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APIXABAN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: UNICHEM LABS LTD · Approved 2025-11-04

Drug application

FDA Application #
ANDA210108
Application type
Abbreviated New Drug Application (Generic)
Brand name
APIXABAN
Generic name
Apixaban
Active ingredients
APIXABAN
Dosage form
TABLET
Route
FILM COATED
Marketing status
None (Tentative Approval)
Sponsor
UNICHEM LABS LTD
First approval
2025-11-04

Source

Authoritative
Drugs@FDA application overview
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