Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203985

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AFINITOR DISPERZ (EVEROLIMUS)
2MG
Marketing Status: Prescription

Active Ingredient: EVEROLIMUS
Proprietary Name: AFINITOR DISPERZ
Dosage Form; Route of Administration: TABLET, FOR SUSPENSION; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N203985
Product Number: 001
Approval Date: Aug 29, 2012
Applicant Holder Full Name: NOVARTIS PHARMACEUTICAL CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

AFINITOR DISPERZ (EVEROLIMUS)
3MG
Marketing Status: Prescription

Active Ingredient: EVEROLIMUS
Proprietary Name: AFINITOR DISPERZ
Dosage Form; Route of Administration: TABLET, FOR SUSPENSION; ORAL
Strength: 3MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N203985
Product Number: 002
Approval Date: Aug 29, 2012
Applicant Holder Full Name: NOVARTIS PHARMACEUTICAL CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

AFINITOR DISPERZ (EVEROLIMUS)
5MG
Marketing Status: Prescription

Active Ingredient: EVEROLIMUS
Proprietary Name: AFINITOR DISPERZ
Dosage Form; Route of Administration: TABLET, FOR SUSPENSION; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N203985
Product Number: 003
Approval Date: Aug 29, 2012
Applicant Holder Full Name: NOVARTIS PHARMACEUTICAL CORP
Marketing Status:  Prescription
Patent and Exclusivity Information