Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 211728
Company: UROGEN PHARMA
Company: UROGEN PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
JELMYTO | MITOMYCIN | 40MG/VIAL | POWDER;PYELOCALYCEAL | 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 |
---|---|---|---|---|---|---|---|
04/15/2020 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211728s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211728Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/211728Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/25/2022 | SUPPL-3 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211728Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/211728Orig1s003ltr.pdf | |
01/14/2021 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211728s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211728Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/25/2022 | SUPPL-3 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211728Orig1s003lbl.pdf |
01/14/2021 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211728s002lbl.pdf | |
04/15/2020 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211728s000lbl.pdf |