Sustiva

NDA 20972, held by Bristol Myers Squibb. Efavirenz.

As of Nov 13, 2026, NDA 20972 (Sustiva), held by Bristol Myers Squibb, was first approved by FDA on Sep 17, 1998, with 45 approved supplements and 0 published complete response letters.

First approved: Sep 17, 1998
Review: Priority
Supplements approved: 45
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 46 submissions below


May 2, 2013	Supplement 43Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review
Aug 13, 2004	Supplement 22Efficacy (new indication or use)	Approved	Review Label Letter
Feb 9, 2000	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Review Label
Sep 17, 1998	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Products

3 strengths and forms


Sustiva50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Efavirenz	DiscontinuedReference drug
Sustiva100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Efavirenz	DiscontinuedReference drug
Sustiva200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Efavirenz	DiscontinuedReference drug

All 46 submissions, including labeling and manufacturing supplements


Nov 8, 2023	Supplement 59Labeling · Standard review	Approved	Letter Label
Oct 29, 2019	Supplement 57Labeling · Standard review	Approved	Letter Label
Oct 10, 2017	Supplement 56Labeling · Standard review	Approved	Letter Label
Jan 30, 2017	Supplement 54Labeling · Standard review	Approved	Letter Label
Oct 12, 2016	Supplement 53Labeling · Standard review	Approved	Label
Aug 31, 2016	Supplement 51Labeling · Standard review	Approved	Letter Label
Jun 3, 2016	Supplement 50Manufacturing · Priority review	Approved	None posted
Mar 31, 2016	Supplement 49Labeling · Standard review	Approved	Letter Label
Mar 27, 2015	Supplement 48Labeling · Standard review	Approved	Label Letter
Aug 14, 2014	Supplement 47Manufacturing · Priority review	Approved	None posted
May 23, 2014	Supplement 46Labeling · Standard review	Approved	Label Letter
Jan 22, 2014	Supplement 45Manufacturing · Priority review	Approved	None posted
Jan 15, 2014	Supplement 44Manufacturing · Priority review	Approved	None posted
May 2, 2013	Supplement 43Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review
Aug 10, 2012	Supplement 42Labeling	Approved	Letter Label
Jun 22, 2012	Supplement 41Labeling · Standard review	Approved	Letter Label
Dec 19, 2011	Supplement 40Labeling	Approved	Letter Label
Sep 26, 2011	Supplement 38Labeling	Approved	Letter Label Pediatric Amendment 7 Pediatric Amendment 6
Nov 30, 2010	Supplement 36Labeling · Standard review	Approved	Letter Label
Mar 31, 2010	Supplement 35Labeling	Approved	Letter Label
Sep 23, 2009	Supplement 33Labeling · Standard review	Approved	Letter Label
Mar 11, 2009	Supplement 31Labeling · Standard review	Approved	Label Letter
Aug 18, 2008	Supplement 30Labeling · Standard review	Approved	Label Letter
Jan 24, 2007	Supplement 29Labeling · Standard review	Approved	Letter Label
Mar 28, 2006	Supplement 27Labeling · Standard review	Approved	Review Label Letter
Apr 20, 2005	Supplement 26Labeling · Standard review	Approved	Label Letter
Oct 22, 2004	Supplement 24Labeling · Standard review	Approved	Label Letter
Aug 13, 2004	Supplement 22Efficacy (new indication or use)	Approved	Review Label Letter
Nov 13, 2003	Supplement 21Labeling · Standard review	Approved	Label Letter
Jun 10, 2003	Supplement 19Labeling · Standard review	Approved	Letter Label
Jun 10, 2003	Supplement 18Labeling · Standard review	Approved	Label Letter
Jan 29, 2003	Supplement 16Labeling · Standard review	Approved	Letter Label
Sep 20, 2002	Supplement 17Labeling · Standard review	Approved	Letter
Mar 1, 2002	Supplement 7Labeling · Standard review	Approved	Letter
Feb 28, 2002	Supplement 14Manufacturing · Priority review	Approved	Review
Nov 21, 2001	Supplement 12Manufacturing · Priority review	Approved	None posted
Oct 16, 2001	Supplement 13Labeling · Standard review	Approved	Label
May 16, 2001	Supplement 9Manufacturing · Priority review	Approved	None posted
Apr 12, 2001	Supplement 8Manufacturing · Priority review	Approved	None posted
Nov 14, 2000	Supplement 6Labeling · Standard review	Approved	None posted
May 31, 2000	Supplement 5Manufacturing · Priority review	Approved	None posted
May 31, 2000	Supplement 3Manufacturing · Priority review	Approved	None posted
Apr 18, 2000	Supplement 4Manufacturing · Priority review	Approved	None posted
Feb 9, 2000	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Review Label
Aug 27, 1999	Supplement 2Manufacturing · Priority review	Approved	None posted
Sep 17, 1998	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 20972
Drugs@FDA: Overview at FDA
Company: Bristol-Myers Squibb

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters