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BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Cantor Fitzgerald
Harvard Business School
Chubb
Mallinckrodt
Covington
Boehringer Ingelheim
Federal Trade Commission
UBS
Colorcon

Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201190

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NDA 201190 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-six 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-one suppliers are listed for this compound. Additional details are available on the quetiapine fumarate profile page.

Summary for 201190

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 201190

Medical Subject Heading (MeSH) Categories for 201190

Suppliers and Packaging for NDA: 201190

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 201190 ANDA Sun Pharma Global FZE 47335-902 47335-902-18 1000 TABLET, FILM COATED in 1 BOTTLE (47335-902-18)
QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 201190 ANDA Sun Pharma Global FZE 47335-902 47335-902-83 30 TABLET, FILM COATED in 1 BOTTLE (47335-902-83)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Serving leading biopharmaceutical companies globally:

Novartis
Medtronic
McKinsey
Citi
Boehringer Ingelheim
Chubb
US Department of Justice
AstraZeneca
Johnson and Johnson
Teva

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