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CRISABOROLE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MACLEODS PHARMS LTD · Approved 2025-06-04

Drug application

FDA Application #
ANDA216242
Application type
Abbreviated New Drug Application (Generic)
Brand name
CRISABOROLE
Generic name
Crisaborole
Active ingredients
CRISABOROLE
Dosage form
OINTMENT
Route
—
Marketing status
None (Tentative Approval)
Sponsor
MACLEODS PHARMS LTD
First approval
2025-06-04

Source

Authoritative
Drugs@FDA application overview
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