Treats acute, uncomplicated influenza A and B. ANDA 202595, held by Natco. Oseltamivir Phosphate.
As of Nov 15, 2026, ANDA 202595 (Oseltamivir Phosphate), held by Natco, was first approved by FDA on Aug 3, 2016, with 3 approved supplements and 0 published complete response letters.
Oseltamivir phosphate capsules are 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 |
|---|---|---|---|
| Aug 3, 2016 | Original application | Approved |
| Oseltamivir PhosphateEQ 30MG BASE · capsule;oral | Oseltamivir Phosphate | Rx |
| Oseltamivir PhosphateEQ 45MG BASE · capsule;oral | Oseltamivir Phosphate | Rx |
| Oseltamivir PhosphateEQ 75MG BASE · capsule;oral | Oseltamivir Phosphate | Rx |
| Apr 9, 2021 | Supplement 5Labeling · Standard review | Approved | None posted |
| Apr 9, 2021 | Supplement 9Labeling · Standard review | Approved | None posted |
| Apr 9, 2021 | Supplement 11Labeling · Standard review | Approved | None posted |
| Aug 3, 2016 | Original application | Approved |
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
