BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Colorcon
Cantor Fitzgerald
Daiichi Sankyo
Federal Trade Commission
Novartis
Queensland Health
Fish and Richardson
Cipla
Accenture
Covington

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203359

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NDA 203359 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-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 203359
Tradename:QUETIAPINE FUMARATE
Applicant:Macleods Pharms Ltd
Ingredient:quetiapine fumarate
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203359
Medical Subject Heading (MeSH) Categories for 203359
Suppliers and Packaging for NDA: 203359
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 203359 ANDA Macleods Pharmaceuticals Limited 33342-099 33342-099-44 1000 TABLET, FILM COATED in 1 BOTTLE (33342-099-44)
QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 203359 ANDA Macleods Pharmaceuticals Limited 33342-099 33342-099-11 100 TABLET, FILM COATED in 1 BOTTLE (33342-099-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:May 17, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:May 17, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:May 17, 2016TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Cipla
Novartis
Express Scripts
Covington
Colorcon
Cerilliant
Moodys
US Department of Justice

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