Application 216974
- Type
- NDA
- Sponsor
- ENTASIS THERAP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | XACDURO (COPACKAGED) | DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM | POWDER;INTRAVENOUS | EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL | Yes | Yes |