approval · primary record
PROBENECID
FDA · NDA · 2025-12-23
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Action date | 2025-12-23 |
| Brand | ORLYNVAH |
| Sponsor | ITERUM THERAP |
| Route | ORAL |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-28T02:34:02.098Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: FDA:PROBENECID:2025-12-23
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