FDAsafety guidance66% confidence
FDA AP — METHADONE HYDROCHLORIDE (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (pain) as Methadone Hydrochloride; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA040241. Sponsor: VISTAPHARM LLC. Submission status: AP. Submission type: SUPPL. Active ingredients: METHADONE HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Pain Management · Opioid
- Sub-indication
- Pain
Related signal: FDA Grants Approval for Methadone Hydrochloride ANDA212093 by Lannett Co Inc