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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021632
Company: VICURON HOLDINGS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ERAXIS ANIDULAFUNGIN 50MG/VIAL POWDER;INTRAVENOUS Prescription None Yes Yes
ERAXIS ANIDULAFUNGIN 100MG/VIAL POWDER;INTRAVENOUS Prescription None Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/05/2020 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021632s030lbl.pdf
09/22/2020 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021632027_S029lbl.pdf
09/22/2020 SUPPL-27 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021632027_S029lbl.pdf
01/05/2018 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021632s026lbl.pdf
08/17/2017 SUPPL-24 Labeling-Package Insert 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/2017/021632s024lbl.pdf
07/20/2012 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021632s011lbl.pdf
06/05/2009 SUPPL-10 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021632s010lbl.pdf
11/09/2007 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021632s006lbl.pdf
02/02/2007 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021632s004.pdf
11/15/2006 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021632s003lbl.pdf
11/15/2006 SUPPL-3 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021632s003lbl.pdf
08/07/2006 SUPPL-2 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021632s002lbl.pdf
08/07/2006 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021632s002lbl.pdf
02/17/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021632s000,021948s000lbl.pdf
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