FDAsafety guidance66% confidence
FDA AP — TRAMADOL HYDROCHLORIDE (ORIG)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (pain) as Buprenorphine Hydrochloride; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA219647. Sponsor: NOVITIUM PHARMA. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: TRAMADOL HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Pain Management · Opioid
- Sub-indication
- Pain
Related signal: FDA Approves Supplement for Buprenorphine Hydrochloride by Rubicon Research