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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Colorcon
US Army
UBS
Harvard Business School
Federal Trade Commission
Queensland Health
Mallinckrodt
Farmers Insurance

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203906

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NDA 203906 describes ARIPIPRAZOLE, which is a drug marketed by Amneal Pharms, Apotex Inc, Silarx Pharms Inc, Alembic Pharms Ltd, Orchid Hlthcare, Accord Hlthcare, Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Macleods Pharms Ltd, Prinston Inc, Santos Biotech, Sciegen Pharms Inc, Teva Pharms Usa, and Torrent Pharms Ltd, and is included in twenty-one NDAs. It is available from thirty-four 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. Thirty-seven suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for 203906
Tradename:ARIPIPRAZOLE
Applicant:Amneal Pharms
Ingredient:aripiprazole
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203906
Medical Subject Heading (MeSH) Categories for 203906
Suppliers and Packaging for NDA: 203906
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARIPIPRAZOLE aripiprazole SOLUTION;ORAL 203906 ANDA Amneal Pharmaceuticals LLC 65162-893 N 65162-893-74

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength1MG/ML
Approval Date:Aug 14, 2015TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Merck
Daiichi Sankyo
Accenture
Colorcon
Queensland Health
Harvard Business School
Cantor Fitzgerald
Express Scripts

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