Drug Approval Package

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Drug Approval Package

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ZANTAC INJECTION (RANITIDINE HYDROCHLORIDE)
Company: Glaxo Wellcome Inc.
Application No.: 019090, S37
Approval Date: 10/29/1999

Approval Letter(s) (PDF)
Medical Review(s) (PDF)
Part 1 (PDF)
Part 2 (PDF)
Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
Part 1 (PDF)
Part 2 (PDF)
Administrative Document(s) & Correspondence (PDF)

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Date created: April 16, 2003

Date created: April 04, 2002

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