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Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201504

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NDA 201504 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 201504
Tradename:QUETIAPINE FUMARATE
Applicant:Alkem Labs Ltd
Ingredient:quetiapine fumarate
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 201504
Medical Subject Heading (MeSH) Categories for 201504
Suppliers and Packaging for NDA: 201504
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 201504 ANDA Major Pharmaceuticals 0904-6638 0904-6638-61 100 BLISTER PACK in 1 CARTON (0904-6638-61) > 1 TABLET in 1 BLISTER PACK
QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 201504 ANDA Major Pharmaceuticals 0904-6639 0904-6639-61 100 BLISTER PACK in 1 CARTON (0904-6639-61) > 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Feb 12, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Feb 12, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Feb 12, 2013TE:ABRLD:No

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