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Serving leading biopharmaceutical companies globally:

Julphar
Baxter
Cerilliant
Harvard Business School
Dow
Medtronic
AstraZeneca
McKinsey
Argus Health
Boehringer Ingelheim

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204111

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NDA 204111 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 204111
Tradename:ARIPIPRAZOLE
Applicant:Macleods Pharms Ltd
Ingredient:aripiprazole
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 204111
Medical Subject Heading (MeSH) Categories for 204111
Suppliers and Packaging for NDA: 204111
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARIPIPRAZOLE aripiprazole TABLET;ORAL 204111 ANDA Macleods Pharmaceuticals Limited 33342-122 33342-122-11 100 TABLET in 1 BOTTLE (33342-122-11)
ARIPIPRAZOLE aripiprazole TABLET;ORAL 204111 ANDA Macleods Pharmaceuticals Limited 33342-122 33342-122-12 10 BLISTER PACK in 1 CARTON (33342-122-12) > 10 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Oct 7, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Oct 7, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 7, 2016TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Cerilliant
Covington
Chinese Patent Office
Farmers Insurance
Teva
UBS
Mallinckrodt
Boehringer Ingelheim
Medtronic

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