Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020272

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RISPERDAL (RISPERIDONE)
0.25MG
Marketing Status: Prescription

Active Ingredient: RISPERIDONE
Proprietary Name: RISPERDAL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020272
Product Number: 008
Approval Date: May 10, 1999
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

RISPERDAL (RISPERIDONE)
0.5MG
Marketing Status: Prescription

Active Ingredient: RISPERIDONE
Proprietary Name: RISPERDAL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020272
Product Number: 007
Approval Date: Jan 27, 1999
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

RISPERDAL (RISPERIDONE)
1MG
Marketing Status: Prescription

Active Ingredient: RISPERIDONE
Proprietary Name: RISPERDAL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020272
Product Number: 001
Approval Date: Dec 29, 1993
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

RISPERDAL (RISPERIDONE)
2MG
Marketing Status: Prescription

Active Ingredient: RISPERIDONE
Proprietary Name: RISPERDAL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020272
Product Number: 002
Approval Date: Dec 29, 1993
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

RISPERDAL (RISPERIDONE)
3MG
Marketing Status: Prescription

Active Ingredient: RISPERIDONE
Proprietary Name: RISPERDAL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 3MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020272
Product Number: 003
Approval Date: Dec 29, 1993
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

RISPERDAL (RISPERIDONE)
4MG
Marketing Status: Prescription

Active Ingredient: RISPERIDONE
Proprietary Name: RISPERDAL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020272
Product Number: 004
Approval Date: Dec 29, 1993
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

RISPERDAL (RISPERIDONE)
5MG
Marketing Status: Discontinued

Active Ingredient: RISPERIDONE
Proprietary Name: RISPERDAL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020272
Product Number: 005
Approval Date: Dec 29, 1993
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information