← FDA DRUG APPROVALS

FDA NDA · NDA021567

REYATAZ

atazanavir

Sponsor: BRISTOL MYERS SQUIBB

APPLICATION
NDA021567
TYPE
NDA
ORIGINAL APPROVAL
2003-06-20
LATEST ACTION
2024-12-05
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription, Discontinued

Products

REYATAZ · ReferencePrescription
ATAZANAVIR SULFATE EQ 200MG BASE · CAPSULE · ORAL
REYATAZ · ReferenceDiscontinued
ATAZANAVIR SULFATE EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
REYATAZ · ReferencePrescription
ATAZANAVIR SULFATE EQ 300MG BASE · CAPSULE · ORAL
REYATAZ · ReferenceDiscontinued
ATAZANAVIR SULFATE EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2024-12-05Labeling · Supplement 49 · standard — Letter ↗AP
2023-11-07Labeling · Supplement 48 · standard — Label ↗AP
2023-04-14Manufacturing (CMC) · Supplement 47 — Letter ↗AP
2020-09-24Labeling · Supplement 44 · standard — Letter ↗AP
2018-04-18Labeling · Supplement 42 · standard — Label ↗AP
2017-10-20Labeling · Supplement 41 · standard — Letter ↗AP
2017-05-23Efficacy · Supplement 40 · standard — Letter ↗AP
2016-09-15Labeling · Supplement 39 · 901 required — Label ↗AP
2015-09-24Efficacy · Supplement 38 · priority — Pediatric Written Request ↗AP
2015-03-27Labeling · Supplement 37 · 901 required — Label ↗AP
2015-02-26Labeling · Supplement 36 · unknown — Letter ↗AP
2014-06-02Efficacy · Supplement 35 · priority — Pediatric Medical Review ↗AP
2014-02-26Manufacturing (CMC) · Supplement 34 · priorityAP
2013-08-15Labeling · Supplement 32 · standard — Label ↗AP
2013-08-15Labeling · Supplement 33 · standard — Label ↗AP
2013-01-30Labeling · Supplement 31 · standard — Letter ↗AP
2012-03-14Labeling · Supplement 28 · standard — Label ↗AP
2012-02-17Labeling · Supplement 27 · 901 required — Letter ↗AP
2011-10-17Efficacy · Supplement 26 · standard — Label ↗AP
2011-02-04Efficacy · Supplement 25 · priority — Review ↗AP
2010-04-26Labeling · Supplement 23 · unknown — Label ↗AP
2010-01-22Labeling · Supplement 22 · standard — Label ↗AP
2009-11-05Efficacy · Supplement 19 · standard — Label ↗AP
2008-09-30Efficacy · Supplement 17 · unknown — Label ↗AP
2008-08-15Labeling · Supplement 16 · standard — Letter ↗AP
2008-03-25Efficacy · Supplement 15 · priority — Label ↗AP
2008-02-20Labeling · Supplement 18 · standard — Label ↗AP
2007-12-21Labeling · Supplement 14 · standard — Label ↗AP
2007-03-22Labeling · Supplement 12 · standard — Label ↗AP
2006-10-16Manufacturing (CMC) · Supplement 9 — Letter ↗AP
2006-08-09Labeling · Supplement 11 · standard — Label ↗AP
2006-08-09Labeling · Supplement 8 · standard — Letter ↗AP
2006-01-25Labeling · Supplement 7 · standard — Label ↗AP
2005-07-18Labeling · Supplement 5 · standard — Label ↗AP
2004-10-05Labeling · Supplement 4 · standard — Label ↗AP
2004-07-06Efficacy · Supplement 2 · unknown — Letter ↗AP
2004-03-16Labeling · Supplement 1 · standard — Letter ↗AP
2003-06-20Type 1 - New Molecular Entity · Original · priority — Label ↗AP
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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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