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Generated: June 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205064

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NDA 205064 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-six 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-three suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for 205064
Tradename:ARIPIPRAZOLE
Applicant:Hetero Labs Ltd V
Ingredient:aripiprazole
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 205064
Medical Subject Heading (MeSH) Categories for 205064
Suppliers and Packaging for NDA: 205064
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARIPIPRAZOLE aripiprazole TABLET;ORAL 205064 ANDA Camber Pharmaceuticals, Inc. 31722-819 N 31722-819-01
ARIPIPRAZOLE aripiprazole TABLET;ORAL 205064 ANDA Camber Pharmaceuticals, Inc. 31722-819 N 31722-819-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Apr 28, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 28, 2015TE:ABRLD:No

Profile for product number 003

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

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