Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021560

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ZORTRESS (EVEROLIMUS)
0.25MG
Marketing Status: Prescription

Active Ingredient: EVEROLIMUS
Proprietary Name: ZORTRESS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021560
Product Number: 001
Approval Date: Apr 20, 2010
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

ZORTRESS (EVEROLIMUS)
0.5MG
Marketing Status: Prescription

Active Ingredient: EVEROLIMUS
Proprietary Name: ZORTRESS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021560
Product Number: 002
Approval Date: Apr 20, 2010
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

ZORTRESS (EVEROLIMUS)
0.75MG
Marketing Status: Prescription

Active Ingredient: EVEROLIMUS
Proprietary Name: ZORTRESS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.75MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021560
Product Number: 003
Approval Date: Apr 20, 2010
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

ZORTRESS (EVEROLIMUS)
1MG
Marketing Status: Prescription

Active Ingredient: EVEROLIMUS
Proprietary Name: ZORTRESS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021560
Product Number: 004
Approval Date: Aug 10, 2018
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information