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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 217006

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ABILIFY ASIMTUFII (ARIPIPRAZOLE)
720MG/2.4ML (300MG/ML)
Marketing Status: Prescription
Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ABILIFY ASIMTUFII
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 720MG/2.4ML (300MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N217006
Product Number: 001
Approval Date: Apr 27, 2023
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ABILIFY ASIMTUFII (ARIPIPRAZOLE)
960MG/3.2ML (300MG/ML)
Marketing Status: Prescription
Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ABILIFY ASIMTUFII
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 960MG/3.2ML (300MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N217006
Product Number: 002
Approval Date: Apr 27, 2023
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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