Application 203568
- Type
- NDA
- Sponsor
- KASTLE THERAPS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KYNAMRO | MIPOMERSEN SODIUM | SOLUTION;SUBCUTANEOUS | 200MG/ML (200MG/ML) | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70688-0502 | Kynamro | MIPOMERSEN SODIUM | Kastle Therapeutics, LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 58044 | SUPPL | 2019-03-20 |
| 58038 | SUPPL | 2019-03-19 |
| 50224 | SUPPL | 2017-10-30 |
| 40313 | SUPPL | 2016-05-25 |
| 10237 | SUPPL | 2016-05-25 |
| 10236 | SUPPL | 2015-07-29 |
| 19485 | SUPPL | 2015-03-03 |
| 10235 | SUPPL | 2015-02-27 |
| 32444 | SUPPL | 2014-05-09 |
| 43440 | ORIG | 2013-02-27 |
| 24440 | ORIG | 2013-02-27 |
| 23503 | ORIG | 2013-02-05 |
| 10234 | ORIG | 2013-01-31 |
| 24116 | ORIG | 2013-01-30 |
| 19484 | ORIG | 2013-01-30 |