Application 209552
- Type
- NDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ARGATROBAN IN SODIUM CHLORIDE | ARGATROBAN | SOLUTION;INTRAVENOUS | 50MG/50ML (1MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55150-241 | Argatroban | Argatroban | AuroMedics Pharma LLC | NDA | Current |
| 55150-241 | Argatroban | Argatroban | AuroMedics Pharma LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 57036 | ORIG | 2018-12-26 |
| 56810 | ORIG | 2018-12-19 |