Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021839
Company: IPSEN INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INCRELEX MECASERMIN RECOMBINANT 40MG/4ML (10MG/ML) INJECTABLE;SUBCUTANEOUS 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
08/30/2005 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021839lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021839ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021839_IncrelexTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/18/2019 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021839s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021839Orig1s021ltr.pdf
03/15/2016 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021839s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021839Orig1s017ltr.pdf
06/03/2014 SUPPL-16 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021839s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021839Orig1s016ltr.pdf
01/16/2013 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/14/2012 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021839s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021839s012ltr.pdf
09/13/2012 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021839s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021839Origs010ltr.pdf
02/16/2011 SUPPL-7 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021839s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021839s007ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/18/2019 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021839s021lbl.pdf
03/15/2016 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021839s017lbl.pdf
06/03/2014 SUPPL-16 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021839s016lbl.pdf
09/13/2012 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021839s010lbl.pdf
06/14/2012 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021839s012lbl.pdf
02/16/2011 SUPPL-7 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021839s007lbl.pdf
02/16/2011 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021839s007lbl.pdf
08/30/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021839lbl.pdf

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