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TRANEXAMIC ACID

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: APPCO · Approved 2025-06-11

Drug application

FDA Application #
ANDA218729
Application type
Abbreviated New Drug Application (Generic)
Brand name
TRANEXAMIC ACID
Generic name
TRANEXAMIC ACID
Active ingredients
TRANEXAMIC ACID
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
APPCO
Manufacturer
Dr. Reddy's Laboratories Inc.
First approval
2025-06-11

Source

Authoritative
Drugs@FDA application overview
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