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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 021884
Company: INSMED

This Former NDA Was Deemed To Be a BLA on March 23, 2020.

Products on BLA 021884

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 021884

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		N/A; 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	Supplement	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	Supplement	Label (PDF) Label (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021884s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021884lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021884Orig1s001.pdf

Labels for BLA 021884

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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