Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203568
Company: KASTLE THERAPS LLC
Company: KASTLE THERAPS LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
KYNAMRO | MIPOMERSEN SODIUM | 200MG/ML (200MG/ML) | SOLUTION;SUBCUTANEOUS | Discontinued | None | Yes | 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 |
---|---|---|---|---|---|---|---|
01/29/2013 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203568s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203568Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203568Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203568Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/18/2019 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203568s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203568Orig1s011ltr.pdf | |
10/25/2017 | SUPPL-9 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203568Orig1s009ltr.pdf |
05/23/2016 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203568s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203568Orig1s008ltr.pdf | |
07/08/2015 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/01/2015 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/28/2015 | SUPPL-5 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203568Orig1s005ltr.pdf |
02/26/2015 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203568s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203568Orig1s004ltr.pdf | |
05/07/2014 | SUPPL-2 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203568Orig1s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/18/2019 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203568s011lbl.pdf | |
05/23/2016 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203568s008lbl.pdf | |
02/26/2015 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203568s004lbl.pdf | |
01/29/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203568s000lbl.pdf |