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FDA NDA · NDA020873

BIVALIRUDIN

Sponsor: SANDOZ

APPLICATION
NDA020873
TYPE
NDA
ORIGINAL APPROVAL
2000-12-15
LATEST ACTION
2019-07-02
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ANGIOMAX · ReferencePrescription
BIVALIRUDIN 250MG/VIAL · INJECTABLE · INTRAVENOUS

Approval history

2019-07-02Labeling · Supplement 39 · standard — Letter ↗AP
2018-12-21Labeling · Supplement 37 · standard — Label ↗AP
2016-05-10Manufacturing (CMC) · Supplement 33 · standardAP
2016-03-21Labeling · Supplement 36 · standard — Letter ↗AP
2016-03-08Manufacturing (CMC) · Supplement 34 · standardAP
2015-09-03Manufacturing (CMC) · Supplement 35 · standardAP
2015-05-29Manufacturing (CMC) · Supplement 32 · standardAP
2014-08-07Manufacturing (CMC) · Supplement 31 · standardAP
2013-07-30Manufacturing (CMC) · Supplement 30 · standardAP
2013-05-17Labeling · Supplement 29 · standard — Letter ↗AP
2013-02-15Manufacturing (CMC) · Supplement 28 · standardAP
2012-11-09Manufacturing (CMC) · Supplement 27 · standardAP
2012-05-30Labeling · Supplement 25 · unknownAP
2010-06-23Labeling · Supplement 23 · standard — Label ↗AP
2005-11-30Efficacy · Supplement 11 · unknown — Letter ↗AP
2005-09-02Labeling · Supplement 14 · standard — Letter ↗AP
2005-06-13Efficacy · Supplement 6 · standard — Letter ↗AP
2004-05-07Labeling · Supplement 9 · standard — Letter ↗AP
2002-06-20Labeling · Supplement 4 · standard — Letter ↗AP
2001-06-22Manufacturing (CMC) · Supplement 3 · standardAP
2001-05-14Manufacturing (CMC) · Supplement 2 · standardAP
2001-04-02Manufacturing (CMC) · Supplement 1 · standardAP
2000-12-15Type 1 - New Molecular Entity · Original · standard — Pediatric Medical Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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