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Serving leading biopharmaceutical companies globally:

Accenture
QuintilesIMS
Cipla
Boehringer Ingelheim
Moodys
Chubb
Medtronic
Merck
Citi
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Generated: January 18, 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, Silarx Pharms Inc, Alembic Pharms Ltd, Accord Hlthcare, Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Macleods Pharms Ltd, Orchid Hlthcare, Santos Biotech, Sciegen Pharms Inc, Teva Pharms Usa, and Torrent Pharms Ltd, and is included in nineteen NDAs. It is available from thirty 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-nine 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 0093-7580-56 30 TABLET in 1 BOTTLE (0093-7580-56)
ARIPIPRAZOLE aripiprazole TABLET;ORAL 078608 ANDA REMEDYREPACK INC. 70518-0678 70518-0678-0 30 TABLET in 1 BLISTER PACK (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 leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
Baxter
Deloitte
Harvard Business School
Fish and Richardson
Medtronic
Dow
Accenture

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