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LURASIDONE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS · Approved 2019-03-19

Drug application

FDA Application #
ANDA208052
Application type
Abbreviated New Drug Application (Generic)
Brand name
LURASIDONE HYDROCHLORIDE
Generic name
LURASIDONE HYDROCHLORIDE
Active ingredients
LURASIDONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
ZYDUS PHARMS
Manufacturer
Zydus Pharmaceuticals USA Inc.
First approval
2019-03-19

Source

Authoritative
Drugs@FDA application overview
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