Drug Approval Package
Zantac Tablets (ranitidine hydrochloride)
Company: Glaxo Wellcome Research and Development.
Application No.: 018703, S056
Approval Date: 10/29/1999
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Approval Letter(s) (PDF)
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Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
Part 1 (PDF)
Part 2 (PDF)