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FDA NDA · NDA201743

ARGATROBAN IN DEXTROSE

Sponsor: SANDOZ

APPLICATION
NDA201743
TYPE
NDA
ORIGINAL APPROVAL
2011-05-09
LATEST ACTION
2026-06-03
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

ARGATROBAN IN DEXTROSEDiscontinued
ARGATROBAN 125MG/125ML (1MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2026-06-03Labeling · Supplement 3 · standard — Letter ↗AP
2018-06-22Labeling · Supplement 2 · standard — Label ↗AP
2016-05-26Labeling · Supplement 1 · standard — Letter ↗AP
2011-05-09Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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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