sep
RX Application: 76102

Drug Name

LISINOPRIL

Product Number

6

Dosage Form

-

Strength

40MG

Approval Date

2002-09-30

76102 / 6

Active Ingredient

LISINOPRIL

Application Number

76102

Product Number

6

Dosage Form

-

Strength

40MG

Approval Date

2002-09-30

Regulatory Status

RX

2004
05 Oct
RX Application: 76674

Drug Name

LISINOPRIL AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;10MG

Approval Date

2004-10-05

76674 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; LISINOPRIL

Application Number

76674

Product Number

1

Dosage Form

-

Strength

12.5MG;10MG

Approval Date

2004-10-05

Regulatory Status

RX

2004
05 Oct
RX Application: 76674

Drug Name

LISINOPRIL AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;20MG

Approval Date

2004-10-05

76674 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; LISINOPRIL

Application Number

76674

Product Number

2

Dosage Form

-

Strength

12.5MG;20MG

Approval Date

2004-10-05

Regulatory Status

RX

2004
05 Oct
RX Application: 76674

Drug Name

LISINOPRIL AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;20MG

Approval Date

2004-10-05

76674 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; LISINOPRIL

Application Number

76674

Product Number

3

Dosage Form

-

Strength

25MG;20MG

Approval Date

2004-10-05

Regulatory Status

RX

2007
28 Feb
RX Application: 77748

Drug Name

LOVASTATIN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2007-02-28

77748 / 1

Active Ingredient

LOVASTATIN

Application Number

77748

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2007-02-28

Regulatory Status

RX

2007
28 Feb
RX Application: 77748

Drug Name

LOVASTATIN

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2007-02-28

77748 / 2

Active Ingredient

LOVASTATIN

Application Number

77748

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2007-02-28

Regulatory Status

RX

2007
28 Feb
RX Application: 77748

Drug Name

LOVASTATIN

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2007-02-28

77748 / 3

Active Ingredient

LOVASTATIN

Application Number

77748

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2007-02-28

Regulatory Status

RX

2006
20 Jul
RX Application: 77882

Drug Name

MELOXICAM

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2006-07-20

77882 / 1

Active Ingredient

MELOXICAM

Application Number

77882

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2006-07-20

Regulatory Status

RX

2006
20 Jul
RX Application: 77882

Drug Name

MELOXICAM

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2006-07-20

77882 / 2

Active Ingredient

MELOXICAM

Application Number

77882

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2006-07-20

Regulatory Status

RX

2019
22 Aug
OTC Application: 211830

Drug Name

NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG;220MG

Approval Date

2019-08-22

211830 / 1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM

Application Number

211830

Product Number

1

Dosage Form

-

Strength

25MG;220MG

Approval Date

2019-08-22

Regulatory Status

OTC

2021
22 Jan
RX Application: 210165

Drug Name

PIOGLITAZONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2021-01-22

210165 / 1

Active Ingredient

PIOGLITAZONE HYDROCHLORIDE

Application Number

210165

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2021-01-22

Regulatory Status

RX

2021
22 Jan
RX Application: 210165

Drug Name

PIOGLITAZONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2021-01-22

210165 / 2

Active Ingredient

PIOGLITAZONE HYDROCHLORIDE

Application Number

210165

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2021-01-22

Regulatory Status

RX

2021
22 Jan
RX Application: 210165

Drug Name

PIOGLITAZONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2021-01-22

210165 / 3

Active Ingredient

PIOGLITAZONE HYDROCHLORIDE

Application Number

210165

Product Number

3

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2021-01-22

Regulatory Status

RX

2008
20 Jun
RX Application: 79116

Drug Name

RAMIPRIL

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

2008-06-20

79116 / 1

Active Ingredient

RAMIPRIL

Application Number

79116

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

2008-06-20

Regulatory Status

RX

2008
20 Jun
RX Application: 79116

Drug Name

RAMIPRIL

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2008-06-20

79116 / 2

Active Ingredient

RAMIPRIL

Application Number

79116

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2008-06-20

Regulatory Status

RX

2008
20 Jun
RX Application: 79116

Drug Name

RAMIPRIL

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2008-06-20

79116 / 3

Active Ingredient

RAMIPRIL

Application Number

79116

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2008-06-20

Regulatory Status

RX

2008
20 Jun
RX Application: 79116

Drug Name

RAMIPRIL

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2008-06-20

79116 / 4

Active Ingredient

RAMIPRIL

Application Number

79116

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2008-06-20

Regulatory Status

RX

2005
31 May
RX Application: 76894

Drug Name

TORSEMIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2005-05-31

76894 / 1

Active Ingredient

TORSEMIDE

Application Number

76894

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2005-05-31

Regulatory Status

RX

2005
31 May
RX Application: 76894

Drug Name

TORSEMIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2005-05-31

76894 / 2

Active Ingredient

TORSEMIDE

Application Number

76894

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2005-05-31

Regulatory Status

RX

2005
31 May
RX Application: 76894

Drug Name

TORSEMIDE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2005-05-31

76894 / 3

Active Ingredient

TORSEMIDE

Application Number

76894

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2005-05-31

Regulatory Status

RX

2005
31 May
RX Application: 76894

Drug Name

TORSEMIDE

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2005-05-31

76894 / 4

Active Ingredient

TORSEMIDE

Application Number

76894

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2005-05-31

Regulatory Status

RX

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Drug Status Breakdown
73 total
  • RX
  • Discontinued
  • Unclassified
  • OTC
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

AMLODIPINE BESYLATE

Application Number

76719

Product Number

1

Active Ingredient

AMLODIPINE BESYLATE

Dosage Form

-

Strength

EQ 2.5MG BASE

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

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