Application 213895
- Type
- NDA
- Sponsor
- XELLIA PHARMS APS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VANCOMYCIN | VANCOMYCIN | SOLUTION;INTRAVENOUS | 5G/100ML | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70594-040 | Vancomycin | Vancomycin | Xellia Pharmaceuticals USA LLC | NDA | Current |