Aptivus

NDA 22292, held by Boehringer Ingelheim. Tipranavir.

As of Nov 13, 2026, NDA 22292 (Aptivus), held by Boehringer Ingelheim, was first approved by FDA on Jun 23, 2008, with 10 approved supplements and 0 published complete response letters.

First approved: Jun 23, 2008
Review: Priority
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jun 23, 2008	Original applicationNew dosage form · Priority review	Approved	Review Summary Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aptivus100MG/ML · solution;oral	Tipranavir	DiscontinuedReference drug

All 11 submissions, including labeling and manufacturing supplements


Jun 18, 2020	Supplement 14Labeling · Standard review	Approved	Label Letter
Jun 22, 2018	Supplement 10Labeling · Standard review	Approved	Letter Label
Sep 15, 2016	Supplement 9Labeling	Approved	Label Letter
Mar 27, 2015	Supplement 8Labeling	Approved	Label Letter
Apr 7, 2014	Supplement 7Labeling · Standard review	Approved	Letter Label
Feb 17, 2012	Supplement 6Labeling	Approved	Letter Label
Apr 5, 2011	Supplement 4Labeling · Standard review	Approved	Letter Label
Aug 16, 2010	Supplement 3Labeling · Standard review	Approved	Letter Label
Apr 27, 2010	Supplement 2Labeling	Approved	Label Letter
Jun 19, 2009	Supplement 1Labeling · Standard review	Approved	Letter Label
Jun 23, 2008	Original applicationNew dosage form · Priority review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 22292
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