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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214835

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RISVAN (RISPERIDONE)
75MG
Marketing Status: Discontinued
Active Ingredient: RISPERIDONE
Proprietary Name: RISVAN
Dosage Form; Route of Administration: FOR SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 75MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214835
Product Number: 001
Approval Date: Mar 29, 2024
Applicant Holder Full Name: LABORATORIOS FARMACEUTICOS ROVI SA
Marketing Status:  Discontinued
Patent and Exclusivity Information
RISVAN (RISPERIDONE)
100MG
Marketing Status: Discontinued
Active Ingredient: RISPERIDONE
Proprietary Name: RISVAN
Dosage Form; Route of Administration: FOR SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214835
Product Number: 002
Approval Date: Mar 29, 2024
Applicant Holder Full Name: LABORATORIOS FARMACEUTICOS ROVI SA
Marketing Status:  Discontinued
Patent and Exclusivity Information
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