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QUETIAPINE FUMARATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALIGNSCIENCE PHARMA · Approved 2018-09-28

Drug application

FDA Application #
ANDA209497
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
ALIGNSCIENCE PHARMA
Manufacturer
AlignScience Pharma Inc.
First approval
2018-09-28

Source

Authoritative
Drugs@FDA application overview
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