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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212849

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RYKINDO (RISPERIDONE)
12.5MG
Marketing Status: Prescription
Active Ingredient: RISPERIDONE
Proprietary Name: RYKINDO
Dosage Form; Route of Administration: FOR SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 12.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212849
Product Number: 001
Approval Date: Jan 13, 2023
Applicant Holder Full Name: SHANDONG LUYE PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
RYKINDO (RISPERIDONE)
25MG
Marketing Status: Prescription
Active Ingredient: RISPERIDONE
Proprietary Name: RYKINDO
Dosage Form; Route of Administration: FOR SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212849
Product Number: 002
Approval Date: Jan 13, 2023
Applicant Holder Full Name: SHANDONG LUYE PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
RYKINDO (RISPERIDONE)
37.5MG
Marketing Status: Prescription
Active Ingredient: RISPERIDONE
Proprietary Name: RYKINDO
Dosage Form; Route of Administration: FOR SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 37.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212849
Product Number: 003
Approval Date: Jan 13, 2023
Applicant Holder Full Name: SHANDONG LUYE PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
RYKINDO (RISPERIDONE)
50MG
Marketing Status: Prescription
Active Ingredient: RISPERIDONE
Proprietary Name: RYKINDO
Dosage Form; Route of Administration: FOR SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212849
Product Number: 004
Approval Date: Jan 13, 2023
Applicant Holder Full Name: SHANDONG LUYE PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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