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QUETIAPINE FUMARATE

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

Drug application

FDA Application #

ANDA209635

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

SCIEGEN PHARMS

Manufacturer

ACI Healthcare USA, Inc.

First approval

2017-11-29

Source

Authoritative

Drugs@FDA application overview

Machine

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