Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 021884
Company: INSMED
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 | 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 |
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 |