Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021436

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ABILIFY (ARIPIPRAZOLE)
2MG
Marketing Status: Prescription

Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ABILIFY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021436
Product Number: 006
Approval Date: Nov 15, 2002
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

ABILIFY (ARIPIPRAZOLE)
5MG
Marketing Status: Prescription

Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ABILIFY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021436
Product Number: 005
Approval Date: Nov 15, 2002
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

ABILIFY (ARIPIPRAZOLE)
10MG
Marketing Status: Prescription

Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ABILIFY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021436
Product Number: 001
Approval Date: Nov 15, 2002
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

ABILIFY (ARIPIPRAZOLE)
15MG
Marketing Status: Prescription

Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ABILIFY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021436
Product Number: 002
Approval Date: Nov 15, 2002
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

ABILIFY (ARIPIPRAZOLE)
20MG
Marketing Status: Prescription

Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ABILIFY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021436
Product Number: 003
Approval Date: Nov 15, 2002
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

ABILIFY (ARIPIPRAZOLE)
30MG
Marketing Status: Prescription

Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ABILIFY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021436
Product Number: 004
Approval Date: Nov 15, 2002
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information