Application 201811
- Type
- NDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ARGATROBAN | ARGATROBAN | INJECTABLE;INJECTION | 250MG/2.5ML (100MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-526 | Argatroban | Argatroban | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-526 | Argatroban | Argatroban | Fresenius Kabi USA, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 52432 | SUPPL | 2018-02-06 |
| 52278 | SUPPL | 2018-02-02 |
| 40088 | SUPPL | 2016-06-01 |
| 9931 | SUPPL | 2016-05-27 |
| 44838 | ORIG | 2016-03-02 |
| 43374 | ORIG | 2016-03-02 |
| 19035 | ORIG | 2015-04-14 |
| 32139 | ORIG | 2015-03-25 |