U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 214835

Expand all

RISVAN (RISPERIDONE)
75MG
Marketing Status: Prescription
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:  Prescription
Patent and Exclusivity Information
RISVAN (RISPERIDONE)
100MG
Marketing Status: Prescription
Active Ingredient: RISPERIDONE
Proprietary Name: RISVAN
Dosage Form; Route of Administration: FOR SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214835
Product Number: 002
Approval Date: Mar 29, 2024
Applicant Holder Full Name: LABORATORIOS FARMACEUTICOS ROVI SA
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top