Assia Chemical Industries Ltd RX
FDA Approved Drugs

Assia Chemical Industries Ltd 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 175
  • Latest Approval Date Jul 01, 2024
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
555
View
Unclassified
5
View
Discontinued
375
View
RX
175
View
Company Overview

Company

Assia Chemical Industries Ltd RX

Country

Israel

Website

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Company Snapshot

Assia Chemical Industries Ltd RX

Neot-Hovav Eco-Industrial Park, Emek Sara P.O Box 2049 Be'er Sheva 8412316

Israel

www.teva.co.il/ View on Map
FDA Approved Drug Records ( 175 records )
1997
22 Apr
RX Application: 74556

Drug Name

ACYCLOVIR

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

1997-04-22

74556 / 2

Active Ingredient

ACYCLOVIR

Application Number

74556

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

1997-04-22

Regulatory Status

RX

1997
22 Apr
RX Application: 74556

Drug Name

ACYCLOVIR

Product Number

3

Dosage Form

-

Strength

800MG

Approval Date

1997-04-22

74556 / 3

Active Ingredient

ACYCLOVIR

Application Number

74556

Product Number

3

Dosage Form

-

Strength

800MG

Approval Date

1997-04-22

Regulatory Status

RX

1997
22 Apr
RX Application: 74578

Drug Name

ACYCLOVIR

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1997-04-22

74578 / 1

Active Ingredient

ACYCLOVIR

Application Number

74578

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1997-04-22

Regulatory Status

RX

1982
01 Jan
RX Application: 85128

Drug Name

ADIPEX-P

Product Number

1

Dosage Form

-

Strength

37.5MG

Approval Date

1982-01-01

85128 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

85128

Product Number

1

Dosage Form

-

Strength

37.5MG

Approval Date

1982-01-01

Regulatory Status

RX

1992
30 Mar
RX Application: 73419

Drug Name

ALBUTEROL SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/5ML

Approval Date

1992-03-30

73419 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

73419

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/5ML

Approval Date

1992-03-30

Regulatory Status

RX

2007
28 Jun
RX Application: 76846

Drug Name

AMLODIPINE BESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2007-06-28

76846 / 1

Active Ingredient

AMLODIPINE BESYLATE

Application Number

76846

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2007-06-28

Regulatory Status

RX

2007
28 Jun
RX Application: 76846

Drug Name

AMLODIPINE BESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2007-06-28

76846 / 2

Active Ingredient

AMLODIPINE BESYLATE

Application Number

76846

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2007-06-28

Regulatory Status

RX

2007
28 Jun
RX Application: 76846

Drug Name

AMLODIPINE BESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-06-28

76846 / 3

Active Ingredient

AMLODIPINE BESYLATE

Application Number

76846

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-06-28

Regulatory Status

RX

1995
18 Jan
RX Application: 74056

Drug Name

ATENOLOL

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1995-01-18

74056 / 1

Active Ingredient

ATENOLOL

Application Number

74056

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1995-01-18

Regulatory Status

RX

1995
18 Jan
RX Application: 74056

Drug Name

ATENOLOL

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1995-01-18

74056 / 2

Active Ingredient

ATENOLOL

Application Number

74056

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1995-01-18

Regulatory Status

RX

2004
19 Jul
RX Application: 74056

Drug Name

ATENOLOL

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

2004-07-19

74056 / 3

Active Ingredient

ATENOLOL

Application Number

74056

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

2004-07-19

Regulatory Status

RX

2023
17 Feb
RX Application: 216354

Drug Name

AUSTEDO XR

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

2023-02-17

216354 / 1

Active Ingredient

DEUTETRABENAZINE

Application Number

216354

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

2023-02-17

Regulatory Status

RX

2023
17 Feb
RX Application: 216354

Drug Name

AUSTEDO XR

Product Number

2

Dosage Form

-

Strength

12MG

Approval Date

2023-02-17

216354 / 2

Active Ingredient

DEUTETRABENAZINE

Application Number

216354

Product Number

2

Dosage Form

-

Strength

12MG

Approval Date

2023-02-17

Regulatory Status

RX

2023
17 Feb
RX Application: 216354

Drug Name

AUSTEDO XR

Product Number

3

Dosage Form

-

Strength

24MG

Approval Date

2023-02-17

216354 / 3

Active Ingredient

DEUTETRABENAZINE

Application Number

216354

Product Number

3

Dosage Form

-

Strength

24MG

Approval Date

2023-02-17

Regulatory Status

RX

2024
29 May
RX Application: 216354

Drug Name

AUSTEDO XR

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2024-05-29

216354 / 4

Active Ingredient

DEUTETRABENAZINE

Application Number

216354

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2024-05-29

Regulatory Status

RX

2024
29 May
RX Application: 216354

Drug Name

AUSTEDO XR

Product Number

5

Dosage Form

-

Strength

36MG

Approval Date

2024-05-29

216354 / 5

Active Ingredient

DEUTETRABENAZINE

Application Number

216354

Product Number

5

Dosage Form

-

Strength

36MG

Approval Date

2024-05-29

Regulatory Status

RX

2024
29 May
RX Application: 216354

Drug Name

AUSTEDO XR

Product Number

6

Dosage Form

-

Strength

42MG

Approval Date

2024-05-29

216354 / 6

Active Ingredient

DEUTETRABENAZINE

Application Number

216354

Product Number

6

Dosage Form

-

Strength

42MG

Approval Date

2024-05-29

Regulatory Status

RX

2024
29 May
RX Application: 216354

Drug Name

AUSTEDO XR

Product Number

7

Dosage Form

-

Strength

48MG

Approval Date

2024-05-29

216354 / 7

Active Ingredient

DEUTETRABENAZINE

Application Number

216354

Product Number

7

Dosage Form

-

Strength

48MG

Approval Date

2024-05-29

Regulatory Status

RX

2024
01 Jul
RX Application: 216354

Drug Name

AUSTEDO XR

Product Number

8

Dosage Form

-

Strength

18MG

Approval Date

2024-07-01

216354 / 8

Active Ingredient

DEUTETRABENAZINE

Application Number

216354

Product Number

8

Dosage Form

-

Strength

18MG

Approval Date

2024-07-01

Regulatory Status

RX

2006
16 May
RX Application: 21641

Drug Name

AZILECT

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2006-05-16

21641 / 1

Active Ingredient

RASAGILINE MESYLATE

Application Number

21641

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2006-05-16

Regulatory Status

RX

2006
16 May
RX Application: 21641

Drug Name

AZILECT

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2006-05-16

21641 / 2

Active Ingredient

RASAGILINE MESYLATE

Application Number

21641

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2006-05-16

Regulatory Status

RX

2005
14 Nov
RX Application: 65193

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2005-11-14

65193 / 1

Active Ingredient

AZITHROMYCIN

Application Number

65193

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2005-11-14

Regulatory Status

RX

2004
11 Feb
RX Application: 76211

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2004-02-11

76211 / 1

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

76211

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2004-02-11

Regulatory Status

RX

2004
11 Feb
RX Application: 76211

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2004-02-11

76211 / 2

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

76211

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2004-02-11

Regulatory Status

RX

2004
11 Feb
RX Application: 76211

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2004-02-11

76211 / 3

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

76211

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2004-02-11

Regulatory Status

RX

2004
11 Feb
RX Application: 76211

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2004-02-11

76211 / 4

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

76211

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2004-02-11

Regulatory Status

RX

2002
28 Feb
RX Application: 75022

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2002-02-28

75022 / 1

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

75022

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2002-02-28

Regulatory Status

RX

2002
28 Feb
RX Application: 75022

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2002-02-28

75022 / 2

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

75022

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2002-02-28

Regulatory Status

RX

2002
28 Feb
RX Application: 75022

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2002-02-28

75022 / 3

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

75022

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2002-02-28

Regulatory Status

RX

2004
25 Mar
RX Application: 75022

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2004-03-25

75022 / 4

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

75022

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2004-03-25

Regulatory Status

RX

2001
12 Oct
RX Application: 75765

Drug Name

CALCITRIOL

Product Number

1

Dosage Form

-

Strength

0.25MCG

Approval Date

2001-10-12

75765 / 1

Active Ingredient

CALCITRIOL

Application Number

75765

Product Number

1

Dosage Form

-

Strength

0.25MCG

Approval Date

2001-10-12

Regulatory Status

RX

2001
12 Oct
RX Application: 75765

Drug Name

CALCITRIOL

Product Number

2

Dosage Form

-

Strength

0.5MCG

Approval Date

2001-10-12

75765 / 2

Active Ingredient

CALCITRIOL

Application Number

75765

Product Number

2

Dosage Form

-

Strength

0.5MCG

Approval Date

2001-10-12

Regulatory Status

RX

2007
05 Sep
RX Application: 76373

Drug Name

CARVEDILOL

Product Number

1

Dosage Form

-

Strength

3.125MG

Approval Date

2007-09-05

76373 / 1

Active Ingredient

CARVEDILOL

Application Number

76373

Product Number

1

Dosage Form

-

Strength

3.125MG

Approval Date

2007-09-05

Regulatory Status

RX

2007
05 Sep
RX Application: 76373

Drug Name

CARVEDILOL

Product Number

2

Dosage Form

-

Strength

6.25MG

Approval Date

2007-09-05

76373 / 2

Active Ingredient

CARVEDILOL

Application Number

76373

Product Number

2

Dosage Form

-

Strength

6.25MG

Approval Date

2007-09-05

Regulatory Status

RX

2007
05 Sep
RX Application: 76373

Drug Name

CARVEDILOL

Product Number

3

Dosage Form

-

Strength

12.5MG

Approval Date

2007-09-05

76373 / 3

Active Ingredient

CARVEDILOL

Application Number

76373

Product Number

3

Dosage Form

-

Strength

12.5MG

Approval Date

2007-09-05

Regulatory Status

RX

2007
05 Sep
RX Application: 76373

Drug Name

CARVEDILOL

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2007-09-05

76373 / 4

Active Ingredient

CARVEDILOL

Application Number

76373

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2007-09-05

Regulatory Status

RX

2002
04 Sep
RX Application: 65058

Drug Name

CEFACLOR

Product Number

1

Dosage Form

-

Strength

EQ 375MG BASE

Approval Date

2002-09-04

65058 / 1

Active Ingredient

CEFACLOR

Application Number

65058

Product Number

1

Dosage Form

-

Strength

EQ 375MG BASE

Approval Date

2002-09-04

Regulatory Status

RX

2002
04 Sep
RX Application: 65058

Drug Name

CEFACLOR

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2002-09-04

65058 / 2

Active Ingredient

CEFACLOR

Application Number

65058

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2002-09-04

Regulatory Status

RX

2005
06 Dec
RX Application: 65208

Drug Name

CEFPROZIL

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2005-12-06

65208 / 1

Active Ingredient

CEFPROZIL

Application Number

65208

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2005-12-06

Regulatory Status

RX

2005
06 Dec
RX Application: 65208

Drug Name

CEFPROZIL

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2005-12-06

65208 / 2

Active Ingredient

CEFPROZIL

Application Number

65208

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2005-12-06

Regulatory Status

RX

2014
30 May
RX Application: 76898

Drug Name

CELECOXIB

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2014-05-30

76898 / 1

Active Ingredient

CELECOXIB

Application Number

76898

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2014-05-30

Regulatory Status

RX

2014
30 May
RX Application: 76898

Drug Name

CELECOXIB

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2014-05-30

76898 / 2

Active Ingredient

CELECOXIB

Application Number

76898

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2014-05-30

Regulatory Status

RX

2014
30 May
RX Application: 76898

Drug Name

CELECOXIB

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2014-05-30

76898 / 3

Active Ingredient

CELECOXIB

Application Number

76898

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2014-05-30

Regulatory Status

RX

2014
30 May
RX Application: 76898

Drug Name

CELECOXIB

Product Number

4

Dosage Form

-

Strength

400MG

Approval Date

2014-05-30

76898 / 4

Active Ingredient

CELECOXIB

Application Number

76898

Product Number

4

Dosage Form

-

Strength

400MG

Approval Date

2014-05-30

Regulatory Status

RX

1987
13 Feb
RX Application: 62702

Drug Name

CEPHALEXIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1987-02-13

62702 / 1

Active Ingredient

CEPHALEXIN

Application Number

62702

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1987-02-13

Regulatory Status

RX

1987
13 Feb
RX Application: 62702

Drug Name

CEPHALEXIN

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1987-02-13

62702 / 2

Active Ingredient

CEPHALEXIN

Application Number

62702

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1987-02-13

Regulatory Status

RX

1987
13 Feb
RX Application: 62703

Drug Name

CEPHALEXIN

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1987-02-13

62703 / 1

Active Ingredient

CEPHALEXIN

Application Number

62703

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1987-02-13

Regulatory Status

RX

1987
13 Feb
RX Application: 62703

Drug Name

CEPHALEXIN

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1987-02-13

62703 / 2

Active Ingredient

CEPHALEXIN

Application Number

62703

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1987-02-13

Regulatory Status

RX

1989
12 Jan
RX Application: 63024

Drug Name

CEPHALEXIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1989-01-12

63024 / 1

Active Ingredient

CEPHALEXIN

Application Number

63024

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1989-01-12

Regulatory Status

RX

1989
12 Jan
RX Application: 63024

Drug Name

CEPHALEXIN

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1989-01-12

63024 / 2

Active Ingredient

CEPHALEXIN

Application Number

63024

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1989-01-12

Regulatory Status

RX

2004
24 Nov
RX Application: 77027

Drug Name

CILOSTAZOL

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-11-24

77027 / 1

Active Ingredient

CILOSTAZOL

Application Number

77027

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-11-24

Regulatory Status

RX

2004
24 Nov
RX Application: 77027

Drug Name

CILOSTAZOL

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2004-11-24

77027 / 2

Active Ingredient

CILOSTAZOL

Application Number

77027

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2004-11-24

Regulatory Status

RX

1994
17 May
RX Application: 74151

Drug Name

CIMETIDINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1994-05-17

74151 / 1

Active Ingredient

CIMETIDINE

Application Number

74151

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1994-05-17

Regulatory Status

RX

1994
17 May
RX Application: 74151

Drug Name

CIMETIDINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1994-05-17

74151 / 2

Active Ingredient

CIMETIDINE

Application Number

74151

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1994-05-17

Regulatory Status

RX

1994
17 May
RX Application: 74151

Drug Name

CIMETIDINE

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

1994-05-17

74151 / 3

Active Ingredient

CIMETIDINE

Application Number

74151

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

1994-05-17

Regulatory Status

RX

1994
17 May
RX Application: 74463

Drug Name

CIMETIDINE

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

1994-05-17

74463 / 1

Active Ingredient

CIMETIDINE

Application Number

74463

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

1994-05-17

Regulatory Status

RX

1996
10 Sep
RX Application: 74569

Drug Name

CLONAZEPAM

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

1996-09-10

74569 / 1

Active Ingredient

CLONAZEPAM

Application Number

74569

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

1996-09-10

Regulatory Status

RX

1996
10 Sep
RX Application: 74569

Drug Name

CLONAZEPAM

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

1996-09-10

74569 / 2

Active Ingredient

CLONAZEPAM

Application Number

74569

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

1996-09-10

Regulatory Status

RX

1996
10 Sep
RX Application: 74569

Drug Name

CLONAZEPAM

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

1996-09-10

74569 / 3

Active Ingredient

CLONAZEPAM

Application Number

74569

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

1996-09-10

Regulatory Status

RX

2012
17 May
RX Application: 76999

Drug Name

CLOPIDOGREL BISULFATE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2012-05-17

76999 / 1

Active Ingredient

CLOPIDOGREL BISULFATE

Application Number

76999

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2012-05-17

Regulatory Status

RX

1995
28 Feb
RX Application: 73306

Drug Name

CLOTRIMAZOLE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1995-02-28

73306 / 1

Active Ingredient

CLOTRIMAZOLE

Application Number

73306

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1995-02-28

Regulatory Status

RX

1998
06 Aug
RX Application: 75219

Drug Name

DICLOFENAC POTASSIUM

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1998-08-06

75219 / 1

Active Ingredient

DICLOFENAC POTASSIUM

Application Number

75219

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1998-08-06

Regulatory Status

RX

1992
31 Jul
RX Application: 73673

Drug Name

DIFLUNISAL

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1992-07-31

73673 / 1

Active Ingredient

DIFLUNISAL

Application Number

73673

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1992-07-31

Regulatory Status

RX

1995
31 May
RX Application: 74185

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1995-05-31

74185 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

74185

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1995-05-31

Regulatory Status

RX

1995
31 May
RX Application: 74185

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

1995-05-31

74185 / 2

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

74185

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

1995-05-31

Regulatory Status

RX

1995
31 May
RX Application: 74185

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

90MG

Approval Date

1995-05-31

74185 / 3

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

74185

Product Number

3

Dosage Form

-

Strength

90MG

Approval Date

1995-05-31

Regulatory Status

RX

1995
31 May
RX Application: 74185

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

120MG

Approval Date

1995-05-31

74185 / 4

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

74185

Product Number

4

Dosage Form

-

Strength

120MG

Approval Date

1995-05-31

Regulatory Status

RX

1985
22 Feb
RX Application: 70101

Drug Name

DISOPYRAMIDE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1985-02-22

70101 / 1

Active Ingredient

DISOPYRAMIDE PHOSPHATE

Application Number

70101

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1985-02-22

Regulatory Status

RX

1985
22 Feb
RX Application: 70102

Drug Name

DISOPYRAMIDE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1985-02-22

70102 / 1

Active Ingredient

DISOPYRAMIDE PHOSPHATE

Application Number

70102

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1985-02-22

Regulatory Status

RX

2000
18 Oct
RX Application: 75536

Drug Name

DOXAZOSIN MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2000-10-18

75536 / 1

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

75536

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2000-10-18

Regulatory Status

RX

2000
18 Oct
RX Application: 75536

Drug Name

DOXAZOSIN MESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2000-10-18

75536 / 2

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

75536

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2000-10-18

Regulatory Status

RX

2000
18 Oct
RX Application: 75536

Drug Name

DOXAZOSIN MESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2000-10-18

75536 / 3

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

75536

Product Number

3

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2000-10-18

Regulatory Status

RX

2000
18 Oct
RX Application: 75536

Drug Name

DOXAZOSIN MESYLATE

Product Number

4

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2000-10-18

75536 / 4

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

75536

Product Number

4

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2000-10-18

Regulatory Status

RX

1986
17 Sep
RX Application: 70541

Drug Name

EPITOL

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1986-09-17

70541 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

70541

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1986-09-17

Regulatory Status

RX

1992
29 Jul
RX Application: 73524

Drug Name

EPITOL

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1992-07-29

73524 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

73524

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1992-07-29

Regulatory Status

RX

2011
23 May
RX Application: 91169

Drug Name

ESZOPICLONE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2011-05-23

91169 / 1

Active Ingredient

ESZOPICLONE

Application Number

91169

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2011-05-23

Regulatory Status

RX

2011
23 May
RX Application: 91169

Drug Name

ESZOPICLONE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2011-05-23

91169 / 2

Active Ingredient

ESZOPICLONE

Application Number

91169

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2011-05-23

Regulatory Status

RX

2011
23 May
RX Application: 91169

Drug Name

ESZOPICLONE

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2011-05-23

91169 / 3

Active Ingredient

ESZOPICLONE

Application Number

91169

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2011-05-23

Regulatory Status

RX

2000
31 Jul
RX Application: 75665

Drug Name

ETODOLAC

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2000-07-31

75665 / 1

Active Ingredient

ETODOLAC

Application Number

75665

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2000-07-31

Regulatory Status

RX

2000
31 Jul
RX Application: 75665

Drug Name

ETODOLAC

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2000-07-31

75665 / 2

Active Ingredient

ETODOLAC

Application Number

75665

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2000-07-31

Regulatory Status

RX

2001
05 Feb
RX Application: 75665

Drug Name

ETODOLAC

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2001-02-05

75665 / 3

Active Ingredient

ETODOLAC

Application Number

75665

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2001-02-05

Regulatory Status

RX

2006
15 Dec
RX Application: 76511

Drug Name

FINASTERIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2006-12-15

76511 / 1

Active Ingredient

FINASTERIDE

Application Number

76511

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2006-12-15

Regulatory Status

RX

1989
06 Feb
RX Application: 72488

Drug Name

FLUOCINONIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1989-02-06

72488 / 1

Active Ingredient

FLUOCINONIDE

Application Number

72488

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1989-02-06

Regulatory Status

RX

1991
27 Dec
RX Application: 73481

Drug Name

FLUOCINONIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1991-12-27

73481 / 1

Active Ingredient

FLUOCINONIDE

Application Number

73481

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1991-12-27

Regulatory Status

RX

1989
07 Feb
RX Application: 72490

Drug Name

FLUOCINONIDE EMULSIFIED BASE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1989-02-07

72490 / 1

Active Ingredient

FLUOCINONIDE

Application Number

72490

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1989-02-07

Regulatory Status

RX

2002
29 Jan
RX Application: 75452

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2002-01-29

75452 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

75452

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2002-01-29

Regulatory Status

RX

2002
29 Jan
RX Application: 75452

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2002-01-29

75452 / 2

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

75452

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2002-01-29

Regulatory Status

RX

2002
29 Jan
RX Application: 75452

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2002-01-29

75452 / 3

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

75452

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2002-01-29

Regulatory Status

RX

2001
02 Aug
RX Application: 75506

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/5ML

Approval Date

2001-08-02

75506 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

75506

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/5ML

Approval Date

2001-08-02

Regulatory Status

RX

2003
25 Nov
RX Application: 76139

Drug Name

FOSINOPRIL SODIUM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2003-11-25

76139 / 1

Active Ingredient

FOSINOPRIL SODIUM

Application Number

76139

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2003-11-25

Regulatory Status

RX

2003
25 Nov
RX Application: 76139

Drug Name

FOSINOPRIL SODIUM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2003-11-25

76139 / 2

Active Ingredient

FOSINOPRIL SODIUM

Application Number

76139

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2003-11-25

Regulatory Status

RX

2003
25 Nov
RX Application: 76139

Drug Name

FOSINOPRIL SODIUM

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2003-11-25

76139 / 3

Active Ingredient

FOSINOPRIL SODIUM

Application Number

76139

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2003-11-25

Regulatory Status

RX

1995
29 Aug
RX Application: 74388

Drug Name

GLYBURIDE

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

1995-08-29

74388 / 1

Active Ingredient

GLYBURIDE

Application Number

74388

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

1995-08-29

Regulatory Status

RX

1995
29 Aug
RX Application: 74388

Drug Name

GLYBURIDE

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

1995-08-29

74388 / 2

Active Ingredient

GLYBURIDE

Application Number

74388

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

1995-08-29

Regulatory Status

RX

1995
29 Aug
RX Application: 74388

Drug Name

GLYBURIDE

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

1995-08-29

74388 / 3

Active Ingredient

GLYBURIDE

Application Number

74388

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

1995-08-29

Regulatory Status

RX

1999
20 Apr
RX Application: 74686

Drug Name

GLYBURIDE (MICRONIZED)

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

1999-04-20

74686 / 1

Active Ingredient

GLYBURIDE

Application Number

74686

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

1999-04-20

Regulatory Status

RX

1999
20 Apr
RX Application: 74686

Drug Name

GLYBURIDE (MICRONIZED)

Product Number

2

Dosage Form

-

Strength

3MG

Approval Date

1999-04-20

74686 / 2

Active Ingredient

GLYBURIDE

Application Number

74686

Product Number

2

Dosage Form

-

Strength

3MG

Approval Date

1999-04-20

Regulatory Status

RX

1999
20 Apr
RX Application: 74686

Drug Name

GLYBURIDE (MICRONIZED)

Product Number

3

Dosage Form

-

Strength

4.5MG

Approval Date

1999-04-20

74686 / 3

Active Ingredient

GLYBURIDE

Application Number

74686

Product Number

3

Dosage Form

-

Strength

4.5MG

Approval Date

1999-04-20

Regulatory Status

RX

1999
20 Apr
RX Application: 74686

Drug Name

GLYBURIDE (MICRONIZED)

Product Number

4

Dosage Form

-

Strength

6MG

Approval Date

1999-04-20

74686 / 4

Active Ingredient

GLYBURIDE

Application Number

74686

Product Number

4

Dosage Form

-

Strength

6MG

Approval Date

1999-04-20

Regulatory Status

RX

2012
30 Mar
RX Application: 77369

Drug Name

IRBESARTAN AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;150MG

Approval Date

2012-03-30

77369 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; IRBESARTAN

Application Number

77369

Product Number

1

Dosage Form

-

Strength

12.5MG;150MG

Approval Date

2012-03-30

Regulatory Status

RX

2012
30 Mar
RX Application: 77369

Drug Name

IRBESARTAN AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;300MG

Approval Date

2012-03-30

77369 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; IRBESARTAN

Application Number

77369

Product Number

2

Dosage Form

-

Strength

12.5MG;300MG

Approval Date

2012-03-30

Regulatory Status

RX

2000
25 Apr
RX Application: 75581

Drug Name

KETOCONAZOLE

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2000-04-25

75581 / 1

Active Ingredient

KETOCONAZOLE

Application Number

75581

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2000-04-25

Regulatory Status

RX

1992
22 Dec
RX Application: 73516

Drug Name

KETOPROFEN

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1992-12-22

73516 / 1

Active Ingredient

KETOPROFEN

Application Number

73516

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1992-12-22

Regulatory Status

RX

1997
16 May
RX Application: 74754

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1997-05-16

74754 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

74754

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1997-05-16

Regulatory Status

RX

2011
20 Jun
RX Application: 76361

Drug Name

LEVOFLOXACIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2011-06-20

76361 / 1

Active Ingredient

LEVOFLOXACIN

Application Number

76361

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2011-06-20

Regulatory Status

RX

2011
20 Jun
RX Application: 76361

Drug Name

LEVOFLOXACIN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2011-06-20

76361 / 2

Active Ingredient

LEVOFLOXACIN

Application Number

76361

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2011-06-20

Regulatory Status

RX

2011
20 Jun
RX Application: 76361

Drug Name

LEVOFLOXACIN

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2011-06-20

76361 / 3

Active Ingredient

LEVOFLOXACIN

Application Number

76361

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2011-06-20

Regulatory Status

RX

1992
30 Apr
RX Application: 73192

Drug Name

LOPERAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1992-04-30

73192 / 1

Active Ingredient

LOPERAMIDE HYDROCHLORIDE

Application Number

73192

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1992-04-30

Regulatory Status

RX

2001
17 Dec
RX Application: 75551

Drug Name

LOVASTATIN

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2001-12-17

75551 / 1

Active Ingredient

LOVASTATIN

Application Number

75551

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2001-12-17

Regulatory Status

RX

2001
17 Dec
RX Application: 75551

Drug Name

LOVASTATIN

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2001-12-17

75551 / 2

Active Ingredient

LOVASTATIN

Application Number

75551

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2001-12-17

Regulatory Status

RX

2001
17 Dec
RX Application: 75551

Drug Name

LOVASTATIN

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2001-12-17

75551 / 3

Active Ingredient

LOVASTATIN

Application Number

75551

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2001-12-17

Regulatory Status

RX

2004
18 Jun
RX Application: 76269

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2004-06-18

76269 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

76269

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2004-06-18

Regulatory Status

RX

2005
12 Apr
RX Application: 76864

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

2005-04-12

76864 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

76864

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

2005-04-12

Regulatory Status

RX

1985
29 Jul
RX Application: 70184

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1985-07-29

70184 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

70184

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1985-07-29

Regulatory Status

RX

1993
15 Jun
RX Application: 72801

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1993-06-15

72801 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

72801

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1993-06-15

Regulatory Status

RX

1995
16 May
RX Application: 74377

Drug Name

MEXILETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

1995-05-16

74377 / 1

Active Ingredient

MEXILETINE HYDROCHLORIDE

Application Number

74377

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

1995-05-16

Regulatory Status

RX

1995
16 May
RX Application: 74377

Drug Name

MEXILETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1995-05-16

74377 / 2

Active Ingredient

MEXILETINE HYDROCHLORIDE

Application Number

74377

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1995-05-16

Regulatory Status

RX

1995
16 May
RX Application: 74377

Drug Name

MEXILETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

250MG

Approval Date

1995-05-16

74377 / 3

Active Ingredient

MEXILETINE HYDROCHLORIDE

Application Number

74377

Product Number

3

Dosage Form

-

Strength

250MG

Approval Date

1995-05-16

Regulatory Status

RX

2003
24 Jan
RX Application: 76119

Drug Name

MIRTAZAPINE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2003-01-24

76119 / 1

Active Ingredient

MIRTAZAPINE

Application Number

76119

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2003-01-24

Regulatory Status

RX

2003
24 Jan
RX Application: 76119

Drug Name

MIRTAZAPINE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2003-01-24

76119 / 2

Active Ingredient

MIRTAZAPINE

Application Number

76119

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2003-01-24

Regulatory Status

RX

2003
19 Jun
RX Application: 76119

Drug Name

MIRTAZAPINE

Product Number

3

Dosage Form

-

Strength

45MG

Approval Date

2003-06-19

76119 / 3

Active Ingredient

MIRTAZAPINE

Application Number

76119

Product Number

3

Dosage Form

-

Strength

45MG

Approval Date

2003-06-19

Regulatory Status

RX

2003
08 May
RX Application: 76204

Drug Name

MOEXIPRIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2003-05-08

76204 / 1

Active Ingredient

MOEXIPRIL HYDROCHLORIDE

Application Number

76204

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2003-05-08

Regulatory Status

RX

2003
08 May
RX Application: 76204

Drug Name

MOEXIPRIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2003-05-08

76204 / 2

Active Ingredient

MOEXIPRIL HYDROCHLORIDE

Application Number

76204

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2003-05-08

Regulatory Status

RX

2007
07 Mar
RX Application: 76980

Drug Name

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;7.5MG

Approval Date

2007-03-07

76980 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE

Application Number

76980

Product Number

1

Dosage Form

-

Strength

12.5MG;7.5MG

Approval Date

2007-03-07

Regulatory Status

RX

2007
07 Mar
RX Application: 76980

Drug Name

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

25MG;15MG

Approval Date

2007-03-07

76980 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE

Application Number

76980

Product Number

2

Dosage Form

-

Strength

25MG;15MG

Approval Date

2007-03-07

Regulatory Status

RX

2007
07 Mar
RX Application: 76980

Drug Name

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

12.5MG;15MG

Approval Date

2007-03-07

76980 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE

Application Number

76980

Product Number

3

Dosage Form

-

Strength

12.5MG;15MG

Approval Date

2007-03-07

Regulatory Status

RX

2003
07 Nov
RX Application: 65085

Drug Name

MUPIROCIN

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2003-11-07

65085 / 1

Active Ingredient

MUPIROCIN

Application Number

65085

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2003-11-07

Regulatory Status

RX

1993
21 Dec
RX Application: 74201

Drug Name

NAPROXEN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1993-12-21

74201 / 1

Active Ingredient

NAPROXEN

Application Number

74201

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1993-12-21

Regulatory Status

RX

1993
21 Dec
RX Application: 74201

Drug Name

NAPROXEN

Product Number

2

Dosage Form

-

Strength

375MG

Approval Date

1993-12-21

74201 / 2

Active Ingredient

NAPROXEN

Application Number

74201

Product Number

2

Dosage Form

-

Strength

375MG

Approval Date

1993-12-21

Regulatory Status

RX

1993
21 Dec
RX Application: 74201

Drug Name

NAPROXEN

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1993-12-21

74201 / 3

Active Ingredient

NAPROXEN

Application Number

74201

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1993-12-21

Regulatory Status

RX

1998
30 Jun
RX Application: 75227

Drug Name

NAPROXEN

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

1998-06-30

75227 / 1

Active Ingredient

NAPROXEN

Application Number

75227

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

1998-06-30

Regulatory Status

RX

1998
30 Jun
RX Application: 75227

Drug Name

NAPROXEN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1998-06-30

75227 / 2

Active Ingredient

NAPROXEN

Application Number

75227

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1998-06-30

Regulatory Status

RX

2003
16 Sep
RX Application: 76037

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2003-09-16

76037 / 1

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

76037

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2003-09-16

Regulatory Status

RX

2003
16 Sep
RX Application: 76037

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2003-09-16

76037 / 2

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

76037

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2003-09-16

Regulatory Status

RX

2003
16 Sep
RX Application: 76037

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2003-09-16

76037 / 3

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

76037

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2003-09-16

Regulatory Status

RX

2003
16 Sep
RX Application: 76037

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2003-09-16

76037 / 4

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

76037

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2003-09-16

Regulatory Status

RX

2003
16 Sep
RX Application: 76037

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

250MG

Approval Date

2003-09-16

76037 / 5

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

76037

Product Number

5

Dosage Form

-

Strength

250MG

Approval Date

2003-09-16

Regulatory Status

RX

1982
01 Jan
RX Application: 60304

Drug Name

NEOMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

60304 / 1

Active Ingredient

NEOMYCIN SULFATE

Application Number

60304

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

RX

1995
27 Mar
RX Application: 74132

Drug Name

NORTRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1995-03-27

74132 / 1

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

74132

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1995-03-27

Regulatory Status

RX

1995
27 Mar
RX Application: 74132

Drug Name

NORTRIPTYLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

1995-03-27

74132 / 2

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

74132

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

1995-03-27

Regulatory Status

RX

1995
27 Mar
RX Application: 74132

Drug Name

NORTRIPTYLINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1995-03-27

74132 / 3

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

74132

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1995-03-27

Regulatory Status

RX

1995
27 Mar
RX Application: 74132

Drug Name

NORTRIPTYLINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

1995-03-27

74132 / 4

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

74132

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

1995-03-27

Regulatory Status

RX

1984
16 Jan
RX Application: 62506

Drug Name

NYSTATIN

Product Number

1

Dosage Form

-

Strength

500,000 UNITS

Approval Date

1984-01-16

62506 / 1

Active Ingredient

NYSTATIN

Application Number

62506

Product Number

1

Dosage Form

-

Strength

500,000 UNITS

Approval Date

1984-01-16

Regulatory Status

RX

2003
02 Sep
RX Application: 76182

Drug Name

OFLOXACIN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2003-09-02

76182 / 1

Active Ingredient

OFLOXACIN

Application Number

76182

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2003-09-02

Regulatory Status

RX

2003
02 Sep
RX Application: 76182

Drug Name

OFLOXACIN

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2003-09-02

76182 / 2

Active Ingredient

OFLOXACIN

Application Number

76182

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2003-09-02

Regulatory Status

RX

2003
02 Sep
RX Application: 76182

Drug Name

OFLOXACIN

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2003-09-02

76182 / 3

Active Ingredient

OFLOXACIN

Application Number

76182

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2003-09-02

Regulatory Status

RX

2011
15 Feb
RX Application: 91443

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2011-02-15

91443 / 1

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

91443

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2011-02-15

Regulatory Status

RX

2011
15 Feb
RX Application: 91443

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2011-02-15

91443 / 2

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

91443

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2011-02-15

Regulatory Status

RX

1992
11 Dec
RX Application: 74131

Drug Name

PIROXICAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1992-12-11

74131 / 1

Active Ingredient

PIROXICAM

Application Number

74131

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1992-12-11

Regulatory Status

RX

1992
11 Dec
RX Application: 74131

Drug Name

PIROXICAM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

1992-12-11

74131 / 2

Active Ingredient

PIROXICAM

Application Number

74131

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

1992-12-11

Regulatory Status

RX

1986
04 Feb
RX Application: 89081

Drug Name

PRELONE

Product Number

1

Dosage Form

-

Strength

15MG/5ML

Approval Date

1986-02-04

89081 / 1

Active Ingredient

PREDNISOLONE

Application Number

89081

Product Number

1

Dosage Form

-

Strength

15MG/5ML

Approval Date

1986-02-04

Regulatory Status

RX

2016
09 Mar
RX Application: 77342

Drug Name

SILDENAFIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2016-03-09

77342 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

77342

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2016-03-09

Regulatory Status

RX

2016
09 Mar
RX Application: 77342

Drug Name

SILDENAFIL CITRATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2016-03-09

77342 / 2

Active Ingredient

SILDENAFIL CITRATE

Application Number

77342

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2016-03-09

Regulatory Status

RX

2016
09 Mar
RX Application: 77342

Drug Name

SILDENAFIL CITRATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2016-03-09

77342 / 3

Active Ingredient

SILDENAFIL CITRATE

Application Number

77342

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2016-03-09

Regulatory Status

RX

2000
01 May
RX Application: 75429

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

2000-05-01

75429 / 1

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

75429

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

2000-05-01

Regulatory Status

RX

2000
01 May
RX Application: 75429

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2000-05-01

75429 / 2

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

75429

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2000-05-01

Regulatory Status

RX

2000
01 May
RX Application: 75429

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2000-05-01

75429 / 3

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

75429

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2000-05-01

Regulatory Status

RX

2000
01 May
RX Application: 75429

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

240MG

Approval Date

2000-05-01

75429 / 4

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

75429

Product Number

4

Dosage Form

-

Strength

240MG

Approval Date

2000-05-01

Regulatory Status

RX

1996
29 Mar
RX Application: 70848

Drug Name

SUCRALFATE

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

1996-03-29

70848 / 1

Active Ingredient

SUCRALFATE

Application Number

70848

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

1996-03-29

Regulatory Status

RX

2002
19 Jun
RX Application: 75977

Drug Name

TRAMADOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2002-06-19

75977 / 1

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

75977

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2002-06-19

Regulatory Status

RX

2023
28 Apr
RX Application: 213586

Drug Name

UZEDY

Product Number

1

Dosage Form

-

Strength

50MG/0.14ML (50MG/0.14ML)

Approval Date

2023-04-28

213586 / 1

Active Ingredient

RISPERIDONE

Application Number

213586

Product Number

1

Dosage Form

-

Strength

50MG/0.14ML (50MG/0.14ML)

Approval Date

2023-04-28

Regulatory Status

RX

2023
28 Apr
RX Application: 213586

Drug Name

UZEDY

Product Number

2

Dosage Form

-

Strength

75MG/0.21ML (75MG/0.21ML)

Approval Date

2023-04-28

213586 / 2

Active Ingredient

RISPERIDONE

Application Number

213586

Product Number

2

Dosage Form

-

Strength

75MG/0.21ML (75MG/0.21ML)

Approval Date

2023-04-28

Regulatory Status

RX

2023
28 Apr
RX Application: 213586

Drug Name

UZEDY

Product Number

3

Dosage Form

-

Strength

100MG/0.28ML (100MG/0.28ML)

Approval Date

2023-04-28

213586 / 3

Active Ingredient

RISPERIDONE

Application Number

213586

Product Number

3

Dosage Form

-

Strength

100MG/0.28ML (100MG/0.28ML)

Approval Date

2023-04-28

Regulatory Status

RX

2023
28 Apr
RX Application: 213586

Drug Name

UZEDY

Product Number

4

Dosage Form

-

Strength

125MG/0.35ML (125MG/0.35ML)

Approval Date

2023-04-28

213586 / 4

Active Ingredient

RISPERIDONE

Application Number

213586

Product Number

4

Dosage Form

-

Strength

125MG/0.35ML (125MG/0.35ML)

Approval Date

2023-04-28

Regulatory Status

RX

2023
28 Apr
RX Application: 213586

Drug Name

UZEDY

Product Number

5

Dosage Form

-

Strength

150MG/0.42ML (150MG/0.42ML)

Approval Date

2023-04-28

213586 / 5

Active Ingredient

RISPERIDONE

Application Number

213586

Product Number

5

Dosage Form

-

Strength

150MG/0.42ML (150MG/0.42ML)

Approval Date

2023-04-28

Regulatory Status

RX

2023
28 Apr
RX Application: 213586

Drug Name

UZEDY

Product Number

6

Dosage Form

-

Strength

200MG/0.56ML (200MG/0.56ML)

Approval Date

2023-04-28

213586 / 6

Active Ingredient

RISPERIDONE

Application Number

213586

Product Number

6

Dosage Form

-

Strength

200MG/0.56ML (200MG/0.56ML)

Approval Date

2023-04-28

Regulatory Status

RX

2023
28 Apr
RX Application: 213586

Drug Name

UZEDY

Product Number

7

Dosage Form

-

Strength

250MG/0.7ML (250MG/0.7ML)

Approval Date

2023-04-28

213586 / 7

Active Ingredient

RISPERIDONE

Application Number

213586

Product Number

7

Dosage Form

-

Strength

250MG/0.7ML (250MG/0.7ML)

Approval Date

2023-04-28

Regulatory Status

RX

2010
28 Jun
RX Application: 76565

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2010-06-28

76565 / 1

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

76565

Product Number

1

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2010-06-28

Regulatory Status

RX

2010
28 Jun
RX Application: 76565

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2010-06-28

76565 / 2

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

76565

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2010-06-28

Regulatory Status

RX

2010
28 Jun
RX Application: 76565

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2010-06-28

76565 / 3

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

76565

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2010-06-28

Regulatory Status

RX

2006
03 Aug
RX Application: 76690

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2006-08-03

76690 / 1

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

76690

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2006-08-03

Regulatory Status

RX

2006
03 Aug
RX Application: 76690

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2006-08-03

76690 / 2

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

76690

Product Number

2

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2006-08-03

Regulatory Status

RX

2006
03 Aug
RX Application: 76690

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2006-08-03

76690 / 3

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

76690

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2006-08-03

Regulatory Status

RX

2006
03 Aug
RX Application: 76690

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2006-08-03

76690 / 4

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

76690

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2006-08-03

Regulatory Status

RX

2006
03 Aug
RX Application: 76690

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2006-08-03

76690 / 5

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

76690

Product Number

5

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2006-08-03

Regulatory Status

RX

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Drug Status Breakdown
175 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

ACYCLOVIR

Application Number

74556

Product Number

2

Active Ingredient

ACYCLOVIR

Dosage Form

-

Strength

400MG

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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