Product Details for NDA 021346
RISPERDAL CONSTA (RISPERIDONE)
12.5MG/VIAL
Marketing Status: Prescription
25MG/VIAL
Marketing Status: Prescription
37.5MG/VIAL
Marketing Status: Prescription
50MG/VIAL
Marketing Status: Prescription
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)
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
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)
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
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)
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
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
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