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Serving leading biopharmaceutical companies globally:

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Harvard Business School
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Generated: January 23, 2018

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 Accord Hlthcare, Intellipharmaceutics, Lupin Ltd, Par Pharm, Pharmadax Inc, Actavis Grp Ptc, Alembic Pharms Ltd, Alkem Labs Ltd, Apotex Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Jubilant Generics, Macleods Pharms Ltd, 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-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-two 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 203150
Tradename:QUETIAPINE FUMARATE
Applicant:Jubilant Generics
Ingredient:quetiapine fumarate
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203150
Medical Subject Heading (MeSH) Categories for 203150
Suppliers and Packaging for NDA: 203150
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 203150 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-348 59746-348-60 60 TABLET in 1 BOTTLE (59746-348-60)
QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 203150 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-348 59746-348-01 100 TABLET in 1 BOTTLE (59746-348-01)

Profile for product number 001

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

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