# ZEJULA
> **NDA214876** · New Drug Application · Sponsor: GLAXOSMITHKLINE · Approved 2023-04-26
## Drug
- **FDA Application Number:** NDA214876
- **Application type:** New Drug Application
- **Brand name:** ZEJULA
- **Generic name:** NIRAPARIB
- **Active ingredients:** NIRAPARIB TOSYLATE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** GLAXOSMITHKLINE
- **Manufacturer:** GlaxoSmithKline LLC
- **First approval:** 2023-04-26
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214876)
---
*AI Analytics · CC0 1.0*