Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213895
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 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
08/26/2021 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer PRIORITY Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213895s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213895Orig1s000ltr.pdf
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

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