FDAsafety guidance66% confidence
FDA AP — ONDANSETRON HYDROCHLORIDE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Sciegen Pharmaceuticals; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA078257. Sponsor: ONESOURCE SPECIALTY. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: ONDANSETRON HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Cardiovascular · Calcium Channel Blocker
- Sub-indication
- General
Related signal: FDA Grants AP Status for Diltiazem Hydrochloride ANDA216327
Source
FDA document
View source