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Drugs@FDA: FDA-Approved Drugs

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZEPBOUND TIRZEPATIDE 2.5MG/0.5ML (2.5MG/0.5ML) INJECTABLE;INJECTION Prescription None No No
ZEPBOUND TIRZEPATIDE 5MG/0.5ML (5MG/0.5ML) INJECTABLE;INJECTION Prescription None No No
ZEPBOUND TIRZEPATIDE 7.5MG/0.5ML (7.5MG/0.5ML) INJECTABLE;INJECTION Prescription None No No
ZEPBOUND TIRZEPATIDE 10MG/0.5ML (10MG/0.5ML) INJECTABLE;INJECTION Prescription None No No
ZEPBOUND TIRZEPATIDE 12.5MG/0.5ML (12.5MG/0.5ML) INJECTABLE;INJECTION Prescription None No No
ZEPBOUND TIRZEPATIDE 15MG/0.5ML (15MG/0.5ML) INJECTABLE;INJECTION Prescription None No No

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)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217806s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217806Orig1s000ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/08/2023 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217806s000lbl.pdf
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