Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021135
Company: AM REGENT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VENOFER IRON SUCROSE EQ 100MG BASE/5ML (EQ 20MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription None Yes Yes
VENOFER IRON SUCROSE EQ 50MG BASE/2.5ML (EQ 20MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription None Yes No
VENOFER IRON SUCROSE EQ 75MG BASE/3.75ML (EQ 20MG BASE/ML) INJECTABLE;INTRAVENOUS Discontinued None No No
VENOFER IRON SUCROSE EQ 200MG BASE/10ML (EQ 20MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription None Yes No
VENOFER IRON SUCROSE EQ 65MG BASE/3.25ML (EQ 20MG BASE/ML) INJECTABLE;INTRAVENOUS Discontinued None No 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
11/06/2000 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21135lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21135ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21135_Venofer.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/19/2018 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021135s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021135Orig1s035Ltr.pdf
11/28/2017 SUPPL-32 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021135s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021135Orig1s032ltr.pdf
05/27/2016 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

06/13/2016 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

05/13/2015 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

06/13/2014 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

03/02/2016 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

09/21/2012 SUPPL-24 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021135s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021135Orig1s024ltr.pdf
03/29/2013 SUPPL-23 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021135s023lbl.pdf
06/22/2011 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021135s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021135s020ltr.pdf
12/03/2007 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021135s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021135s017ltr.pdf
02/09/2007 SUPPL-15 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021135s015lbl.pdf
10/17/2005 SUPPL-13 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021135s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021135s013ltr.pdf
03/29/2005 SUPPL-10 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021135s010ltr.pdf
06/17/2005 SUPPL-8 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021135s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021135s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021135_S008_VENOFER.pdf
06/02/2003 SUPPL-6 Efficacy-New Dosing Regimen Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21135se2-006ltr.pdf
07/26/2002 SUPPL-5 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21135se2-005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21135se2-005ltr.pdf
12/05/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

01/22/2002 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

02/13/2001 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/19/2018 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021135s035lbl.pdf
11/28/2017 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021135s032lbl.pdf
11/28/2017 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021135s032lbl.pdf
03/29/2013 SUPPL-23 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021135s023lbl.pdf
09/21/2012 SUPPL-24 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021135s024lbl.pdf
06/22/2011 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021135s020lbl.pdf
12/03/2007 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021135s017lbl.pdf
02/09/2007 SUPPL-15 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021135s015lbl.pdf
02/09/2007 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021135s015lbl.pdf
10/17/2005 SUPPL-13 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021135s013lbl.pdf
06/17/2005 SUPPL-8 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021135s008lbl.pdf
07/26/2002 SUPPL-5 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21135se2-005ltr.pdf
11/06/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21135lbl.pdf

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