← FDA DRUG APPROVALS

FDA NDA · NDA022577

VIREAD

tenofovir disoproxil fumarate

Sponsor: GILEAD SCIENCES INC

APPLICATION
NDA022577
TYPE
NDA
ORIGINAL APPROVAL
2012-01-18
LATEST ACTION
2019-04-24
ROUTE
ORAL
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

VIREAD · ReferencePrescription
TENOFOVIR DISOPROXIL FUMARATE 40MG/SCOOPFUL · POWDER · ORAL

Approval history

2019-04-24Labeling · Supplement 14 · standard — Letter ↗AP
2018-12-11Efficacy · Supplement 13 · priority — Label ↗AP
2018-07-30Labeling · Supplement 12 · standard — Label ↗AP
2017-04-07Labeling · Supplement 11 · standard — Label ↗AP
2016-02-16Labeling · Supplement 9 · standard — Letter ↗AP
2015-12-02Manufacturing (CMC) · Supplement 8 · priorityAP
2015-05-29Efficacy · Supplement 7 · standard — Label ↗AP
2013-10-23Labeling · Supplement 6 · 901 required — Label ↗AP
2013-07-24Efficacy · Supplement 3 · standard — Label ↗AP
2013-04-02Labeling · Supplement 4 · standard — Label ↗AP
2012-08-16Efficacy · Supplement 2 · priority — Label ↗AP
2012-08-07Efficacy · Supplement 1 · standard — Letter ↗AP
2012-01-18Type 3 - New Dosage Form · Original · priority — Summary Review ↗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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