Oseltamivir Phosphate

Treats acute, uncomplicated influenza A and B. ANDA 207211, held by Macleods Pharms. Oseltamivir Phosphate.

As of Nov 15, 2026, ANDA 207211 (Oseltamivir Phosphate), held by Macleods Pharms, was first approved by FDA on Sep 14, 2017, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 14, 2017
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Oseltamivir phosphate capsules USP, 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Sep 14, 2017	Original application	Approved	None posted

Products

3 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Mar 16, 2021	Supplement 8Labeling · Standard review	Approved	None posted
Mar 16, 2021	Supplement 5Labeling · Standard review	Approved	None posted
Mar 16, 2021	Supplement 3Labeling · Standard review	Approved	None posted
Sep 14, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 207211
Drugs@FDA: Overview at FDA
Company: Macleods Pharmaceuticals

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