Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 021839
Company: IPSEN INC
Company: IPSEN INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
INCRELEX | MECASERMIN RECOMBINANT | 40MG/4ML (10MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | 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 |
---|---|---|---|---|---|---|---|
08/30/2005 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021839lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021839ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021839_IncrelexTOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/15/2024 | SUPPL-31 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021839s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021839Orig1s031ltr.pdf | |
10/20/2023 | SUPPL-27 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021839s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021839Orig1s027ltr.pdf | |
12/03/2019 | SUPPL-24 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021839s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021839Orig1s024ltr.pdf | |
01/18/2019 | SUPPL-21 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021839s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021839Orig1s021ltr.pdf | |
03/15/2016 | SUPPL-17 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021839s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021839Orig1s017ltr.pdf | |
06/03/2014 | SUPPL-16 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021839s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021839Orig1s016ltr.pdf | |
01/16/2013 | SUPPL-14 | Supplement |
Label is not available on this site. |
||
06/14/2012 | SUPPL-12 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021839s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021839s012ltr.pdf | |
09/13/2012 | SUPPL-10 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021839s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021839Origs010ltr.pdf | |
02/16/2011 | SUPPL-7 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021839s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021839s007ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/15/2024 | SUPPL-31 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021839s031lbl.pdf | |
10/20/2023 | SUPPL-27 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021839s027lbl.pdf | |
10/20/2023 | SUPPL-27 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021839s027lbl.pdf | |
10/20/2023 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021839s027lbl.pdf | |
12/03/2019 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021839s024lbl.pdf | |
01/18/2019 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021839s021lbl.pdf | |
03/15/2016 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021839s017lbl.pdf | |
06/03/2014 | SUPPL-16 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021839s016lbl.pdf | |
09/13/2012 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021839s010lbl.pdf | |
06/14/2012 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021839s012lbl.pdf | |
02/16/2011 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021839s007lbl.pdf | |
02/16/2011 | SUPPL-7 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021839s007lbl.pdf | |
08/30/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021839lbl.pdf |