Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 203568
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English