Apotex Inc OTC
FDA Approved Drugs

Apotex Inc OTC

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.

OTC
  • Total Records 2
  • Latest Approval Date Dec 27, 2007
  • Data Source FDA
  • First Approval Date Dec 27, 2007
All
194
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Unclassified
38
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Discontinued
114
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OTC
2
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RX
40
View
Company Overview

Company

Apotex Inc OTC

Country

Canada

Email

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Company Snapshot
FDA Approved Drug Records ( 2 records )
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

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Drug Status Breakdown
2 total
  • OTC
Official Source

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

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FDA Approved Drug Record Details Preview

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

Drug Name

CETIRIZINE HYDROCHLORIDE ALLERGY

Application Number

78317

Product Number

1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Dosage Form

-

Strength

5MG

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