Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215256

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WEGOVY (SEMAGLUTIDE)
0.25MG/0.5ML (0.25MG/0.5ML)
Marketing Status: Prescription

Active Ingredient: SEMAGLUTIDE
Proprietary Name: WEGOVY
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 0.25MG/0.5ML (0.25MG/0.5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215256
Product Number: 001
Approval Date: Jun 4, 2021
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
Patent and Exclusivity Information

WEGOVY (SEMAGLUTIDE)
0.5MG/0.5ML (0.5MG/0.5ML)
Marketing Status: Prescription

Active Ingredient: SEMAGLUTIDE
Proprietary Name: WEGOVY
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 0.5MG/0.5ML (0.5MG/0.5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215256
Product Number: 002
Approval Date: Jun 4, 2021
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
Patent and Exclusivity Information

WEGOVY (SEMAGLUTIDE)
1MG/0.5ML (1MG/0.5ML)
Marketing Status: Prescription

Active Ingredient: SEMAGLUTIDE
Proprietary Name: WEGOVY
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 1MG/0.5ML (1MG/0.5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215256
Product Number: 003
Approval Date: Jun 4, 2021
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
Patent and Exclusivity Information

WEGOVY (SEMAGLUTIDE)
1.7MG/0.75ML (1.7MG/0.75ML)
Marketing Status: Prescription

Active Ingredient: SEMAGLUTIDE
Proprietary Name: WEGOVY
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 1.7MG/0.75ML (1.7MG/0.75ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215256
Product Number: 004
Approval Date: Jun 4, 2021
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
Patent and Exclusivity Information

WEGOVY (SEMAGLUTIDE)
2.4MG/0.75ML (2.4MG/0.75ML)
Marketing Status: Prescription

Active Ingredient: SEMAGLUTIDE
Proprietary Name: WEGOVY
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 2.4MG/0.75ML (2.4MG/0.75ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215256
Product Number: 005
Approval Date: Jun 4, 2021
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
Patent and Exclusivity Information