FDAsafety guidance77% confidence
FDA AP — OXYCODONE HYDROCHLORIDE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Azelastine Hydrochloride; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA201194. Sponsor: VISTAPHARM LLC. Submission status: AP. Submission type: SUPPL. Review priority: N/A. Active ingredients: OXYCODONE HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Allergy · Nasal Spray
- Sub-indication
- General
Related signal: FDA Grants AP Status for Azelastine Hydrochloride and Fluticasone Propionate