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EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MSN LABS PVT LTD · Approved 2023-01-31

Drug application

FDA Application #
ANDA212362
Application type
Abbreviated New Drug Application (Generic)
Brand name
EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE
Generic name
Empagliflozin
Active ingredients
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
None (Tentative Approval)
Sponsor
MSN LABS PVT LTD
First approval
2023-01-31

Source

Authoritative
Drugs@FDA application overview
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