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FDA NDA · NDA022485

ARGATROBAN

Sponsor: PLANO PHARMS

APPLICATION
NDA022485
TYPE
NDA
ORIGINAL APPROVAL
2011-05-09
LATEST ACTION
2019-04-29
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ARGATROBAN IN SODIUM CHLORIDE · ReferencePrescription
ARGATROBAN 125MG/125ML (1MG/ML) · INJECTABLE · INTRAVENOUS

Approval history

2019-04-29Labeling · Supplement 13 · standard — Letter ↗AP
2018-07-03Labeling · Supplement 11 · standard — Letter ↗AP
2016-05-26Labeling · Supplement 9 · standard — Label ↗AP
2015-12-01Manufacturing (CMC) · Supplement 5 · standardAP
2014-09-11Manufacturing (CMC) · Supplement 2 · standardAP
2011-05-09Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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