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Medtronic
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Cantor Fitzgerald
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Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090960

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NDA 090960 describes QUETIAPINE FUMARATE, which is a drug marketed by Accord Hlthcare, Anchen Pharms, Aurobindo Pharma Ltd, Intellipharmaceutics, Lupin Ltd, Macleods Pharms Ltd, Novast Labs Ltd, Par Pharm, Pharmadax Inc, Sciegen Pharms Inc, Actavis Grp Ptc, Alembic Pharms Ltd, Alkem Labs Ltd, Apotex Inc, Dr Reddys Labs Ltd, Jubilant Generics, Mylan Pharms Inc, Sandoz, Sun Pharma Global, Teva Pharms, Torrent Pharms Ltd, Unichem Labs Ltd, and West-ward Pharms Int, and is included in twenty-nine NDAs. It is available from fifty suppliers. Additional details are available on the QUETIAPINE FUMARATE profile page.

The generic ingredient in QUETIAPINE FUMARATE is quetiapine fumarate. There are fifty-two drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the quetiapine fumarate profile page.
Summary for 090960
Tradename:QUETIAPINE FUMARATE
Applicant:Apotex Inc
Ingredient:quetiapine fumarate
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090960
Medical Subject Heading (MeSH) Categories for 090960
Suppliers and Packaging for NDA: 090960
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 090960 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-150 N 43353-150-53
QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 090960 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-153 N 43353-153-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Mar 27, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Mar 27, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Mar 27, 2012TE:ABRLD:No

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US Department of Justice
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