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Serving leading biopharmaceutical companies globally:

US Department of Justice
Argus Health
Chinese Patent Office
US Army

Generated: October 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203150

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NDA 203150 describes QUETIAPINE FUMARATE, which is a drug marketed by Lupin Ltd, Alkem Labs Ltd, West-ward Pharms Int, Mylan Pharms Inc, Intellipharmaceutics, Teva Pharms, Jubilant Generics, Accord Hlthcare, Macleods Pharms Ltd, Pharmadax Inc, Apotex Inc, Actavis Grp Ptc, Torrent Pharms Ltd, Unichem Labs Ltd, Sandoz, Dr Reddys Labs Ltd, Par Pharm, Aurobindo Pharma Ltd, Alembic Pharms Ltd, and Sun Pharma Global, and is included in twenty-three 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-one drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the quetiapine fumarate profile page.

Summary for NDA: 203150

Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 203150

Suppliers and Packaging for NDA: 203150

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
quetiapine fumarate
TABLET;ORAL 203150 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-348 59746-348-01 100 TABLET in 1 BOTTLE (59746-348-01)
quetiapine fumarate
TABLET;ORAL 203150 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-348 59746-348-03 10 BLISTER PACK in 1 CARTON (59746-348-03) > 10 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Nov 26, 2013TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Queensland Health
Fish and Richardson
Boehringer Ingelheim
Argus Health
Chinese Patent Office
Johnson and Johnson

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