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CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MACLEODS PHARMACEUTICALS LTD · Approved 2025-10-01

Drug application

FDA Application #
ANDA215255
Application type
Abbreviated New Drug Application (Generic)
Brand name
CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Generic name
Metformin Hydrochloride
Active ingredients
METFORMIN HYDROCHLORIDE; CANAGLIFLOZIN
Dosage form
TABLET, EXTENDED RELEASE
Route
—
Marketing status
None (Tentative Approval)
Sponsor
MACLEODS PHARMACEUTICALS LTD
First approval
2025-10-01

Source

Authoritative
Drugs@FDA application overview
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