Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021884
Company: INSMED
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IPLEX MECASERMIN RINFABATE RECOMBINANT 36MG/0.6ML INJECTABLE;SUBCUTANEOUS 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
12/12/2005 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021884lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021884ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021884_s000_IplexTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/21/2006 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021884s002ltr.pdf
02/27/2007 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021884s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021884s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021884Orig1s001.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/27/2007 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021884s001lbl.pdf
12/12/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021884lbl.pdf

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