Tamiflu

Treats acute, uncomplicated influenza A and B. NDA 21087, held by Roche. Oseltamivir Phosphate.

As of Nov 14, 2026, NDA 21087 (Tamiflu), held by Roche, was first approved by FDA on Oct 27, 1999, with 63 approved supplements and 0 published complete response letters.

First approved: Oct 27, 1999
Review: Priority
Supplements approved: 63
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

TAMIFLU 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 64 submissions below


Aug 2, 2019	Supplement 71Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 21, 2012	Supplement 62Efficacy (new indication or use) · Priority review	Approved	Review Letter Label Summary Review
Feb 22, 2010	Supplement 49Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
Dec 21, 2005	Supplement 30Efficacy (new indication or use)	Approved	Review Letter Label Patient Package Insert
Feb 14, 2003	Supplement 14Efficacy (new indication or use) · Priority review	Approved	Letter
Nov 17, 2000	Supplement 2Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Oct 27, 1999	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label Pediatric Medical Review

Products

3 strengths and forms


TamifluEQ 75MG BASE · capsule;oral	Oseltamivir Phosphate	RxReference drug
TamifluEQ 45MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Oseltamivir Phosphate	DiscontinuedReference drug
TamifluEQ 30MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Oseltamivir Phosphate	DiscontinuedReference drug

All 64 submissions, including labeling and manufacturing supplements


Aug 2, 2019	Supplement 71Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 12, 2018	Supplement 70Labeling · Standard review	Approved	Label Letter
Apr 4, 2018	Supplement 69Labeling · Standard review	Approved	Label Letter
Jun 20, 2016	Supplement 68Labeling · Standard review	Approved	Letter Label
Dec 15, 2014	Supplement 67Manufacturing · Priority review	Approved	None posted
Nov 26, 2014	Supplement 60Labeling · Standard review	Approved	Label Letter
Oct 14, 2014	Supplement 65Labeling · Standard review	Approved	Letter Label
Oct 8, 2014	Supplement 66Manufacturing · Priority review	Approved	None posted
May 30, 2014	Supplement 64Labeling · Standard review	Approved	Letter Label
Dec 20, 2013	Supplement 63Manufacturing · Priority review	Approved	None posted
Jan 29, 2013	Supplement 61Labeling · Standard review	Approved	Label Other Letter
Dec 21, 2012	Supplement 62Efficacy (new indication or use) · Priority review	Approved	Review Letter Label Summary Review
Aug 16, 2012	Supplement 59Labeling · Standard review	Approved	Letter Label
Mar 21, 2011	Supplement 56Labeling · Standard review	Approved	Review Letter Label
Feb 7, 2011	Supplement 57Labeling	Approved	Letter Label
Dec 15, 2010	Supplement 45Labeling · Standard review	Approved	Letter Label
Nov 5, 2010	Supplement 55Labeling · Standard review	Approved	Letter Label
Feb 22, 2010	Supplement 48Labeling · Standard review	Approved	Review Label Letter
Feb 22, 2010	Supplement 49Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
Sep 25, 2008	Supplement 47Labeling · Standard review	Approved	Letter Label
Jun 10, 2008	Supplement 46Labeling · Standard review	Approved	Letter
May 5, 2008	Supplement 43Manufacturing · Priority review	Approved	Letter
Jan 17, 2008	Supplement 42Labeling · Standard review	Approved	Letter Label
Dec 3, 2007	Supplement 44Manufacturing · Priority review	Approved	Letter
Oct 5, 2007	Supplement 41Labeling · Standard review	Approved	Letter Label
Jul 2, 2007	Supplement 40Manufacturing	Approved	Review Letter Label
Mar 26, 2007	Supplement 39Manufacturing · Priority review	Approved	Letter
Mar 22, 2007	Supplement 38Manufacturing · Priority review	Approved	Letter
Mar 12, 2007	Supplement 37Manufacturing · Priority review	Approved	Letter
Feb 27, 2007	Supplement 36Manufacturing · Priority review	Approved	Letter
Feb 1, 2007	Supplement 35Manufacturing · Priority review	Approved	Letter
Dec 19, 2006	Supplement 34Manufacturing · Priority review	Approved	Letter
Nov 13, 2006	Supplement 33Labeling · Standard review	Approved	Letter Label Patient Package Insert
Jun 23, 2006	Supplement 31Manufacturing · Priority review	Approved	Letter
Dec 21, 2005	Supplement 30Efficacy (new indication or use)	Approved	Review Letter Label Patient Package Insert
Dec 1, 2005	Supplement 29Manufacturing · Priority review	Approved	Letter
Oct 27, 2005	Supplement 25Labeling · Standard review	Approved	Letter Label
Oct 14, 2005	Supplement 27Manufacturing · Priority review	Approved	Letter
Oct 14, 2005	Supplement 28Manufacturing · Priority review	Approved	Letter
Aug 16, 2005	Supplement 26Labeling · Standard review	Approved	Letter Label
May 19, 2005	Supplement 24Manufacturing · Priority review	Approved	Letter
Apr 20, 2005	Supplement 23Manufacturing · Priority review	Approved	Letter Label
Jan 18, 2005	Supplement 21Manufacturing · Priority review	Approved	Letter
Oct 19, 2004	Supplement 20Manufacturing · Priority review	Approved	Letter
Aug 12, 2004	Supplement 19Manufacturing · Priority review	Approved	None posted
Jun 24, 2004	Supplement 16Labeling · Standard review	Approved	Review Label Letter
Apr 26, 2004	Supplement 17Manufacturing · Priority review	Approved	Letter
Apr 24, 2004	Supplement 18Manufacturing · Priority review	Approved	Letter
Mar 10, 2003	Supplement 13Manufacturing · Priority review	Approved	Letter
Feb 28, 2003	Supplement 15Manufacturing · Priority review	Approved	Letter
Feb 14, 2003	Supplement 14Efficacy (new indication or use) · Priority review	Approved	Letter
May 7, 2002	Supplement 12Manufacturing · Priority review	Approved	Review
Apr 26, 2002	Supplement 10Labeling · Standard review	Approved	Review Letter Label
Mar 28, 2002	Supplement 11Manufacturing · Priority review	Approved	Review
Nov 5, 2001	Supplement 9Labeling · Standard review	Approved	Review Label
Jul 24, 2001	Supplement 5Labeling · Priority review	Approved	Review Label
Jul 24, 2001	Supplement 6Labeling · Standard review	Approved	Review Label
Jul 24, 2001	Supplement 8Labeling · Standard review	Approved	Review Label
Jul 13, 2001	Supplement 7Manufacturing · Priority review	Approved	Review
Mar 6, 2001	Supplement 4Manufacturing · Priority review	Approved	Review
Nov 17, 2000	Supplement 2Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Nov 9, 2000	Supplement 3Manufacturing · Priority review	Approved	Review
Oct 31, 2000	Supplement 1Manufacturing · Priority review	Approved	Review
Oct 27, 1999	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label Pediatric Medical Review

Show all 64

Identifiers

Application: NDA 21087
Drugs@FDA: Overview at FDA
Company: Roche

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