FDAsafety guidance66% confidence
FDA AP — TRAMADOL HYDROCHLORIDE (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (pain) as Novitium Pharma; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA208708. Sponsor: RUBICON RESEARCH. Submission status: AP. Submission type: SUPPL. Active ingredients: TRAMADOL HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Pain Management · Opioid
- Sub-indication
- Pain
Related signal: Novitium Pharma's Tramadol Hydrochloride ANDA219647 Receives AP Status