Product Details for NDA 021729
ABILIFY (ARIPIPRAZOLE)
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
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)
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Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
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
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
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)
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 effectiveness reasons**
Reference Listed Drug: Yes
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
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness 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 effectiveness 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)
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 effectiveness 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
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness 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 effectiveness 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
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 effectiveness 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