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FDA NDA · NDA020883

ARGATROBAN

Sponsor: SANDOZ

APPLICATION
NDA020883
TYPE
NDA
ORIGINAL APPROVAL
2000-06-30
LATEST ACTION
2026-06-16
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ARGATROBAN · ReferenceDiscontinued
ARGATROBAN 250MG/2.5ML (100MG/ML) · INJECTABLE · INJECTION

Approval history

2026-06-16Labeling · Supplement 21 · standard — Letter ↗AP
2017-08-08Labeling · Supplement 19 · standard — Label ↗AP
2016-05-25Labeling · Supplement 18 · standard — Letter ↗AP
2016-01-26Manufacturing (CMC) · Supplement 15AP
2014-03-10Labeling · Supplement 16 · standard — Letter ↗AP
2008-05-05Efficacy · Supplement 14 · priority — Label ↗AP
2005-09-01Labeling · Supplement 9 · standard — Letter ↗AP
2005-04-11Labeling · Supplement 10 · standard — Letter ↗AP
2003-10-29Labeling · Supplement 7 · standard — Letter ↗AP
2002-07-01Manufacturing (CMC) · Supplement 5 · standardAP
2002-04-03Efficacy · Supplement 4 · priority — Label ↗AP
2000-08-22Labeling · Supplement 3 · standardAP
2000-06-30Type 1 - New Molecular Entity · Original · standard — Letter ↗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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