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QUETIAPINE FUMARATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PRINSTON INC · Approved 2022-04-26

Drug application

FDA Application #

ANDA208781

Application type

Abbreviated New Drug Application (Generic)

Brand name

QUETIAPINE FUMARATE

Generic name

QUETIAPINE

Active ingredients

QUETIAPINE FUMARATE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

PRINSTON INC

Manufacturer

Solco Healthcare U.S., LLC

First approval

2022-04-26

Source

Authoritative

Drugs@FDA application overview

Machine

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