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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 090120

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NDA 090120 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-nine 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 090120

Tradename:	QUETIAPINE FUMARATE
Applicant:	Hikma
Ingredient:	quetiapine fumarate
Patents:	0

Pharmacology for NDA: 090120

Medical Subject Heading (MeSH) Categories for 090120

Antipsychotic Agents

Suppliers and Packaging for NDA: 090120

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
QUETIAPINE FUMARATE	quetiapine fumarate	TABLET;ORAL	090120	ANDA	Hikma Pharmaceuticals USA Inc.	0054-0220	0054-0220-20	10 BLISTER PACK in 1 CARTON (0054-0220-20) / 10 TABLET in 1 BLISTER PACK
QUETIAPINE FUMARATE	quetiapine fumarate	TABLET;ORAL	090120	ANDA	Hikma Pharmaceuticals USA Inc.	0054-0220	0054-0220-25	100 TABLET in 1 BOTTLE (0054-0220-25)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 25MG BASE
Approval Date:	Mar 27, 2012	TE:	AB	RLD:	No

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