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FDA NDA · NDA022434

ARGATROBAN IN SODIUM CHLORIDE

Sponsor: CIPLA

APPLICATION
NDA022434
TYPE
NDA
ORIGINAL APPROVAL
2011-06-29
LATEST ACTION
2026-06-10
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ARGATROBAN IN SODIUM CHLORIDE · ReferenceDiscontinued
ARGATROBAN 50MG/50ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INTRAVENOUS

Approval history

2026-06-10Labeling · Supplement 14 · standard — Letter ↗AP
2019-12-06Labeling · Supplement 13 · standard — Letter ↗AP
2018-06-18Labeling · Supplement 11 · standard — Letter ↗AP
2016-05-26Labeling · Supplement 10 · standard — Label ↗AP
2015-08-18Manufacturing (CMC) · Supplement 8 · standardAP
2015-08-05Manufacturing (CMC) · Supplement 7 · standardAP
2014-09-09Labeling · Supplement 6 · standard — Label ↗AP
2014-01-16Manufacturing (CMC) · Supplement 5 · standardAP
2013-06-10Manufacturing (CMC) · Supplement 4 · standardAP
2013-05-20Manufacturing (CMC) · Supplement 3 · standardAP
2011-06-29Type 5 - New Formulation or New Manufacturer · Original · standard — 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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