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As of Nov 15, 2026, ANDA 215313 (Oseltamivir Phosphate), held by Msn, was first approved by FDA on May 2, 2022, with 0 approved supplements and 0 published complete response letters.
First approved: May 2, 2022
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Oseltamivir phosphate for oral suspension is an influenza neuraminidase inhibitor (NAI) indicated for:
Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours.
Prophylaxis of influenza A and B in patients 1 year and older. Limitations of Use:
Not a substitute for annual influenza vaccination.
Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use.
Not recommended for patients with end-stage renal disease not undergoing dialysis. 1.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
