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QUETIAPINE FUMARATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVAST LABS · Approved 2017-11-29

Drug application

FDA Application #

ANDA208947

Application type

Abbreviated New Drug Application (Generic)

Brand name

QUETIAPINE FUMARATE

Generic name

QUETIAPINE FUMARATE

Active ingredients

QUETIAPINE FUMARATE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

NOVAST LABS

Manufacturer

Ingenus Pharmaceuticals, LLC

First approval

2017-11-29

Source

Authoritative

Drugs@FDA application overview

Machine

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