Treats acute, uncomplicated influenza A and B. ANDA 209421, held by Strides Pharma. Oseltamivir Phosphate.
As of Nov 15, 2026, ANDA 209421 (Oseltamivir Phosphate), held by Strides Pharma, was first approved by FDA on Jun 8, 2018, with 2 approved supplements and 0 published complete response letters.
Oseltamivir Phosphate capsule 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 |
|---|---|---|---|
| Jun 8, 2018 | Original application | Approved | None posted |
| 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 |
| Jul 6, 2021 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jul 6, 2021 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jun 8, 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
