Sandoz B2B RX

2016

22 Mar

RX Application: 204052

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

Approval Date

2016-03-22

204052 / 1 View Details

Active Ingredient

ACETAMINOPHEN

Application Number

204052

Product Number

1

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

Approval Date

2016-03-22

Regulatory Status

RX

2021

01 Jun

RX Application: 207085

Drug Name

ALBUTEROL SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 0.09MG BASE/INH

Approval Date

2021-06-01

207085 / 1 View Details

Active Ingredient

ALBUTEROL SULFATE

Application Number

207085

Product Number

1

Dosage Form

-

Strength

EQ 0.09MG BASE/INH

Approval Date

2021-06-01

Regulatory Status

RX

1995

29 Dec

RX Application: 74112

Drug Name

ALPRAZOLAM

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

1995-12-29

74112 / 1 View Details

Active Ingredient

ALPRAZOLAM

Application Number

74112

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

1995-12-29

Regulatory Status

RX

1995

29 Dec

RX Application: 74112

Drug Name

ALPRAZOLAM

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

1995-12-29

74112 / 2 View Details

Active Ingredient

ALPRAZOLAM

Application Number

74112

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

1995-12-29

Regulatory Status

RX

1995

29 Dec

RX Application: 74112

Drug Name

ALPRAZOLAM

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

1995-12-29

74112 / 3 View Details

Active Ingredient

ALPRAZOLAM

Application Number

74112

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

1995-12-29

Regulatory Status

RX

1998

25 Mar

RX Application: 74909

Drug Name

ALPRAZOLAM

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1998-03-25

74909 / 1 View Details

Active Ingredient

ALPRAZOLAM

Application Number

74909

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1998-03-25

Regulatory Status

RX

1987

18 Feb

RX Application: 71293

Drug Name

AMANTADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1987-02-18

71293 / 1 View Details

Active Ingredient

AMANTADINE HYDROCHLORIDE

Application Number

71293

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1987-02-18

Regulatory Status

RX

1982

01 Jan

RX Application: 85968

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

85968 / 1 View Details

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

85968

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

RX

1982

01 Jan

RX Application: 85968

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

85968 / 2 View Details

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

85968

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

RX

1982

01 Jan

RX Application: 85968

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

85968 / 3 View Details

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

85968

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

RX

1982

01 Jan

RX Application: 85968

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

85968 / 4 View Details

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

85968

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

RX

1982

01 Jan

RX Application: 85968

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

1982-01-01

85968 / 5 View Details

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

85968

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

1982-01-01

Regulatory Status

RX

1982

01 Jan

RX Application: 85968

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

75MG

Approval Date

1982-01-01

85968 / 6 View Details

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

85968

Product Number

6

Dosage Form

-

Strength

75MG

Approval Date

1982-01-01

Regulatory Status

RX

1994

30 Sep

RX Application: 64076

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1994-09-30

64076 / 1 View Details

Active Ingredient

AMOXICILLIN

Application Number

64076

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1994-09-30

Regulatory Status

RX

1994

30 Sep

RX Application: 64076

Drug Name

AMOXICILLIN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1994-09-30

64076 / 2 View Details

Active Ingredient

AMOXICILLIN

Application Number

64076

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1994-09-30

Regulatory Status

RX

2005

13 Jul

RX Application: 65228

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2005-07-13

65228 / 1 View Details

Active Ingredient

AMOXICILLIN

Application Number

65228

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2005-07-13

Regulatory Status

RX

2005

13 Jul

RX Application: 65228

Drug Name

AMOXICILLIN

Product Number

2

Dosage Form

-

Strength

875MG

Approval Date

2005-07-13

65228 / 2 View Details

Active Ingredient

AMOXICILLIN

Application Number

65228

Product Number

2

Dosage Form

-

Strength

875MG

Approval Date

2005-07-13

Regulatory Status

RX

2007

26 Mar

RX Application: 65378

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

200MG/5ML

Approval Date

2007-03-26

65378 / 1 View Details

Active Ingredient

AMOXICILLIN

Application Number

65378

Product Number

1

Dosage Form

-

Strength

200MG/5ML

Approval Date

2007-03-26

Regulatory Status

RX

2007

26 Mar

RX Application: 65378

Drug Name

AMOXICILLIN

Product Number

2

Dosage Form

-

Strength

400MG/5ML

Approval Date

2007-03-26

65378 / 2 View Details

Active Ingredient

AMOXICILLIN

Application Number

65378

Product Number

2

Dosage Form

-

Strength

400MG/5ML

Approval Date

2007-03-26

Regulatory Status

RX

2007

26 Mar

RX Application: 65387

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

2007-03-26

65387 / 1 View Details

Active Ingredient

AMOXICILLIN

Application Number

65387

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

2007-03-26

Regulatory Status

RX

2007

26 Mar

RX Application: 65387

Drug Name

AMOXICILLIN

Product Number

2

Dosage Form

-

Strength

250MG/5ML

Approval Date

2007-03-26

65387 / 2 View Details

Active Ingredient

AMOXICILLIN

Application Number

65387

Product Number

2

Dosage Form

-

Strength

250MG/5ML

Approval Date

2007-03-26

Regulatory Status

RX

2002

14 Mar

RX Application: 65063

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

1

Dosage Form

-

Strength

875MG;EQ 125MG BASE

Approval Date

2002-03-14

65063 / 1 View Details

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

65063

Product Number

1

Dosage Form

-

Strength

875MG;EQ 125MG BASE

Approval Date

2002-03-14

Regulatory Status

RX

2002

15 Mar

RX Application: 65064

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

1

Dosage Form

-

Strength

500MG;EQ 125MG BASE

Approval Date

2002-03-15

65064 / 1 View Details

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

65064

Product Number

1

Dosage Form

-

Strength

500MG;EQ 125MG BASE

Approval Date

2002-03-15

Regulatory Status

RX

2002

05 Jun

RX Application: 65066

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

1

Dosage Form

-

Strength

200MG/5ML;EQ 28.5MG BASE/5ML

Approval Date

2002-06-05

65066 / 1 View Details

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

65066

Product Number

1

Dosage Form

-

Strength

200MG/5ML;EQ 28.5MG BASE/5ML

Approval Date

2002-06-05

Regulatory Status

RX

2002

05 Jun

RX Application: 65066

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

2

Dosage Form

-

Strength

400MG/5ML;EQ 57MG BASE/5ML

Approval Date

2002-06-05

65066 / 2 View Details

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

65066

Product Number

2

Dosage Form

-

Strength

400MG/5ML;EQ 57MG BASE/5ML

Approval Date

2002-06-05

Regulatory Status

RX

2005

23 Aug

RX Application: 65189

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

1

Dosage Form

-

Strength

250MG;EQ 125MG BASE

Approval Date

2005-08-23

65189 / 1 View Details

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

65189

Product Number

1

Dosage Form

-

Strength

250MG;EQ 125MG BASE

Approval Date

2005-08-23

Regulatory Status

RX

2010

21 Apr

RX Application: 90227

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

1

Dosage Form

-

Strength

1GM;EQ 62.5MG BASE

Approval Date

2010-04-21

90227 / 1 View Details

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

90227

Product Number

1

Dosage Form

-

Strength

1GM;EQ 62.5MG BASE

Approval Date

2010-04-21

Regulatory Status

RX

2006

25 Jul

RX Application: 65240

Drug Name

AMPICILLIN AND SULBACTAM

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL

Approval Date

2006-07-25

65240 / 1 View Details

Active Ingredient

AMPICILLIN SODIUM; SULBACTAM SODIUM

Application Number

65240

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL

Approval Date

2006-07-25

Regulatory Status

RX

2006

25 Jul

RX Application: 65241

Drug Name

AMPICILLIN AND SULBACTAM

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL

Approval Date

2006-07-25

65241 / 1 View Details

Active Ingredient

AMPICILLIN SODIUM; SULBACTAM SODIUM

Application Number

65241

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL

Approval Date

2006-07-25

Regulatory Status

RX

2006

25 Jul

RX Application: 65241

Drug Name

AMPICILLIN AND SULBACTAM

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL

Approval Date

2006-07-25

65241 / 2 View Details

Active Ingredient

AMPICILLIN SODIUM; SULBACTAM SODIUM

Application Number

65241

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL

Approval Date

2006-07-25

Regulatory Status

RX

1982

01 Jan

RX Application: 61395

Drug Name

AMPICILLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/VIAL

Approval Date

1982-01-01

61395 / 1 View Details

Active Ingredient

AMPICILLIN SODIUM

Application Number

61395

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

RX

1982

01 Jan

RX Application: 61395

Drug Name

AMPICILLIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

1982-01-01

61395 / 2 View Details

Active Ingredient

AMPICILLIN SODIUM

Application Number

61395

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

RX

1982

01 Jan

RX Application: 61395

Drug Name

AMPICILLIN SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1982-01-01

61395 / 3 View Details

Active Ingredient

AMPICILLIN SODIUM

Application Number

61395

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

RX

1982

01 Jan

RX Application: 61395

Drug Name

AMPICILLIN SODIUM

Product Number

4

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1982-01-01

61395 / 4 View Details

Active Ingredient

AMPICILLIN SODIUM

Application Number

61395

Product Number

4

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

RX

1982

01 Jan

RX Application: 61395

Drug Name

AMPICILLIN SODIUM

Product Number

5

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1982-01-01

61395 / 5 View Details

Active Ingredient

AMPICILLIN SODIUM

Application Number

61395

Product Number

5

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

RX

1982

01 Jan

RX Application: 61395

Drug Name

AMPICILLIN SODIUM

Product Number

6

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1982-01-01

61395 / 6 View Details

Active Ingredient

AMPICILLIN SODIUM

Application Number

61395

Product Number

6

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

RX

1995

29 Aug

RX Application: 64082

Drug Name

AMPICILLIN TRIHYDRATE

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1995-08-29

64082 / 2 View Details

Active Ingredient

AMPICILLIN/AMPICILLIN TRIHYDRATE

Application Number

64082

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1995-08-29

Regulatory Status

RX

1982

01 Jan

RX Application: 8453

Drug Name

ANECTINE

Product Number

2

Dosage Form

-

Strength

20MG/ML

Approval Date

1982-01-01

8453 / 2 View Details

Active Ingredient

SUCCINYLCHOLINE CHLORIDE

Application Number

8453

Product Number

2

Dosage Form

-

Strength

20MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

2000

15 Dec

RX Application: 20873

Drug Name

ANGIOMAX

Product Number

1

Dosage Form

-

Strength

250MG/VIAL

Approval Date

2000-12-15

20873 / 1 View Details

Active Ingredient

BIVALIRUDIN

Application Number

20873

Product Number

1

Dosage Form

-

Strength

250MG/VIAL

Approval Date

2000-12-15

Regulatory Status

RX

2012

24 Sep

RX Application: 90999

Drug Name

APREPITANT

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2012-09-24

90999 / 1 View Details

Active Ingredient

APREPITANT

Application Number

90999

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2012-09-24

Regulatory Status

RX

2012

24 Sep

RX Application: 90999

Drug Name

APREPITANT

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2012-09-24

90999 / 2 View Details

Active Ingredient

APREPITANT

Application Number

90999

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2012-09-24

Regulatory Status

RX

2012

24 Sep

RX Application: 90999

Drug Name

APREPITANT

Product Number

3

Dosage Form

-

Strength

125MG

Approval Date

2012-09-24

90999 / 3 View Details

Active Ingredient

APREPITANT

Application Number

90999

Product Number

3

Dosage Form

-

Strength

125MG

Approval Date

2012-09-24

Regulatory Status

RX

2005

28 Oct

RX Application: 21877

Drug Name

ARRANON

Product Number

1

Dosage Form

-

Strength

250MG/50ML (5MG/ML)

Approval Date

2005-10-28

21877 / 1 View Details

Active Ingredient

NELARABINE

Application Number

21877

Product Number

1

Dosage Form

-

Strength

250MG/50ML (5MG/ML)

Approval Date

2005-10-28

Regulatory Status

RX

2021

02 Dec

RX Application: 215359

Drug Name

ARSENIC TRIOXIDE

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2021-12-02

215359 / 1 View Details

Active Ingredient

ARSENIC TRIOXIDE

Application Number

215359

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2021-12-02

Regulatory Status

RX

2017

18 Jan

RX Application: 206739

Drug Name

ASPIRIN AND DIPYRIDAMOLE

Product Number

1

Dosage Form

-

Strength

25MG;200MG

Approval Date

2017-01-18

206739 / 1 View Details

Active Ingredient

ASPIRIN; DIPYRIDAMOLE

Application Number

206739

Product Number

1

Dosage Form

-

Strength

25MG;200MG

Approval Date

2017-01-18

Regulatory Status

RX

2012

31 May

RX Application: 202305

Drug Name

AZELASTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2012-05-31

202305 / 1 View Details

Active Ingredient

AZELASTINE HYDROCHLORIDE

Application Number

202305

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2012-05-31

Regulatory Status

RX

2005

14 Nov

RX Application: 65209

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 600MG BASE

Approval Date

2005-11-14

65209 / 1 View Details

Active Ingredient

AZITHROMYCIN

Application Number

65209

Product Number

1

Dosage Form

-

Strength

EQ 600MG BASE

Approval Date

2005-11-14

Regulatory Status

RX

2005

14 Nov

RX Application: 65211

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2005-11-14

65211 / 1 View Details

Active Ingredient

AZITHROMYCIN

Application Number

65211

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2005-11-14

Regulatory Status

RX

2005

14 Nov

RX Application: 65212

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2005-11-14

65212 / 1 View Details

Active Ingredient

AZITHROMYCIN

Application Number

65212

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2005-11-14

Regulatory Status

RX

1998

01 Apr

RX Application: 20816

Drug Name

AZOPT

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1998-04-01

20816 / 1 View Details

Active Ingredient

BRINZOLAMIDE

Application Number

20816

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1998-04-01

Regulatory Status

RX

2004

11 Feb

RX Application: 76631

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

2004-02-11

76631 / 1 View Details

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

76631

Product Number

1

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

2004-02-11

Regulatory Status

RX

2004

11 Feb

RX Application: 76631

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2004-02-11

76631 / 2 View Details

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

76631

Product Number

2

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2004-02-11

Regulatory Status

RX

2004

11 Feb

RX Application: 76631

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2004-02-11

76631 / 3 View Details

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

76631

Product Number

3

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2004-02-11

Regulatory Status

RX

2004

11 Feb

RX Application: 76631

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

4

Dosage Form

-

Strength

20MG;25MG

Approval Date

2004-02-11

76631 / 4 View Details

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

76631

Product Number

4

Dosage Form

-

Strength

20MG;25MG

Approval Date

2004-02-11

Regulatory Status

RX

1985

30 Aug

RX Application: 19270

Drug Name

BETOPTIC

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

1985-08-30

19270 / 1 View Details

Active Ingredient

BETAXOLOL HYDROCHLORIDE

Application Number

19270

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

1985-08-30

Regulatory Status

RX

2009

06 Jul

RX Application: 78575

Drug Name

BICALUTAMIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2009-07-06

78575 / 1 View Details

Active Ingredient

BICALUTAMIDE

Application Number

78575

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2009-07-06

Regulatory Status

RX

2015

05 May

RX Application: 202565

Drug Name

BIMATOPROST

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

2015-05-05

202565 / 1 View Details

Active Ingredient

BIMATOPROST

Application Number

202565

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

2015-05-05

Regulatory Status

RX

2016

19 Apr

RX Application: 202719

Drug Name

BIMATOPROST

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

2016-04-19

202719 / 1 View Details

Active Ingredient

BIMATOPROST

Application Number

202719

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

2016-04-19

Regulatory Status

RX

2003

16 Sep

RX Application: 76254

Drug Name

BRIMONIDINE TARTRATE

Product Number

1

Dosage Form

-

Strength

0.2%

Approval Date

2003-09-16

76254 / 1 View Details

Active Ingredient

BRIMONIDINE TARTRATE

Application Number

76254

Product Number

1

Dosage Form

-

Strength

0.2%

Approval Date

2003-09-16

Regulatory Status

RX

2008

30 Jan

RX Application: 78075

Drug Name

BRIMONIDINE TARTRATE

Product Number

1

Dosage Form

-

Strength

0.2%

Approval Date

2008-01-30

78075 / 1 View Details

Active Ingredient

BRIMONIDINE TARTRATE

Application Number

78075

Product Number

1

Dosage Form

-

Strength

0.2%

Approval Date

2008-01-30

Regulatory Status

RX

2024

04 Mar

RX Application: 203172

Drug Name

BRIMONIDINE TARTRATE

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2024-03-04

203172 / 1 View Details

Active Ingredient

BRIMONIDINE TARTRATE

Application Number

203172

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2024-03-04

Regulatory Status

RX

2022

04 Apr

RX Application: 91087

Drug Name

BRIMONIDINE TARTRATE AND TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

0.2%;EQ 0.5% BASE

Approval Date

2022-04-04

91087 / 1 View Details

Active Ingredient

BRIMONIDINE TARTRATE; TIMOLOL MALEATE

Application Number

91087

Product Number

1

Dosage Form

-

Strength

0.2%;EQ 0.5% BASE

Approval Date

2022-04-04

Regulatory Status

RX

1998

13 Jan

RX Application: 74631

Drug Name

BROMOCRIPTINE MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

1998-01-13

74631 / 1 View Details

Active Ingredient

BROMOCRIPTINE MESYLATE

Application Number

74631

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

1998-01-13

Regulatory Status

RX

1996

21 Nov

RX Application: 74700

Drug Name

BUMETANIDE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

1996-11-21

74700 / 1 View Details

Active Ingredient

BUMETANIDE

Application Number

74700

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

1996-11-21

Regulatory Status

RX

1996

21 Nov

RX Application: 74700

Drug Name

BUMETANIDE

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

1996-11-21

74700 / 2 View Details

Active Ingredient

BUMETANIDE

Application Number

74700

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

1996-11-21

Regulatory Status

RX

1996

21 Nov

RX Application: 74700

Drug Name

BUMETANIDE

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

1996-11-21

74700 / 3 View Details

Active Ingredient

BUMETANIDE

Application Number

74700

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

1996-11-21

Regulatory Status

RX

2008

12 Mar

RX Application: 77475

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2008-03-12

77475 / 1 View Details

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

77475

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2008-03-12

Regulatory Status

RX

2008

08 May

RX Application: 78280

Drug Name

CARBOPLATIN

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2008-05-08

78280 / 1 View Details

Active Ingredient

CARBOPLATIN

Application Number

78280

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2008-05-08

Regulatory Status

RX

2008

08 May

RX Application: 78280

Drug Name

CARBOPLATIN

Product Number

2

Dosage Form

-

Strength

150MG/15ML (10MG/ML)

Approval Date

2008-05-08

78280 / 2 View Details

Active Ingredient

CARBOPLATIN

Application Number

78280

Product Number

2

Dosage Form

-

Strength

150MG/15ML (10MG/ML)

Approval Date

2008-05-08

Regulatory Status

RX

2008

08 May

RX Application: 78280

Drug Name

CARBOPLATIN

Product Number

3

Dosage Form

-

Strength

450MG/45ML (10MG/ML)

Approval Date

2008-05-08

78280 / 3 View Details

Active Ingredient

CARBOPLATIN

Application Number

78280

Product Number

3

Dosage Form

-

Strength

450MG/45ML (10MG/ML)

Approval Date

2008-05-08

Regulatory Status

RX

2000

03 Jan

RX Application: 75476

Drug Name

CARTEOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2000-01-03

75476 / 1 View Details

Active Ingredient

CARTEOLOL HYDROCHLORIDE

Application Number

75476

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2000-01-03

Regulatory Status

RX

2007

05 Sep

RX Application: 78227

Drug Name

CARVEDILOL

Product Number

1

Dosage Form

-

Strength

3.125MG

Approval Date

2007-09-05

78227 / 1 View Details

Active Ingredient

CARVEDILOL

Application Number

78227

Product Number

1

Dosage Form

-

Strength

3.125MG

Approval Date

2007-09-05

Regulatory Status

RX

2007

05 Sep

RX Application: 78227

Drug Name

CARVEDILOL

Product Number

2

Dosage Form

-

Strength

6.25MG

Approval Date

2007-09-05

78227 / 2 View Details

Active Ingredient

CARVEDILOL

Application Number

78227

Product Number

2

Dosage Form

-

Strength

6.25MG

Approval Date

2007-09-05

Regulatory Status

RX

2007

05 Sep

RX Application: 78227

Drug Name

CARVEDILOL

Product Number

3

Dosage Form

-

Strength

12.5MG

Approval Date

2007-09-05

78227 / 3 View Details

Active Ingredient

CARVEDILOL

Application Number

78227

Product Number

3

Dosage Form

-

Strength

12.5MG

Approval Date

2007-09-05

Regulatory Status

RX

2007

05 Sep

RX Application: 78227

Drug Name

CARVEDILOL

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2007-09-05

78227 / 4 View Details

Active Ingredient

CARVEDILOL

Application Number

78227

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2007-09-05

Regulatory Status

RX

1988

09 Dec

RX Application: 62831

Drug Name

CEFAZOLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1988-12-09

62831 / 1 View Details

Active Ingredient

CEFAZOLIN SODIUM

Application Number

62831

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1988-12-09

Regulatory Status

RX

1988

09 Dec

RX Application: 62831

Drug Name

CEFAZOLIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1988-12-09

62831 / 2 View Details

Active Ingredient

CEFAZOLIN SODIUM

Application Number

62831

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1988-12-09

Regulatory Status

RX

1992

25 Sep

RX Application: 62831

Drug Name

CEFAZOLIN SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1992-09-25

62831 / 3 View Details

Active Ingredient

CEFAZOLIN SODIUM

Application Number

62831

Product Number

3

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1992-09-25

Regulatory Status

RX

2008

28 May

RX Application: 65462

Drug Name

CEFPODOXIME PROXETIL

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2008-05-28

65462 / 1 View Details

Active Ingredient

CEFPODOXIME PROXETIL

Application Number

65462

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2008-05-28

Regulatory Status

RX

2008

28 May

RX Application: 65462

Drug Name

CEFPODOXIME PROXETIL

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2008-05-28

65462 / 2 View Details

Active Ingredient

CEFPODOXIME PROXETIL

Application Number

65462

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2008-05-28

Regulatory Status

RX

2005

17 May

RX Application: 65168

Drug Name

CEFTRIAXONE

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2005-05-17

65168 / 1 View Details

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65168

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2005-05-17

Regulatory Status

RX

2005

09 May

RX Application: 65169

Drug Name

CEFTRIAXONE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

2005-05-09

65169 / 1 View Details

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65169

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

2005-05-09

Regulatory Status

RX

2005

09 May

RX Application: 65169

Drug Name

CEFTRIAXONE

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2005-05-09

65169 / 2 View Details

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65169

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2005-05-09

Regulatory Status

RX

2005

09 May

RX Application: 65169

Drug Name

CEFTRIAXONE

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2005-05-09

65169 / 3 View Details

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65169

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2005-05-09

Regulatory Status

RX

2005

09 May

RX Application: 65169

Drug Name

CEFTRIAXONE

Product Number

4

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2005-05-09

65169 / 4 View Details

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65169

Product Number

4

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2005-05-09

Regulatory Status

RX

1990

31 Dec

RX Application: 19992

Drug Name

CILOXAN

Product Number

1

Dosage Form

-

Strength

EQ 0.3% BASE

Approval Date

1990-12-31

19992 / 1 View Details

Active Ingredient

CIPROFLOXACIN HYDROCHLORIDE

Application Number

19992

Product Number

1

Dosage Form

-

Strength

EQ 0.3% BASE

Approval Date

1990-12-31

Regulatory Status

RX

1998

30 Mar

RX Application: 20369

Drug Name

CILOXAN

Product Number

1

Dosage Form

-

Strength

EQ 0.3% BASE

Approval Date

1998-03-30

20369 / 1 View Details

Active Ingredient

CIPROFLOXACIN HYDROCHLORIDE

Application Number

20369

Product Number

1

Dosage Form

-

Strength

EQ 0.3% BASE

Approval Date

1998-03-30

Regulatory Status

RX

1998

10 Feb

RX Application: 20805

Drug Name

CIPRO HC

Product Number

1

Dosage Form

-

Strength

EQ 0.2% BASE;1%

Approval Date

1998-02-10

20805 / 1 View Details

Active Ingredient

CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE

Application Number

20805

Product Number

1

Dosage Form

-

Strength

EQ 0.2% BASE;1%

Approval Date

1998-02-10

Regulatory Status

RX

2003

18 Jul

RX Application: 21537

Drug Name

CIPRODEX

Product Number

1

Dosage Form

-

Strength

0.3%;0.1%

Approval Date

2003-07-18

21537 / 1 View Details

Active Ingredient

CIPROFLOXACIN; DEXAMETHASONE

Application Number

21537

Product Number

1

Dosage Form

-

Strength

0.3%;0.1%

Approval Date

2003-07-18

Regulatory Status

RX

2005

25 Aug

RX Application: 65136

Drug Name

CLARITHROMYCIN

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2005-08-25

65136 / 1 View Details

Active Ingredient

CLARITHROMYCIN

Application Number

65136

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2005-08-25

Regulatory Status

RX

2005

18 Oct

RX Application: 65144

Drug Name

CLARITHROMYCIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2005-10-18

65144 / 1 View Details

Active Ingredient

CLARITHROMYCIN

Application Number

65144

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2005-10-18

Regulatory Status

RX

2007

04 Sep

RX Application: 65283

Drug Name

CLARITHROMYCIN

Product Number

2

Dosage Form

-

Strength

125MG/5ML

Approval Date

2007-09-04

65283 / 2 View Details

Active Ingredient

CLARITHROMYCIN

Application Number

65283

Product Number

2

Dosage Form

-

Strength

125MG/5ML

Approval Date

2007-09-04

Regulatory Status

RX

2007

04 Sep

RX Application: 65283

Drug Name

CLARITHROMYCIN

Product Number

3

Dosage Form

-

Strength

250MG/5ML

Approval Date

2007-09-04

65283 / 3 View Details

Active Ingredient

CLARITHROMYCIN

Application Number

65283

Product Number

3

Dosage Form

-

Strength

250MG/5ML

Approval Date

2007-09-04

Regulatory Status

RX

1997

25 Jun

RX Application: 74953

Drug Name

CLOMIPRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1997-06-25

74953 / 1 View Details

Active Ingredient

CLOMIPRAMINE HYDROCHLORIDE

Application Number

74953

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1997-06-25

Regulatory Status

RX

1997

25 Jun

RX Application: 74953

Drug Name

CLOMIPRAMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1997-06-25

74953 / 2 View Details

Active Ingredient

CLOMIPRAMINE HYDROCHLORIDE

Application Number

74953

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1997-06-25

Regulatory Status

RX

1997

25 Jun

RX Application: 74953

Drug Name

CLOMIPRAMINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

1997-06-25

74953 / 3 View Details

Active Ingredient

CLOMIPRAMINE HYDROCHLORIDE

Application Number

74953

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

1997-06-25

Regulatory Status

RX

1997

29 Aug

RX Application: 74979

Drug Name

CLONAZEPAM

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

1997-08-29

74979 / 1 View Details

Active Ingredient

CLONAZEPAM

Application Number

74979

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

1997-08-29

Regulatory Status

RX

1997

29 Aug

RX Application: 74979

Drug Name

CLONAZEPAM

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

1997-08-29

74979 / 2 View Details

Active Ingredient

CLONAZEPAM

Application Number

74979

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

1997-08-29

Regulatory Status

RX

1997

29 Aug

RX Application: 74979

Drug Name

CLONAZEPAM

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

1997-08-29

74979 / 3 View Details

Active Ingredient

CLONAZEPAM

Application Number

74979

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

1997-08-29

Regulatory Status

RX

2012

29 Jun

RX Application: 202147

Drug Name

COSYNTROPIN

Product Number

1

Dosage Form

-

Strength

0.25MG/VIAL

Approval Date

2012-06-29

202147 / 1 View Details

Active Ingredient

COSYNTROPIN

Application Number

202147

Product Number

1

Dosage Form

-

Strength

0.25MG/VIAL

Approval Date

2012-06-29

Regulatory Status

RX

1999

16 Jun

RX Application: 75282

Drug Name

CROMOLYN SODIUM

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

1999-06-16

75282 / 1 View Details

Active Ingredient

CROMOLYN SODIUM

Application Number

75282

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

1999-06-16

Regulatory Status

RX

2021

04 Jan

RX Application: 212915

Drug Name

CYANOCOBALAMIN

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2021-01-04

212915 / 1 View Details

Active Ingredient

CYANOCOBALAMIN

Application Number

212915

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2021-01-04

Regulatory Status

RX

2023

12 Sep

RX Application: 217150

Drug Name

CYCLOPHOSPHAMIDE

Product Number

1

Dosage Form

-

Strength

500MG/5ML (100MG/ML)

Approval Date

2023-09-12

217150 / 1 View Details

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

217150

Product Number

1

Dosage Form

-

Strength

500MG/5ML (100MG/ML)

Approval Date

2023-09-12

Regulatory Status

RX

2023

12 Sep

RX Application: 217150

Drug Name

CYCLOPHOSPHAMIDE

Product Number

2

Dosage Form

-

Strength

1GM/10ML (100MG/ML)

Approval Date

2023-09-12

217150 / 2 View Details

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

217150

Product Number

2

Dosage Form

-

Strength

1GM/10ML (100MG/ML)

Approval Date

2023-09-12

Regulatory Status

RX

2023

12 Sep

RX Application: 217150

Drug Name

CYCLOPHOSPHAMIDE

Product Number

3

Dosage Form

-

Strength

2GM/20ML (100MG/ML)

Approval Date

2023-09-12

217150 / 3 View Details

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

217150

Product Number

3

Dosage Form

-

Strength

2GM/20ML (100MG/ML)

Approval Date

2023-09-12

Regulatory Status

RX

2000

13 Jan

RX Application: 65017

Drug Name

CYCLOSPORINE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2000-01-13

65017 / 1 View Details

Active Ingredient

CYCLOSPORINE

Application Number

65017

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2000-01-13

Regulatory Status

RX

2000

13 Jan

RX Application: 65017

Drug Name

CYCLOSPORINE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2000-01-13

65017 / 2 View Details

Active Ingredient

CYCLOSPORINE

Application Number

65017

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2000-01-13

Regulatory Status

RX

2026

06 Apr

RX Application: 211312

Drug Name

DAPAGLIFLOZIN

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2026-04-06

211312 / 1 View Details

Active Ingredient

DAPAGLIFLOZIN

Application Number

211312

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2026-04-06

Regulatory Status

RX

2026

06 Apr

RX Application: 211312

Drug Name

DAPAGLIFLOZIN

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2026-04-06

211312 / 2 View Details

Active Ingredient

DAPAGLIFLOZIN

Application Number

211312

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2026-04-06

Regulatory Status

RX

2014

28 Aug

RX Application: 202969

Drug Name

DECITABINE

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2014-08-28

202969 / 1 View Details

Active Ingredient

DECITABINE

Application Number

202969

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2014-08-28

Regulatory Status

RX

2002

14 Jun

RX Application: 40439

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

1

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2002-06-14

40439 / 1 View Details

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40439

Product Number

1

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2002-06-14

Regulatory Status

RX

2002

14 Jun

RX Application: 40439

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

2

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2002-06-14

40439 / 2 View Details

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40439

Product Number

2

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2002-06-14

Regulatory Status

RX

2002

14 Jun

RX Application: 40439

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

3

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2002-06-14

40439 / 3 View Details

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40439

Product Number

3

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2002-06-14

Regulatory Status

RX

2002

27 Sep

RX Application: 40439

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

4

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2002-09-27

40439 / 4 View Details

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40439

Product Number

4

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2002-09-27

Regulatory Status

RX

2008

06 Feb

RX Application: 78031

Drug Name

DICLOFENAC SODIUM

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2008-02-06

78031 / 1 View Details

Active Ingredient

DICLOFENAC SODIUM

Application Number

78031

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2008-02-06

Regulatory Status

RX

2003

21 Aug

RX Application: 40481

Drug Name

DIGOXIN

Product Number

1

Dosage Form

-

Strength

0.25MG/ML

Approval Date

2003-08-21

40481 / 1 View Details

Active Ingredient

DIGOXIN

Application Number

40481

Product Number

1

Dosage Form

-

Strength

0.25MG/ML

Approval Date

2003-08-21

Regulatory Status

RX

2011

29 Jun

RX Application: 201525

Drug Name

DOCETAXEL

Product Number

1

Dosage Form

-

Strength

20MG/2ML (10MG/ML)

Approval Date

2011-06-29

201525 / 1 View Details

Active Ingredient

DOCETAXEL

Application Number

201525

Product Number

1

Dosage Form

-

Strength

20MG/2ML (10MG/ML)

Approval Date

2011-06-29

Regulatory Status

RX

2011

29 Jun

RX Application: 201525

Drug Name

DOCETAXEL

Product Number

2

Dosage Form

-

Strength

80MG/8ML (10MG/ML)

Approval Date

2011-06-29

201525 / 2 View Details

Active Ingredient

DOCETAXEL

Application Number

201525

Product Number

2

Dosage Form

-

Strength

80MG/8ML (10MG/ML)

Approval Date

2011-06-29

Regulatory Status

RX

2011

29 Jun

RX Application: 201525

Drug Name

DOCETAXEL

Product Number

3

Dosage Form

-

Strength

160MG/16ML (10MG/ML)

Approval Date

2011-06-29

201525 / 3 View Details

Active Ingredient

DOCETAXEL

Application Number

201525

Product Number

3

Dosage Form

-

Strength

160MG/16ML (10MG/ML)

Approval Date

2011-06-29

Regulatory Status

RX

2008

06 Nov

RX Application: 78748

Drug Name

DORZOLAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE

Approval Date

2008-11-06

78748 / 1 View Details

Active Ingredient

DORZOLAMIDE HYDROCHLORIDE

Application Number

78748

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE

Approval Date

2008-11-06

Regulatory Status

RX

2009

13 Apr

RX Application: 78981

Drug Name

DORZOLAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE

Approval Date

2009-04-13

78981 / 1 View Details

Active Ingredient

DORZOLAMIDE HYDROCHLORIDE

Application Number

78981

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE

Approval Date

2009-04-13

Regulatory Status

RX

2008

06 Nov

RX Application: 78749

Drug Name

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE;EQ 0.5% BASE

Approval Date

2008-11-06

78749 / 1 View Details

Active Ingredient

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

Application Number

78749

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE;EQ 0.5% BASE

Approval Date

2008-11-06

Regulatory Status

RX

2009

18 Nov

RX Application: 90604

Drug Name

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE;EQ 0.5% BASE

Approval Date

2009-11-18

90604 / 1 View Details

Active Ingredient

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

Application Number

90604

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE;EQ 0.5% BASE

Approval Date

2009-11-18

Regulatory Status

RX

2014

05 May

RX Application: 91333

Drug Name

DOXERCALCIFEROL

Product Number

1

Dosage Form

-

Strength

4MCG/2ML (2MCG/ML)

Approval Date

2014-05-05

91333 / 1 View Details

Active Ingredient

DOXERCALCIFEROL

Application Number

91333

Product Number

1

Dosage Form

-

Strength

4MCG/2ML (2MCG/ML)

Approval Date

2014-05-05

Regulatory Status

RX

2008

23 Jun

RX Application: 22212

Drug Name

DUREZOL

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2008-06-23

22212 / 1 View Details

Active Ingredient

DIFLUPREDNATE

Application Number

22212

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2008-06-23

Regulatory Status

RX

2024

23 Dec

RX Application: 216902

Drug Name

EDARAVONE

Product Number

1

Dosage Form

-

Strength

30MG/100ML (0.3MG/ML)

Approval Date

2024-12-23

216902 / 1 View Details

Active Ingredient

EDARAVONE

Application Number

216902

Product Number

1

Dosage Form

-

Strength

30MG/100ML (0.3MG/ML)

Approval Date

2024-12-23

Regulatory Status

RX

2010

23 Jul

RX Application: 77857

Drug Name

ENOXAPARIN SODIUM (PRESERVATIVE FREE)

Product Number

1

Dosage Form

-

Strength

100MG/ML (100MG/ML)

Approval Date

2010-07-23

77857 / 1 View Details

Active Ingredient

ENOXAPARIN SODIUM

Application Number

77857

Product Number

1

Dosage Form

-

Strength

100MG/ML (100MG/ML)

Approval Date

2010-07-23

Regulatory Status

RX

2010

23 Jul

RX Application: 77857

Drug Name

ENOXAPARIN SODIUM (PRESERVATIVE FREE)

Product Number

2

Dosage Form

-

Strength

30MG/0.3ML (100MG/ML)

Approval Date

2010-07-23

77857 / 2 View Details

Active Ingredient

ENOXAPARIN SODIUM

Application Number

77857

Product Number

2

Dosage Form

-

Strength

30MG/0.3ML (100MG/ML)

Approval Date

2010-07-23

Regulatory Status

RX

2010

23 Jul

RX Application: 77857

Drug Name

ENOXAPARIN SODIUM (PRESERVATIVE FREE)

Product Number

3

Dosage Form

-

Strength

40MG/0.4ML (100MG/ML)

Approval Date

2010-07-23

77857 / 3 View Details

Active Ingredient

ENOXAPARIN SODIUM

Application Number

77857

Product Number

3

Dosage Form

-

Strength

40MG/0.4ML (100MG/ML)

Approval Date

2010-07-23

Regulatory Status

RX

2010

23 Jul

RX Application: 77857

Drug Name

ENOXAPARIN SODIUM (PRESERVATIVE FREE)

Product Number

4

Dosage Form

-

Strength

60MG/0.6ML (100MG/ML)

Approval Date

2010-07-23

77857 / 4 View Details

Active Ingredient

ENOXAPARIN SODIUM

Application Number

77857

Product Number

4

Dosage Form

-

Strength

60MG/0.6ML (100MG/ML)

Approval Date

2010-07-23

Regulatory Status

RX

2010

23 Jul

RX Application: 77857

Drug Name

ENOXAPARIN SODIUM (PRESERVATIVE FREE)

Product Number

5

Dosage Form

-

Strength

80MG/0.8ML (100MG/ML)

Approval Date

2010-07-23

77857 / 5 View Details

Active Ingredient

ENOXAPARIN SODIUM

Application Number

77857

Product Number

5

Dosage Form

-

Strength

80MG/0.8ML (100MG/ML)

Approval Date

2010-07-23

Regulatory Status

RX

2010

23 Jul

RX Application: 77857

Drug Name

ENOXAPARIN SODIUM (PRESERVATIVE FREE)

Product Number

6

Dosage Form

-

Strength

120MG/0.8ML (150MG/ML)

Approval Date

2010-07-23

77857 / 6 View Details

Active Ingredient

ENOXAPARIN SODIUM

Application Number

77857

Product Number

6

Dosage Form

-

Strength

120MG/0.8ML (150MG/ML)

Approval Date

2010-07-23

Regulatory Status

RX

2010

23 Jul

RX Application: 77857

Drug Name

ENOXAPARIN SODIUM (PRESERVATIVE FREE)

Product Number

7

Dosage Form

-

Strength

150MG/ML (150MG/ML)

Approval Date

2010-07-23

77857 / 7 View Details

Active Ingredient

ENOXAPARIN SODIUM

Application Number

77857

Product Number

7

Dosage Form

-

Strength

150MG/ML (150MG/ML)

Approval Date

2010-07-23

Regulatory Status

RX

2026

20 Apr

RX Application: 216068

Drug Name

ENZALUTAMIDE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2026-04-20

216068 / 1 View Details

Active Ingredient

ENZALUTAMIDE

Application Number

216068

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2026-04-20

Regulatory Status

RX

2026

20 Apr

RX Application: 216068

Drug Name

ENZALUTAMIDE

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2026-04-20

216068 / 2 View Details

Active Ingredient

ENZALUTAMIDE

Application Number

216068

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2026-04-20

Regulatory Status

RX

2017

23 Aug

RX Application: 209784

Drug Name

EPHEDRINE SULFATE

Product Number

1

Dosage Form

-

Strength

50MG/ML (50MG/ML)

Approval Date

2017-08-23

209784 / 1 View Details

Active Ingredient

EPHEDRINE SULFATE

Application Number

209784

Product Number

1

Dosage Form

-

Strength

50MG/ML (50MG/ML)

Approval Date

2017-08-23

Regulatory Status

RX

2008

01 Aug

RX Application: 78510

Drug Name

EPLERENONE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2008-08-01

78510 / 1 View Details

Active Ingredient

EPLERENONE

Application Number

78510

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2008-08-01

Regulatory Status

RX

2008

01 Aug

RX Application: 78510

Drug Name

EPLERENONE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2008-08-01

78510 / 2 View Details

Active Ingredient

EPLERENONE

Application Number

78510

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2008-08-01

Regulatory Status

RX

2025

09 Jun

RX Application: 214310

Drug Name

ERIBULIN MESYLATE

Product Number

1

Dosage Form

-

Strength

1MG/2ML (0.5MG/ML)

Approval Date

2025-06-09

214310 / 1 View Details

Active Ingredient

ERIBULIN MESYLATE

Application Number

214310

Product Number

1

Dosage Form

-

Strength

1MG/2ML (0.5MG/ML)

Approval Date

2025-06-09

Regulatory Status

RX

2007

06 Jul

RX Application: 22083

Drug Name

EXELON

Product Number

1

Dosage Form

-

Strength

4.6MG/24HR

Approval Date

2007-07-06

22083 / 1 View Details

Active Ingredient

RIVASTIGMINE

Application Number

22083

Product Number

1

Dosage Form

-

Strength

4.6MG/24HR

Approval Date

2007-07-06

Regulatory Status

RX

2007

06 Jul

RX Application: 22083

Drug Name

EXELON

Product Number

2

Dosage Form

-

Strength

9.5MG/24HR

Approval Date

2007-07-06

22083 / 2 View Details

Active Ingredient

RIVASTIGMINE

Application Number

22083

Product Number

2

Dosage Form

-

Strength

9.5MG/24HR

Approval Date

2007-07-06

Regulatory Status

RX

2012

31 Aug

RX Application: 22083

Drug Name

EXELON

Product Number

5

Dosage Form

-

Strength

13.3MG/24HR

Approval Date

2012-08-31

22083 / 5 View Details

Active Ingredient

RIVASTIGMINE

Application Number

22083

Product Number

5

Dosage Form

-

Strength

13.3MG/24HR

Approval Date

2012-08-31

Regulatory Status

RX

2017

12 Jun

RX Application: 203931

Drug Name

EZETIMIBE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2017-06-12

203931 / 1 View Details

Active Ingredient

EZETIMIBE

Application Number

203931

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2017-06-12

Regulatory Status

RX

2021

15 Jan

RX Application: 206604

Drug Name

FERUMOXYTOL

Product Number

1

Dosage Form

-

Strength

EQ 510MG IRON/17ML (EQ 30MG IRON/ML)

Approval Date

2021-01-15

206604 / 1 View Details

Active Ingredient

FERUMOXYTOL

Application Number

206604

Product Number

1

Dosage Form

-

Strength

EQ 510MG IRON/17ML (EQ 30MG IRON/ML)

Approval Date

2021-01-15

Regulatory Status

RX

2026

13 Aug

RX Application: 220465

Drug Name

FIDAXOMICIN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2026-08-13

220465 / 1 View Details

Active Ingredient

FIDAXOMICIN

Application Number

220465

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2026-08-13

Regulatory Status

RX

2005

03 May

RX Application: 77071

Drug Name

FLUMAZENIL

Product Number

1

Dosage Form

-

Strength

0.5MG/5ML (0.1MG/ML)

Approval Date

2005-05-03

77071 / 1 View Details

Active Ingredient

FLUMAZENIL

Application Number

77071

Product Number

1

Dosage Form

-

Strength

0.5MG/5ML (0.1MG/ML)

Approval Date

2005-05-03

Regulatory Status

RX

2005

03 May

RX Application: 77071

Drug Name

FLUMAZENIL

Product Number

2

Dosage Form

-

Strength

1MG/10ML (0.1MG/ML)

Approval Date

2005-05-03

77071 / 2 View Details

Active Ingredient

FLUMAZENIL

Application Number

77071

Product Number

2

Dosage Form

-

Strength

1MG/10ML (0.1MG/ML)

Approval Date

2005-05-03

Regulatory Status

RX

2026

12 Feb

RX Application: 218819

Drug Name

FLUOROMETHOLONE

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2026-02-12

218819 / 1 View Details

Active Ingredient

FLUOROMETHOLONE

Application Number

218819

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2026-02-12

Regulatory Status

RX

2001

13 Nov

RX Application: 21278

Drug Name

FOCALIN

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2001-11-13

21278 / 1 View Details

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

21278

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2001-11-13

Regulatory Status

RX

2001

13 Nov

RX Application: 21278

Drug Name

FOCALIN

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2001-11-13

21278 / 2 View Details

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

21278

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2001-11-13

Regulatory Status

RX

2001

13 Nov

RX Application: 21278

Drug Name

FOCALIN

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2001-11-13

21278 / 3 View Details

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

21278

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2001-11-13

Regulatory Status

RX

2005

26 May

RX Application: 21802

Drug Name

FOCALIN XR

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2005-05-26

21802 / 1 View Details

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

21802

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2005-05-26

Regulatory Status

RX

2005

26 May

RX Application: 21802

Drug Name

FOCALIN XR

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2005-05-26

21802 / 2 View Details

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

21802

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2005-05-26

Regulatory Status

RX

2005

26 May

RX Application: 21802

Drug Name

FOCALIN XR

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2005-05-26

21802 / 3 View Details

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

21802

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2005-05-26

Regulatory Status

RX

2006

01 Aug

RX Application: 21802

Drug Name

FOCALIN XR

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2006-08-01

21802 / 4 View Details

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

21802

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2006-08-01

Regulatory Status

RX

2009

23 Oct

RX Application: 21802

Drug Name

FOCALIN XR

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

2009-10-23

21802 / 5 View Details

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

21802

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

2009-10-23

Regulatory Status

RX

2010

11 Aug

RX Application: 21802

Drug Name

FOCALIN XR

Product Number

6

Dosage Form

-

Strength

40MG

Approval Date

2010-08-11

21802 / 6 View Details

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

21802

Product Number

6

Dosage Form

-

Strength

40MG

Approval Date

2010-08-11

Regulatory Status

RX

2011

21 Apr

RX Application: 21802

Drug Name

FOCALIN XR

Product Number

7

Dosage Form

-

Strength

35MG

Approval Date

2011-04-21

21802 / 7 View Details

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

21802

Product Number

7

Dosage Form

-

Strength

35MG

Approval Date

2011-04-21

Regulatory Status

RX

2011

21 Apr

RX Application: 21802

Drug Name

FOCALIN XR

Product Number

8

Dosage Form

-

Strength

25MG

Approval Date

2011-04-21

21802 / 8 View Details

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

21802

Product Number

8

Dosage Form

-

Strength

25MG

Approval Date

2011-04-21

Regulatory Status

RX

2005

28 Sep

RX Application: 76961

Drug Name

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2005-09-28

76961 / 1 View Details

Active Ingredient

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

Application Number

76961

Product Number

1

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2005-09-28

Regulatory Status

RX

2005

28 Sep

RX Application: 76961

Drug Name

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2005-09-28

76961 / 2 View Details

Active Ingredient

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

Application Number

76961

Product Number

2

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2005-09-28

Regulatory Status

RX

2019

14 May

RX Application: 205935

Drug Name

FULVESTRANT

Product Number

1

Dosage Form

-

Strength

250MG/5ML (50MG/ML)

Approval Date

2019-05-14

205935 / 1 View Details

Active Ingredient

FULVESTRANT

Application Number

205935

Product Number

1

Dosage Form

-

Strength

250MG/5ML (50MG/ML)

Approval Date

2019-05-14

Regulatory Status

RX

2009

22 Jun

RX Application: 77589

Drug Name

GALANTAMINE HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2009-06-22

77589 / 1 View Details

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

77589

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2009-06-22

Regulatory Status

RX

2009

22 Jun

RX Application: 77589

Drug Name

GALANTAMINE HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2009-06-22

77589 / 2 View Details

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

77589

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2009-06-22

Regulatory Status

RX

2009

22 Jun

RX Application: 77589

Drug Name

GALANTAMINE HYDROBROMIDE

Product Number

3

Dosage Form

-

Strength

EQ 12MG BASE

Approval Date

2009-06-22

77589 / 3 View Details

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

77589

Product Number

3

Dosage Form

-

Strength

EQ 12MG BASE

Approval Date

2009-06-22

Regulatory Status

RX

2016

11 Jul

RX Application: 204227

Drug Name

GATIFLOXACIN

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2016-07-11

204227 / 1 View Details

Active Ingredient

GATIFLOXACIN

Application Number

204227

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2016-07-11

Regulatory Status

RX

1982

01 Jan

RX Application: 62196

Drug Name

GENTAMICIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 0.3% BASE

Approval Date

1982-01-01

62196 / 1 View Details

Active Ingredient

GENTAMICIN SULFATE

Application Number

62196

Product Number

1

Dosage Form

-

Strength

EQ 0.3% BASE

Approval Date

1982-01-01

Regulatory Status

RX

2015

16 Apr

RX Application: 90218

Drug Name

GLATOPA

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2015-04-16

90218 / 1 View Details

Active Ingredient

GLATIRAMER ACETATE

Application Number

90218

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2015-04-16

Regulatory Status

RX

2018

12 Feb

RX Application: 206921

Drug Name

GLATOPA

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2018-02-12

206921 / 1 View Details

Active Ingredient

GLATIRAMER ACETATE

Application Number

206921

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2018-02-12

Regulatory Status

RX

2019

14 May

RX Application: 211334

Drug Name

GLYCOPYRROLATE

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2019-05-14

211334 / 1 View Details

Active Ingredient

GLYCOPYRROLATE

Application Number

211334

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2019-05-14

Regulatory Status

RX

2009

30 Apr

RX Application: 78531

Drug Name

GRANISETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML (EQ 1MG BASE/ML)

Approval Date

2009-04-30

78531 / 1 View Details

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

78531

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML (EQ 1MG BASE/ML)

Approval Date

2009-04-30

Regulatory Status

RX

2009

30 Apr

RX Application: 78531

Drug Name

GRANISETRON HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

Approval Date

2009-04-30

78531 / 2 View Details

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

78531

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

Approval Date

2009-04-30

Regulatory Status

RX

2009

30 Apr

RX Application: 78534

Drug Name

GRANISETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)

Approval Date

2009-04-30

78534 / 1 View Details

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

78534

Product Number

1

Dosage Form

-

Strength

EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)

Approval Date

2009-04-30

Regulatory Status

RX

2013

07 Aug

RX Application: 91592

Drug Name

GRISEOFULVIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2013-08-07

91592 / 1 View Details

Active Ingredient

GRISEOFULVIN, MICROSIZE

Application Number

91592

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2013-08-07

Regulatory Status

RX

2013

07 Aug

RX Application: 91592

Drug Name

GRISEOFULVIN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2013-08-07

91592 / 2 View Details

Active Ingredient

GRISEOFULVIN, MICROSIZE

Application Number

91592

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2013-08-07

Regulatory Status

RX

2018

26 Dec

RX Application: 202805

Drug Name

GRISEOFULVIN, ULTRAMICROSIZE

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2018-12-26

202805 / 1 View Details

Active Ingredient

GRISEOFULVIN, ULTRAMICROSIZE

Application Number

202805

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2018-12-26

Regulatory Status

RX

2018

26 Dec

RX Application: 202805

Drug Name

GRISEOFULVIN, ULTRAMICROSIZE

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2018-12-26

202805 / 2 View Details

Active Ingredient

GRISEOFULVIN, ULTRAMICROSIZE

Application Number

202805

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2018-12-26

Regulatory Status

RX

2015

03 Jun

RX Application: 202568

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2015-06-03

202568 / 1 View Details

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

202568

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2015-06-03

Regulatory Status

RX

2015

03 Jun

RX Application: 202568

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2015-06-03

202568 / 2 View Details

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

202568

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2015-06-03

Regulatory Status

RX

2015

03 Jun

RX Application: 202568

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2015-06-03

202568 / 3 View Details

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

202568

Product Number

3

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2015-06-03

Regulatory Status

RX

2015

03 Jun

RX Application: 202568

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2015-06-03

202568 / 4 View Details

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

202568

Product Number

4

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2015-06-03

Regulatory Status

RX

1996

28 May

RX Application: 20671

Drug Name

HYCAMTIN

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/VIAL

Approval Date

1996-05-28

20671 / 1 View Details

Active Ingredient

TOPOTECAN HYDROCHLORIDE

Application Number

20671

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/VIAL

Approval Date

1996-05-28

Regulatory Status

RX

2007

11 Oct

RX Application: 20981

Drug Name

HYCAMTIN

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE

Approval Date

2007-10-11

20981 / 1 View Details

Active Ingredient

TOPOTECAN HYDROCHLORIDE

Application Number

20981

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE

Approval Date

2007-10-11

Regulatory Status

RX

2007

11 Oct

RX Application: 20981

Drug Name

HYCAMTIN

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2007-10-11

20981 / 2 View Details

Active Ingredient

TOPOTECAN HYDROCHLORIDE

Application Number

20981

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2007-10-11

Regulatory Status

RX

1995

30 Nov

RX Application: 40104

Drug Name

HYDROXYCHLOROQUINE SULFATE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1995-11-30

40104 / 1 View Details

Active Ingredient

HYDROXYCHLOROQUINE SULFATE

Application Number

40104

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1995-11-30

Regulatory Status

RX

1982

01 Jan

RX Application: 86183

Drug Name

HYDROXYZINE PAMOATE

Product Number

1

Dosage Form

-

Strength

EQ 50MG HYDROCHLORIDE

Approval Date

1982-01-01

86183 / 1 View Details

Active Ingredient

HYDROXYZINE PAMOATE

Application Number

86183

Product Number

1

Dosage Form

-

Strength

EQ 50MG HYDROCHLORIDE

Approval Date

1982-01-01

Regulatory Status

RX

1982

01 Jan

RX Application: 87479

Drug Name

HYDROXYZINE PAMOATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG HYDROCHLORIDE

Approval Date

1982-01-01

87479 / 1 View Details

Active Ingredient

HYDROXYZINE PAMOATE

Application Number

87479

Product Number

1

Dosage Form

-

Strength

EQ 25MG HYDROCHLORIDE

Approval Date

1982-01-01

Regulatory Status

RX

1982

01 Jan

RX Application: 83745

Drug Name

IMIPRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

83745 / 1 View Details

Active Ingredient

IMIPRAMINE HYDROCHLORIDE

Application Number

83745

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

RX

1982

01 Jan

RX Application: 84936

Drug Name

IMIPRAMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

84936 / 2 View Details

Active Ingredient

IMIPRAMINE HYDROCHLORIDE

Application Number

84936

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

RX

1982

01 Jan

RX Application: 84937

Drug Name

IMIPRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

84937 / 1 View Details

Active Ingredient

IMIPRAMINE HYDROCHLORIDE

Application Number

84937

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

RX

1987

29 Apr

RX Application: 70673

Drug Name

INDOMETHACIN

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1987-04-29

70673 / 1 View Details

Active Ingredient

INDOMETHACIN

Application Number

70673

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1987-04-29

Regulatory Status

RX

1987

29 Apr

RX Application: 70674

Drug Name

INDOMETHACIN

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1987-04-29

70674 / 1 View Details

Active Ingredient

INDOMETHACIN

Application Number

70674

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1987-04-29

Regulatory Status

RX

2000

18 May

RX Application: 21163

Drug Name

INFUVITE ADULT

Product Number

1

Dosage Form

-

Strength

2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML

Approval Date

2000-05-18

21163 / 1 View Details

Active Ingredient

ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K

Application Number

21163

Product Number

1

Dosage Form

-

Strength

2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML

Approval Date

2000-05-18

Regulatory Status

RX

2003

16 Jun

RX Application: 21163

Drug Name

INFUVITE ADULT

Product Number

2

Dosage Form

-

Strength

2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML

Approval Date

2003-06-16

21163 / 2 View Details

Active Ingredient

ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K

Application Number

21163

Product Number

2

Dosage Form

-

Strength

2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML

Approval Date

2003-06-16

Regulatory Status

RX

2001

21 Feb

RX Application: 21265

Drug Name

INFUVITE PEDIATRIC

Product Number

1

Dosage Form

-

Strength

80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL

Approval Date

2001-02-21

21265 / 1 View Details

Active Ingredient

ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K

Application Number

21265

Product Number

1

Dosage Form

-

Strength

80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL

Approval Date

2001-02-21

Regulatory Status

RX

2004

29 Jan

RX Application: 21265

Drug Name

INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)

Product Number

2

Dosage Form

-

Strength

80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL

Approval Date

2004-01-29

21265 / 2 View Details

Active Ingredient

ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K

Application Number

21265

Product Number

2

Dosage Form

-

Strength

80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL

Approval Date

2004-01-29

Regulatory Status

RX

2012

27 Sep

RX Application: 77466

Drug Name

IRBESARTAN

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2012-09-27

77466 / 1 View Details

Active Ingredient

IRBESARTAN

Application Number

77466

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2012-09-27

Regulatory Status

RX

2012

27 Sep

RX Application: 77466

Drug Name

IRBESARTAN

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2012-09-27

77466 / 2 View Details

Active Ingredient

IRBESARTAN

Application Number

77466

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2012-09-27

Regulatory Status

RX

2012

27 Sep

RX Application: 77466

Drug Name

IRBESARTAN

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2012-09-27

77466 / 3 View Details

Active Ingredient

IRBESARTAN

Application Number

77466

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2012-09-27

Regulatory Status

RX

2012

27 Sep

RX Application: 77446

Drug Name

IRBESARTAN AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;150MG

Approval Date

2012-09-27

77446 / 1 View Details

Active Ingredient

HYDROCHLOROTHIAZIDE; IRBESARTAN

Application Number

77446

Product Number

1

Dosage Form

-

Strength

12.5MG;150MG

Approval Date

2012-09-27

Regulatory Status

RX

2012

27 Sep

RX Application: 77446

Drug Name

IRBESARTAN AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;300MG

Approval Date

2012-09-27

77446 / 2 View Details

Active Ingredient

HYDROCHLOROTHIAZIDE; IRBESARTAN

Application Number

77446

Product Number

2

Dosage Form

-

Strength

12.5MG;300MG

Approval Date

2012-09-27

Regulatory Status

RX

2025

08 Aug

RX Application: 212340

Drug Name

IRON SUCROSE

Product Number

1

Dosage Form

-

Strength

EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)

Approval Date

2025-08-08

212340 / 1 View Details

Active Ingredient

IRON SUCROSE

Application Number

212340

Product Number

1

Dosage Form

-

Strength

EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)

Approval Date

2025-08-08

Regulatory Status

RX

2025

08 Aug

RX Application: 212340

Drug Name

IRON SUCROSE

Product Number

2

Dosage Form

-

Strength

EQ 100MG IRON/5ML (EQ 20MG IRON/ML)

Approval Date

2025-08-08

212340 / 2 View Details

Active Ingredient

IRON SUCROSE

Application Number

212340

Product Number

2

Dosage Form

-

Strength

EQ 100MG IRON/5ML (EQ 20MG IRON/ML)

Approval Date

2025-08-08

Regulatory Status

RX

2025

08 Aug

RX Application: 212340

Drug Name

IRON SUCROSE

Product Number

3

Dosage Form

-

Strength

EQ 200MG IRON/10ML (EQ 20MG IRON/ML)

Approval Date

2025-08-08

212340 / 3 View Details

Active Ingredient

IRON SUCROSE

Application Number

212340

Product Number

3

Dosage Form

-

Strength

EQ 200MG IRON/10ML (EQ 20MG IRON/ML)

Approval Date

2025-08-08

Regulatory Status

RX

2005

05 Jul

RX Application: 40648

Drug Name

ISONIAZID

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2005-07-05

40648 / 1 View Details

Active Ingredient

ISONIAZID

Application Number

40648

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2005-07-05

Regulatory Status

RX

2010

22 Jun

RX Application: 200890

Drug Name

ISOPTO CARPINE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2010-06-22

200890 / 1 View Details

Active Ingredient

PILOCARPINE HYDROCHLORIDE

Application Number

200890

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2010-06-22

Regulatory Status

RX

2010

22 Jun

RX Application: 200890

Drug Name

ISOPTO CARPINE

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

2010-06-22

200890 / 2 View Details

Active Ingredient

PILOCARPINE HYDROCHLORIDE

Application Number

200890

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

2010-06-22

Regulatory Status

RX

2010

22 Jun

RX Application: 200890

Drug Name

ISOPTO CARPINE

Product Number

3

Dosage Form

-

Strength

4%

Approval Date

2010-06-22

200890 / 3 View Details

Active Ingredient

PILOCARPINE HYDROCHLORIDE

Application Number

200890

Product Number

3

Dosage Form

-

Strength

4%

Approval Date

2010-06-22

Regulatory Status

RX

1988

07 Jan

RX Application: 86221

Drug Name

ISOSORBIDE DINITRATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1988-01-07

86221 / 1 View Details

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

86221

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1988-01-07

Regulatory Status

RX

1988

07 Jan

RX Application: 86223

Drug Name

ISOSORBIDE DINITRATE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1988-01-07

86223 / 1 View Details

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

86223

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1988-01-07

Regulatory Status

RX

1988

07 Apr

RX Application: 89367

Drug Name

ISOSORBIDE DINITRATE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1988-04-07

89367 / 1 View Details

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

89367

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1988-04-07

Regulatory Status

RX

2004

28 May

RX Application: 76104

Drug Name

ITRACONAZOLE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2004-05-28

76104 / 1 View Details

Active Ingredient

ITRACONAZOLE

Application Number

76104

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2004-05-28

Regulatory Status

RX

2004

06 Oct

RX Application: 76271

Drug Name

KETOROLAC TROMETHAMINE

Product Number

2

Dosage Form

-

Strength

30MG/ML

Approval Date

2004-10-06

76271 / 2 View Details

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

76271

Product Number

2

Dosage Form

-

Strength

30MG/ML

Approval Date

2004-10-06

Regulatory Status

RX

2009

05 Nov

RX Application: 76583

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2009-11-05

76583 / 1 View Details

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

76583

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2009-11-05

Regulatory Status

RX

1985

11 Oct

RX Application: 86996

Drug Name

LANORINAL

Product Number

2

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

1985-10-11

86996 / 2 View Details

Active Ingredient

ASPIRIN; BUTALBITAL; CAFFEINE

Application Number

86996

Product Number

2

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

1985-10-11

Regulatory Status

RX

2014

04 Mar

RX Application: 202588

Drug Name

LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)

Product Number

1

Dosage Form

-

Strength

500MG;500MG;30MG

Approval Date

2014-03-04

202588 / 1 View Details

Active Ingredient

AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE

Application Number

202588

Product Number

1

Dosage Form

-

Strength

500MG;500MG;30MG

Approval Date

2014-03-04

Regulatory Status

RX

2011

22 Mar

RX Application: 91449

Drug Name

LATANOPROST

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2011-03-22

91449 / 1 View Details

Active Ingredient

LATANOPROST

Application Number

91449

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2011-03-22

Regulatory Status

RX

2000

06 Oct

RX Application: 21192

Drug Name

LESCOL XL

Product Number

1

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2000-10-06

21192 / 1 View Details

Active Ingredient

FLUVASTATIN SODIUM

Application Number

21192

Product Number

1

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2000-10-06

Regulatory Status

RX

1998

04 Aug

RX Application: 74728

Drug Name

LEUPROLIDE ACETATE

Product Number

1

Dosage Form

-

Strength

14MG/2.8ML (1MG/0.2ML)

Approval Date

1998-08-04

74728 / 1 View Details

Active Ingredient

LEUPROLIDE ACETATE

Application Number

74728

Product Number

1

Dosage Form

-

Strength

14MG/2.8ML (1MG/0.2ML)

Approval Date

1998-08-04

Regulatory Status

RX

2015

09 Mar

RX Application: 203563

Drug Name

LEVOLEUCOVORIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)

Approval Date

2015-03-09

203563 / 1 View Details

Active Ingredient

LEVOLEUCOVORIN CALCIUM

Application Number

203563

Product Number

1

Dosage Form

-

Strength

EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)

Approval Date

2015-03-09

Regulatory Status

RX

2015

16 Jul

RX Application: 200904

Drug Name

LINEZOLID

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2015-07-16

200904 / 1 View Details

Active Ingredient

LINEZOLID

Application Number

200904

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2015-07-16

Regulatory Status

RX

2015

16 Jul

RX Application: 200904

Drug Name

LINEZOLID

Product Number

2

Dosage Form

-

Strength

600MG/300ML (2MG/ML)

Approval Date

2015-07-16

200904 / 2 View Details

Active Ingredient

LINEZOLID

Application Number

200904

Product Number

2

Dosage Form

-

Strength

600MG/300ML (2MG/ML)

Approval Date

2015-07-16

Regulatory Status

RX

2026

01 Jul

RX Application: 212972

Drug Name

LIRAGLUTIDE

Product Number

1

Dosage Form

-

Strength

18MG/3ML (6MG/ML)

Approval Date

2026-07-01

212972 / 1 View Details

Active Ingredient

LIRAGLUTIDE

Application Number

212972

Product Number

1

Dosage Form

-

Strength

18MG/3ML (6MG/ML)

Approval Date

2026-07-01

Regulatory Status

RX

2024

26 Jul

RX Application: 202836

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2024-07-26

202836 / 1 View Details

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

202836

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2024-07-26

Regulatory Status

RX

2024

26 Jul

RX Application: 202836

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2024-07-26

202836 / 2 View Details

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

202836

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2024-07-26

Regulatory Status

RX

2024

26 Jul

RX Application: 202836

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2024-07-26

202836 / 3 View Details

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

202836

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2024-07-26

Regulatory Status

RX

2024

26 Jul

RX Application: 202836

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

4

Dosage Form

-

Strength

50MG

Approval Date

2024-07-26

202836 / 4 View Details

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

202836

Product Number

4

Dosage Form

-

Strength

50MG

Approval Date

2024-07-26

Regulatory Status

RX

2024

26 Jul

RX Application: 202836

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

5

Dosage Form

-

Strength

60MG

Approval Date

2024-07-26

202836 / 5 View Details

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

202836

Product Number

5

Dosage Form

-

Strength

60MG

Approval Date

2024-07-26

Regulatory Status

RX

2024

26 Jul

RX Application: 202836

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

6

Dosage Form

-

Strength

70MG

Approval Date

2024-07-26

202836 / 6 View Details

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

202836

Product Number

6

Dosage Form

-

Strength

70MG

Approval Date

2024-07-26

Regulatory Status

RX

2024

26 Dec

RX Application: 202836

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

7

Dosage Form

-

Strength

10MG

Approval Date

2024-12-26

202836 / 7 View Details

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

202836

Product Number

7

Dosage Form

-

Strength

10MG

Approval Date

2024-12-26

Regulatory Status

RX

1987

21 Apr

RX Application: 71141

Drug Name

LORAZEPAM

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1987-04-21

71141 / 1 View Details

Active Ingredient

LORAZEPAM

Application Number

71141

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1987-04-21

Regulatory Status

RX

1987

21 Apr

RX Application: 71141

Drug Name

LORAZEPAM

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

1987-04-21

71141 / 2 View Details

Active Ingredient

LORAZEPAM

Application Number

71141

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

1987-04-21

Regulatory Status

RX

1987

21 Apr

RX Application: 71141

Drug Name

LORAZEPAM

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

1987-04-21

71141 / 3 View Details

Active Ingredient

LORAZEPAM

Application Number

71141

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

1987-04-21

Regulatory Status

RX

1982

01 Jan

RX Application: 50065

Drug Name

MAXITROL

Product Number

2

Dosage Form

-

Strength

0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

Approval Date

1982-01-01

50065 / 2 View Details

Active Ingredient

DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

50065

Product Number

2

Dosage Form

-

Strength

0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

Approval Date

1982-01-01

Regulatory Status

RX

1984

22 May

RX Application: 62341

Drug Name

MAXITROL

Product Number

1

Dosage Form

-

Strength

0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Approval Date

1984-05-22

62341 / 1 View Details

Active Ingredient

DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

62341

Product Number

1

Dosage Form

-

Strength

0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Approval Date

1984-05-22

Regulatory Status

RX

1989

22 May

RX Application: 84843

Drug Name

MECLIZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

12.5MG

Approval Date

1989-05-22

84843 / 2 View Details

Active Ingredient

MECLIZINE HYDROCHLORIDE

Application Number

84843

Product Number

2

Dosage Form

-

Strength

12.5MG

Approval Date

1989-05-22

Regulatory Status

RX

2019

12 Jun

RX Application: 202065

Drug Name

MESALAMINE

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2019-06-12

202065 / 1 View Details

Active Ingredient

MESALAMINE

Application Number

202065

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2019-06-12

Regulatory Status

RX

2026

10 Mar

RX Application: 219997

Drug Name

MESALAMINE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2026-03-10

219997 / 1 View Details

Active Ingredient

MESALAMINE

Application Number

219997

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2026-03-10

Regulatory Status

RX

2026

10 Mar

RX Application: 219997

Drug Name

MESALAMINE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2026-03-10

219997 / 2 View Details

Active Ingredient

MESALAMINE

Application Number

219997

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2026-03-10

Regulatory Status

RX

2010

31 Mar

RX Application: 40445

Drug Name

METAXALONE

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

2010-03-31

40445 / 1 View Details

Active Ingredient

METAXALONE

Application Number

40445

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

2010-03-31

Regulatory Status

RX

2004

14 Dec

RX Application: 76873

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2004-12-14

76873 / 1 View Details

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

76873

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2004-12-14

Regulatory Status

RX

1997

31 Oct

RX Application: 40194

Drug Name

METHYLPREDNISOLONE

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1997-10-31

40194 / 1 View Details

Active Ingredient

METHYLPREDNISOLONE

Application Number

40194

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1997-10-31

Regulatory Status

RX

2009

29 Jan

RX Application: 40719

Drug Name

METHYLPREDNISOLONE ACETATE

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2009-01-29

40719 / 1 View Details

Active Ingredient

METHYLPREDNISOLONE ACETATE

Application Number

40719

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2009-01-29

Regulatory Status

RX

2009

29 Jan

RX Application: 40719

Drug Name

METHYLPREDNISOLONE ACETATE

Product Number

2

Dosage Form

-

Strength

80MG/ML

Approval Date

2009-01-29

40719 / 2 View Details

Active Ingredient

METHYLPREDNISOLONE ACETATE

Application Number

40719

Product Number

2

Dosage Form

-

Strength

80MG/ML

Approval Date

2009-01-29

Regulatory Status

RX

2009

05 Mar

RX Application: 40794

Drug Name

METHYLPREDNISOLONE ACETATE

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2009-03-05

40794 / 1 View Details

Active Ingredient

METHYLPREDNISOLONE ACETATE

Application Number

40794

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2009-03-05

Regulatory Status

RX

2009

05 Mar

RX Application: 40794

Drug Name

METHYLPREDNISOLONE ACETATE

Product Number

2

Dosage Form

-

Strength

80MG/ML

Approval Date

2009-03-05

40794 / 2 View Details

Active Ingredient

METHYLPREDNISOLONE ACETATE

Application Number

40794

Product Number

2

Dosage Form

-

Strength

80MG/ML

Approval Date

2009-03-05

Regulatory Status

RX

2003

19 Dec

RX Application: 76466

Drug Name

METOLAZONE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2003-12-19

76466 / 1 View Details

Active Ingredient

METOLAZONE

Application Number

76466

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2003-12-19

Regulatory Status

RX

2003

19 Dec

RX Application: 76466

Drug Name

METOLAZONE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2003-12-19

76466 / 2 View Details

Active Ingredient

METOLAZONE

Application Number

76466

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2003-12-19

Regulatory Status

RX

2003

19 Dec

RX Application: 76732

Drug Name

METOLAZONE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2003-12-19

76732 / 1 View Details

Active Ingredient

METOLAZONE

Application Number

76732

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2003-12-19

Regulatory Status

RX

2007

02 Oct

RX Application: 77360

Drug Name

METOPROLOL TARTRATE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2007-10-02

77360 / 1 View Details

Active Ingredient

METOPROLOL TARTRATE

Application Number

77360

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2007-10-02

Regulatory Status

RX

2009

13 Aug

RX Application: 90422

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2009-08-13

90422 / 1 View Details

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

90422

Product Number

1

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2009-08-13

Regulatory Status

RX

2009

13 Aug

RX Application: 90422

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 90MG BASE

Approval Date

2009-08-13

90422 / 2 View Details

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

90422

Product Number

2

Dosage Form

-

Strength

EQ 90MG BASE

Approval Date

2009-08-13

Regulatory Status

RX

2009

13 Aug

RX Application: 90422

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 135MG BASE

Approval Date

2009-08-13

90422 / 3 View Details

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

90422

Product Number

3

Dosage Form

-

Strength

EQ 135MG BASE

Approval Date

2009-08-13

Regulatory Status

RX

2008

15 Oct

RX Application: 65379

Drug Name

MYCOPHENOLATE MOFETIL

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2008-10-15

65379 / 1 View Details

Active Ingredient

MYCOPHENOLATE MOFETIL

Application Number

65379

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2008-10-15

Regulatory Status

RX

2008

15 Oct

RX Application: 65451

Drug Name

MYCOPHENOLATE MOFETIL

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2008-10-15

65451 / 1 View Details

Active Ingredient

MYCOPHENOLATE MOFETIL

Application Number

65451

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2008-10-15

Regulatory Status

RX

1982

01 Jan

RX Application: 84305

Drug Name

MYDRIACYL

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

84305 / 1 View Details

Active Ingredient

TROPICAMIDE

Application Number

84305

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

Regulatory Status

RX

1995

09 Nov

RX Application: 74501

Drug Name

NADOLOL

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1995-11-09

74501 / 1 View Details

Active Ingredient

NADOLOL

Application Number

74501

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1995-11-09

Regulatory Status

RX

1995

09 Nov

RX Application: 74501

Drug Name

NADOLOL

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

1995-11-09

74501 / 2 View Details

Active Ingredient

NADOLOL

Application Number

74501

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

1995-11-09

Regulatory Status

RX

1995

09 Nov

RX Application: 74501

Drug Name

NADOLOL

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

1995-11-09

74501 / 3 View Details

Active Ingredient

NADOLOL

Application Number

74501

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

1995-11-09

Regulatory Status

RX

1983

25 Aug

RX Application: 62423

Drug Name

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Approval Date

1983-08-25

62423 / 1 View Details

Active Ingredient

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

62423

Product Number

1

Dosage Form

-

Strength

1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Approval Date

1983-08-25

Regulatory Status

RX

1985

06 Nov

RX Application: 62488

Drug Name

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Approval Date

1985-11-06

62488 / 1 View Details

Active Ingredient

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

62488

Product Number

1

Dosage Form

-

Strength

1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Approval Date

1985-11-06

Regulatory Status

RX

1988

11 May

RX Application: 62874

Drug Name

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Approval Date

1988-05-11

62874 / 1 View Details

Active Ingredient

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

62874

Product Number

1

Dosage Form

-

Strength

1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Approval Date

1988-05-11

Regulatory Status

RX

2014

03 Apr

RX Application: 203411

Drug Name

NEVIRAPINE

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2014-04-03

203411 / 1 View Details

Active Ingredient

NEVIRAPINE

Application Number

203411

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2014-04-03

Regulatory Status

RX

2026

02 Apr

RX Application: 216915

Drug Name

NINTEDANIB ESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2026-04-02

216915 / 1 View Details

Active Ingredient

NINTEDANIB ESYLATE

Application Number

216915

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2026-04-02

Regulatory Status

RX

2026

02 Apr

RX Application: 216915

Drug Name

NINTEDANIB ESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2026-04-02

216915 / 2 View Details

Active Ingredient

NINTEDANIB ESYLATE

Application Number

216915

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2026-04-02

Regulatory Status

RX

2005

05 Apr

RX Application: 77066

Drug Name

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

Product Number

1

Dosage Form

-

Strength

75MG;25MG

Approval Date

2005-04-05

77066 / 1 View Details

Active Ingredient

NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

Application Number

77066

Product Number

1

Dosage Form

-

Strength

75MG;25MG

Approval Date

2005-04-05

Regulatory Status

RX

2018

18 Oct

RX Application: 211359

Drug Name

NOREPINEPHRINE BITARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2018-10-18

211359 / 1 View Details

Active Ingredient

NOREPINEPHRINE BITARTRATE

Application Number

211359

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2018-10-18

Regulatory Status

RX

2003

28 Jan

RX Application: 75757

Drug Name

OMEPRAZOLE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2003-01-28

75757 / 1 View Details

Active Ingredient

OMEPRAZOLE

Application Number

75757

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2003-01-28

Regulatory Status

RX

2003

28 Jan

RX Application: 75757

Drug Name

OMEPRAZOLE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2003-01-28

75757 / 2 View Details

Active Ingredient

OMEPRAZOLE

Application Number

75757

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2003-01-28

Regulatory Status

RX

2009

21 Jan

RX Application: 76515

Drug Name

OMEPRAZOLE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2009-01-21

76515 / 1 View Details

Active Ingredient

OMEPRAZOLE

Application Number

76515

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2009-01-21

Regulatory Status

RX

1982

01 Jan

RX Application: 17469

Drug Name

OMNIPRED

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

17469 / 1 View Details

Active Ingredient

PREDNISOLONE ACETATE

Application Number

17469

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

RX

2007

13 Aug

RX Application: 78050

Drug Name

ONDANSETRON

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2007-08-13

78050 / 1 View Details

Active Ingredient

ONDANSETRON

Application Number

78050

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2007-08-13

Regulatory Status

RX

2007

13 Aug

RX Application: 78050

Drug Name

ONDANSETRON

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

2007-08-13

78050 / 2 View Details

Active Ingredient

ONDANSETRON

Application Number

78050

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

2007-08-13

Regulatory Status

RX

2007

27 Jun

RX Application: 77430

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2007-06-27

77430 / 1 View Details

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77430

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2007-06-27

Regulatory Status

RX

2007

27 Jun

RX Application: 77551

Drug Name

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2007-06-27

77551 / 1 View Details

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77551

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2007-06-27

Regulatory Status

RX

2000

15 Feb

RX Application: 40327

Drug Name

ORPHENADRINE CITRATE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2000-02-15

40327 / 1 View Details

Active Ingredient

ORPHENADRINE CITRATE

Application Number

40327

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2000-02-15

Regulatory Status

RX

2011

24 Jan

RX Application: 78817

Drug Name

OXALIPLATIN

Product Number

1

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

2011-01-24

78817 / 1 View Details

Active Ingredient

OXALIPLATIN

Application Number

78817

Product Number

1

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

2011-01-24

Regulatory Status

RX

2011

24 Jan

RX Application: 78817

Drug Name

OXALIPLATIN

Product Number

2

Dosage Form

-

Strength

100MG/20ML (5MG/ML)

Approval Date

2011-01-24

78817 / 2 View Details

Active Ingredient

OXALIPLATIN

Application Number

78817

Product Number

2

Dosage Form

-

Strength

100MG/20ML (5MG/ML)

Approval Date

2011-01-24

Regulatory Status

RX

2015

13 Oct

RX Application: 202521

Drug Name

PALONOSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)

Approval Date

2015-10-13

202521 / 1 View Details

Active Ingredient

PALONOSETRON HYDROCHLORIDE

Application Number

202521

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)

Approval Date

2015-10-13

Regulatory Status

RX

2011

27 Jul

RX Application: 91108

Drug Name

PARICALCITOL

Product Number

1

Dosage Form

-

Strength

0.002MG/ML (0.002MG/ML)

Approval Date

2011-07-27

91108 / 1 View Details

Active Ingredient

PARICALCITOL

Application Number

91108

Product Number

1

Dosage Form

-

Strength

0.002MG/ML (0.002MG/ML)

Approval Date

2011-07-27

Regulatory Status

RX

2011

27 Jul

RX Application: 91108

Drug Name

PARICALCITOL

Product Number

2

Dosage Form

-

Strength

0.005MG/ML (0.005MG/ML)

Approval Date

2011-07-27

91108 / 2 View Details

Active Ingredient

PARICALCITOL

Application Number

91108

Product Number

2

Dosage Form

-

Strength

0.005MG/ML (0.005MG/ML)

Approval Date

2011-07-27

Regulatory Status

RX

2011

27 Jul

RX Application: 91108

Drug Name

PARICALCITOL

Product Number

3

Dosage Form

-

Strength

0.01MG/2ML (0.005MG/ML)

Approval Date

2011-07-27

91108 / 3 View Details

Active Ingredient

PARICALCITOL

Application Number

91108

Product Number

3

Dosage Form

-

Strength

0.01MG/2ML (0.005MG/ML)

Approval Date

2011-07-27

Regulatory Status

RX

2022

26 May

RX Application: 214657

Drug Name

PEMETREXED DISODIUM

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/4ML (EQ 25MG BASE/ML)

Approval Date

2022-05-26

214657 / 1 View Details

Active Ingredient

PEMETREXED DISODIUM

Application Number

214657

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/4ML (EQ 25MG BASE/ML)

Approval Date

2022-05-26

Regulatory Status

RX

2022

26 May

RX Application: 214657

Drug Name

PEMETREXED DISODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/20ML (EQ 25MG BASE/ML)

Approval Date

2022-05-26

214657 / 2 View Details

Active Ingredient

PEMETREXED DISODIUM

Application Number

214657

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/20ML (EQ 25MG BASE/ML)

Approval Date

2022-05-26

Regulatory Status

RX

2022

26 May

RX Application: 214657

Drug Name

PEMETREXED DISODIUM

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/40ML (EQ 25MG BASE/ML)

Approval Date

2022-05-26

214657 / 3 View Details

Active Ingredient

PEMETREXED DISODIUM

Application Number

214657

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/40ML (EQ 25MG BASE/ML)

Approval Date

2022-05-26

Regulatory Status

RX

2002

30 Aug

RX Application: 65079

Drug Name

PENICILLIN G POTASSIUM

Product Number

2

Dosage Form

-

Strength

5,000,000 UNITS/VIAL

Approval Date

2002-08-30

65079 / 2 View Details

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

65079

Product Number

2

Dosage Form

-

Strength

5,000,000 UNITS/VIAL

Approval Date

2002-08-30

Regulatory Status

RX

2002

30 Aug

RX Application: 65079

Drug Name

PENICILLIN G POTASSIUM

Product Number

3

Dosage Form

-

Strength

20,000,000 UNITS/VIAL

Approval Date

2002-08-30

65079 / 3 View Details

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

65079

Product Number

3

Dosage Form

-

Strength

20,000,000 UNITS/VIAL

Approval Date

2002-08-30

Regulatory Status

RX

2001

26 Feb

RX Application: 65068

Drug Name

PENICILLIN G SODIUM

Product Number

1

Dosage Form

-

Strength

5,000,000 UNITS/VIAL

Approval Date

2001-02-26

65068 / 1 View Details

Active Ingredient

PENICILLIN G SODIUM

Application Number

65068

Product Number

1

Dosage Form

-

Strength

5,000,000 UNITS/VIAL

Approval Date

2001-02-26

Regulatory Status

RX

1988

08 Dec

RX Application: 89685

Drug Name

PERPHENAZINE

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

1988-12-08

89685 / 1 View Details

Active Ingredient

PERPHENAZINE

Application Number

89685

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

1988-12-08

Regulatory Status

RX

1988

08 Dec

RX Application: 89685

Drug Name

PERPHENAZINE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

1988-12-08

89685 / 2 View Details

Active Ingredient

PERPHENAZINE

Application Number

89685

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

1988-12-08

Regulatory Status

RX

1988

08 Dec

RX Application: 89685

Drug Name

PERPHENAZINE

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

1988-12-08

89685 / 3 View Details

Active Ingredient

PERPHENAZINE

Application Number

89685

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

1988-12-08

Regulatory Status

RX

1988

08 Dec

RX Application: 89685

Drug Name

PERPHENAZINE

Product Number

4

Dosage Form

-

Strength

16MG

Approval Date

1988-12-08

89685 / 4 View Details

Active Ingredient

PERPHENAZINE

Application Number

89685

Product Number

4

Dosage Form

-

Strength

16MG

Approval Date

1988-12-08

Regulatory Status

RX

1983

20 Jul

RX Application: 86945

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1983-07-20

86945 / 1 View Details

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

86945

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1983-07-20

Regulatory Status

RX

1982

01 Jan

RX Application: 87190

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

87190 / 1 View Details

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

87190

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

Regulatory Status

RX

1982

01 Jan

RX Application: 87190

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

87190 / 2 View Details

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

87190

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

Regulatory Status

RX

2019

31 Jan

RX Application: 208905

Drug Name

PHENYLEPHRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML (10MG/ML)

Approval Date

2019-01-31

208905 / 1 View Details

Active Ingredient

PHENYLEPHRINE HYDROCHLORIDE

Application Number

208905

Product Number

1

Dosage Form

-

Strength

10MG/ML (10MG/ML)

Approval Date

2019-01-31

Regulatory Status

RX

2019

31 Jan

RX Application: 208905

Drug Name

PHENYLEPHRINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2019-01-31

208905 / 2 View Details

Active Ingredient

PHENYLEPHRINE HYDROCHLORIDE

Application Number

208905

Product Number

2

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2019-01-31

Regulatory Status

RX

2019

31 Jan

RX Application: 208905

Drug Name

PHENYLEPHRINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2019-01-31

208905 / 3 View Details

Active Ingredient

PHENYLEPHRINE HYDROCHLORIDE

Application Number

208905

Product Number

3

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2019-01-31

Regulatory Status

RX

2010

21 Oct

RX Application: 65362

Drug Name

PIPERACILLIN AND TAZOBACTAM

Product Number

1

Dosage Form

-

Strength

EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL

Approval Date

2010-10-21

65362 / 1 View Details

Active Ingredient

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Application Number

65362

Product Number

1

Dosage Form

-

Strength

EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL

Approval Date

2010-10-21

Regulatory Status

RX

2010

21 Oct

RX Application: 65362

Drug Name

PIPERACILLIN AND TAZOBACTAM

Product Number

2

Dosage Form

-

Strength

EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL

Approval Date

2010-10-21

65362 / 2 View Details

Active Ingredient

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Application Number

65362

Product Number

2

Dosage Form

-

Strength

EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL

Approval Date

2010-10-21

Regulatory Status

RX

2010

21 Oct

RX Application: 65362

Drug Name

PIPERACILLIN AND TAZOBACTAM

Product Number

3

Dosage Form

-

Strength

EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL

Approval Date

2010-10-21

65362 / 3 View Details

Active Ingredient

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Application Number

65362

Product Number

3

Dosage Form

-

Strength

EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL

Approval Date

2010-10-21

Regulatory Status

RX

2014

29 Oct

RX Application: 203557

Drug Name

PIPERACILLIN AND TAZOBACTAM

Product Number

1

Dosage Form

-

Strength

EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL

Approval Date

2014-10-29

203557 / 1 View Details

Active Ingredient

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Application Number

203557

Product Number

1

Dosage Form

-

Strength

EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL

Approval Date

2014-10-29

Regulatory Status

RX

2021

08 Jul

RX Application: 203557

Drug Name

PIPERACILLIN AND TAZOBACTAM

Product Number

2

Dosage Form

-

Strength

EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL

Approval Date

2021-07-08

203557 / 2 View Details

Active Ingredient

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Application Number

203557

Product Number

2

Dosage Form

-

Strength

EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL

Approval Date

2021-07-08

Regulatory Status

RX

2022

28 Apr

RX Application: 212560

Drug Name

PIRFENIDONE

Product Number

1

Dosage Form

-

Strength

267MG

Approval Date

2022-04-28

212560 / 1 View Details

Active Ingredient

PIRFENIDONE

Application Number

212560

Product Number

1

Dosage Form

-

Strength

267MG

Approval Date

2022-04-28

Regulatory Status

RX

2022

28 Apr

RX Application: 212560

Drug Name

PIRFENIDONE

Product Number

2

Dosage Form

-

Strength

801MG

Approval Date

2022-04-28

212560 / 2 View Details

Active Ingredient

PIRFENIDONE

Application Number

212560

Product Number

2

Dosage Form

-

Strength

801MG

Approval Date

2022-04-28

Regulatory Status

RX

2022

13 Jun

RX Application: 212600

Drug Name

PIRFENIDONE

Product Number

1

Dosage Form

-

Strength

267MG

Approval Date

2022-06-13

212600 / 1 View Details

Active Ingredient

PIRFENIDONE

Application Number

212600

Product Number

1

Dosage Form

-

Strength

267MG

Approval Date

2022-06-13

Regulatory Status

RX

1982

01 Jan

RX Application: 84176

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

84176 / 1 View Details

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

84176

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

RX

1982

01 Jan

RX Application: 84176

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

84176 / 3 View Details

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

84176

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

RX

2006

22 May

RX Application: 21764

Drug Name

QOLIANA

Product Number

1

Dosage Form

-

Strength

0.15%

Approval Date

2006-05-22

21764 / 1 View Details

Active Ingredient

BRIMONIDINE TARTRATE

Application Number

21764

Product Number

1

Dosage Form

-

Strength

0.15%

Approval Date

2006-05-22

Regulatory Status

RX

1997

29 Aug

RX Application: 74467

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1997-08-29

74467 / 1 View Details

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

74467

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1997-08-29

Regulatory Status

RX

1997

29 Aug

RX Application: 74467

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

1997-08-29

74467 / 2 View Details

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

74467

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

1997-08-29

Regulatory Status

RX

1997

22 Oct

RX Application: 74655

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1997-10-22

74655 / 1 View Details

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

74655

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1997-10-22

Regulatory Status

RX

1997

22 Oct

RX Application: 74655

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

1997-10-22

74655 / 2 View Details

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

74655

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

1997-10-22

Regulatory Status

RX

2007

16 Apr

RX Application: 21817

Drug Name

RECLAST

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/100ML

Approval Date

2007-04-16

21817 / 1 View Details

Active Ingredient

ZOLEDRONIC ACID

Application Number

21817

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/100ML

Approval Date

2007-04-16

Regulatory Status

RX

1982

01 Jan

RX Application: 17398

Drug Name

REGONOL

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1982-01-01

17398 / 1 View Details

Active Ingredient

PYRIDOSTIGMINE BROMIDE

Application Number

17398

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

2006

03 Oct

RX Application: 77743

Drug Name

RIBAVIRIN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2006-10-03

77743 / 1 View Details

Active Ingredient

RIBAVIRIN

Application Number

77743

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2006-10-03

Regulatory Status

RX

2009

22 Dec

RX Application: 78116

Drug Name

RISPERIDONE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2009-12-22

78116 / 1 View Details

Active Ingredient

RISPERIDONE

Application Number

78116

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2009-12-22

Regulatory Status

RX

2009

22 Dec

RX Application: 78116

Drug Name

RISPERIDONE

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2009-12-22

78116 / 2 View Details

Active Ingredient

RISPERIDONE

Application Number

78116

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2009-12-22

Regulatory Status

RX

2009

22 Dec

RX Application: 78116

Drug Name

RISPERIDONE

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2009-12-22

78116 / 3 View Details

Active Ingredient

RISPERIDONE

Application Number

78116

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2009-12-22

Regulatory Status

RX

2009

22 Dec

RX Application: 78116

Drug Name

RISPERIDONE

Product Number

4

Dosage Form

-

Strength

3MG

Approval Date

2009-12-22

78116 / 4 View Details

Active Ingredient

RISPERIDONE

Application Number

78116

Product Number

4

Dosage Form

-

Strength

3MG

Approval Date

2009-12-22

Regulatory Status

RX

2009

22 Dec

RX Application: 78116

Drug Name

RISPERIDONE

Product Number

5

Dosage Form

-

Strength

4MG

Approval Date

2009-12-22

78116 / 5 View Details

Active Ingredient

RISPERIDONE

Application Number

78116

Product Number

5

Dosage Form

-

Strength

4MG

Approval Date

2009-12-22

Regulatory Status

RX

2009

16 Oct

RX Application: 78528

Drug Name

RISPERIDONE

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2009-10-16

78528 / 1 View Details

Active Ingredient

RISPERIDONE

Application Number

78528

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2009-10-16

Regulatory Status

RX

2009

16 Oct

RX Application: 78528

Drug Name

RISPERIDONE

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2009-10-16

78528 / 2 View Details

Active Ingredient

RISPERIDONE

Application Number

78528

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2009-10-16

Regulatory Status

RX

2009

16 Oct

RX Application: 78528

Drug Name

RISPERIDONE

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2009-10-16

78528 / 3 View Details

Active Ingredient

RISPERIDONE

Application Number

78528

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2009-10-16

Regulatory Status

RX

2009

16 Oct

RX Application: 78528

Drug Name

RISPERIDONE

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2009-10-16

78528 / 4 View Details

Active Ingredient

RISPERIDONE

Application Number

78528

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2009-10-16

Regulatory Status

RX

2009

16 Oct

RX Application: 78528

Drug Name

RISPERIDONE

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2009-10-16

78528 / 5 View Details

Active Ingredient

RISPERIDONE

Application Number

78528

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2009-10-16

Regulatory Status

RX

2009

16 Oct

RX Application: 78528

Drug Name

RISPERIDONE

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2009-10-16

78528 / 6 View Details

Active Ingredient

RISPERIDONE

Application Number

78528

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2009-10-16

Regulatory Status

RX

1982

01 Jan

RX Application: 10187

Drug Name

RITALIN

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

10187 / 3 View Details

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

10187

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

RX

1982

01 Jan

RX Application: 10187

Drug Name

RITALIN

Product Number

6

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

10187 / 6 View Details

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

10187

Product Number

6

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

RX

1982

01 Jan

RX Application: 10187

Drug Name

RITALIN

Product Number

10

Dosage Form

-

Strength

20MG

Approval Date

1982-01-01

10187 / 10 View Details

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

10187

Product Number

10

Dosage Form

-

Strength

20MG

Approval Date

1982-01-01

Regulatory Status

RX

2002

05 Jun

RX Application: 21284

Drug Name

RITALIN LA

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2002-06-05

21284 / 1 View Details

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

21284

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2002-06-05

Regulatory Status

RX

2002

05 Jun

RX Application: 21284

Drug Name

RITALIN LA

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2002-06-05

21284 / 2 View Details

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

21284

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2002-06-05

Regulatory Status

RX

2002

05 Jun

RX Application: 21284

Drug Name

RITALIN LA

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2002-06-05

21284 / 3 View Details

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

21284

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2002-06-05

Regulatory Status

RX

2004

10 Apr

RX Application: 21284

Drug Name

RITALIN LA

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2004-04-10

21284 / 4 View Details

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

21284

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2004-04-10

Regulatory Status

RX

2008

05 Dec

RX Application: 79195

Drug Name

ROCURONIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2008-12-05

79195 / 1 View Details

Active Ingredient

ROCURONIUM BROMIDE

Application Number

79195

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2008-12-05

Regulatory Status

RX

2008

05 Dec

RX Application: 79195

Drug Name

ROCURONIUM BROMIDE

Product Number

2

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2008-12-05

79195 / 2 View Details

Active Ingredient

ROCURONIUM BROMIDE

Application Number

79195

Product Number

2

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2008-12-05

Regulatory Status

RX

2025

02 Dec

RX Application: 202388

Drug Name

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG;EQ 50MG BASE

Approval Date

2025-12-02

202388 / 1 View Details

Active Ingredient

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

Application Number

202388

Product Number

1

Dosage Form

-

Strength

500MG;EQ 50MG BASE

Approval Date

2025-12-02

Regulatory Status

RX

2025

02 Dec

RX Application: 202388

Drug Name

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

1GM;EQ 50MG BASE

Approval Date

2025-12-02

202388 / 2 View Details

Active Ingredient

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

Application Number

202388

Product Number

2

Dosage Form

-

Strength

1GM;EQ 50MG BASE

Approval Date

2025-12-02

Regulatory Status

RX

2026

14 Jan

RX Application: 202387

Drug Name

SITAGLIPTIN PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2026-01-14

202387 / 1 View Details

Active Ingredient

SITAGLIPTIN PHOSPHATE

Application Number

202387

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2026-01-14

Regulatory Status

RX

2026

14 Jan

RX Application: 202387

Drug Name

SITAGLIPTIN PHOSPHATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2026-01-14

202387 / 2 View Details

Active Ingredient

SITAGLIPTIN PHOSPHATE

Application Number

202387

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2026-01-14

Regulatory Status

RX

2026

14 Jan

RX Application: 202387

Drug Name

SITAGLIPTIN PHOSPHATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2026-01-14

202387 / 3 View Details

Active Ingredient

SITAGLIPTIN PHOSPHATE

Application Number

202387

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2026-01-14

Regulatory Status

RX

2026

28 Jul

RX Application: 214311

Drug Name

SUGAMMADEX SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/2ML (EQ 100MG BASE/ML)

Approval Date

2026-07-28

214311 / 1 View Details

Active Ingredient

SUGAMMADEX SODIUM

Application Number

214311

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/2ML (EQ 100MG BASE/ML)

Approval Date

2026-07-28

Regulatory Status

RX

2026

28 Jul

RX Application: 214311

Drug Name

SUGAMMADEX SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/5ML (EQ 100MG BASE/ML)

Approval Date

2026-07-28

214311 / 2 View Details

Active Ingredient

SUGAMMADEX SODIUM

Application Number

214311

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/5ML (EQ 100MG BASE/ML)

Approval Date

2026-07-28

Regulatory Status

RX

2009

10 Aug

RX Application: 65461

Drug Name

TACROLIMUS

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2009-08-10

65461 / 1 View Details

Active Ingredient

TACROLIMUS

Application Number

65461

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2009-08-10

Regulatory Status

RX

2009

10 Aug

RX Application: 65461

Drug Name

TACROLIMUS

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2009-08-10

65461 / 2 View Details

Active Ingredient

TACROLIMUS

Application Number

65461

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2009-08-10

Regulatory Status

RX

2009

10 Aug

RX Application: 65461

Drug Name

TACROLIMUS

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2009-08-10

65461 / 3 View Details

Active Ingredient

TACROLIMUS

Application Number

65461

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2009-08-10

Regulatory Status

RX

2022

28 Jan

RX Application: 209040

Drug Name

TAFLUPROST

Product Number

1

Dosage Form

-

Strength

0.0015%

Approval Date

2022-01-28

209040 / 1 View Details

Active Ingredient

TAFLUPROST

Application Number

209040

Product Number

1

Dosage Form

-

Strength

0.0015%

Approval Date

2022-01-28

Regulatory Status

RX

2014

03 Nov

RX Application: 203867

Drug Name

TELMISARTAN

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2014-11-03

203867 / 1 View Details

Active Ingredient

TELMISARTAN

Application Number

203867

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2014-11-03

Regulatory Status

RX

2014

03 Nov

RX Application: 203867

Drug Name

TELMISARTAN

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2014-11-03

203867 / 2 View Details

Active Ingredient

TELMISARTAN

Application Number

203867

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2014-11-03

Regulatory Status

RX

2014

03 Nov

RX Application: 203867

Drug Name

TELMISARTAN

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

2014-11-03

203867 / 3 View Details

Active Ingredient

TELMISARTAN

Application Number

203867

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

2014-11-03

Regulatory Status

RX

2019

03 Jan

RX Application: 209710

Drug Name

TERIFLUNOMIDE

Product Number

1

Dosage Form

-

Strength

7MG

Approval Date

2019-01-03

209710 / 1 View Details

Active Ingredient

TERIFLUNOMIDE

Application Number

209710

Product Number

1

Dosage Form

-

Strength

7MG

Approval Date

2019-01-03

Regulatory Status

RX

2019

03 Jan

RX Application: 209710

Drug Name

TERIFLUNOMIDE

Product Number

2

Dosage Form

-

Strength

14MG

Approval Date

2019-01-03

209710 / 2 View Details

Active Ingredient

TERIFLUNOMIDE

Application Number

209710

Product Number

2

Dosage Form

-

Strength

14MG

Approval Date

2019-01-03

Regulatory Status

RX

2015

27 May

RX Application: 91620

Drug Name

TIGECYCLINE

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2015-05-27

91620 / 1 View Details

Active Ingredient

TIGECYCLINE

Application Number

91620

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2015-05-27

Regulatory Status

RX

1998

21 Oct

RX Application: 20963

Drug Name

TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 0.25% BASE

Approval Date

1998-10-21

20963 / 1 View Details

Active Ingredient

TIMOLOL MALEATE

Application Number

20963

Product Number

1

Dosage Form

-

Strength

EQ 0.25% BASE

Approval Date

1998-10-21

Regulatory Status

RX

1998

21 Oct

RX Application: 20963

Drug Name

TIMOLOL MALEATE

Product Number

2

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

1998-10-21

20963 / 2 View Details

Active Ingredient

TIMOLOL MALEATE

Application Number

20963

Product Number

2

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

1998-10-21

Regulatory Status

RX

1995

28 Apr

RX Application: 74261

Drug Name

TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 0.25% BASE

Approval Date

1995-04-28

74261 / 1 View Details

Active Ingredient

TIMOLOL MALEATE

Application Number

74261

Product Number

1

Dosage Form

-

Strength

EQ 0.25% BASE

Approval Date

1995-04-28

Regulatory Status

RX

1995

28 Apr

RX Application: 74262

Drug Name

TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

1995-04-28

74262 / 1 View Details

Active Ingredient

TIMOLOL MALEATE

Application Number

74262

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

1995-04-28

Regulatory Status

RX

1988

18 Aug

RX Application: 50592

Drug Name

TOBRADEX

Product Number

1

Dosage Form

-

Strength

0.1%;0.3%

Approval Date

1988-08-18

50592 / 1 View Details

Active Ingredient

DEXAMETHASONE; TOBRAMYCIN

Application Number

50592

Product Number

1

Dosage Form

-

Strength

0.1%;0.3%

Approval Date

1988-08-18

Regulatory Status

RX

1984

13 Dec

RX Application: 62535

Drug Name

TOBREX

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

1984-12-13

62535 / 1 View Details

Active Ingredient

TOBRAMYCIN

Application Number

62535

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

1984-12-13

Regulatory Status

RX

2006

21 Sep

RX Application: 21994

Drug Name

TRAVATAN Z

Product Number

1

Dosage Form

-

Strength

0.004%

Approval Date

2006-09-21

21994 / 1 View Details

Active Ingredient

TRAVOPROST

Application Number

21994

Product Number

1

Dosage Form

-

Strength

0.004%

Approval Date

2006-09-21

Regulatory Status

RX

2017

30 Nov

RX Application: 203649

Drug Name

TREPROSTINIL

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2017-11-30

203649 / 1 View Details

Active Ingredient

TREPROSTINIL

Application Number

203649

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2017-11-30

Regulatory Status

RX

2017

30 Nov

RX Application: 203649

Drug Name

TREPROSTINIL

Product Number

2

Dosage Form

-

Strength

2.5MG/ML

Approval Date

2017-11-30

203649 / 2 View Details

Active Ingredient

TREPROSTINIL

Application Number

203649

Product Number

2

Dosage Form

-

Strength

2.5MG/ML

Approval Date

2017-11-30

Regulatory Status

RX

2017

30 Nov

RX Application: 203649

Drug Name

TREPROSTINIL

Product Number

3

Dosage Form

-

Strength

5MG/ML

Approval Date

2017-11-30

203649 / 3 View Details

Active Ingredient

TREPROSTINIL

Application Number

203649

Product Number

3

Dosage Form

-

Strength

5MG/ML

Approval Date

2017-11-30

Regulatory Status

RX

2017

30 Nov

RX Application: 203649

Drug Name

TREPROSTINIL

Product Number

4

Dosage Form

-

Strength

10MG/ML

Approval Date

2017-11-30

203649 / 4 View Details

Active Ingredient

TREPROSTINIL

Application Number

203649

Product Number

4

Dosage Form

-

Strength

10MG/ML

Approval Date

2017-11-30

Regulatory Status

RX

1992

30 Apr

RX Application: 73281

Drug Name

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG;37.5MG

Approval Date

1992-04-30

73281 / 1 View Details

Active Ingredient

HYDROCHLOROTHIAZIDE; TRIAMTERENE

Application Number

73281

Product Number

1

Dosage Form

-

Strength

25MG;37.5MG

Approval Date

1992-04-30

Regulatory Status

RX

1997

05 Jun

RX Application: 74821

Drug Name

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG;37.5MG

Approval Date

1997-06-05

74821 / 1 View Details

Active Ingredient

HYDROCHLOROTHIAZIDE; TRIAMTERENE

Application Number

74821

Product Number

1

Dosage Form

-

Strength

25MG;37.5MG

Approval Date

1997-06-05

Regulatory Status

RX

1982

01 Jan

RX Application: 85785

Drug Name

TRIFLUOPERAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

1982-01-01

85785 / 1 View Details

Active Ingredient

TRIFLUOPERAZINE HYDROCHLORIDE

Application Number

85785

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

1982-01-01

Regulatory Status

RX

1982

01 Jan

RX Application: 85786

Drug Name

TRIFLUOPERAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

1982-01-01

85786 / 1 View Details

Active Ingredient

TRIFLUOPERAZINE HYDROCHLORIDE

Application Number

85786

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

1982-01-01

Regulatory Status

RX

1982

01 Jan

RX Application: 85788

Drug Name

TRIFLUOPERAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1982-01-01

85788 / 1 View Details

Active Ingredient

TRIFLUOPERAZINE HYDROCHLORIDE

Application Number

85788

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1982-01-01

Regulatory Status

RX

1982

01 Jan

RX Application: 85789

Drug Name

TRIFLUOPERAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1982-01-01

85789 / 1 View Details

Active Ingredient

TRIFLUOPERAZINE HYDROCHLORIDE

Application Number

85789

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1982-01-01

Regulatory Status

RX

1995

06 Oct

RX Application: 74311

Drug Name

TRIFLURIDINE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1995-10-06

74311 / 1 View Details

Active Ingredient

TRIFLURIDINE

Application Number

74311

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1995-10-06

Regulatory Status

RX

1998

13 Apr

RX Application: 64211

Drug Name

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE

Product Number

1

Dosage Form

-

Strength

10,000 UNITS/ML;EQ 1MG BASE/ML

Approval Date

1998-04-13

64211 / 1 View Details

Active Ingredient

POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE

Application Number

64211

Product Number

1

Dosage Form

-

Strength

10,000 UNITS/ML;EQ 1MG BASE/ML

Approval Date

1998-04-13

Regulatory Status

RX

2026

06 May

RX Application: 212068

Drug Name

VASOPRESSIN

Product Number

1

Dosage Form

-

Strength

20UNITS/ML (20UNITS/ML)

Approval Date

2026-05-06

212068 / 1 View Details

Active Ingredient

VASOPRESSIN

Application Number

212068

Product Number

1

Dosage Form

-

Strength

20UNITS/ML (20UNITS/ML)

Approval Date

2026-05-06

Regulatory Status

RX

2026

06 May

RX Application: 212069

Drug Name

VASOPRESSIN

Product Number

1

Dosage Form

-

Strength

200UNITS/10ML (20UNITS/ML)

Approval Date

2026-05-06

212069 / 1 View Details

Active Ingredient

VASOPRESSIN

Application Number

212069

Product Number

1

Dosage Form

-

Strength

200UNITS/10ML (20UNITS/ML)

Approval Date

2026-05-06

Regulatory Status

RX

1999

08 Jan

RX Application: 20538

Drug Name

VIVELLE-DOT

Product Number

5

Dosage Form

-

Strength

0.0375MG/24HR

Approval Date

1999-01-08

20538 / 5 View Details

Active Ingredient

ESTRADIOL

Application Number

20538

Product Number

5

Dosage Form

-

Strength

0.0375MG/24HR

Approval Date

1999-01-08

Regulatory Status

RX

1999

08 Jan

RX Application: 20538

Drug Name

VIVELLE-DOT

Product Number

6

Dosage Form

-

Strength

0.05MG/24HR

Approval Date

1999-01-08

20538 / 6 View Details

Active Ingredient

ESTRADIOL

Application Number

20538

Product Number

6

Dosage Form

-

Strength

0.05MG/24HR

Approval Date

1999-01-08

Regulatory Status

RX

1999

08 Jan

RX Application: 20538

Drug Name

VIVELLE-DOT

Product Number

7

Dosage Form

-

Strength

0.075MG/24HR

Approval Date

1999-01-08

20538 / 7 View Details

Active Ingredient

ESTRADIOL

Application Number

20538

Product Number

7

Dosage Form

-

Strength

0.075MG/24HR

Approval Date

1999-01-08

Regulatory Status

RX

1999

08 Jan

RX Application: 20538

Drug Name

VIVELLE-DOT

Product Number

8

Dosage Form

-

Strength

0.1MG/24HR

Approval Date

1999-01-08

20538 / 8 View Details

Active Ingredient

ESTRADIOL

Application Number

20538

Product Number

8

Dosage Form

-

Strength

0.1MG/24HR

Approval Date

1999-01-08

Regulatory Status

RX

2002

03 May

RX Application: 20538

Drug Name

VIVELLE-DOT

Product Number

9

Dosage Form

-

Strength

0.025MG/24HR

Approval Date

2002-05-03

20538 / 9 View Details

Active Ingredient

ESTRADIOL

Application Number

20538

Product Number

9

Dosage Form

-

Strength

0.025MG/24HR

Approval Date

2002-05-03

Regulatory Status

RX

2007

23 Apr

RX Application: 77322

Drug Name

ZOLPIDEM TARTRATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-04-23

77322 / 1 View Details

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

77322

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-04-23

Regulatory Status

RX

2007

23 Apr

RX Application: 77322

Drug Name

ZOLPIDEM TARTRATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-04-23

77322 / 2 View Details

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

77322

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-04-23

Regulatory Status

RX

2011

01 Jul

RX Application: 90107

Drug Name

ZOLPIDEM TARTRATE

Product Number

1

Dosage Form

-

Strength

6.25MG

Approval Date

2011-07-01

90107 / 1 View Details

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

90107

Product Number

1

Dosage Form

-

Strength

6.25MG

Approval Date

2011-07-01

Regulatory Status

RX

2011

01 Jul

RX Application: 90107

Drug Name

ZOLPIDEM TARTRATE

Product Number

2

Dosage Form

-

Strength

12.5MG

Approval Date

2011-07-01

90107 / 2 View Details

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

90107

Product Number

2

Dosage Form

-

Strength

12.5MG

Approval Date

2011-07-01

Regulatory Status

RX

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