Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209637

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

Active Ingredient: SEMAGLUTIDE
Proprietary Name: OZEMPIC
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: N209637
Product Number: 005
Approval Date: May 5, 2026
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: SEMAGLUTIDE
Proprietary Name: OZEMPIC
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: N209637
Product Number: 006
Approval Date: May 5, 2026
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: SEMAGLUTIDE
Proprietary Name: OZEMPIC
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: N209637
Product Number: 007
Approval Date: May 5, 2026
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
Patent and Exclusivity Information

OZEMPIC (SEMAGLUTIDE)
2MG/3ML (0.68MG/ML)
Marketing Status: Prescription

Active Ingredient: SEMAGLUTIDE
Proprietary Name: OZEMPIC
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 2MG/3ML (0.68MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209637
Product Number: 004
Approval Date: Oct 6, 2022
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
Patent and Exclusivity Information

OZEMPIC (SEMAGLUTIDE)
4MG/3ML (1.34MG/ML)
Marketing Status: Prescription

Active Ingredient: SEMAGLUTIDE
Proprietary Name: OZEMPIC
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 4MG/3ML (1.34MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209637
Product Number: 002
Approval Date: Apr 9, 2019
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
Patent and Exclusivity Information

OZEMPIC (SEMAGLUTIDE)
8MG/3ML (2.68MG/ML)
Marketing Status: Prescription

Active Ingredient: SEMAGLUTIDE
Proprietary Name: OZEMPIC
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 8MG/3ML (2.68MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209637
Product Number: 003
Approval Date: Mar 28, 2022
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
Patent and Exclusivity Information

OZEMPIC (SEMAGLUTIDE)
2MG/1.5ML (1.34MG/ML)
Marketing Status: Discontinued

Active Ingredient: SEMAGLUTIDE
Proprietary Name: OZEMPIC
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 2MG/1.5ML (1.34MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209637
Product Number: 001
Approval Date: Dec 5, 2017
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Discontinued
Patent and Exclusivity Information