← FDA Drug Approvals (Drugs@FDA)

TRANEXAMIC ACID

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: FRESENIUS KABI USA · Approved 2024-08-15

Drug application

FDA Application #

ANDA218242

Application type

Abbreviated New Drug Application (Generic)

Brand name

TRANEXAMIC ACID

Generic name

TRANEXAMIC ACID

Active ingredients

TRANEXAMIC ACID

Dosage form

SOLUTION

Route

INTRAVENOUS

Marketing status

Prescription

Sponsor

FRESENIUS KABI USA

Manufacturer

HP Halden Pharma AS

First approval

2024-08-15

Source

Authoritative

Drugs@FDA application overview

Machine

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