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FDA NDA · NDA215866

MOUNJARO

tirzepatide

Sponsor: ELI LILLY AND CO

APPLICATION
NDA215866
TYPE
NDA
ORIGINAL APPROVAL
2022-05-13
LATEST ACTION
2026-01-20
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

MOUNJARO · ReferencePrescription
TIRZEPATIDE 60MG/2.4ML (25MG/ML) · SOLUTION · SUBCUTANEOUS
MOUNJARO KWIKPEN · ReferencePrescription
TIRZEPATIDE 60MG/2.4ML (25MG/ML) · SOLUTION · SUBCUTANEOUS
MOUNJARO · ReferencePrescription
TIRZEPATIDE 40MG/2.4ML (16.7MG/ML) · SOLUTION · SUBCUTANEOUS
MOUNJARO · ReferencePrescription
TIRZEPATIDE 5MG/0.5ML (5MG/0.5ML) · SOLUTION · SUBCUTANEOUS
MOUNJARO KWIKPEN · ReferencePrescription
TIRZEPATIDE 40MG/2.4ML (16.7MG/ML) · SOLUTION · SUBCUTANEOUS
MOUNJARO · ReferencePrescription
TIRZEPATIDE 20MG/2.4ML (8.33MG/ML) · SOLUTION · SUBCUTANEOUS
MOUNJARO (AUTOINJECTOR) · ReferencePrescription
TIRZEPATIDE 15MG/0.5ML (15MG/0.5ML) · SOLUTION · SUBCUTANEOUS
MOUNJARO KWIKPEN · ReferencePrescription
TIRZEPATIDE 20MG/2.4ML (8.33MG/ML) · SOLUTION · SUBCUTANEOUS
MOUNJARO · ReferencePrescription
TIRZEPATIDE 15MG/0.5ML (15MG/0.5ML) · SOLUTION · SUBCUTANEOUS
MOUNJARO (AUTOINJECTOR) · ReferencePrescription
TIRZEPATIDE 10MG/0.5ML (10MG/0.5ML) · SOLUTION · SUBCUTANEOUS
MOUNJARO · ReferencePrescription
TIRZEPATIDE 10MG/0.5ML (10MG/0.5ML) · SOLUTION · SUBCUTANEOUS
MOUNJARO (AUTOINJECTOR) · ReferencePrescription
TIRZEPATIDE 5MG/0.5ML (5MG/0.5ML) · SOLUTION · SUBCUTANEOUS
MOUNJARO KWIKPEN · ReferencePrescription
TIRZEPATIDE 10MG/2.4ML (4.17MG/ML) · SOLUTION · SUBCUTANEOUS
MOUNJARO · ReferencePrescription
TIRZEPATIDE 50MG/2.4ML (20.8MG/ML) · SOLUTION · SUBCUTANEOUS
MOUNJARO · ReferencePrescription
TIRZEPATIDE 7.5MG/0.5ML (7.5MG/0.5ML) · SOLUTION · SUBCUTANEOUS
MOUNJARO KWIKPEN · ReferencePrescription
TIRZEPATIDE 50MG/2.4ML (20.8MG/ML) · SOLUTION · SUBCUTANEOUS
MOUNJARO · ReferencePrescription
TIRZEPATIDE 30MG/2.4ML (12.5MG/ML) · SOLUTION · SUBCUTANEOUS
MOUNJARO · ReferencePrescription
TIRZEPATIDE 2.5MG/0.5ML (2.5MG/0.5ML) · SOLUTION · SUBCUTANEOUS
MOUNJARO KWIKPEN · ReferencePrescription
TIRZEPATIDE 30MG/2.4ML (12.5MG/ML) · SOLUTION · SUBCUTANEOUS
MOUNJARO · ReferencePrescription
TIRZEPATIDE 10MG/2.4ML (4.17MG/ML) · SOLUTION · SUBCUTANEOUS
MOUNJARO (AUTOINJECTOR) · ReferencePrescription
TIRZEPATIDE 12.5MG/0.5ML (12.5MG/0.5ML) · SOLUTION · SUBCUTANEOUS
MOUNJARO · ReferencePrescription
TIRZEPATIDE 12.5MG/0.5ML (12.5MG/0.5ML) · SOLUTION · SUBCUTANEOUS
MOUNJARO (AUTOINJECTOR) · ReferencePrescription
TIRZEPATIDE 7.5MG/0.5ML (7.5MG/0.5ML) · SOLUTION · SUBCUTANEOUS
MOUNJARO (AUTOINJECTOR) · ReferencePrescription
TIRZEPATIDE 2.5MG/0.5ML (2.5MG/0.5ML) · SOLUTION · SUBCUTANEOUS

Approval history

2026-01-20Labeling · Supplement 9 · standard — Letter ↗AP
2026-01-07Manufacturing (CMC) · Supplement 41 · standard — Letter ↗AP
2025-12-19Efficacy · Supplement 39 · priority — Label ↗AP
2025-09-25Labeling · Supplement 34 · standard — Letter ↗AP
2025-05-28Labeling · Supplement 31 · standard — Letter ↗AP
2024-11-01Labeling · Supplement 15 · standard — Letter ↗AP
2024-11-01Labeling · Supplement 22 · 901 required — Letter ↗AP
2024-11-01Labeling · Supplement 10 · standard — Letter ↗AP
2023-07-28Labeling · Supplement 6 · standard — Letter ↗AP
2023-07-28Labeling · Supplement 2 · standard — Letter ↗AP
2022-05-13Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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