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Serving 500+ biopharmaceutical companies globally:

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Generated: July 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201109

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NDA 201109 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-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-three suppliers are listed for this compound. Additional details are available on the quetiapine fumarate profile page.

Summary for NDA: 201109

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

Pharmacology for NDA: 201109

Suppliers and Packaging for NDA: 201109

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUETIAPINE FUMARATE
quetiapine fumarate
TABLET;ORAL 201109 ANDA LUPIN LIMITED 57297-445 57297-445-01 100 TABLET in 1 BOTTLE (57297-445-01)
QUETIAPINE FUMARATE
quetiapine fumarate
TABLET;ORAL 201109 ANDA LUPIN LIMITED 57297-445 57297-445-03 1000 TABLET in 1 BOTTLE (57297-445-03)

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 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
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Argus Health
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