Application 125277
- Type
- BLA
- Sponsor
- DYAX CORP.
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KALBITOR | ECALLANTIDE | INJECTABLE; INJECTION | 10MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 47783-101 | Kalbitor | Ecallantide | Takeda Pharmaceuticals America, Inc. | BLA | Current |
| 47783-101 | KALBITOR | ECALLANTIDE | Dyax Corp. | BLA | Current |
| 47783-101 | Kalbitor | Ecallantide | Takeda Pharmaceuticals America, Inc. | BLA | Current |
| 47783-101 | KALBITOR | ECALLANTIDE | Dyax Corp. | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 65778 | SUPPL | 2020-12-29 |
| 65773 | SUPPL | 2020-12-28 |
| 65772 | SUPPL | 2020-12-28 |
| 9672 | SUPPL | 2014-09-10 |
| 39894 | SUPPL | 2014-09-09 |
| 9671 | SUPPL | 2014-04-02 |
| 18843 | SUPPL | 2014-04-01 |
| 9670 | SUPPL | 2013-04-16 |
| 9669 | SUPPL | 2012-04-27 |
| 9668 | SUPPL | 2011-09-13 |
| 9667 | SUPPL | 2011-05-17 |
| 44796 | ORIG | 2010-02-14 |
| 43314 | ORIG | 2010-02-14 |
| 9666 | ORIG | 2009-12-08 |
| 39893 | ORIG | 2009-12-02 |
| 23459 | ORIG | 2009-12-02 |