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Drugs@FDA: FDA-Approved Drugs

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