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Last Updated: November 2, 2024

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 seven NDAs. It is available from one supplier. There are forty-six 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-seven 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:1
Medical Subject Heading (MeSH) Categories for 021713

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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Dec 10, 2004TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Mar 2, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)

Expired US Patents for NDA 021713

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka ABILIFY aripiprazole SOLUTION;ORAL 021713-001 Dec 10, 2004 ⤷  Sign Up ⤷  Sign Up
Otsuka ABILIFY aripiprazole SOLUTION;ORAL 021713-001 Dec 10, 2004 ⤷  Sign Up ⤷  Sign Up
Otsuka ABILIFY aripiprazole SOLUTION;ORAL 021713-001 Dec 10, 2004 ⤷  Sign Up ⤷  Sign Up
Otsuka ABILIFY aripiprazole SOLUTION;ORAL 021713-001 Dec 10, 2004 ⤷  Sign Up ⤷  Sign Up
Otsuka ABILIFY aripiprazole SOLUTION;ORAL 021713-001 Dec 10, 2004 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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