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FDA NDA · NDA217806

ZEPBOUND

tirzepatide

Sponsor: ELI LILLY AND CO

APPLICATION
NDA217806
TYPE
NDA
ORIGINAL APPROVAL
2023-11-08
LATEST ACTION
2026-02-25
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

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

Approval history

2026-02-25Labeling · Supplement 42 · standard — Letter ↗AP
2026-01-20Labeling · Supplement 2 · standard — Letter ↗AP
2026-01-07Manufacturing (CMC) · Supplement 37 · standard — Letter ↗AP
2025-09-25Labeling · Supplement 31 · standard — Letter ↗AP
2025-02-07Labeling · Supplement 20 · standard — Letter ↗AP
2024-12-20Efficacy · Supplement 13 · priority — Label ↗AP
2024-10-18Labeling · Supplement 19 · 901 required — Letter ↗AP
2024-10-18Efficacy · Supplement 6 · standard — Letter ↗AP
2024-10-18Labeling · Supplement 15 · standard — Letter ↗AP
2024-10-18Labeling · Supplement 11 · standard — Letter ↗AP
2024-10-18Labeling · Supplement 5 · standard — Letter ↗AP
2024-03-28Labeling · Supplement 3 · standard — Label ↗AP
2023-11-08Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated · 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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