Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021729

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ABILIFY (ARIPIPRAZOLE)
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ABILIFY
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021729
Product Number: 002
Approval Date: Jun 7, 2006
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

ABILIFY (ARIPIPRAZOLE)
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ABILIFY
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021729
Product Number: 003
Approval Date: Jun 7, 2006
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

ABILIFY (ARIPIPRAZOLE)
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ABILIFY
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021729
Product Number: 004
Approval Date: Jun 7, 2006
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

ABILIFY (ARIPIPRAZOLE)
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ABILIFY
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021729
Product Number: 005
Approval Date: Jun 7, 2006
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

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