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Last Updated: May 16, 2021

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Details for New Drug Application (NDA): 021713

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NDA 021713 describes ABILIFY, which is a drug marketed by Otsuka and Otsuka Pharm Co Ltd and is included in six NDAs. It is available from two suppliers. There are forty-eight patents protecting this drug and three Paragraph IV challenges. Additional details are available on the ABILIFY profile page.

The generic ingredient in ABILIFY is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for 021713
Tradename:ABILIFY
Applicant:Otsuka
Ingredient:aripiprazole
Patents:5
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021713
Paragraph IV (Patent) Challenges for 021713
Tradename Dosage Ingredient NDA Submissiondate
ABILIFY SOLUTION;ORAL aripiprazole 021713 2007-12-20

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrength1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 10, 2004TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 12, 2021
Regulatory Exclusivity Use:
Patent:  Get Started for $10Patent Expiration:Oct 24, 2022Product Flag?Substance Flag?Delist Request?Y
Patent:  Get Started for $10Patent Expiration:Jan 28, 2022Product Flag?Substance Flag?Delist Request?

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