Drug application
XACDURO (COPACKAGED) (DURLOBACTAM SODIUM, SULBACTAM SODIUM)
Drugs@FDA NDA 216974 · ENTASIS THERAP
Key facts
| Drug name | XACDURO (COPACKAGED) |
|---|---|
| Active ingredients | DURLOBACTAM SODIUM, SULBACTAM SODIUM |
| Application type | NDA |
| Application number | 216974 |
| Company | ENTASIS THERAP |
| Dosage forms | POWDER, INTRAVENOUS |
| Strength | EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL |
| Marketing status | Prescription |
| Reference listed drug | Yes |
| Latest submission class | Type 1 - New Molecular Entity and Type 4 - New Combination |
| Latest submission status date | May 23, 2023 |
At a glance
- 1–9 Submissions
- 1–9 Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: