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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210655

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PERSERIS KIT (RISPERIDONE)
90MG
Marketing Status: Prescription
Active Ingredient: RISPERIDONE
Proprietary Name: PERSERIS KIT
Dosage Form; Route of Administration: FOR SUSPENSION, EXTENDED RELEASE; SUBCUTANEOUS
Strength: 90MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210655
Product Number: 001
Approval Date: Jul 27, 2018
Applicant Holder Full Name: INDIVIOR INC
Marketing Status:  Prescription
Patent and Exclusivity Information
PERSERIS KIT (RISPERIDONE)
120MG
Marketing Status: Prescription
Active Ingredient: RISPERIDONE
Proprietary Name: PERSERIS KIT
Dosage Form; Route of Administration: FOR SUSPENSION, EXTENDED RELEASE; SUBCUTANEOUS
Strength: 120MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210655
Product Number: 002
Approval Date: Jul 27, 2018
Applicant Holder Full Name: INDIVIOR INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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