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Serving leading biopharmaceutical companies globally:

Cerilliant
US Army
Chubb
Julphar
Baxter
Argus Health
Chinese Patent Office
UBS
Colorcon
Queensland Health

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078607

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NDA 078607 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 078607
Tradename:ARIPIPRAZOLE
Applicant:Teva Pharms Usa
Ingredient:aripiprazole
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078607
Medical Subject Heading (MeSH) Categories for 078607
Suppliers and Packaging for NDA: 078607
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARIPIPRAZOLE aripiprazole TABLET;ORAL 078607 ANDA Teva Pharmaceuticals USA, Inc. 0093-7569 0093-7569-56 30 TABLET in 1 BOTTLE (0093-7569-56)
ARIPIPRAZOLE aripiprazole TABLET;ORAL 078607 ANDA Teva Pharmaceuticals USA, Inc. 0093-7613 0093-7613-56 30 TABLET in 1 BOTTLE (0093-7613-56)

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

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Serving leading biopharmaceutical companies globally:

Baxter
McKinsey
Medtronic
Johnson and Johnson
Merck
Boehringer Ingelheim
Chubb
Fuji
Teva

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