Apotex Inc
FDA Approved Drugs

Apotex Inc

FDA Approved Drugs Database

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

Discontinued RX Unclassified OTC
  • Total Records 194
  • Latest Approval Date Dec 23, 2015
  • Data Source FDA
  • First Approval Date Mar 25, 1987
All
194
View
Unclassified
38
View
Discontinued
114
View
OTC
2
View
RX
40
View
Company Overview

Company

Apotex Inc

Country

Canada

Website

Visit Website

Email

Social Profiles

Company Snapshot

Apotex Inc

150 Signet Drive, Toronto, Ontario, M9L 1T9

Canada

www.apotex.com/global/error-pages?initialRequestUrl=https%3a%2f%2fwww.apotex.com%2fglobal%2fdefault.asp View on Map
FDA Approved Drug Records ( 194 records )
2012
17 Dec
Discontinued Application: 201570

Drug Name

ABACAVIR SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2012-12-17

201570 / 1

Active Ingredient

ABACAVIR SULFATE

Application Number

201570

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2012-12-17

Regulatory Status

Discontinued

2007
02 Feb
Discontinued Application: 75717

Drug Name

ALBUTEROL SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 0.083% BASE

Approval Date

2007-02-02

75717 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

75717

Product Number

1

Dosage Form

-

Strength

EQ 0.083% BASE

Approval Date

2007-02-02

Regulatory Status

Discontinued

2003
01 Apr
Discontinued Application: 76391

Drug Name

ALBUTEROL SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2003-04-01

76391 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

76391

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2003-04-01

Regulatory Status

Discontinued

2010
05 Apr
Discontinued Application: 78623

Drug Name

ALBUTEROL SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 0.021% BASE

Approval Date

2010-04-05

78623 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

78623

Product Number

1

Dosage Form

-

Strength

EQ 0.021% BASE

Approval Date

2010-04-05

Regulatory Status

Discontinued

2010
05 Apr
Discontinued Application: 78623

Drug Name

ALBUTEROL SULFATE

Product Number

2

Dosage Form

-

Strength

EQ 0.042% BASE

Approval Date

2010-04-05

78623 / 2

Active Ingredient

ALBUTEROL SULFATE

Application Number

78623

Product Number

2

Dosage Form

-

Strength

EQ 0.042% BASE

Approval Date

2010-04-05

Regulatory Status

Discontinued

2007
31 Dec
Discontinued Application: 77117

Drug Name

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.083% BASE;0.017%

Approval Date

2007-12-31

77117 / 1

Active Ingredient

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Application Number

77117

Product Number

1

Dosage Form

-

Strength

EQ 0.083% BASE;0.017%

Approval Date

2007-12-31

Regulatory Status

Discontinued

2011
18 Jul
RX Application: 79013

Drug Name

ALFUZOSIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2011-07-18

79013 / 1

Active Ingredient

ALFUZOSIN HYDROCHLORIDE

Application Number

79013

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2011-07-18

Regulatory Status

RX

2007
19 Jan
Discontinued Application: 77741

Drug Name

ALPRAZOLAM

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2007-01-19

77741 / 1

Active Ingredient

ALPRAZOLAM

Application Number

77741

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2007-01-19

Regulatory Status

Discontinued

2007
19 Jan
Discontinued Application: 77741

Drug Name

ALPRAZOLAM

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2007-01-19

77741 / 2

Active Ingredient

ALPRAZOLAM

Application Number

77741

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2007-01-19

Regulatory Status

Discontinued

2007
19 Jan
Discontinued Application: 77741

Drug Name

ALPRAZOLAM

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2007-01-19

77741 / 3

Active Ingredient

ALPRAZOLAM

Application Number

77741

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2007-01-19

Regulatory Status

Discontinued

2007
19 Jan
Discontinued Application: 77741

Drug Name

ALPRAZOLAM

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2007-01-19

77741 / 4

Active Ingredient

ALPRAZOLAM

Application Number

77741

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2007-01-19

Regulatory Status

Discontinued

2008
12 Nov
Discontinued Application: 78449

Drug Name

ALPRAZOLAM

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2008-11-12

78449 / 1

Active Ingredient

ALPRAZOLAM

Application Number

78449

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2008-11-12

Regulatory Status

Discontinued

2008
12 Nov
Discontinued Application: 78449

Drug Name

ALPRAZOLAM

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2008-11-12

78449 / 2

Active Ingredient

ALPRAZOLAM

Application Number

78449

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2008-11-12

Regulatory Status

Discontinued

2008
12 Nov
Discontinued Application: 78449

Drug Name

ALPRAZOLAM

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2008-11-12

78449 / 3

Active Ingredient

ALPRAZOLAM

Application Number

78449

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2008-11-12

Regulatory Status

Discontinued

2015
23 Dec
Discontinued Application: 78449

Drug Name

ALPRAZOLAM

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

2015-12-23

78449 / 4

Active Ingredient

ALPRAZOLAM

Application Number

78449

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

2015-12-23

Regulatory Status

Discontinued

2008
20 Oct
Discontinued Application: 65317

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

3

Dosage Form

-

Strength

875MG;EQ 125MG BASE

Approval Date

2008-10-20

65317 / 3

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

65317

Product Number

3

Dosage Form

-

Strength

875MG;EQ 125MG BASE

Approval Date

2008-10-20

Regulatory Status

Discontinued

2009
24 Feb
Discontinued Application: 65333

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

1

Dosage Form

-

Strength

250MG;EQ 125MG BASE

Approval Date

2009-02-24

65333 / 1

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

65333

Product Number

1

Dosage Form

-

Strength

250MG;EQ 125MG BASE

Approval Date

2009-02-24

Regulatory Status

Discontinued

2009
24 Feb
Discontinued Application: 65333

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

2

Dosage Form

-

Strength

500MG;EQ 125MG BASE

Approval Date

2009-02-24

65333 / 2

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

65333

Product Number

2

Dosage Form

-

Strength

500MG;EQ 125MG BASE

Approval Date

2009-02-24

Regulatory Status

Discontinued

2012
11 May
Discontinued Application: 200654

Drug Name

ANASTROZOLE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2012-05-11

200654 / 1

Active Ingredient

ANASTROZOLE

Application Number

200654

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2012-05-11

Regulatory Status

Discontinued

2012
29 May
RX Application: 90548

Drug Name

ATORVASTATIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-05-29

90548 / 1

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

90548

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-05-29

Regulatory Status

RX

2012
29 May
RX Application: 90548

Drug Name

ATORVASTATIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-05-29

90548 / 2

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

90548

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-05-29

Regulatory Status

RX

2012
29 May
RX Application: 90548

Drug Name

ATORVASTATIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2012-05-29

90548 / 3

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

90548

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2012-05-29

Regulatory Status

RX

2012
29 May
RX Application: 90548

Drug Name

ATORVASTATIN CALCIUM

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2012-05-29

90548 / 4

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

90548

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2012-05-29

Regulatory Status

RX

2009
30 Apr
RX Application: 77954

Drug Name

AZELASTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.137MG/SPRAY

Approval Date

2009-04-30

77954 / 1

Active Ingredient

AZELASTINE HYDROCHLORIDE

Application Number

77954

Product Number

1

Dosage Form

-

Strength

0.137MG/SPRAY

Approval Date

2009-04-30

Regulatory Status

RX

2012
31 Aug
Discontinued Application: 201846

Drug Name

AZELASTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.2055MG/SPRAY

Approval Date

2012-08-31

201846 / 1

Active Ingredient

AZELASTINE HYDROCHLORIDE

Application Number

201846

Product Number

1

Dosage Form

-

Strength

0.2055MG/SPRAY

Approval Date

2012-08-31

Regulatory Status

Discontinued

2000
28 Sep
Discontinued Application: 75446

Drug Name

BETAXOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2000-09-28

75446 / 1

Active Ingredient

BETAXOLOL HYDROCHLORIDE

Application Number

75446

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2000-09-28

Regulatory Status

Discontinued

-
Unclassified Application: 203404

Drug Name

BIMATOPROST

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

-

203404 / 1

Active Ingredient

BIMATOPROST

Application Number

203404

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

-

Regulatory Status

Unclassified

2008
17 Nov
RX Application: 76396

Drug Name

CALCITONIN-SALMON

Product Number

1

Dosage Form

-

Strength

200 IU/SPRAY

Approval Date

2008-11-17

76396 / 1

Active Ingredient

CALCITONIN SALMON

Application Number

76396

Product Number

1

Dosage Form

-

Strength

200 IU/SPRAY

Approval Date

2008-11-17

Regulatory Status

RX

2012
04 Dec
Discontinued Application: 202884

Drug Name

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

16MG;12.5MG

Approval Date

2012-12-04

202884 / 1

Active Ingredient

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Application Number

202884

Product Number

1

Dosage Form

-

Strength

16MG;12.5MG

Approval Date

2012-12-04

Regulatory Status

Discontinued

2012
04 Dec
Discontinued Application: 202884

Drug Name

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

32MG;12.5MG

Approval Date

2012-12-04

202884 / 2

Active Ingredient

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Application Number

202884

Product Number

2

Dosage Form

-

Strength

32MG;12.5MG

Approval Date

2012-12-04

Regulatory Status

Discontinued

2013
03 Jun
Discontinued Application: 202884

Drug Name

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

32MG;25MG

Approval Date

2013-06-03

202884 / 3

Active Ingredient

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Application Number

202884

Product Number

3

Dosage Form

-

Strength

32MG;25MG

Approval Date

2013-06-03

Regulatory Status

Discontinued

2011
25 Nov
RX Application: 78986

Drug Name

CARBAMAZEPINE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2011-11-25

78986 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

78986

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2011-11-25

Regulatory Status

RX

2011
25 Nov
RX Application: 78986

Drug Name

CARBAMAZEPINE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2011-11-25

78986 / 2

Active Ingredient

CARBAMAZEPINE

Application Number

78986

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2011-11-25

Regulatory Status

RX

2011
25 Nov
RX Application: 78986

Drug Name

CARBAMAZEPINE

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2011-11-25

78986 / 3

Active Ingredient

CARBAMAZEPINE

Application Number

78986

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2011-11-25

Regulatory Status

RX

2008
02 Jun
Discontinued Application: 77120

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

1

Dosage Form

-

Strength

10MG;100MG

Approval Date

2008-06-02

77120 / 1

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

77120

Product Number

1

Dosage Form

-

Strength

10MG;100MG

Approval Date

2008-06-02

Regulatory Status

Discontinued

2008
02 Jun
Discontinued Application: 77120

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

2

Dosage Form

-

Strength

25MG;100MG

Approval Date

2008-06-02

77120 / 2

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

77120

Product Number

2

Dosage Form

-

Strength

25MG;100MG

Approval Date

2008-06-02

Regulatory Status

Discontinued

2008
02 Jun
Discontinued Application: 77120

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

3

Dosage Form

-

Strength

25MG;250MG

Approval Date

2008-06-02

77120 / 3

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

77120

Product Number

3

Dosage Form

-

Strength

25MG;250MG

Approval Date

2008-06-02

Regulatory Status

Discontinued

2002
06 Feb
Discontinued Application: 76097

Drug Name

CARTEOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2002-02-06

76097 / 1

Active Ingredient

CARTEOLOL HYDROCHLORIDE

Application Number

76097

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2002-02-06

Regulatory Status

Discontinued

2008
26 Mar
Discontinued Application: 65327

Drug Name

CEFPROZIL

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2008-03-26

65327 / 1

Active Ingredient

CEFPROZIL

Application Number

65327

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2008-03-26

Regulatory Status

Discontinued

2008
26 Mar
Discontinued Application: 65327

Drug Name

CEFPROZIL

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2008-03-26

65327 / 2

Active Ingredient

CEFPROZIL

Application Number

65327

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2008-03-26

Regulatory Status

Discontinued

2012
29 Feb
Discontinued Application: 65351

Drug Name

CEFPROZIL

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

2012-02-29

65351 / 1

Active Ingredient

CEFPROZIL

Application Number

65351

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

2012-02-29

Regulatory Status

Discontinued

2012
29 Feb
Discontinued Application: 65351

Drug Name

CEFPROZIL

Product Number

2

Dosage Form

-

Strength

250MG/5ML

Approval Date

2012-02-29

65351 / 2

Active Ingredient

CEFPROZIL

Application Number

65351

Product Number

2

Dosage Form

-

Strength

250MG/5ML

Approval Date

2012-02-29

Regulatory Status

Discontinued

2007
27 Dec
OTC Application: 78317

Drug Name

CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-12-27

78317 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

78317

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-12-27

Regulatory Status

OTC

2007
27 Dec
OTC Application: 78317

Drug Name

CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-12-27

78317 / 2

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

78317

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-12-27

Regulatory Status

OTC

2011
25 Aug
Discontinued Application: 91260

Drug Name

CEVIMELINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2011-08-25

91260 / 1

Active Ingredient

CEVIMELINE HYDROCHLORIDE

Application Number

91260

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2011-08-25

Regulatory Status

Discontinued

2000
27 Nov
Discontinued Application: 75703

Drug Name

CLEMASTINE FUMARATE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE/5ML

Approval Date

2000-11-27

75703 / 1

Active Ingredient

CLEMASTINE FUMARATE

Application Number

75703

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE/5ML

Approval Date

2000-11-27

Regulatory Status

Discontinued

2012
17 May
RX Application: 76274

Drug Name

CLOPIDOGREL BISULFATE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2012-05-17

76274 / 1

Active Ingredient

CLOPIDOGREL BISULFATE

Application Number

76274

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2012-05-17

Regulatory Status

RX

2014
04 Mar
RX Application: 76274

Drug Name

CLOPIDOGREL BISULFATE

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2014-03-04

76274 / 2

Active Ingredient

CLOPIDOGREL BISULFATE

Application Number

76274

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2014-03-04

Regulatory Status

RX

2001
26 Jan
Discontinued Application: 75615

Drug Name

CROMOLYN SODIUM

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

2001-01-26

75615 / 1

Active Ingredient

CROMOLYN SODIUM

Application Number

75615

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

2001-01-26

Regulatory Status

Discontinued

-
Unclassified Application: 211442

Drug Name

DAPAGLIFLOZIN

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

-

211442 / 1

Active Ingredient

DAPAGLIFLOZIN

Application Number

211442

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 211442

Drug Name

DAPAGLIFLOZIN

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

-

211442 / 2

Active Ingredient

DAPAGLIFLOZIN

Application Number

211442

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

-

Regulatory Status

Unclassified

2012
11 Jan
Discontinued Application: 22312

Drug Name

DOCETAXEL

Product Number

1

Dosage Form

-

Strength

20MG/0.5ML (40MG/ML)

Approval Date

2012-01-11

22312 / 1

Active Ingredient

DOCETAXEL

Application Number

22312

Product Number

1

Dosage Form

-

Strength

20MG/0.5ML (40MG/ML)

Approval Date

2012-01-11

Regulatory Status

Discontinued

2012
11 Jan
Discontinued Application: 22312

Drug Name

DOCETAXEL

Product Number

2

Dosage Form

-

Strength

80MG/2ML (40MG/ML)

Approval Date

2012-01-11

22312 / 2

Active Ingredient

DOCETAXEL

Application Number

22312

Product Number

2

Dosage Form

-

Strength

80MG/2ML (40MG/ML)

Approval Date

2012-01-11

Regulatory Status

Discontinued

-
Unclassified Application: 201536

Drug Name

ELETRIPTAN HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

-

201536 / 1

Active Ingredient

ELETRIPTAN HYDROBROMIDE

Application Number

201536

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 201536

Drug Name

ELETRIPTAN HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

-

201536 / 2

Active Ingredient

ELETRIPTAN HYDROBROMIDE

Application Number

201536

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 218575

Drug Name

ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

-

218575 / 2

Active Ingredient

ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE

Application Number

218575

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 218575

Drug Name

ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

-

218575 / 3

Active Ingredient

ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE

Application Number

218575

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 218575

Drug Name

ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE

Product Number

4

Dosage Form

-

Strength

6MG

Approval Date

-

218575 / 4

Active Ingredient

ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE

Application Number

218575

Product Number

4

Dosage Form

-

Strength

6MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 218575

Drug Name

ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE

Product Number

5

Dosage Form

-

Strength

90MG

Approval Date

-

218575 / 5

Active Ingredient

ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE

Application Number

218575

Product Number

5

Dosage Form

-

Strength

90MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 218575

Drug Name

ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE

Product Number

6

Dosage Form

-

Strength

120MG

Approval Date

-

218575 / 6

Active Ingredient

ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE

Application Number

218575

Product Number

6

Dosage Form

-

Strength

120MG

Approval Date

-

Regulatory Status

Unclassified

2002
02 Aug
Discontinued Application: 75942

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2002-08-02

75942 / 1

Active Ingredient

FAMOTIDINE

Application Number

75942

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2002-08-02

Regulatory Status

Discontinued

-
Unclassified Application: 216108

Drug Name

FENFLURAMINE

Product Number

1

Dosage Form

-

Strength

2.2MG/ML

Approval Date

-

216108 / 1

Active Ingredient

FENFLURAMINE

Application Number

216108

Product Number

1

Dosage Form

-

Strength

2.2MG/ML

Approval Date

-

Regulatory Status

Unclassified

2007
06 Aug
Discontinued Application: 78126

Drug Name

FOSPHENYTOIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 50MG PHENYTOIN NA/ML

Approval Date

2007-08-06

78126 / 1

Active Ingredient

FOSPHENYTOIN SODIUM

Application Number

78126

Product Number

1

Dosage Form

-

Strength

EQ 50MG PHENYTOIN NA/ML

Approval Date

2007-08-06

Regulatory Status

Discontinued

2011
27 Sep
Discontinued Application: 77781

Drug Name

GALANTAMINE HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2011-09-27

77781 / 1

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

77781

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2011-09-27

Regulatory Status

Discontinued

2011
27 Sep
Discontinued Application: 77781

Drug Name

GALANTAMINE HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2011-09-27

77781 / 2

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

77781

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2011-09-27

Regulatory Status

Discontinued

2011
27 Sep
Discontinued Application: 77781

Drug Name

GALANTAMINE HYDROBROMIDE

Product Number

3

Dosage Form

-

Strength

EQ 12MG BASE

Approval Date

2011-09-27

77781 / 3

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

77781

Product Number

3

Dosage Form

-

Strength

EQ 12MG BASE

Approval Date

2011-09-27

Regulatory Status

Discontinued

2011
19 Aug
Discontinued Application: 79084

Drug Name

GATIFLOXACIN

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2011-08-19

79084 / 1

Active Ingredient

GATIFLOXACIN

Application Number

79084

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2011-08-19

Regulatory Status

Discontinued

2008
27 Feb
Discontinued Application: 78843

Drug Name

GRANISETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2008-02-27

78843 / 1

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

78843

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2008-02-27

Regulatory Status

Discontinued

2012
19 Mar
RX Application: 78948

Drug Name

IBANDRONATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2012-03-19

78948 / 1

Active Ingredient

IBANDRONATE SODIUM

Application Number

78948

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2012-03-19

Regulatory Status

RX

2012
06 Apr
Discontinued Application: 91308

Drug Name

IMIQUIMOD

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2012-04-06

91308 / 1

Active Ingredient

IMIQUIMOD

Application Number

91308

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2012-04-06

Regulatory Status

Discontinued

2001
28 Mar
Discontinued Application: 75441

Drug Name

IPRATROPIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

0.02%

Approval Date

2001-03-28

75441 / 1

Active Ingredient

IPRATROPIUM BROMIDE

Application Number

75441

Product Number

1

Dosage Form

-

Strength

0.02%

Approval Date

2001-03-28

Regulatory Status

Discontinued

2003
18 Apr
RX Application: 76155

Drug Name

IPRATROPIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

0.042MG/SPRAY

Approval Date

2003-04-18

76155 / 1

Active Ingredient

IPRATROPIUM BROMIDE

Application Number

76155

Product Number

1

Dosage Form

-

Strength

0.042MG/SPRAY

Approval Date

2003-04-18

Regulatory Status

RX

2003
18 Apr
RX Application: 76156

Drug Name

IPRATROPIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

0.021MG/SPRAY

Approval Date

2003-04-18

76156 / 1

Active Ingredient

IPRATROPIUM BROMIDE

Application Number

76156

Product Number

1

Dosage Form

-

Strength

0.021MG/SPRAY

Approval Date

2003-04-18

Regulatory Status

RX

2012
15 Oct
Discontinued Application: 200832

Drug Name

IRBESARTAN

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2012-10-15

200832 / 1

Active Ingredient

IRBESARTAN

Application Number

200832

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2012-10-15

Regulatory Status

Discontinued

2012
15 Oct
Discontinued Application: 200832

Drug Name

IRBESARTAN

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2012-10-15

200832 / 2

Active Ingredient

IRBESARTAN

Application Number

200832

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2012-10-15

Regulatory Status

Discontinued

2012
15 Oct
Discontinued Application: 200832

Drug Name

IRBESARTAN

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2012-10-15

200832 / 3

Active Ingredient

IRBESARTAN

Application Number

200832

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2012-10-15

Regulatory Status

Discontinued

2012
15 Oct
Discontinued Application: 201505

Drug Name

IRBESARTAN AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;150MG

Approval Date

2012-10-15

201505 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; IRBESARTAN

Application Number

201505

Product Number

1

Dosage Form

-

Strength

12.5MG;150MG

Approval Date

2012-10-15

Regulatory Status

Discontinued

2012
15 Oct
Discontinued Application: 201505

Drug Name

IRBESARTAN AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;300MG

Approval Date

2012-10-15

201505 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; IRBESARTAN

Application Number

201505

Product Number

2

Dosage Form

-

Strength

12.5MG;300MG

Approval Date

2012-10-15

Regulatory Status

Discontinued

-
Unclassified Application: 201505

Drug Name

IRBESARTAN HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;300MG

Approval Date

-

201505 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; IRBESARTAN

Application Number

201505

Product Number

3

Dosage Form

-

Strength

25MG;300MG

Approval Date

-

Regulatory Status

Unclassified

2001
24 Jul
Discontinued Application: 75626

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

2001-07-24

75626 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

75626

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

2001-07-24

Regulatory Status

Discontinued

2005
14 Oct
Discontinued Application: 77201

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

2005-10-14

77201 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

77201

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

2005-10-14

Regulatory Status

Discontinued

2006
09 May
Discontinued Application: 77354

Drug Name

KETOTIFEN FUMARATE

Product Number

1

Dosage Form

-

Strength

EQ 0.025% BASE

Approval Date

2006-05-09

77354 / 1

Active Ingredient

KETOTIFEN FUMARATE

Application Number

77354

Product Number

1

Dosage Form

-

Strength

EQ 0.025% BASE

Approval Date

2006-05-09

Regulatory Status

Discontinued

2011
22 Mar
Discontinued Application: 77697

Drug Name

LATANOPROST

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2011-03-22

77697 / 1

Active Ingredient

LATANOPROST

Application Number

77697

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2011-03-22

Regulatory Status

Discontinued

2012
19 Apr
Discontinued Application: 91303

Drug Name

LETROZOLE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2012-04-19

91303 / 1

Active Ingredient

LETROZOLE

Application Number

91303

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2012-04-19

Regulatory Status

Discontinued

2011
05 Aug
Discontinued Application: 90187

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2011-08-05

90187 / 1

Active Ingredient

LEVETIRACETAM

Application Number

90187

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2011-08-05

Regulatory Status

Discontinued

2011
12 Sep
RX Application: 91261

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2011-09-12

91261 / 1

Active Ingredient

LEVETIRACETAM

Application Number

91261

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2011-09-12

Regulatory Status

RX

2011
12 Sep
RX Application: 91261

Drug Name

LEVETIRACETAM

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2011-09-12

91261 / 2

Active Ingredient

LEVETIRACETAM

Application Number

91261

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2011-09-12

Regulatory Status

RX

2000
03 Aug
Discontinued Application: 75473

Drug Name

LEVOBUNOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2000-08-03

75473 / 1

Active Ingredient

LEVOBUNOLOL HYDROCHLORIDE

Application Number

75473

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2000-08-03

Regulatory Status

Discontinued

2000
03 Aug
Discontinued Application: 75475

Drug Name

LEVOBUNOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2000-08-03

75475 / 1

Active Ingredient

LEVOBUNOLOL HYDROCHLORIDE

Application Number

75475

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2000-08-03

Regulatory Status

Discontinued

-
Unclassified Application: 211528

Drug Name

LEVOCETIRIZINE DIHYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG/5ML

Approval Date

-

211528 / 1

Active Ingredient

LEVOCETIRIZINE DIHYDROCHLORIDE

Application Number

211528

Product Number

1

Dosage Form

-

Strength

2.5MG/5ML

Approval Date

-

Regulatory Status

Unclassified

2011
29 Sep
Discontinued Application: 90787

Drug Name

LEVOFLOXACIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2011-09-29

90787 / 1

Active Ingredient

LEVOFLOXACIN

Application Number

90787

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2011-09-29

Regulatory Status

Discontinued

2011
29 Sep
Discontinued Application: 90787

Drug Name

LEVOFLOXACIN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2011-09-29

90787 / 2

Active Ingredient

LEVOFLOXACIN

Application Number

90787

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2011-09-29

Regulatory Status

Discontinued

2011
29 Sep
Discontinued Application: 90787

Drug Name

LEVOFLOXACIN

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2011-09-29

90787 / 3

Active Ingredient

LEVOFLOXACIN

Application Number

90787

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2011-09-29

Regulatory Status

Discontinued

2004
22 Nov
Discontinued Application: 76795

Drug Name

LITHIUM CARBONATE

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2004-11-22

76795 / 1

Active Ingredient

LITHIUM CARBONATE

Application Number

76795

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2004-11-22

Regulatory Status

Discontinued

2000
27 Jan
Discontinued Application: 75235

Drug Name

METAPROTERENOL SULFATE

Product Number

1

Dosage Form

-

Strength

10MG/5ML

Approval Date

2000-01-27

75235 / 1

Active Ingredient

METAPROTERENOL SULFATE

Application Number

75235

Product Number

1

Dosage Form

-

Strength

10MG/5ML

Approval Date

2000-01-27

Regulatory Status

Discontinued

2001
28 Feb
Discontinued Application: 75402

Drug Name

METAPROTERENOL SULFATE

Product Number

1

Dosage Form

-

Strength

0.4%

Approval Date

2001-02-28

75402 / 1

Active Ingredient

METAPROTERENOL SULFATE

Application Number

75402

Product Number

1

Dosage Form

-

Strength

0.4%

Approval Date

2001-02-28

Regulatory Status

Discontinued

2001
28 Feb
Discontinued Application: 75403

Drug Name

METAPROTERENOL SULFATE

Product Number

1

Dosage Form

-

Strength

0.6%

Approval Date

2001-02-28

75403 / 1

Active Ingredient

METAPROTERENOL SULFATE

Application Number

75403

Product Number

1

Dosage Form

-

Strength

0.6%

Approval Date

2001-02-28

Regulatory Status

Discontinued

1998
29 Apr
Discontinued Application: 74924

Drug Name

MINOXIDIL (FOR MEN)

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1998-04-29

74924 / 1

Active Ingredient

MINOXIDIL

Application Number

74924

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1998-04-29

Regulatory Status

Discontinued

1998
29 Apr
Discontinued Application: 74924

Drug Name

MINOXIDIL (FOR WOMEN)

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

1998-04-29

74924 / 2

Active Ingredient

MINOXIDIL

Application Number

74924

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

1998-04-29

Regulatory Status

Discontinued

2001
01 Oct
Discontinued Application: 75839

Drug Name

MINOXIDIL EXTRA STRENGTH (FOR MEN)

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2001-10-01

75839 / 1

Active Ingredient

MINOXIDIL

Application Number

75839

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2001-10-01

Regulatory Status

Discontinued

2008
02 Jun
Discontinued Application: 78454

Drug Name

MOEXIPRIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2008-06-02

78454 / 1

Active Ingredient

MOEXIPRIL HYDROCHLORIDE

Application Number

78454

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2008-06-02

Regulatory Status

Discontinued

2008
02 Jun
Discontinued Application: 78454

Drug Name

MOEXIPRIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2008-06-02

78454 / 2

Active Ingredient

MOEXIPRIL HYDROCHLORIDE

Application Number

78454

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2008-06-02

Regulatory Status

Discontinued

2012
03 Aug
Discontinued Application: 201508

Drug Name

MONTELUKAST SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2012-08-03

201508 / 1

Active Ingredient

MONTELUKAST SODIUM

Application Number

201508

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2012-08-03

Regulatory Status

Discontinued

2012
03 Aug
Discontinued Application: 201508

Drug Name

MONTELUKAST SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-08-03

201508 / 2

Active Ingredient

MONTELUKAST SODIUM

Application Number

201508

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-08-03

Regulatory Status

Discontinued

2012
21 Aug
RX Application: 91558

Drug Name

MYCOPHENOLATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 180MG BASE

Approval Date

2012-08-21

91558 / 1

Active Ingredient

MYCOPHENOLATE SODIUM

Application Number

91558

Product Number

1

Dosage Form

-

Strength

EQ 180MG BASE

Approval Date

2012-08-21

Regulatory Status

RX

2014
19 Aug
RX Application: 91558

Drug Name

MYCOPHENOLATE SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 360MG BASE

Approval Date

2014-08-19

91558 / 2

Active Ingredient

MYCOPHENOLATE SODIUM

Application Number

91558

Product Number

2

Dosage Form

-

Strength

EQ 360MG BASE

Approval Date

2014-08-19

Regulatory Status

RX

2012
22 May
Discontinued Application: 203021

Drug Name

NEVIRAPINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2012-05-22

203021 / 1

Active Ingredient

NEVIRAPINE

Application Number

203021

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2012-05-22

Regulatory Status

Discontinued

2003
23 Jan
Discontinued Application: 76383

Drug Name

NIZATIDINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2003-01-23

76383 / 1

Active Ingredient

NIZATIDINE

Application Number

76383

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2003-01-23

Regulatory Status

Discontinued

2003
23 Jan
Discontinued Application: 76383

Drug Name

NIZATIDINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2003-01-23

76383 / 2

Active Ingredient

NIZATIDINE

Application Number

76383

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2003-01-23

Regulatory Status

Discontinued

2004
14 May
RX Application: 76513

Drug Name

OFLOXACIN

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2004-05-14

76513 / 1

Active Ingredient

OFLOXACIN

Application Number

76513

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2004-05-14

Regulatory Status

RX

2007
28 Sep
RX Application: 76527

Drug Name

OFLOXACIN

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2007-09-28

76527 / 1

Active Ingredient

OFLOXACIN

Application Number

76527

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2007-09-28

Regulatory Status

RX

2012
23 Apr
RX Application: 90798

Drug Name

OLANZAPINE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2012-04-23

90798 / 1

Active Ingredient

OLANZAPINE

Application Number

90798

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2012-04-23

Regulatory Status

RX

2012
23 Apr
RX Application: 90798

Drug Name

OLANZAPINE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2012-04-23

90798 / 2

Active Ingredient

OLANZAPINE

Application Number

90798

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2012-04-23

Regulatory Status

RX

2012
23 Apr
RX Application: 90798

Drug Name

OLANZAPINE

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

2012-04-23

90798 / 3

Active Ingredient

OLANZAPINE

Application Number

90798

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

2012-04-23

Regulatory Status

RX

2012
23 Apr
RX Application: 90798

Drug Name

OLANZAPINE

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2012-04-23

90798 / 4

Active Ingredient

OLANZAPINE

Application Number

90798

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2012-04-23

Regulatory Status

RX

2012
23 Apr
RX Application: 90798

Drug Name

OLANZAPINE

Product Number

5

Dosage Form

-

Strength

15MG

Approval Date

2012-04-23

90798 / 5

Active Ingredient

OLANZAPINE

Application Number

90798

Product Number

5

Dosage Form

-

Strength

15MG

Approval Date

2012-04-23

Regulatory Status

RX

2012
23 Apr
RX Application: 90798

Drug Name

OLANZAPINE

Product Number

6

Dosage Form

-

Strength

20MG

Approval Date

2012-04-23

90798 / 6

Active Ingredient

OLANZAPINE

Application Number

90798

Product Number

6

Dosage Form

-

Strength

20MG

Approval Date

2012-04-23

Regulatory Status

RX

2011
24 Oct
RX Application: 91265

Drug Name

OLANZAPINE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-10-24

91265 / 1

Active Ingredient

OLANZAPINE

Application Number

91265

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-10-24

Regulatory Status

RX

2011
24 Oct
RX Application: 91265

Drug Name

OLANZAPINE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-10-24

91265 / 2

Active Ingredient

OLANZAPINE

Application Number

91265

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-10-24

Regulatory Status

RX

2011
24 Oct
RX Application: 91265

Drug Name

OLANZAPINE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2011-10-24

91265 / 3

Active Ingredient

OLANZAPINE

Application Number

91265

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2011-10-24

Regulatory Status

RX

2011
24 Oct
RX Application: 91265

Drug Name

OLANZAPINE

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2011-10-24

91265 / 4

Active Ingredient

OLANZAPINE

Application Number

91265

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2011-10-24

Regulatory Status

RX

2014
08 Oct
RX Application: 91572

Drug Name

OLOPATADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.665MG/SPRAY

Approval Date

2014-10-08

91572 / 1

Active Ingredient

OLOPATADINE HYDROCHLORIDE

Application Number

91572

Product Number

1

Dosage Form

-

Strength

0.665MG/SPRAY

Approval Date

2014-10-08

Regulatory Status

RX

2006
26 Dec
Discontinued Application: 77368

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

77368 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77368

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

Regulatory Status

Discontinued

2006
26 Dec
Discontinued Application: 77343

Drug Name

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

77343 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77343

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

Regulatory Status

Discontinued

-
Unclassified Application: 219450

Drug Name

OZANIMOD

Product Number

2

Dosage Form

-

Strength

0.46MG

Approval Date

-

219450 / 2

Active Ingredient

OZANIMOD

Application Number

219450

Product Number

2

Dosage Form

-

Strength

0.46MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 219450

Drug Name

OZANIMOD

Product Number

3

Dosage Form

-

Strength

0.23MG

Approval Date

-

219450 / 3

Active Ingredient

OZANIMOD

Application Number

219450

Product Number

3

Dosage Form

-

Strength

0.23MG

Approval Date

-

Regulatory Status

Unclassified

2006
05 Dec
Discontinued Application: 77395

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/5ML

Approval Date

2006-12-05

77395 / 1

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

77395

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/5ML

Approval Date

2006-12-05

Regulatory Status

Discontinued

-
Unclassified Application: 202998

Drug Name

PREGABALIN

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

-

202998 / 1

Active Ingredient

PREGABALIN

Application Number

202998

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 203022

Drug Name

PREGABALIN

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

-

203022 / 1

Active Ingredient

PREGABALIN

Application Number

203022

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 203022

Drug Name

PREGABALIN

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

-

203022 / 2

Active Ingredient

PREGABALIN

Application Number

203022

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 203022

Drug Name

PREGABALIN

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

-

203022 / 3

Active Ingredient

PREGABALIN

Application Number

203022

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 203022

Drug Name

PREGABALIN

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

-

203022 / 4

Active Ingredient

PREGABALIN

Application Number

203022

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 203022

Drug Name

PREGABALIN

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

-

203022 / 5

Active Ingredient

PREGABALIN

Application Number

203022

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 203022

Drug Name

PREGABALIN

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

-

203022 / 6

Active Ingredient

PREGABALIN

Application Number

203022

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 203022

Drug Name

PREGABALIN

Product Number

7

Dosage Form

-

Strength

225MG

Approval Date

-

203022 / 7

Active Ingredient

PREGABALIN

Application Number

203022

Product Number

7

Dosage Form

-

Strength

225MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 203022

Drug Name

PREGABALIN

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

-

203022 / 8

Active Ingredient

PREGABALIN

Application Number

203022

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

-

Regulatory Status

Unclassified

2006
26 Jan
Discontinued Application: 76240

Drug Name

QUINAPRIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2006-01-26

76240 / 1

Active Ingredient

QUINAPRIL HYDROCHLORIDE

Application Number

76240

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2006-01-26

Regulatory Status

Discontinued

2006
26 Jan
Discontinued Application: 76240

Drug Name

QUINAPRIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2006-01-26

76240 / 2

Active Ingredient

QUINAPRIL HYDROCHLORIDE

Application Number

76240

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2006-01-26

Regulatory Status

Discontinued

2006
26 Jan
Discontinued Application: 76240

Drug Name

QUINAPRIL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2006-01-26

76240 / 3

Active Ingredient

QUINAPRIL HYDROCHLORIDE

Application Number

76240

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2006-01-26

Regulatory Status

Discontinued

2006
26 Jan
Discontinued Application: 76240

Drug Name

QUINAPRIL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2006-01-26

76240 / 4

Active Ingredient

QUINAPRIL HYDROCHLORIDE

Application Number

76240

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2006-01-26

Regulatory Status

Discontinued

2007
17 Sep
Discontinued Application: 77602

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE/ML

Approval Date

2007-09-17

77602 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

77602

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE/ML

Approval Date

2007-09-17

Regulatory Status

Discontinued

2012
31 May
Discontinued Application: 200172

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2012-05-31

200172 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

200172

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2012-05-31

Regulatory Status

Discontinued

2013
12 Sep
Discontinued Application: 201950

Drug Name

RASAGILINE MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2013-09-12

201950 / 1

Active Ingredient

RASAGILINE MESYLATE

Application Number

201950

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2013-09-12

Regulatory Status

Discontinued

2013
12 Sep
Discontinued Application: 201950

Drug Name

RASAGILINE MESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2013-09-12

201950 / 2

Active Ingredient

RASAGILINE MESYLATE

Application Number

201950

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2013-09-12

Regulatory Status

Discontinued

2008
15 Sep
Discontinued Application: 77953

Drug Name

RISPERIDONE

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2008-09-15

77953 / 1

Active Ingredient

RISPERIDONE

Application Number

77953

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2008-09-15

Regulatory Status

Discontinued

2008
15 Sep
Discontinued Application: 77953

Drug Name

RISPERIDONE

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2008-09-15

77953 / 2

Active Ingredient

RISPERIDONE

Application Number

77953

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2008-09-15

Regulatory Status

Discontinued

2008
15 Sep
Discontinued Application: 77953

Drug Name

RISPERIDONE

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2008-09-15

77953 / 3

Active Ingredient

RISPERIDONE

Application Number

77953

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2008-09-15

Regulatory Status

Discontinued

2008
15 Sep
Discontinued Application: 77953

Drug Name

RISPERIDONE

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2008-09-15

77953 / 4

Active Ingredient

RISPERIDONE

Application Number

77953

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2008-09-15

Regulatory Status

Discontinued

2008
15 Sep
Discontinued Application: 77953

Drug Name

RISPERIDONE

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2008-09-15

77953 / 5

Active Ingredient

RISPERIDONE

Application Number

77953

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2008-09-15

Regulatory Status

Discontinued

2008
15 Sep
Discontinued Application: 77953

Drug Name

RISPERIDONE

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2008-09-15

77953 / 6

Active Ingredient

RISPERIDONE

Application Number

77953

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2008-09-15

Regulatory Status

Discontinued

2013
16 May
Discontinued Application: 91072

Drug Name

RIVASTIGMINE TARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 1.5MG BASE

Approval Date

2013-05-16

91072 / 1

Active Ingredient

RIVASTIGMINE TARTRATE

Application Number

91072

Product Number

1

Dosage Form

-

Strength

EQ 1.5MG BASE

Approval Date

2013-05-16

Regulatory Status

Discontinued

2013
16 May
Discontinued Application: 91072

Drug Name

RIVASTIGMINE TARTRATE

Product Number

2

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2013-05-16

91072 / 2

Active Ingredient

RIVASTIGMINE TARTRATE

Application Number

91072

Product Number

2

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2013-05-16

Regulatory Status

Discontinued

2013
16 May
Discontinued Application: 91072

Drug Name

RIVASTIGMINE TARTRATE

Product Number

3

Dosage Form

-

Strength

EQ 4.5MG BASE

Approval Date

2013-05-16

91072 / 3

Active Ingredient

RIVASTIGMINE TARTRATE

Application Number

91072

Product Number

3

Dosage Form

-

Strength

EQ 4.5MG BASE

Approval Date

2013-05-16

Regulatory Status

Discontinued

2013
16 May
Discontinued Application: 91072

Drug Name

RIVASTIGMINE TARTRATE

Product Number

4

Dosage Form

-

Strength

EQ 6MG BASE

Approval Date

2013-05-16

91072 / 4

Active Ingredient

RIVASTIGMINE TARTRATE

Application Number

91072

Product Number

4

Dosage Form

-

Strength

EQ 6MG BASE

Approval Date

2013-05-16

Regulatory Status

Discontinued

2012
31 Dec
Discontinued Application: 202244

Drug Name

RIZATRIPTAN BENZOATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-12-31

202244 / 1

Active Ingredient

RIZATRIPTAN BENZOATE

Application Number

202244

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-12-31

Regulatory Status

Discontinued

2012
31 Dec
Discontinued Application: 202244

Drug Name

RIZATRIPTAN BENZOATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-12-31

202244 / 2

Active Ingredient

RIZATRIPTAN BENZOATE

Application Number

202244

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-12-31

Regulatory Status

Discontinued

2013
01 Jul
Discontinued Application: 202477

Drug Name

RIZATRIPTAN BENZOATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2013-07-01

202477 / 1

Active Ingredient

RIZATRIPTAN BENZOATE

Application Number

202477

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2013-07-01

Regulatory Status

Discontinued

2013
01 Jul
Discontinued Application: 202477

Drug Name

RIZATRIPTAN BENZOATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2013-07-01

202477 / 2

Active Ingredient

RIZATRIPTAN BENZOATE

Application Number

202477

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2013-07-01

Regulatory Status

Discontinued

-
Unclassified Application: 208869

Drug Name

RUXOLITINIB

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

-

208869 / 2

Active Ingredient

RUXOLITINIB

Application Number

208869

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 208869

Drug Name

RUXOLITINIB

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

-

208869 / 3

Active Ingredient

RUXOLITINIB

Application Number

208869

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 208869

Drug Name

RUXOLITINIB

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

-

208869 / 4

Active Ingredient

RUXOLITINIB

Application Number

208869

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 208869

Drug Name

RUXOLITINIB

Product Number

5

Dosage Form

-

Strength

25MG

Approval Date

-

208869 / 5

Active Ingredient

RUXOLITINIB

Application Number

208869

Product Number

5

Dosage Form

-

Strength

25MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 220314

Drug Name

SEMAGLUTIDE

Product Number

1

Dosage Form

-

Strength

2MG/3ML

Approval Date

-

220314 / 1

Active Ingredient

SEMAGLUTIDE

Application Number

220314

Product Number

1

Dosage Form

-

Strength

2MG/3ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 220314

Drug Name

SEMAGLUTIDE

Product Number

2

Dosage Form

-

Strength

4MG/3ML

Approval Date

-

220314 / 2

Active Ingredient

SEMAGLUTIDE

Application Number

220314

Product Number

2

Dosage Form

-

Strength

4MG/3ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 220314

Drug Name

SEMAGLUTIDE

Product Number

3

Dosage Form

-

Strength

8MG/3ML

Approval Date

-

220314 / 3

Active Ingredient

SEMAGLUTIDE

Application Number

220314

Product Number

3

Dosage Form

-

Strength

8MG/3ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 214494

Drug Name

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

-

214494 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE, SITAGLIPTIN

Application Number

214494

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 214494

Drug Name

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

-

214494 / 3

Active Ingredient

METFORMIN HYDROCHLORIDE, SITAGLIPTIN

Application Number

214494

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 214494

Drug Name

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

500MG

Approval Date

-

214494 / 4

Active Ingredient

METFORMIN HYDROCHLORIDE, SITAGLIPTIN

Application Number

214494

Product Number

4

Dosage Form

-

Strength

500MG

Approval Date

-

Regulatory Status

Unclassified

2000
08 Sep
Discontinued Application: 75411

Drug Name

TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 0.25% BASE

Approval Date

2000-09-08

75411 / 1

Active Ingredient

TIMOLOL MALEATE

Application Number

75411

Product Number

1

Dosage Form

-

Strength

EQ 0.25% BASE

Approval Date

2000-09-08

Regulatory Status

Discontinued

2000
08 Sep
Discontinued Application: 75412

Drug Name

TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2000-09-08

75412 / 1

Active Ingredient

TIMOLOL MALEATE

Application Number

75412

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2000-09-08

Regulatory Status

Discontinued

2012
03 Feb
RX Application: 78868

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2012-02-03

78868 / 1

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

78868

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2012-02-03

Regulatory Status

RX

2012
03 Feb
RX Application: 78868

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2012-02-03

78868 / 2

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

78868

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2012-02-03

Regulatory Status

RX

2012
03 Feb
RX Application: 78868

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 6MG BASE

Approval Date

2012-02-03

78868 / 3

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

78868

Product Number

3

Dosage Form

-

Strength

EQ 6MG BASE

Approval Date

2012-02-03

Regulatory Status

RX

2002
25 Feb
Discontinued Application: 65087

Drug Name

TOBRAMYCIN

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2002-02-25

65087 / 1

Active Ingredient

TOBRAMYCIN

Application Number

65087

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2002-02-25

Regulatory Status

Discontinued

1987
25 Mar
RX Application: 71196

Drug Name

TRAZODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1987-03-25

71196 / 1

Active Ingredient

TRAZODONE HYDROCHLORIDE

Application Number

71196

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1987-03-25

Regulatory Status

RX

1999
26 Apr
RX Application: 71196

Drug Name

TRAZODONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

1999-04-26

71196 / 2

Active Ingredient

TRAZODONE HYDROCHLORIDE

Application Number

71196

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

1999-04-26

Regulatory Status

RX

1999
26 Apr
RX Application: 71196

Drug Name

TRAZODONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

1999-04-26

71196 / 3

Active Ingredient

TRAZODONE HYDROCHLORIDE

Application Number

71196

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

1999-04-26

Regulatory Status

RX

1988
17 Apr
RX Application: 71251

Drug Name

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

50MG;75MG

Approval Date

1988-04-17

71251 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; TRIAMTERENE

Application Number

71251

Product Number

1

Dosage Form

-

Strength

50MG;75MG

Approval Date

1988-04-17

Regulatory Status

RX

1998
05 May
RX Application: 71251

Drug Name

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

25MG;37.5MG

Approval Date

1998-05-05

71251 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; TRIAMTERENE

Application Number

71251

Product Number

2

Dosage Form

-

Strength

25MG;37.5MG

Approval Date

1998-05-05

Regulatory Status

RX

2013
21 Mar
Discontinued Application: 203026

Drug Name

VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;80MG

Approval Date

2013-03-21

203026 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

203026

Product Number

1

Dosage Form

-

Strength

12.5MG;80MG

Approval Date

2013-03-21

Regulatory Status

Discontinued

2013
21 Mar
Discontinued Application: 203026

Drug Name

VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;160MG

Approval Date

2013-03-21

203026 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

203026

Product Number

2

Dosage Form

-

Strength

12.5MG;160MG

Approval Date

2013-03-21

Regulatory Status

Discontinued

2013
21 Mar
Discontinued Application: 203026

Drug Name

VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

12.5MG;320MG

Approval Date

2013-03-21

203026 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

203026

Product Number

3

Dosage Form

-

Strength

12.5MG;320MG

Approval Date

2013-03-21

Regulatory Status

Discontinued

2013
21 Mar
Discontinued Application: 203026

Drug Name

VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

4

Dosage Form

-

Strength

25MG;160MG

Approval Date

2013-03-21

203026 / 4

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

203026

Product Number

4

Dosage Form

-

Strength

25MG;160MG

Approval Date

2013-03-21

Regulatory Status

Discontinued

2013
21 Mar
Discontinued Application: 203026

Drug Name

VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

5

Dosage Form

-

Strength

25MG;320MG

Approval Date

2013-03-21

203026 / 5

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

203026

Product Number

5

Dosage Form

-

Strength

25MG;320MG

Approval Date

2013-03-21

Regulatory Status

Discontinued

-
Unclassified Application: 211130

Drug Name

VORTIOXETINE HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

-

211130 / 2

Active Ingredient

VORTIOXETINE HYDROBROMIDE

Application Number

211130

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 211130

Drug Name

VORTIOXETINE HYDROBROMIDE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

-

211130 / 3

Active Ingredient

VORTIOXETINE HYDROBROMIDE

Application Number

211130

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 211130

Drug Name

VORTIOXETINE HYDROBROMIDE

Product Number

4

Dosage Form

-

Strength

5MG

Approval Date

-

211130 / 4

Active Ingredient

VORTIOXETINE HYDROBROMIDE

Application Number

211130

Product Number

4

Dosage Form

-

Strength

5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 78533

Drug Name

ZOLEDRONIC ACID

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/5ML

Approval Date

-

78533 / 1

Active Ingredient

ZOLEDRONIC ACID

Application Number

78533

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/5ML

Approval Date

-

Regulatory Status

Unclassified

2013
14 May
Discontinued Application: 202078

Drug Name

ZOLMITRIPTAN

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2013-05-14

202078 / 1

Active Ingredient

ZOLMITRIPTAN

Application Number

202078

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2013-05-14

Regulatory Status

Discontinued

2013
14 May
Discontinued Application: 202078

Drug Name

ZOLMITRIPTAN

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2013-05-14

202078 / 2

Active Ingredient

ZOLMITRIPTAN

Application Number

202078

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2013-05-14

Regulatory Status

Discontinued

2013
14 May
Discontinued Application: 202476

Drug Name

ZOLMITRIPTAN

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2013-05-14

202476 / 1

Active Ingredient

ZOLMITRIPTAN

Application Number

202476

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2013-05-14

Regulatory Status

Discontinued

2013
14 May
Discontinued Application: 202476

Drug Name

ZOLMITRIPTAN

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2013-05-14

202476 / 2

Active Ingredient

ZOLMITRIPTAN

Application Number

202476

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2013-05-14

Regulatory Status

Discontinued

2007
23 Apr
Discontinued Application: 77884

Drug Name

ZOLPIDEM TARTRATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-04-23

77884 / 1

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

77884

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-04-23

Regulatory Status

Discontinued

2007
23 Apr
Discontinued Application: 77884

Drug Name

ZOLPIDEM TARTRATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-04-23

77884 / 2

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

77884

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-04-23

Regulatory Status

Discontinued

Related Databases
  • FDA Inspections
    9 View
  • EDQM CEP
    0 View
  • KDMF
    0 View
  • Japan DMF
    0 View
  • Eudra GMP
    2 View
  • NDC Database
    0 View
  • FDA Approved Drugs Database
    194 View
Drug Status Breakdown
194 total
  • Discontinued
  • RX
  • Unclassified
  • OTC
Official Source

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

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

ABACAVIR SULFATE

Application Number

201570

Product Number

1

Active Ingredient

ABACAVIR SULFATE

Dosage Form

-

Strength

EQ 300MG BASE

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

Create a New Buying Request

Fields marked with * are mandatory.

Please enter quantity.
Please select a unit.
Please select quality standard.
Please select request type.
Please provide product specifications.
Please enter additional details.
Please select shipping preference.
Notice: By submitting this buying request, the provided product details and requirements may be published publicly on our marketplace.
Login to Submit