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EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: LUPIN LTD · Approved 2021-01-06

Drug application

FDA Application #
ANDA213654
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
LUPIN LTD
First approval
2021-01-06

Source

Authoritative
Drugs@FDA application overview
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