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FDA ANDA · ANDA217155

TRANEXAMIC ACID IN SODIUM CHLORIDE

tranexamic acid

Sponsor: AMNEAL

APPLICATION
ANDA217155
TYPE
ANDA
ORIGINAL APPROVAL
2023-10-16
LATEST ACTION
2025-06-09
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

TRANEXAMIC ACIDPrescription
TRANEXAMIC ACID 1GM/100ML (10MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2025-06-09Labeling · Supplement 3 · standardAP
2024-03-01Labeling · Supplement 1 · standardAP
2023-10-16UNKNOWN · Original · standard — Letter ↗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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