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
Marketing Status: Discontinued
Active Ingredient: RISPERIDONE
Proprietary Name: RISPERDAL
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 0.5MG
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
Marketing Status: Discontinued
Active Ingredient: RISPERIDONE
Proprietary Name: RISPERDAL
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 1MG
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
Marketing Status: Discontinued
Active Ingredient: RISPERIDONE
Proprietary Name: RISPERDAL
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 2MG
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
Marketing Status: Discontinued
Active Ingredient: RISPERIDONE
Proprietary Name: RISPERDAL
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 3MG
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
Marketing Status: Discontinued
Active Ingredient: RISPERIDONE
Proprietary Name: RISPERDAL
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 4MG
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

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