Treats acute, uncomplicated influenza A and B. ANDA 210186, held by Amneal Pharms Ny. Oseltamivir Phosphate.
As of Nov 15, 2026, ANDA 210186 (Oseltamivir Phosphate), held by Amneal Pharms Ny, was first approved by FDA on Feb 27, 2018, with 4 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 |
|---|---|---|---|
| Feb 27, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oseltamivir PhosphateEQ 6MG BASE/ML · for suspension;oral | Oseltamivir Phosphate | Discontinued |
| Aug 7, 2023 | Supplement 16Labeling · Standard review | Approved | None posted |
| Jun 7, 2021 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jun 7, 2021 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jun 7, 2021 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 27, 2018 | Original application | Approved | None posted |
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
