Sandoz B2B OTC
FDA Approved Drugs

Sandoz B2B 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 Feb 14, 2008
  • Data Source FDA
  • First Approval Date Feb 14, 2008
All
751
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Unclassified
50
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Discontinued
316
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OTC
2
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383
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Company

Sandoz B2B OTC

Country

Switzerland

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Sandoz B2B OTC

Forum 1, Novartis Campus, CH-4056 Basel

Switzerland

www.sandoz.com/ sandoz.b2b@sandoz.com View on Map
FDA Approved Drug Records ( 2 records )
2008
14 Feb
OTC Application: 78692

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2008-02-14

78692 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

78692

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2008-02-14

Regulatory Status

OTC

2008
14 Feb
OTC Application: 78692

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2008-02-14

78692 / 2

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

78692

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2008-02-14

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.

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY

Application Number

78692

Product Number

1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Dosage Form

-

Strength

5MG

FDA Approved Drug Data

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