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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202971

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ABILIFY MAINTENA KIT (ARIPIPRAZOLE)
300MG/VIAL
Marketing Status: Prescription
Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ABILIFY MAINTENA KIT
Dosage Form; Route of Administration: FOR SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 300MG/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202971
Product Number: 001
Approval Date: Feb 28, 2013
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ABILIFY MAINTENA KIT (ARIPIPRAZOLE)
300MG
Marketing Status: Prescription
Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ABILIFY MAINTENA KIT
Dosage Form; Route of Administration: FOR SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202971
Product Number: 003
Approval Date: Sep 29, 2014
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ABILIFY MAINTENA KIT (ARIPIPRAZOLE)
400MG
Marketing Status: Prescription
Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ABILIFY MAINTENA KIT
Dosage Form; Route of Administration: FOR SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 400MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202971
Product Number: 004
Approval Date: Sep 29, 2014
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ABILIFY MAINTENA KIT (ARIPIPRAZOLE)
400MG/VIAL
Marketing Status: Prescription
Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ABILIFY MAINTENA KIT
Dosage Form; Route of Administration: FOR SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 400MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N202971
Product Number: 002
Approval Date: Feb 28, 2013
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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