Aptivus

NDA 21814, held by Boehringer Ingelheim. Tipranavir.

As of Nov 15, 2026, NDA 21814 (Aptivus), held by Boehringer Ingelheim, was first approved by FDA on Jun 22, 2005, with 16 approved supplements and 0 published complete response letters.

First approved: Jun 22, 2005
Review: Priority
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below


Jun 23, 2008	Supplement 5Efficacy (new indication or use) · Priority review	Approved	Review Summary Review Letter Label
Oct 4, 2007	Supplement 3Efficacy (new indication or use)	Approved	Label Letter
Jun 22, 2005	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label Pediatric Medical Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aptivus250MG · capsule;oral	Tipranavir	RxReference drug

All 17 submissions, including labeling and manufacturing supplements


Apr 3, 2024	Supplement 30Labeling · Standard review	Approved	Letter Label
Jun 18, 2020	Supplement 21Labeling · Standard review	Approved	Label Letter
Jun 22, 2018	Supplement 18Labeling · Standard review	Approved	Letter Label
Sep 15, 2016	Supplement 16Labeling	Approved	Label Letter
Mar 27, 2015	Supplement 15Labeling	Approved	Label Letter
Apr 7, 2014	Supplement 14Labeling · Standard review	Approved	Letter Label
Feb 17, 2012	Supplement 13Labeling	Approved	Letter Label
Apr 5, 2011	Supplement 11Labeling · Standard review	Approved	Letter Label
Aug 16, 2010	Supplement 9Labeling · Standard review	Approved	Letter Label
Apr 27, 2010	Supplement 8Labeling	Approved	Label Letter
Jun 19, 2009	Supplement 6Labeling · Standard review	Approved	Letter Label
Jun 23, 2008	Supplement 5Efficacy (new indication or use) · Priority review	Approved	Review Summary Review Letter Label
Oct 4, 2007	Supplement 3Efficacy (new indication or use)	Approved	Label Letter
May 14, 2007	Supplement 4Labeling · Standard review	Approved	Letter
Aug 11, 2006	Supplement 1Labeling · Standard review	Approved	Letter Label
Aug 11, 2006	Supplement 2Labeling · Standard review	Approved	Letter Label
Jun 22, 2005	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label Pediatric Medical Review

Identifiers

Application: NDA 21814
Drugs@FDA: Overview at FDA
Company: Boehringer Ingelheim Pharmaceuticals, Inc.

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