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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 217806
Company: ELI LILLY AND CO

Medication Guide

Products on NDA 217806

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 217806

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/08/2023	ORIG-1	Approval		PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217806s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217806Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217806Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/18/2024	SUPPL-19	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s005s006s011s015s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217806Orig1s005, 006, 011, 015, 019ltr.pdf
10/18/2024	SUPPL-15	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s005s006s011s015s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217806Orig1s005, 006, 011, 015, 019ltr.pdf
12/20/2024	SUPPL-13	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217806Orig1s013ltr.pdf
10/18/2024	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s005s006s011s015s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217806Orig1s005, 006, 011, 015, 019ltr.pdf
10/18/2024	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s005s006s011s015s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217806Orig1s005, 006, 011, 015, 019ltr.pdf
10/18/2024	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s005s006s011s015s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217806Orig1s005, 006, 011, 015, 019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217806Orig1s005, 006, 011, 015, 019ltr.pdf
03/28/2024	SUPPL-3	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217806Orig1s003Corrected_ltr.pdf

Labels for NDA 217806

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/20/2024	SUPPL-13	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s013lbl.pdf
10/18/2024	SUPPL-19	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s005s006s011s015s019lbl.pdf
10/18/2024	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s005s006s011s015s019lbl.pdf
10/18/2024	SUPPL-15	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s005s006s011s015s019lbl.pdf
10/18/2024	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s005s006s011s015s019lbl.pdf
10/18/2024	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s005s006s011s015s019lbl.pdf
10/18/2024	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s005s006s011s015s019lbl.pdf
10/18/2024	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s005s006s011s015s019lbl.pdf
10/18/2024	SUPPL-5	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s005s006s011s015s019lbl.pdf
03/28/2024	SUPPL-3	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s003lbl.pdf
03/28/2024	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s003lbl.pdf
03/28/2024	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s003lbl.pdf
11/08/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217806s000lbl.pdf

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