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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209497
Company: ALIGNSCIENCE PHARMA

Products on ANDA 209497

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209497

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/28/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/19/2021	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/19/2021	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/19/2021	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/23/2020	SUPPL-2	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/23/2020	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209497

QUETIAPINE FUMARATE

TABLET, EXTENDED RELEASE;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	090681	ACCORD HLTHCARE
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209497	ALIGNSCIENCE PHARMA
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	207655	AUROBINDO PHARMA
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202939	INTELLIPHARMACEUTICS
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204203	LUPIN LTD
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204253	MACLEODS PHARMS LTD
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	208947	NOVAST LABS
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	090482	PAR PHARM
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	206260	PHARMADAX INC
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	208781	PRINSTON INC
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209635	SCIEGEN PHARMS INC
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	215478	UNICHEM
SEROQUEL XR	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	022047	ASTRAZENECA

TABLET, EXTENDED RELEASE;ORAL; EQ 200MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	090681	ACCORD HLTHCARE
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209497	ALIGNSCIENCE PHARMA
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	207655	AUROBINDO PHARMA
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202939	INTELLIPHARMACEUTICS
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204203	LUPIN LTD
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204253	MACLEODS PHARMS LTD
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	208947	NOVAST LABS
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	090482	PAR PHARM
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	206260	PHARMADAX INC
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	208781	PRINSTON INC
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209635	SCIEGEN PHARMS INC
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	215478	UNICHEM
SEROQUEL XR	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	022047	ASTRAZENECA

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