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LURASIDONE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PAR PHARM INC · Approved 2017-05-19

Drug application

FDA Application #

ANDA207948

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

None (Tentative Approval)

Sponsor

PAR PHARM INC

First approval

2017-05-19

Source

Authoritative

Drugs@FDA application overview

Machine

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