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 |
| 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 |