Product Details for NDA 213051
RYBELSUS (SEMAGLUTIDE)
1.5MG
Marketing Status: Prescription
3MG
Marketing Status: Prescription
4MG
Marketing Status: Prescription
7MG
Marketing Status: Prescription
9MG
Marketing Status: Prescription
14MG
Marketing Status: Prescription
1.5MG
Marketing Status: Prescription
Active Ingredient: SEMAGLUTIDE
Proprietary Name: RYBELSUS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N213051
Product Number: 004
Approval Date: Dec 9, 2024
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status: Prescription
Patent and Exclusivity Information
RYBELSUS (SEMAGLUTIDE)
Proprietary Name: RYBELSUS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N213051
Product Number: 004
Approval Date: Dec 9, 2024
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status: Prescription
Patent and Exclusivity Information
3MG
Marketing Status: Prescription
Active Ingredient: SEMAGLUTIDE
Proprietary Name: RYBELSUS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 3MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N213051
Product Number: 001
Approval Date: Sep 20, 2019
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status: Prescription
Patent and Exclusivity Information
RYBELSUS (SEMAGLUTIDE)
Proprietary Name: RYBELSUS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 3MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N213051
Product Number: 001
Approval Date: Sep 20, 2019
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status: Prescription
Patent and Exclusivity Information
4MG
Marketing Status: Prescription
Active Ingredient: SEMAGLUTIDE
Proprietary Name: RYBELSUS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N213051
Product Number: 005
Approval Date: Dec 9, 2024
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status: Prescription
Patent and Exclusivity Information
RYBELSUS (SEMAGLUTIDE)
Proprietary Name: RYBELSUS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N213051
Product Number: 005
Approval Date: Dec 9, 2024
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status: Prescription
Patent and Exclusivity Information
7MG
Marketing Status: Prescription
Active Ingredient: SEMAGLUTIDE
Proprietary Name: RYBELSUS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 7MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N213051
Product Number: 002
Approval Date: Sep 20, 2019
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status: Prescription
Patent and Exclusivity Information
RYBELSUS (SEMAGLUTIDE)
Proprietary Name: RYBELSUS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 7MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N213051
Product Number: 002
Approval Date: Sep 20, 2019
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status: Prescription
Patent and Exclusivity Information
9MG
Marketing Status: Prescription
Active Ingredient: SEMAGLUTIDE
Proprietary Name: RYBELSUS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 9MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N213051
Product Number: 006
Approval Date: Dec 9, 2024
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status: Prescription
Patent and Exclusivity Information
RYBELSUS (SEMAGLUTIDE)
Proprietary Name: RYBELSUS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 9MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N213051
Product Number: 006
Approval Date: Dec 9, 2024
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status: Prescription
Patent and Exclusivity Information
14MG
Marketing Status: Prescription
Active Ingredient: SEMAGLUTIDE
Proprietary Name: RYBELSUS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 14MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N213051
Product Number: 003
Approval Date: Sep 20, 2019
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: RYBELSUS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 14MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N213051
Product Number: 003
Approval Date: Sep 20, 2019
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status: Prescription
Patent and Exclusivity Information