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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022192

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FANAPT (ILOPERIDONE)
1MG
Marketing Status: Prescription
Active Ingredient: ILOPERIDONE
Proprietary Name: FANAPT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022192
Product Number: 001
Approval Date: May 6, 2009
Applicant Holder Full Name: VANDA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
FANAPT (ILOPERIDONE)
2MG
Marketing Status: Prescription
Active Ingredient: ILOPERIDONE
Proprietary Name: FANAPT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022192
Product Number: 002
Approval Date: May 6, 2009
Applicant Holder Full Name: VANDA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
FANAPT (ILOPERIDONE)
4MG
Marketing Status: Prescription
Active Ingredient: ILOPERIDONE
Proprietary Name: FANAPT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022192
Product Number: 003
Approval Date: May 6, 2009
Applicant Holder Full Name: VANDA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
FANAPT (ILOPERIDONE)
6MG
Marketing Status: Prescription
Active Ingredient: ILOPERIDONE
Proprietary Name: FANAPT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 6MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022192
Product Number: 004
Approval Date: May 6, 2009
Applicant Holder Full Name: VANDA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
FANAPT (ILOPERIDONE)
8MG
Marketing Status: Prescription
Active Ingredient: ILOPERIDONE
Proprietary Name: FANAPT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 8MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022192
Product Number: 005
Approval Date: May 6, 2009
Applicant Holder Full Name: VANDA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
FANAPT (ILOPERIDONE)
10MG
Marketing Status: Prescription
Active Ingredient: ILOPERIDONE
Proprietary Name: FANAPT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022192
Product Number: 006
Approval Date: May 6, 2009
Applicant Holder Full Name: VANDA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
FANAPT (ILOPERIDONE)
12MG
Marketing Status: Prescription
Active Ingredient: ILOPERIDONE
Proprietary Name: FANAPT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022192
Product Number: 007
Approval Date: May 6, 2009
Applicant Holder Full Name: VANDA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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