Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208562
Company: XELLIA PHARMS APS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VORICONAZOLE VORICONAZOLE 200MG/VIAL POWDER;INTRAVENOUS Prescription AP No No
VORICONAZOLE VORICONAZOLE 200MG INJECTABLE;INJECTION Prescription None TBD 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
03/09/2017 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208562s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208562Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208562Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/26/2018 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208562s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208562s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/26/2018 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208562s002lbl.pdf
03/09/2017 ORIG-1 Approval Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208562s000lbl.pdf

VORICONAZOLE

POWDER;INTRAVENOUS; 200MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VORICONAZOLE VORICONAZOLE 200MG/VIAL POWDER;INTRAVENOUS Prescription No AP 208562 XELLIA PHARMS APS

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