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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078679

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NDA 078679 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 078679

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

Pharmacology for NDA: 078679

Medical Subject Heading (MeSH) Categories for 078679

Suppliers and Packaging for NDA: 078679

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 078679 ANDA Sandoz Inc 0781-5342 0781-5342-31 30 TABLET in 1 BOTTLE (0781-5342-31)
QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 078679 ANDA Sandoz Inc 0781-5342 0781-5342-01 100 TABLET in 1 BOTTLE (0781-5342-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Dec 14, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Dec 14, 2012TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Dec 14, 2012TE:ABRLD:No


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