Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021999

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INVEGA (PALIPERIDONE)
1.5MG
Marketing Status: Prescription

Active Ingredient: PALIPERIDONE
Proprietary Name: INVEGA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 1.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021999
Product Number: 006
Approval Date: Aug 26, 2008
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

INVEGA (PALIPERIDONE)
3MG
Marketing Status: Prescription

Active Ingredient: PALIPERIDONE
Proprietary Name: INVEGA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 3MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021999
Product Number: 001
Approval Date: Dec 19, 2006
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

INVEGA (PALIPERIDONE)
6MG
Marketing Status: Prescription

Active Ingredient: PALIPERIDONE
Proprietary Name: INVEGA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 6MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021999
Product Number: 002
Approval Date: Dec 19, 2006
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

INVEGA (PALIPERIDONE)
9MG
Marketing Status: Prescription

Active Ingredient: PALIPERIDONE
Proprietary Name: INVEGA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 9MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021999
Product Number: 003
Approval Date: Dec 19, 2006
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

INVEGA (PALIPERIDONE)
12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: PALIPERIDONE
Proprietary Name: INVEGA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N021999
Product Number: 004
Approval Date: Dec 19, 2006
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information