FDA application evidence
ANDA078257
ONDANSETRON HYDROCHLORIDE
Application summary
- Application number
- ANDA078257
- Sponsor
- ONESOURCE SPECIALTY
- Product / brand name
- ONDANSETRON HYDROCHLORIDE
- Active ingredients
- ONDANSETRON HYDROCHLORIDE
- Submission type
- SUPPL
- Submission status
- AP
- Submission date
- 20260415
- Review priority
- STANDARD
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Discontinued