Drug Approval Package

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Drug Approval Package

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Zantac (ranitidine hydrochloride) Premixed IV Injection
Company: Glaxo Wellcome Research and Development
Application No.: 019593, S28
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 30, 2003

Date created: April 04, 2002

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