FDA NDA 020103, ZOFRAN, SANDOZ, 12/31/1992

Contents: Summary Basis of Approval for Zofran Tablets (NDA 020103) initial NDA approval, approved December 31, 1992, including the clinical pharmacology and biopharmaceutics reviews.

NDA: 020103
Company: SANDOZ
Drug Name: ZOFRAN
Active Ingredients: ONDANSETRON HYDROCHLORIDE
Strength: EQ 24MG BASE
Dosage Form/Route: TABLET;ORAL
Action Date: 12/31/1992
Marketing Status: Discontinued
Submission Classification: ORIG-1
Action Date: None

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