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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Chinese Patent Office
Accenture
Mallinckrodt
Cipla
US Department of Justice
McKesson
Colorcon
Cantor Fitzgerald

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078608

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NDA 078608 describes ARIPIPRAZOLE, which is a drug marketed by Amneal Pharms, Apotex Inc, Lannett Co Inc, Alembic Pharms Ltd, Orchid Hlthcare, Sciegen Pharms Inc, Accord Hlthcare, Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Macleods Pharms Ltd, Prinston Inc, Santos Biotech, Teva Pharms Usa, and Torrent Pharms Ltd, and is included in twenty-two NDAs. It is available from thirty-five suppliers. Additional details are available on the ARIPIPRAZOLE profile page.

The generic ingredient in ARIPIPRAZOLE is aripiprazole. There are forty-five drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for 078608
Tradename:ARIPIPRAZOLE
Applicant:Teva Pharms Usa
Ingredient:aripiprazole
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078608
Medical Subject Heading (MeSH) Categories for 078608
Suppliers and Packaging for NDA: 078608
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARIPIPRAZOLE aripiprazole TABLET;ORAL 078608 ANDA Teva Pharmaceuticals USA, Inc. 0093-7580 N 0093-7580-56
ARIPIPRAZOLE aripiprazole TABLET;ORAL 078608 ANDA REMEDYREPACK INC. 70518-0678 N 70518-0678-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Apr 28, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Farmers Insurance
Cerilliant
Accenture
Medtronic
Merck
Teva
Chubb
Cipla

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