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Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078708

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NDA 078708 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-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. Forty-one suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for 078708
Tradename:ARIPIPRAZOLE
Applicant:Teva Pharms Usa
Ingredient:aripiprazole
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078708
Medical Subject Heading (MeSH) Categories for 078708
Suppliers and Packaging for NDA: 078708
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARIPIPRAZOLE aripiprazole TABLET;ORAL 078708 ANDA Teva Pharmaceuticals USA, Inc. 0093-7581 N 0093-7581-56
ARIPIPRAZOLE aripiprazole TABLET;ORAL 078708 ANDA Teva Pharmaceuticals USA, Inc. 0093-7582 N 0093-7582-56

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Apr 28, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Apr 28, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Apr 28, 2015TE:ABRLD:No

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