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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 206252

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NDA 206252 describes QUETIAPINE FUMARATE, which is a drug marketed by Accord Hlthcare, Alignscience Pharma, Amneal Pharms, Aurobindo Pharma, Endo Operations, Intellipharmaceutics, Lupin Ltd, Macleods Pharms Ltd, Novast Labs, Pharmadax Inc, Prinston Inc, Rising, Sciegen Pharms Inc, Unichem, Actavis Grp Ptc, Alembic, Alkem Labs Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma, Ipca Labs Ltd, Jubilant Generics, Norvium Bioscience, Sandoz, Sun Pharm, Teva Pharms, and Torrent Pharms Ltd, and is included in thirty-seven NDAs. It is available from forty-seven 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. Forty-eight suppliers are listed for this compound. Additional details are available on the quetiapine fumarate profile page.

Summary for 206252

Tradename:	QUETIAPINE FUMARATE
Applicant:	Accord Hlthcare
Ingredient:	quetiapine fumarate
Patents:	0

Pharmacology for NDA: 206252

Medical Subject Heading (MeSH) Categories for 206252

Antipsychotic Agents

Suppliers and Packaging for NDA: 206252

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
QUETIAPINE FUMARATE	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	206252	ANDA	Accord Healthcare Inc.	16729-132	16729-132-12	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-132-12)
QUETIAPINE FUMARATE	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	206252	ANDA	Bluepoint Laboratories	68001-511	68001-511-06	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-511-06)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 50MG BASE
Approval Date:	Nov 29, 2017	TE:	AB	RLD:	No

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