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LURASIDONE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HERITAGE PHARMA AVET · Approved 2019-09-04

Drug application

FDA Application #

ANDA208058

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

HERITAGE PHARMA AVET

Manufacturer

Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc.

First approval

2019-09-04

Source

Authoritative

Drugs@FDA application overview

Machine

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