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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215866
Company: ELI LILLY AND CO

Medication Guide

Products on NDA 215866

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MOUNJARO	TIRZEPATIDE	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
MOUNJARO	TIRZEPATIDE	5MG/0.5ML (5MG/0.5ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
MOUNJARO	TIRZEPATIDE	7.5MG/0.5ML (7.5MG/0.5ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
MOUNJARO	TIRZEPATIDE	10MG/0.5ML (10MG/0.5ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
MOUNJARO	TIRZEPATIDE	12.5MG/0.5ML (12.5MG/0.5ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
MOUNJARO	TIRZEPATIDE	15MG/0.5ML (15MG/0.5ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
MOUNJARO (AUTOINJECTOR)	TIRZEPATIDE	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
MOUNJARO (AUTOINJECTOR)	TIRZEPATIDE	5MG/0.5ML (5MG/0.5ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
MOUNJARO (AUTOINJECTOR)	TIRZEPATIDE	7.5MG/0.5ML (7.5MG/0.5ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
MOUNJARO (AUTOINJECTOR)	TIRZEPATIDE	10MG/0.5ML (10MG/0.5ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
MOUNJARO (AUTOINJECTOR)	TIRZEPATIDE	12.5MG/0.5ML (12.5MG/0.5ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
MOUNJARO (AUTOINJECTOR)	TIRZEPATIDE	15MG/0.5ML (15MG/0.5ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215866

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/13/2022	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215866s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215866Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215866Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/28/2023	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215866Orig1s002s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215866Orig1s002,s006ltr.pdf
07/28/2023	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215866Orig1s002s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215866Orig1s002,s006ltr.pdf

Labels for NDA 215866

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/28/2023	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215866Orig1s002s006lbl.pdf
07/28/2023	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215866Orig1s002s006lbl.pdf
07/28/2023	SUPPL-2	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215866Orig1s002s006lbl.pdf
07/28/2023	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215866Orig1s002s006lbl.pdf
05/13/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215866s000lbl.pdf

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