Product Details for NDA 209884
MAYZENT (SIPONIMOD)
EQ 0.25MG BASE
Marketing Status: Prescription
EQ 1MG BASE
Marketing Status: Prescription
EQ 2MG BASE
Marketing Status: Prescription
EQ 0.25MG BASE
Marketing Status: Prescription
Active Ingredient: SIPONIMOD
Proprietary Name: MAYZENT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 0.25MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N209884
Product Number: 001
Approval Date: Mar 26, 2019
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status: Prescription
Patent and Exclusivity Information
MAYZENT (SIPONIMOD)
Proprietary Name: MAYZENT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 0.25MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N209884
Product Number: 001
Approval Date: Mar 26, 2019
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 1MG BASE
Marketing Status: Prescription
Active Ingredient: SIPONIMOD
Proprietary Name: MAYZENT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 1MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N209884
Product Number: 003
Approval Date: Aug 24, 2021
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status: Prescription
Patent and Exclusivity Information
MAYZENT (SIPONIMOD)
Proprietary Name: MAYZENT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 1MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N209884
Product Number: 003
Approval Date: Aug 24, 2021
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 2MG BASE
Marketing Status: Prescription
Active Ingredient: SIPONIMOD
Proprietary Name: MAYZENT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N209884
Product Number: 002
Approval Date: Mar 26, 2019
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: MAYZENT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N209884
Product Number: 002
Approval Date: Mar 26, 2019
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status: Prescription
Patent and Exclusivity Information