FDA NDA 020007, ZOFRAN PRESERVATIVE FREE, SANDOZ, 01/04/1991

Contents: Summary Basis of Approval for Zofran Injection (NDA 020007) initial NDA approval, approved January 4, 1991. Including the clinical pharmacology and biopharmaceutics reviews.

NDA: 020007
Company: SANDOZ
Drug Name: ZOFRAN PRESERVATIVE FREE
Active Ingredients: ONDANSETRON HYDROCHLORIDE
Strength: EQ 2MG BASE/ML
Dosage Form/Route: INJECTABLE;INJECTION
Action Date: 01/04/1991
Marketing Status: Discontinued
Submission Classification: ORIG-1
Action Date: None

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