Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 213895
Company: XELLIA PHARMS APS
Company: XELLIA PHARMS APS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VANCOMYCIN | VANCOMYCIN | 5GM/100ML (50MG/ML) | SOLUTION;INTRAVENOUS, ORAL | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 08/26/2021 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213895s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213895Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/213895Orig1s000TOC.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/26/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213895s000lbl.pdf |