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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021346

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RISPERDAL CONSTA (RISPERIDONE)
12.5MG/VIAL
Marketing Status: Prescription
Active Ingredient: RISPERIDONE
Proprietary Name: RISPERDAL CONSTA
Dosage Form; Route of Administration: INJECTABLE; INTRAMUSCULAR
Strength: 12.5MG/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021346
Product Number: 004
Approval Date: Apr 12, 2007
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
RISPERDAL CONSTA (RISPERIDONE)
25MG/VIAL
Marketing Status: Prescription
Active Ingredient: RISPERIDONE
Proprietary Name: RISPERDAL CONSTA
Dosage Form; Route of Administration: INJECTABLE; INTRAMUSCULAR
Strength: 25MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021346
Product Number: 001
Approval Date: Oct 29, 2003
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
RISPERDAL CONSTA (RISPERIDONE)
37.5MG/VIAL
Marketing Status: Prescription
Active Ingredient: RISPERIDONE
Proprietary Name: RISPERDAL CONSTA
Dosage Form; Route of Administration: INJECTABLE; INTRAMUSCULAR
Strength: 37.5MG/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021346
Product Number: 002
Approval Date: Oct 29, 2003
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
RISPERDAL CONSTA (RISPERIDONE)
50MG/VIAL
Marketing Status: Prescription
Active Ingredient: RISPERIDONE
Proprietary Name: RISPERDAL CONSTA
Dosage Form; Route of Administration: INJECTABLE; INTRAMUSCULAR
Strength: 50MG/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021346
Product Number: 003
Approval Date: Oct 29, 2003
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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