← FDA DRUG APPROVALS

FDA NDA · NDA021087

TAMIFLU

oseltamivir phosphate

Sponsor: ROCHE

APPLICATION
NDA021087
TYPE
NDA
ORIGINAL APPROVAL
1999-10-27
LATEST ACTION
2019-08-02
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued, Prescription

Products

TAMIFLU · ReferenceDiscontinued
OSELTAMIVIR PHOSPHATE EQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
TAMIFLU · ReferencePrescription
OSELTAMIVIR PHOSPHATE EQ 75MG BASE · CAPSULE · ORAL
TAMIFLU · ReferenceDiscontinued
OSELTAMIVIR PHOSPHATE EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2019-08-02Efficacy · Supplement 71 · standardLabelAP
2018-12-12Labeling · Supplement 70 · standardLabelAP
2018-04-04Labeling · Supplement 69 · standardLetterAP
2016-06-20Labeling · Supplement 68 · standardLetterAP
2014-12-15Manufacturing (CMC) · Supplement 67 · priorityAP
2014-11-26Labeling · Supplement 60 · standardLetterAP
2014-10-14Labeling · Supplement 65 · standardLabelAP
2014-10-08Manufacturing (CMC) · Supplement 66 · priorityAP
2014-05-30Labeling · Supplement 64 · standardLabelAP
2013-12-20Manufacturing (CMC) · Supplement 63 · priorityAP
2013-01-29Labeling · Supplement 61 · standardOtherAP
2012-12-21Efficacy · Supplement 62 · prioritySummary ReviewAP
2012-08-16Labeling · Supplement 59 · standardLabelAP
2011-03-21Labeling · Supplement 56 · standardLetterAP
2011-02-07Labeling · Supplement 57 · 901 requiredLetterAP
2010-12-15Labeling · Supplement 45 · standardLabelAP
2010-11-05Labeling · Supplement 55 · standardLabelAP
2010-02-22Labeling · Supplement 48 · standardReviewAP
2010-02-22Efficacy · Supplement 49 · priorityReviewAP
2008-09-25Labeling · Supplement 47 · standardLetterAP
2008-06-10Labeling · Supplement 46 · standardLetterAP
2008-05-05Manufacturing (CMC) · Supplement 43 · priorityLetterAP
2008-01-17Labeling · Supplement 42 · standardLabelAP
2007-12-03Manufacturing (CMC) · Supplement 44 · priorityLetterAP
2007-10-05Labeling · Supplement 41 · standardLabelAP
2007-07-02Manufacturing (CMC) · Supplement 40LetterAP
2007-03-26Manufacturing (CMC) · Supplement 39 · priorityLetterAP
2007-03-22Manufacturing (CMC) · Supplement 38 · priorityLetterAP
2007-03-12Manufacturing (CMC) · Supplement 37 · priorityLetterAP
2007-02-27Manufacturing (CMC) · Supplement 36 · priorityLetterAP
2007-02-01Manufacturing (CMC) · Supplement 35 · priorityLetterAP
2006-12-19Manufacturing (CMC) · Supplement 34 · priorityLetterAP
2006-11-13Labeling · Supplement 33 · standardPatient Package InsertAP
2006-06-23Manufacturing (CMC) · Supplement 31 · priorityLetterAP
2005-12-21Efficacy · Supplement 30 · unknownLetterAP
2005-12-01Manufacturing (CMC) · Supplement 29 · priorityLetterAP
2005-10-27Labeling · Supplement 25 · standardLetterAP
2005-10-14Manufacturing (CMC) · Supplement 28 · priorityLetterAP
2005-10-14Manufacturing (CMC) · Supplement 27 · priorityLetterAP
2005-08-16Labeling · Supplement 26 · standardLetterAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →