| Application # | Type | Sponsor | Notes | Product # | Drug Name | Form | Strength | Active Ingredient | Approval Date | Marketing Status | Reference Standard |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 213972 | NDA | ITERUM THERAP | 001 | ORLYNVAH | TABLET;ORAL | 500MG;500MG | PROBENECID; SULOPENEM ETZADROXIL | 2024-10-25 | Discontinued | No |