← FDA DRUG APPROVALS

FDA NDA · NDA021356

VIREAD

tenofovir disoproxil fumarate

Sponsor: GILEAD SCIENCES INC

APPLICATION
NDA021356
TYPE
NDA
ORIGINAL APPROVAL
2001-10-26
LATEST ACTION
2019-04-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

VIREAD · ReferencePrescription
TENOFOVIR DISOPROXIL FUMARATE 200MG · TABLET · ORAL
VIREAD · ReferencePrescription
TENOFOVIR DISOPROXIL FUMARATE 300MG · TABLET · ORAL
VIREAD · ReferencePrescription
TENOFOVIR DISOPROXIL FUMARATE 250MG · TABLET · ORAL
VIREAD · ReferencePrescription
TENOFOVIR DISOPROXIL FUMARATE 150MG · TABLET · ORAL

Approval history

2019-04-24Labeling · Supplement 58 · standardLetterAP
2018-12-11Efficacy · Supplement 57 · priorityLabelAP
2018-07-30Labeling · Supplement 56 · standardLetterAP
2017-04-07Labeling · Supplement 55 · standardLabelAP
2016-03-10Manufacturing (CMC) · Supplement 53 · priorityAP
2016-02-16Labeling · Supplement 52 · standardLabelAP
2015-11-18Manufacturing (CMC) · Supplement 51 · priorityAP
2015-05-29Efficacy · Supplement 49 · standardLabelAP
2013-10-23Labeling · Supplement 48 · 901 requiredLetterAP
2013-07-24Efficacy · Supplement 46 · standardLetterAP
2013-04-02Labeling · Supplement 47 · standardLetterAP
2013-03-12Manufacturing (CMC) · Supplement 45 · priorityAP
2012-08-16Efficacy · Supplement 42 · priorityLetterAP
2012-08-07Efficacy · Supplement 40 · standardLetterAP
2012-01-18Efficacy · Supplement 38 · priorityPediatric Written RequestAP
2011-11-18Labeling · Supplement 41 · 901 requiredLabelAP
2011-09-19Efficacy · Supplement 37 · standardLetterAP
2010-10-14Efficacy · Supplement 35 · standardLabelAP
2010-10-01Efficacy · Supplement 34 · standardLetterAP
2010-03-24Efficacy · Supplement 33 · priorityLetterAP
2010-01-15Labeling · Supplement 32 · standardAP
2009-11-10Labeling · Supplement 28 · standardLetterAP
2009-10-07Efficacy · Supplement 27 · standardLetterAP
2008-11-04Labeling · Supplement 26 · standardLetterAP
2008-08-11Efficacy · Supplement 25 · standardLetterAP
2008-05-16Efficacy · Supplement 24 · unknownLetterAP
2007-05-21Labeling · Supplement 21 · standardLetterAP
2006-03-08Efficacy · Supplement 16 · unknownLabelAP
2005-11-30Labeling · Supplement 17 · standardLetterAP
2005-05-12Efficacy · Supplement 11 · unknownLetterAP
2004-07-01Labeling · Supplement 10 · standardLetterAP
2003-10-31Labeling · Supplement 6 · standardLetterAP
2003-10-14Labeling · Supplement 5 · standardLabelAP
2003-08-15Efficacy · Supplement 3 · standardLabelAP
2002-12-02Labeling · Supplement 1 · standardLetterAP
2001-10-26Type 1 - New Molecular Entity · Original · priorityLabelAP
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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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