Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022334

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AFINITOR (EVEROLIMUS)
2.5MG
Marketing Status: Prescription

Active Ingredient: EVEROLIMUS
Proprietary Name: AFINITOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022334
Product Number: 003
Approval Date: Jul 9, 2010
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

AFINITOR (EVEROLIMUS)
5MG
Marketing Status: Prescription

Active Ingredient: EVEROLIMUS
Proprietary Name: AFINITOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022334
Product Number: 001
Approval Date: Mar 30, 2009
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

AFINITOR (EVEROLIMUS)
7.5MG
Marketing Status: Prescription

Active Ingredient: EVEROLIMUS
Proprietary Name: AFINITOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 7.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022334
Product Number: 004
Approval Date: Mar 30, 2012
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

AFINITOR (EVEROLIMUS)
10MG
Marketing Status: Prescription

Active Ingredient: EVEROLIMUS
Proprietary Name: AFINITOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022334
Product Number: 002
Approval Date: Mar 30, 2009
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information