Tools / Drug approvals and letters / Drugs Zerit NDA 20412, held by Bristol . Stavudine
As of Nov 14, 2026, NDA 20412 (Zerit), held by Bristol, was first approved by FDA on Jun 24, 1994, with 32 approved supplements and 0 published complete response letters.
First approved : Jun 24, 1994 Review : Priority Supplements approved : 32 Complete response letters : 0
Approvals and New Uses The original application and every efficacy supplement, newest first; all 33 submissions below Date Submission Status Documents Mar 29, 2002 Supplement 16Efficacy (new indication or use) · Standard review Approved Letter Label Jul 1, 1999 Supplement 10Efficacy (new indication or use) · Standard review Approved None posted Sep 6, 1996 Supplement 4Efficacy (new indication or use) · Priority review Approved None posted Dec 21, 1995 Supplement 2Efficacy (new indication or use) Approved None posted Jun 24, 1994 Original applicationNew molecular entity · Priority review Approved None posted
Products 5 strengths and forms Product Active ingredient Marketing Zerit5MG · capsule;oral Stavudine Discontinued Zerit15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral Stavudine Discontinued Reference drug Zerit20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral Stavudine Discontinued Reference drug Zerit30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral Stavudine Discontinued Reference drug Zerit40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral Stavudine Discontinued Reference drug
All 33 submissions, including labeling and manufacturing supplements Date Submission Status Documents Dec 17, 2018 Supplement 41Labeling · Standard review Approved Letter Label Medication Guide Dec 19, 2017 Supplement 40Labeling · Standard review Approved Letter Label Jul 14, 2015 Supplement 39Manufacturing · Priority review Approved None posted Nov 18, 2011 Supplement 38Labeling Approved Letter Label May 11, 2011 Supplement 37REMS Approved Letter Dec 10, 2010 Supplement 36Labeling · Standard review Approved Letter Label Jul 8, 2009 Supplement 34Labeling · Standard review Approved Letter Label Feb 13, 2009 Supplement 33Labeling · Standard review Approved Label Letter Dec 11, 2008 Supplement 32Labeling · Standard review Approved Label Letter Apr 14, 2008 Supplement 30Labeling · Standard review Approved Label Letter Apr 14, 2008 Supplement 29Labeling · Standard review Approved Label Letter Jun 20, 2007 Supplement 27Labeling · Standard review Approved Letter Letter Dec 20, 2005 Supplement 24Labeling · Priority review Approved Label Jun 4, 2004 Supplement 23Labeling · Standard review Approved Letter Label Mar 29, 2002 Supplement 16Efficacy (new indication or use) · Standard review Approved Letter Label Feb 20, 2002 Supplement 18Labeling · Standard review Approved Letter Feb 20, 2002 Supplement 17Labeling · Standard review Approved Letter Oct 16, 2001 Supplement 15Labeling · Standard review Approved Label Apr 17, 2001 Supplement 14Manufacturing · Priority review Approved None posted Sep 27, 2000 Supplement 13Labeling · Standard review Approved None posted Jul 1, 1999 Supplement 10Efficacy (new indication or use) · Standard review Approved None posted Jun 10, 1999 Supplement 12Manufacturing · Priority review Approved None posted Sep 16, 1998 Supplement 11Labeling · Standard review Approved None posted Aug 19, 1998 Supplement 9Manufacturing · Priority review Approved None posted Feb 4, 1998 Supplement 5Labeling · Standard review Approved None posted Feb 3, 1998 Supplement 7Manufacturing · Priority review Approved None posted Jan 16, 1998 Supplement 8Manufacturing · Priority review Approved None posted Sep 26, 1997 Supplement 6Manufacturing · Priority review Approved None posted Sep 6, 1996 Supplement 4Efficacy (new indication or use) · Priority review Approved None posted Feb 9, 1996 Supplement 3Manufacturing · Priority review Approved None posted Dec 21, 1995 Supplement 2Efficacy (new indication or use) Approved None posted Aug 2, 1994 Supplement 1Manufacturing · Priority review Approved None posted Jun 24, 1994 Original applicationNew molecular entity · Priority review Approved None posted
Identifiers
Application NDA 20412 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
