Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 125277
Company: DYAX CORP.
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KALBITOR ECALLANTIDE 10MG/ML INJECTABLE; INJECTION 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
12/01/2009 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125277lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125277s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125277s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125277s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/28/2020 SUPPL-81 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125277s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125277Orig1s081ltr.pdf
09/08/2014 SUPPL-71 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125277s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125277Orig1s071ltr.pdf
03/28/2014 SUPPL-70 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125277s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125277Orig1s70ltr.pdf
04/10/2013 SUPPL-65 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125277Orig1s065ltr.pdf
04/24/2012 SUPPL-50 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125277s0050ltr.pdf
08/17/2011 SUPPL-37 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125277s037ltr.pdf
04/05/2011 SUPPL-32 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125277s032ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/28/2020 SUPPL-81 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125277s081lbl.pdf
09/08/2014 SUPPL-71 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125277s071lbl.pdf
03/28/2014 SUPPL-70 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125277s070lbl.pdf
12/01/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125277lbl.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