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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 090482

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NDA 090482 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 090482

Tradename:	QUETIAPINE FUMARATE
Applicant:	Ph Health
Ingredient:	quetiapine fumarate
Patents:	0

Medical Subject Heading (MeSH) Categories for 090482

Antipsychotic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 50MG BASE
Approval Date:	May 9, 2017	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 150MG BASE
Approval Date:	May 9, 2017	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 200MG BASE
Approval Date:	May 9, 2017	TE:		RLD:	No

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