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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Daiichi Sankyo
US Army

Generated: March 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204838

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NDA 204838 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-two 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 suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for 204838
Applicant:Amneal Pharms
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 204838
Medical Subject Heading (MeSH) Categories for 204838
Suppliers and Packaging for NDA: 204838
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARIPIPRAZOLE aripiprazole TABLET;ORAL 204838 ANDA REMEDYREPACK INC. 61786-853 E 61786-853-02
ARIPIPRAZOLE aripiprazole TABLET;ORAL 204838 ANDA Proficient Rx LP 63187-965 N 63187-965-90

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Jun 17, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jun 17, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jun 17, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Argus Health
Queensland Health
Johnson and Johnson

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