FDA NDA · NDA212035

ARGATROBAN

Sponsor: ACCORD HLTHCARE

APPLICATION

NDA212035

TYPE

NDA

ORIGINAL APPROVAL

2021-06-07

LATEST ACTION

2026-05-21

ROUTE

INTRAVENOUS

DOSAGE FORM

SOLUTION

MARKETING STATUS

Prescription

Products

ARGATROBAN IN SODIUM CHLORIDE · ReferencePrescription

ARGATROBAN 50MG/50ML (1MG/ML) · SOLUTION · INTRAVENOUS

2026-05-21Labeling · Supplement 3 · standard — Label ↗AP

2021-06-07Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗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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