FDA NDA · NDA201811

ARGATROBAN

Sponsor: FRESENIUS KABI USA

APPLICATION

NDA201811

TYPE

NDA

ORIGINAL APPROVAL

2015-03-23

LATEST ACTION

2026-07-13

ROUTE

INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Discontinued

Products

ARGATROBANDiscontinued

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

2026-07-13Labeling · Supplement 12 · standard — Label ↗AP

2018-01-30Labeling · Supplement 6 · standard — Letter ↗AP

2016-05-25Labeling · Supplement 3 · standard — Label ↗AP

2015-12-11Labeling · Supplement 1 · standardAP

2015-03-23Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP

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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