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FDA NDA · NDA021246

TAMIFLU

oseltamivir phosphate

Sponsor: ROCHE

APPLICATION
NDA021246
TYPE
NDA
ORIGINAL APPROVAL
2000-12-14
LATEST ACTION
2021-08-10
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued, Prescription

Products

TAMIFLUDiscontinued
OSELTAMIVIR PHOSPHATE EQ 12MG BASE/ML · FOR SUSPENSION · ORAL
TAMIFLU · ReferencePrescription
OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML · FOR SUSPENSION · ORAL

Approval history

2021-08-10Manufacturing (CMC) · Supplement 55 — Letter ↗AP
2019-08-02Efficacy · Supplement 54 · standard — Label ↗AP
2018-12-12Labeling · Supplement 53 · standard — Label ↗AP
2018-04-04Labeling · Supplement 52 · standard — Letter ↗AP
2016-06-20Labeling · Supplement 51 · standard — Letter ↗AP
2015-03-16Manufacturing (CMC) · Supplement 50 · priorityAP
2014-11-26Labeling · Supplement 43 · standard — Letter ↗AP
2014-10-14Labeling · Supplement 48 · standard — Label ↗AP
2014-05-30Labeling · Supplement 47 · standard — Label ↗AP
2013-02-07Manufacturing (CMC) · Supplement 46 · priorityAP
2013-01-29Labeling · Supplement 44 · standard — Label ↗AP
2012-12-21Efficacy · Supplement 45 · priority — Label ↗AP
2012-08-16Labeling · Supplement 42 · standard — Letter ↗AP
2011-03-21Labeling · Supplement 39 · unknown — Letter ↗AP
2011-02-07Labeling · Supplement 40 · 901 required — Label ↗AP
2010-12-15Labeling · Supplement 31 · standard — Letter ↗AP
2010-11-05Labeling · Supplement 38 · standard — Letter ↗AP
2010-02-22Labeling · Supplement 34 · standard — Label ↗AP
2010-02-22Efficacy · Supplement 35 · priority — Label ↗AP
2009-02-23Manufacturing (CMC) · Supplement 32 · priority — Letter ↗AP
2008-09-25Labeling · Supplement 33 · standard — Letter ↗AP
2008-01-17Labeling · Supplement 30 · standard — Letter ↗AP
2007-10-05Labeling · Supplement 28 · standard — Label ↗AP
2007-07-02Manufacturing (CMC) · Supplement 27 — Label ↗AP
2007-03-26Manufacturing (CMC) · Supplement 26 · priority — Letter ↗AP
2007-03-22Manufacturing (CMC) · Supplement 25 · priority — Letter ↗AP
2007-03-12Manufacturing (CMC) · Supplement 24 · priority — Letter ↗AP
2007-02-01Manufacturing (CMC) · Supplement 22 · priority — Letter ↗AP
2006-12-14Manufacturing (CMC) · Supplement 23 · priority — Letter ↗AP
2006-11-13Labeling · Supplement 21 · standard — Patient Package Insert ↗AP
2006-06-23Manufacturing (CMC) · Supplement 20 · priority — Letter ↗AP
2005-12-21Efficacy · Supplement 17 · unknown — Label ↗AP
2005-12-01Manufacturing (CMC) · Supplement 19 · priority — Letter ↗AP
2005-10-14Manufacturing (CMC) · Supplement 18 · priority — Letter ↗AP
2005-05-19Manufacturing (CMC) · Supplement 16 · priority — Letter ↗AP
2005-01-18Manufacturing (CMC) · Supplement 14 · priority — Letter ↗AP
2004-10-19Manufacturing (CMC) · Supplement 13 · priority — Letter ↗AP
2004-08-12Manufacturing (CMC) · Supplement 12 · priority — Letter ↗AP
2004-06-24Labeling · Supplement 10 · standard — Review ↗AP
2004-04-26Manufacturing (CMC) · Supplement 11 · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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