Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215866

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MOUNJARO (TIRZEPATIDE)
2.5MG/0.5ML (2.5MG/0.5ML)
Marketing Status: Prescription

Active Ingredient: TIRZEPATIDE
Proprietary Name: MOUNJARO
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 2.5MG/0.5ML (2.5MG/0.5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215866
Product Number: 007
Approval Date: Jul 28, 2023
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

MOUNJARO (TIRZEPATIDE)
5MG/0.5ML (5MG/0.5ML)
Marketing Status: Prescription

Active Ingredient: TIRZEPATIDE
Proprietary Name: MOUNJARO
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 5MG/0.5ML (5MG/0.5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215866
Product Number: 008
Approval Date: Jul 28, 2023
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

MOUNJARO (TIRZEPATIDE)
7.5MG/0.5ML (7.5MG/0.5ML)
Marketing Status: Prescription

Active Ingredient: TIRZEPATIDE
Proprietary Name: MOUNJARO
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 7.5MG/0.5ML (7.5MG/0.5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215866
Product Number: 009
Approval Date: Jul 28, 2023
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

MOUNJARO (TIRZEPATIDE)
10MG/0.5ML (10MG/0.5ML)
Marketing Status: Prescription

Active Ingredient: TIRZEPATIDE
Proprietary Name: MOUNJARO
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 10MG/0.5ML (10MG/0.5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215866
Product Number: 010
Approval Date: Jul 28, 2023
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

MOUNJARO (TIRZEPATIDE)
12.5MG/0.5ML (12.5MG/0.5ML)
Marketing Status: Prescription

Active Ingredient: TIRZEPATIDE
Proprietary Name: MOUNJARO
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 12.5MG/0.5ML (12.5MG/0.5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215866
Product Number: 011
Approval Date: Jul 28, 2023
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

MOUNJARO (TIRZEPATIDE)
15MG/0.5ML (15MG/0.5ML)
Marketing Status: Prescription

Active Ingredient: TIRZEPATIDE
Proprietary Name: MOUNJARO
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 15MG/0.5ML (15MG/0.5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215866
Product Number: 012
Approval Date: Jul 28, 2023
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

MOUNJARO (AUTOINJECTOR) (TIRZEPATIDE)
2.5MG/0.5ML (2.5MG/0.5ML)
Marketing Status: Prescription

Active Ingredient: TIRZEPATIDE
Proprietary Name: MOUNJARO (AUTOINJECTOR)
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 2.5MG/0.5ML (2.5MG/0.5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215866
Product Number: 001
Approval Date: May 13, 2022
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

MOUNJARO (AUTOINJECTOR) (TIRZEPATIDE)
5MG/0.5ML (5MG/0.5ML)
Marketing Status: Prescription

Active Ingredient: TIRZEPATIDE
Proprietary Name: MOUNJARO (AUTOINJECTOR)
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 5MG/0.5ML (5MG/0.5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215866
Product Number: 002
Approval Date: May 13, 2022
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

MOUNJARO (AUTOINJECTOR) (TIRZEPATIDE)
7.5MG/0.5ML (7.5MG/0.5ML)
Marketing Status: Prescription

Active Ingredient: TIRZEPATIDE
Proprietary Name: MOUNJARO (AUTOINJECTOR)
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 7.5MG/0.5ML (7.5MG/0.5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215866
Product Number: 003
Approval Date: May 13, 2022
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

MOUNJARO (AUTOINJECTOR) (TIRZEPATIDE)
10MG/0.5ML (10MG/0.5ML)
Marketing Status: Prescription

Active Ingredient: TIRZEPATIDE
Proprietary Name: MOUNJARO (AUTOINJECTOR)
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 10MG/0.5ML (10MG/0.5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215866
Product Number: 004
Approval Date: May 13, 2022
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

MOUNJARO (AUTOINJECTOR) (TIRZEPATIDE)
12.5MG/0.5ML (12.5MG/0.5ML)
Marketing Status: Prescription

Active Ingredient: TIRZEPATIDE
Proprietary Name: MOUNJARO (AUTOINJECTOR)
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 12.5MG/0.5ML (12.5MG/0.5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215866
Product Number: 005
Approval Date: May 13, 2022
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

MOUNJARO (AUTOINJECTOR) (TIRZEPATIDE)
15MG/0.5ML (15MG/0.5ML)
Marketing Status: Prescription

Active Ingredient: TIRZEPATIDE
Proprietary Name: MOUNJARO (AUTOINJECTOR)
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 15MG/0.5ML (15MG/0.5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215866
Product Number: 006
Approval Date: May 13, 2022
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information