Drug Approval Package

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Drug Approval Package

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Claritin RediTabs 12 Hour (5 mg loratadine) orally disintegrating tablets
Company: Schering-Plough HealthCare Products
NDA: 021993
Approval Date: 12/12/2006

Approval Letter(s) (PDF)
Printed Labeling (PDF)
Medical Review(s) (PDF)
Chemistry Review(s) (PDF)
Pharmacology Review(s) (PDF)
Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
Proprietary Name Review(s) (PDF)
Administrative Document(s) and Correspondence (PDF)

Date created: October 3, 2008

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