Angiomax

For heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis…. NDA 20873, held by Sandoz. Bivalirudin.

As of Nov 14, 2026, NDA 20873 (Angiomax), held by Sandoz, was first approved by FDA on Dec 15, 2000, with 22 approved supplements and 0 published complete response letters.

First approved: Dec 15, 2000
Review: Standard
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Bivalirudin for injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. Bivalirudin for injection is a direct thrombin inhibitor indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below


Nov 30, 2005	Supplement 11Efficacy (new indication or use)	Approved	Letter Label
Jun 13, 2005	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter
Dec 15, 2000	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter Pediatric Medical Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Angiomax250MG/VIAL · injectable;intravenous	Bivalirudin	RxReference drug

All 23 submissions, including labeling and manufacturing supplements


Jul 2, 2019	Supplement 39Labeling · Standard review	Approved	Label Letter
Dec 21, 2018	Supplement 37Labeling · Standard review	Approved	Label
May 10, 2016	Supplement 33Manufacturing · Standard review	Approved	None posted
Mar 21, 2016	Supplement 36Labeling · Standard review	Approved	Letter Label
Mar 8, 2016	Supplement 34Manufacturing · Standard review	Approved	None posted
Sep 3, 2015	Supplement 35Manufacturing · Standard review	Approved	None posted
May 29, 2015	Supplement 32Manufacturing · Standard review	Approved	None posted
Aug 7, 2014	Supplement 31Manufacturing · Standard review	Approved	None posted
Jul 30, 2013	Supplement 30Manufacturing · Standard review	Approved	None posted
May 17, 2013	Supplement 29Labeling · Standard review	Approved	Letter Label
Feb 15, 2013	Supplement 28Manufacturing · Standard review	Approved	None posted
Nov 9, 2012	Supplement 27Manufacturing · Standard review	Approved	None posted
May 30, 2012	Supplement 25Labeling	Approved	None posted
Jun 23, 2010	Supplement 23Labeling · Standard review	Approved	Label Letter
Nov 30, 2005	Supplement 11Efficacy (new indication or use)	Approved	Letter Label
Sep 2, 2005	Supplement 14Labeling · Standard review	Approved	Letter
Jun 13, 2005	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter
May 7, 2004	Supplement 9Labeling · Standard review	Approved	Letter
Jun 20, 2002	Supplement 4Labeling · Standard review	Approved	Letter
Jun 22, 2001	Supplement 3Manufacturing · Standard review	Approved	None posted
May 14, 2001	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 2, 2001	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 15, 2000	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter Pediatric Medical Review

Identifiers

Application: NDA 20873
Drugs@FDA: Overview at FDA
Company: Sandoz

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