U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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

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

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
05/13/2022 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215866s000lbl.pdf
Back to Top