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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209830

ARISTADA INITIO KIT (ARIPIPRAZOLE LAUROXIL)
675MG/2.4ML (281.25MG/ML)
Marketing Status: Prescription
Active Ingredient: ARIPIPRAZOLE LAUROXIL
Proprietary Name: ARISTADA INITIO KIT
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 675MG/2.4ML (281.25MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209830
Product Number: 001
Approval Date: Jun 29, 2018
Applicant Holder Full Name: ALKERMES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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