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Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson
Chinese Patent Office
Fish and Richardson

Generated: November 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091388

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NDA 091388 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-five 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 suppliers are listed for this compound. Additional details are available on the quetiapine fumarate profile page.

Summary for 091388

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

Pharmacology for NDA: 091388

Medical Subject Heading (MeSH) Categories for 091388

Suppliers and Packaging for NDA: 091388

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
quetiapine fumarate
TABLET;ORAL 091388 ANDA Safecor Health, LLC 48433-324 48433-324-10 100 POUCH in 1 BOX, UNIT-DOSE (48433-324-10) > 1 TABLET, FILM COATED in 1 POUCH (48433-324-01)
quetiapine fumarate
TABLET;ORAL 091388 ANDA Citron Pharma LLC 57237-079 57237-079-01 100 TABLET, FILM COATED in 1 BOTTLE (57237-079-01)

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:

Argus Health
Express Scripts
Johnson and Johnson

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