Apotex Inc RX
FDA Approved Drugs

Apotex Inc RX

FDA Approved Drugs Database

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

RX
  • Total Records 40
  • Latest Approval Date Oct 08, 2014
  • 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 RX

Country

Canada

Website

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Company Snapshot

Apotex Inc RX

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 ( 40 records )
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

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

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

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

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

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

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

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

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

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

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

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

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Drug Status Breakdown
40 total
  • RX
Official Source

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

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

ALFUZOSIN HYDROCHLORIDE

Application Number

79013

Product Number

1

Active Ingredient

ALFUZOSIN HYDROCHLORIDE

Dosage Form

-

Strength

10MG

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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Searchable pharmaceutical data

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