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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 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
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
02/27/2007 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021884lbl.pdf
12/12/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021884lbl.pdf
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