Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021444

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RISPERDAL (RISPERIDONE)
0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: RISPERIDONE
Proprietary Name: RISPERDAL
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021444
Product Number: 001
Approval Date: Apr 2, 2003
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

RISPERDAL (RISPERIDONE)
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: RISPERIDONE
Proprietary Name: RISPERDAL
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021444
Product Number: 002
Approval Date: Apr 2, 2003
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

RISPERDAL (RISPERIDONE)
2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: RISPERIDONE
Proprietary Name: RISPERDAL
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021444
Product Number: 003
Approval Date: Apr 2, 2003
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

RISPERDAL (RISPERIDONE)
3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: RISPERIDONE
Proprietary Name: RISPERDAL
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021444
Product Number: 004
Approval Date: Dec 23, 2004
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

RISPERDAL (RISPERIDONE)
4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: RISPERIDONE
Proprietary Name: RISPERDAL
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021444
Product Number: 005
Approval Date: Dec 23, 2004
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information