Treats acute, uncomplicated influenza A and B. ANDA 211894, held by Strides Pharma. Oseltamivir Phosphate.
As of Nov 15, 2026, ANDA 211894 (Oseltamivir Phosphate), held by Strides Pharma, was first approved by FDA on Jan 13, 2022, with 0 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 13, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oseltamivir PhosphateEQ 6MG BASE/ML · for suspension;oral | Oseltamivir Phosphate | Rx |
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
