Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 215866
Company: ELI LILLY AND CO
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 |
---|---|---|---|---|---|
11/01/2024 | SUPPL-22 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215866s010s015s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215866Orig1s010, s015, s022ltr.pdf | |
11/01/2024 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215866s010s015s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215866Orig1s010, s015, s022ltr.pdf | |
11/01/2024 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215866s010s015s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215866Orig1s010, s015, s022ltr.pdf | |
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 |
---|---|---|---|---|---|
11/01/2024 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215866s010s015s022lbl.pdf | |
11/01/2024 | SUPPL-22 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215866s010s015s022lbl.pdf | |
11/01/2024 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215866s010s015s022lbl.pdf | |
11/01/2024 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215866s010s015s022lbl.pdf | |
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 |