Application 206243
- Type
- ANDA
- Sponsor
- XELLIA PHARMS APS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 5GM BASE/VIAL | No | No |
| 002 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 45932-0031 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | Xellia Pharmaceuticals ApS | ANDA | Current |
| 45932-0032 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | Xellia Pharmaceuticals ApS | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 10552 | ORIG | 2015-12-30 |