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BOSUTINIB

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SUN PHARM INDUSTRIES · Approved 2023-08-25

Drug application

FDA Application #
ANDA209577
Application type
Abbreviated New Drug Application (Generic)
Brand name
BOSUTINIB
Generic name
Bosutinib Monohydrate
Active ingredients
BOSUTINIB MONOHYDRATE
Dosage form
TABLET
Route
FILM COATED
Marketing status
None (Tentative Approval)
Sponsor
SUN PHARM INDUSTRIES
First approval
2023-08-25

Source

Authoritative
Drugs@FDA application overview
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