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FDA ANDA · ANDA209497

QUETIAPINE EXTENDED-RELEASE

quetiapine

Sponsor: ALIGNSCIENCE PHARMA

APPLICATION
ANDA209497
TYPE
ANDA
ORIGINAL APPROVAL
2018-09-28
LATEST ACTION
2021-07-19
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 200MG BASE · TABLET, EXTENDED RELEASE · ORAL
QUETIAPINE FUMARATEPrescription
QUETIAPINE FUMARATE EQ 150MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2021-07-19Labeling · Supplement 5 · standardAP
2021-07-19Labeling · Supplement 6 · standardAP
2021-07-19Labeling · Supplement 4 · standardAP
2020-01-23Labeling · Supplement 1 · standardAP
2020-01-23Labeling · Supplement 2 · standardAP
2018-09-28UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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