Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022180
Company: AMAG PHARMS INC
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 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
06/30/2009 ORIG-1 Approval Type 2 - New Active Ingredient STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022180lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022180s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022180s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022180s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/11/2019 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022180s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022180Orig1s023ltr.pdf
11/15/2016 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/22/2017 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022180s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022180Orig1s016ltr.pdf
10/26/2015 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/28/2015 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/16/2015 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022180s011s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022180Orig1s011,022180Orig1s013ltr_corrected.pdf
07/27/2015 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/16/2015 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022180s011s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022180Orig1s011,022180Orig1s013ltr_corrected.pdf
12/23/2013 SUPPL-10 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022180s010lbl.pdf
02/02/2018 SUPPL-9 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022180s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022180Orig1s009ltr.pdf
06/05/2012 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

06/21/2011 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022180s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022180s006ltr.pdf
11/24/2010 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022180s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022180s003,022180s005ltr.pdf
11/24/2010 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022180s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022180s003,022180s005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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