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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 021866


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NDA 021866 describes ABILIFY, which is a drug marketed by Otsuka and Otsuka Pharm Co Ltd and is included in seven NDAs. It is available from one supplier. There are forty-five 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-eight suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for 021866
Tradename:ABILIFY
Applicant:Otsuka
Ingredient:aripiprazole
Patents:2
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021866

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAMUSCULARStrength9.75MG/1.3ML (7.5MG/ML)
Approval Date:Sep 20, 2006TE:RLD:No
Patent:⤷  Try a TrialPatent Expiration:Jan 21, 2025Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Try a TrialPatent Expiration:Jan 21, 2025Product Flag?Substance Flag?Delist Request?Y

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