# ORLYNVAH
> **NDA213972** · New Drug Application · Sponsor: ITERUM THERAP · Approved 2024-10-25
## Drug
- **FDA Application Number:** NDA213972
- **Application type:** New Drug Application
- **Brand name:** ORLYNVAH
- **Generic name:** SULOPENEM ETZADROXIL AND PROBENECID
- **Active ingredients:** PROBENECID; SULOPENEM ETZADROXIL
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ITERUM THERAP
- **Manufacturer:** ITERUM THERAPEUTICS US LIMITED
- **First approval:** 2024-10-25
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213972)
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