Norvir

NDA 20659, held by Abbvie. Ritonavir.

As of Nov 15, 2026, NDA 20659 (Norvir), held by Abbvie, was first approved by FDA on Mar 1, 1996, with 57 approved supplements and 0 published complete response letters.

First approved: Mar 1, 1996
Review: Priority
Supplements approved: 57
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 58 submissions below


Oct 6, 2005	Supplement 34Efficacy (new indication or use) · Priority review	Approved	Review Letter Label Pediatric Medical Review
May 26, 1999	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Review
Mar 14, 1997	Supplement 8Efficacy (new indication or use) · Priority review	Approved	None posted
Mar 1, 1996	Original applicationNew molecular entity · Priority review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Norvir80MG/ML · solution;oral	Ritonavir	DiscontinuedReference drug

All 58 submissions, including labeling and manufacturing supplements


Dec 15, 2022	Supplement 73Labeling · Standard review	Approved	Label Letter
Oct 21, 2020	Supplement 72Labeling · Standard review	Approved	Label Letter
Dec 19, 2019	Supplement 71Labeling · Standard review	Approved	Label Letter
Aug 21, 2019	Supplement 70Labeling · Standard review	Approved	Letter Label
Nov 15, 2018	Supplement 69Labeling · Standard review	Approved	Letter Label
Sep 29, 2017	Supplement 68Labeling · Standard review	Approved	Label Letter
Jun 29, 2017	Supplement 66Labeling · Standard review	Approved	Label Letter
Jun 7, 2017	Supplement 67Labeling · Standard review	Approved	Label Letter
Dec 22, 2016	Supplement 64Labeling · Standard review	Approved	Letter Label
Nov 22, 2016	Supplement 63Labeling · Standard review	Approved	Label Letter
Sep 15, 2016	Supplement 65Labeling	Approved	Letter Label
Nov 10, 2015	Supplement 62Labeling · Standard review	Approved	Letter Label
Mar 27, 2015	Supplement 61Labeling	Approved	Label Letter
Mar 16, 2015	Supplement 60Labeling · Standard review	Approved	Label Letter
Nov 7, 2013	Supplement 58Labeling · Standard review	Approved	Label Letter
Nov 20, 2012	Supplement 57Labeling · Standard review	Approved	Label Letter
Feb 17, 2012	Supplement 56Labeling	Approved	Letter Label
Dec 6, 2011	Supplement 55Labeling · Standard review	Approved	Label Letter
Apr 27, 2010	Supplement 50Labeling	Approved	Label Letter
Feb 10, 2010	Supplement 45Labeling · Standard review	Approved	Letter Label
Nov 23, 2009	Supplement 47Labeling · Standard review	Approved	Letter Label
Oct 1, 2008	Supplement 43Labeling · Standard review	Approved	Label Letter
Aug 29, 2008	Supplement 42Labeling · Standard review	Approved	Letter Label
May 16, 2008	Supplement 39Labeling · Standard review	Approved	Letter
Jul 31, 2007	Supplement 40Labeling · Standard review	Approved	Letter Label
May 10, 2007	Supplement 36Labeling · Standard review	Approved	Letter Label
Nov 9, 2005	Supplement 33Labeling · Standard review	Approved	Review Letter Label
Oct 6, 2005	Supplement 34Efficacy (new indication or use) · Priority review	Approved	Review Letter Label Pediatric Medical Review
Mar 28, 2005	Supplement 32Labeling · Standard review	Approved	Letter Label
Sep 10, 2003	Supplement 30Labeling · Standard review	Approved	Letter Label
Dec 24, 2002	Supplement 28Manufacturing · Priority review	Approved	None posted
Mar 14, 2002	Supplement 27Labeling · Standard review	Approved	Letter Label
Aug 21, 2001	Supplement 25Labeling · Standard review	Approved	Label
Mar 6, 2001	Supplement 26Labeling · Standard review	Approved	Letter
Sep 1, 2000	Supplement 24Manufacturing · Priority review	Approved	None posted
May 8, 2000	Supplement 23Labeling · Standard review	Approved	None posted
Oct 28, 1999	Supplement 20Manufacturing · Priority review	Approved	None posted
Oct 26, 1999	Supplement 22Labeling · Standard review	Approved	None posted
Oct 21, 1999	Supplement 21Labeling · Standard review	Approved	None posted
May 26, 1999	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Review
Apr 12, 1999	Supplement 18Labeling · Standard review	Approved	None posted
Apr 9, 1999	Supplement 19Labeling · Standard review	Approved	None posted
Feb 26, 1999	Supplement 17Manufacturing · Priority review	Approved	None posted
Oct 30, 1998	Supplement 16Labeling · Standard review	Approved	None posted
Sep 25, 1998	Supplement 15Manufacturing · Priority review	Approved	None posted
Jul 24, 1998	Supplement 14Manufacturing · Priority review	Approved	None posted
May 1, 1998	Supplement 11Manufacturing · Priority review	Approved	None posted
Feb 12, 1998	Supplement 12Labeling · Standard review	Approved	None posted
Jan 23, 1998	Supplement 10Manufacturing · Priority review	Approved	None posted
Oct 31, 1997	Supplement 9Labeling · Standard review	Approved	None posted
Sep 17, 1997	Supplement 6Manufacturing · Priority review	Approved	None posted
May 9, 1997	Supplement 7Manufacturing · Priority review	Approved	None posted
Mar 14, 1997	Supplement 8Efficacy (new indication or use) · Priority review	Approved	None posted
Jan 8, 1997	Supplement 5Labeling · Standard review	Approved	None posted
Oct 1, 1996	Supplement 3Manufacturing · Priority review	Approved	None posted
Oct 1, 1996	Supplement 1Manufacturing · Priority review	Approved	None posted
Sep 24, 1996	Supplement 4Labeling · Standard review	Approved	None posted
Mar 1, 1996	Original applicationNew molecular entity · Priority review	Approved	Review

Show all 58

Identifiers

Application: NDA 20659
Drugs@FDA: Overview at FDA
Company: AbbVie

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