Product Details for NDA 021560
ZORTRESS (EVEROLIMUS)
0.25MG
Marketing Status: Prescription
0.5MG
Marketing Status: Prescription
0.75MG
Marketing Status: Prescription
1MG
Marketing Status: Prescription
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)
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
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)
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
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)
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
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
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