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Generated: November 17, 2018

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Details for New Drug Application (NDA): 021436

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NDA 021436 describes ABILIFY, which is a drug marketed by Otsuka and Otsuka Pharm Co Ltd and is included in six NDAs. It is available from eight suppliers. There are forty-nine 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-eight drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for 021436
Tradename:ABILIFY
Applicant:Otsuka
Ingredient:aripiprazole
Patents:10
Formulation / Manufacturing:see details
Pharmacology for NDA: 021436
Medical Subject Heading (MeSH) Categories for 021436
Suppliers and Packaging for NDA: 021436
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABILIFY aripiprazole TABLET;ORAL 021436 NDA Rebel Distributors Corp. 21695-002 21695-002-15 15 TABLET in 1 BOTTLE, PLASTIC (21695-002-15)
ABILIFY aripiprazole TABLET;ORAL 021436 NDA Rebel Distributors Corp. 21695-002 21695-002-30 30 TABLET in 1 BOTTLE, PLASTIC (21695-002-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Nov 15, 2002TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Dec 12, 2021
Regulatory Exclusivity Use:TREATMENT OF PEDIATRIC PATIENTS WITH TOURETTE'S
Patent:➤ Try a Free TrialPatent Expiration:Jan 28, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
Patent:➤ Try a Free TrialPatent Expiration:Dec 16, 2024Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021436

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-005 Nov 15, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-003 Nov 15, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-003 Nov 15, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-006 Nov 15, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-005 Nov 15, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-001 Nov 15, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-001 Nov 15, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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