Treats acute, uncomplicated influenza A and B. NDA 21246, held by Roche. Oseltamivir Phosphate.
As of Nov 15, 2026, NDA 21246 (Tamiflu), held by Roche, was first approved by FDA on Dec 14, 2000, with 47 approved supplements and 0 published complete response letters.
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.
| Aug 2, 2019 | Supplement 54Efficacy (new indication or use) · Standard review | Approved | |
| Dec 21, 2012 | Supplement 45Efficacy (new indication or use) · Priority review | Approved | |
| Feb 22, 2010 | Supplement 35Efficacy (new indication or use) · Priority review | Approved | |
| Dec 21, 2005 | Supplement 17Efficacy (new indication or use) | Approved | |
| Feb 14, 2003 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Dec 14, 2000 | Original applicationNew dosage form · Priority review | Approved |
| TamifluEQ 12MG BASE/ML · for suspension;oral | Oseltamivir Phosphate | Discontinued |
| TamifluEQ 6MG BASE/ML · for suspension;oral | Oseltamivir Phosphate | RxReference drug |
| Aug 10, 2021 | Supplement 55Manufacturing | Approved | |
| Aug 2, 2019 | Supplement 54Efficacy (new indication or use) · Standard review | Approved | |
| Dec 12, 2018 | Supplement 53Labeling · Standard review | Approved | |
| Apr 4, 2018 | Supplement 52Labeling · Standard review | Approved | |
| Jun 20, 2016 | Supplement 51Labeling · Standard review | Approved | |
| Mar 16, 2015 | Supplement 50Manufacturing · Priority review | Approved | None posted |
| Nov 26, 2014 | Supplement 43Labeling · Standard review | Approved | |
| Oct 14, 2014 | Supplement 48Labeling · Standard review | Approved | |
| May 30, 2014 | Supplement 47Labeling · Standard review | Approved | |
| Feb 7, 2013 | Supplement 46Manufacturing · Priority review | Approved | None posted |
| Jan 29, 2013 | Supplement 44Labeling · Standard review | Approved | |
| Dec 21, 2012 | Supplement 45Efficacy (new indication or use) · Priority review | Approved | |
| Aug 16, 2012 | Supplement 42Labeling · Standard review | Approved | |
| Mar 21, 2011 | Supplement 39Labeling | Approved | |
| Feb 7, 2011 | Supplement 40Labeling | Approved | |
| Dec 15, 2010 | Supplement 31Labeling · Standard review | Approved | |
| Nov 5, 2010 | Supplement 38Labeling · Standard review | Approved | |
| Feb 22, 2010 | Supplement 34Labeling · Standard review | Approved | |
| Feb 22, 2010 | Supplement 35Efficacy (new indication or use) · Priority review | Approved | |
| Feb 23, 2009 | Supplement 32Manufacturing · Priority review | Approved | |
| Sep 25, 2008 | Supplement 33Labeling · Standard review | Approved | |
| Jan 17, 2008 | Supplement 30Labeling · Standard review | Approved | |
| Oct 5, 2007 | Supplement 28Labeling · Standard review | Approved | |
| Jul 2, 2007 | Supplement 27Manufacturing | Approved | |
| Mar 26, 2007 | Supplement 26Manufacturing · Priority review | Approved | |
| Mar 22, 2007 | Supplement 25Manufacturing · Priority review | Approved | |
| Mar 12, 2007 | Supplement 24Manufacturing · Priority review | Approved | |
| Feb 1, 2007 | Supplement 22Manufacturing · Priority review | Approved | |
| Dec 14, 2006 | Supplement 23Manufacturing · Priority review | Approved | |
| Nov 13, 2006 | Supplement 21Labeling · Standard review | Approved | |
| Jun 23, 2006 | Supplement 20Manufacturing · Priority review | Approved | |
| Dec 21, 2005 | Supplement 17Efficacy (new indication or use) | Approved | |
| Dec 1, 2005 | Supplement 19Manufacturing · Priority review | Approved | |
| Oct 14, 2005 | Supplement 18Manufacturing · Priority review | Approved | |
| May 19, 2005 | Supplement 16Manufacturing · Priority review | Approved | |
| Jan 18, 2005 | Supplement 14Manufacturing · Priority review | Approved | |
| Oct 19, 2004 | Supplement 13Manufacturing · Priority review | Approved | |
| Aug 12, 2004 | Supplement 12Manufacturing · Priority review | Approved | |
| Jun 24, 2004 | Supplement 10Labeling · Standard review | Approved | |
| Apr 26, 2004 | Supplement 11Manufacturing · Priority review | Approved | |
| Feb 14, 2003 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Apr 26, 2002 | Supplement 7Labeling · Standard review | Approved | |
| Mar 4, 2002 | Supplement 6Manufacturing · Priority review | Approved | |
| Nov 5, 2001 | Supplement 4Labeling · Standard review | Approved | |
| Jul 24, 2001 | Supplement 3Labeling · Standard review | Approved | |
| Jul 24, 2001 | Supplement 1Labeling · Standard review | Approved | |
| Jul 5, 2001 | Supplement 2Manufacturing · Priority review | Approved | |
| Dec 14, 2000 | Original applicationNew dosage form · Priority review | 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
