Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022180
Company: COVIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FERAHEME FERUMOXYTOL EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION;INTRAVENOUS Prescription AB Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/11/2020 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022180s024lbl.pdf
10/11/2019 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022180s023lbl.pdf
02/02/2018 SUPPL-9 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022180s009lbl.pdf
12/22/2017 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022180s016lbl.pdf
03/16/2015 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022180s011s013lbl.pdf
03/16/2015 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022180s011s013lbl.pdf
12/23/2013 SUPPL-10 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022180s010lbl.pdf
06/21/2011 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022180s006lbl.pdf
11/24/2010 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022180s003s005lbl.pdf
11/24/2010 SUPPL-3 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022180s003s005lbl.pdf
11/24/2010 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022180s003s005lbl.pdf
06/30/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022180lbl.pdf

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