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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 209497

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NDA 209497 describes QUETIAPINE FUMARATE, which is a drug marketed by Accord Hlthcare, Alignscience Pharma, Amneal Pharms, Aurobindo Pharma, Lupin Ltd, Macleods Pharms Ltd, Medicap Labs, Novast Labs, Ph Health, Pharmadax Inc, Prinston Inc, Rising, Sciegen Pharms Inc, Unichem, Actavis Grp Ptc, Alembic, Alkem Labs Ltd, Aurobindo Pharma Ltd, Chartwell Rx, Hetero Labs Ltd V, Hikma, Ipca Labs Ltd, Jubilant Generics, Pharmobedient, Sun Pharm, Teva Pharms, and Torrent Pharms Ltd, and is included in thirty-eight NDAs. It is available from forty-eight suppliers. Additional details are available on the QUETIAPINE FUMARATE profile page.

The generic ingredient in QUETIAPINE FUMARATE is quetiapine fumarate. There are fifty-three drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the quetiapine fumarate profile page.

Summary for 209497

Tradename:	QUETIAPINE FUMARATE
Applicant:	Alignscience Pharma
Ingredient:	quetiapine fumarate
Patents:	0

Medical Subject Heading (MeSH) Categories for 209497

Antipsychotic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 150MG BASE
Approval Date:	Sep 28, 2018	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 200MG BASE
Approval Date:	Sep 28, 2018	TE:	AB	RLD:	No

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