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Last Updated: December 11, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206251

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NDA 206251 describes ARIPIPRAZOLE, which is a drug marketed by Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Lannett Co Inc, Alembic Pharms Ltd, Orchid Hlthcare, Sciegen Pharms Inc, Zydus Pharms, Accord Hlthcare, Ajanta Pharma Ltd, Alkem Labs Ltd, Boscogen, Hetero Labs Ltd V, Macleods Pharms Ltd, Mylan, Prinston Inc, Teva Pharms Usa, and Torrent, and is included in twenty-seven NDAs. It is available from forty-two suppliers. Additional details are available on the ARIPIPRAZOLE profile page.

The generic ingredient in ARIPIPRAZOLE is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for 206251
Tradename:ARIPIPRAZOLE
Applicant:Accord Hlthcare
Ingredient:aripiprazole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206251
Medical Subject Heading (MeSH) Categories for 206251
Suppliers and Packaging for NDA: 206251
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARIPIPRAZOLE aripiprazole TABLET;ORAL 206251 ANDA Accord Healthcare, Inc. 16729-278 16729-278-01 100 TABLET in 1 BOTTLE, PLASTIC (16729-278-01)
ARIPIPRAZOLE aripiprazole TABLET;ORAL 206251 ANDA Accord Healthcare, Inc. 16729-278 16729-278-10 30 TABLET in 1 BOTTLE, PLASTIC (16729-278-10)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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