FDAsafety guidance66% confidence
FDA AP — HYDROCODONE BITARTRATE AND ACETAMINOPHEN (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (pain) as Aurobindo Pharma; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA205001. Sponsor: STRIDES PHARMA INTL. Submission status: AP. Submission type: SUPPL. Active ingredients: ACETAMINOPHEN, HYDROCODONE BITARTRATE.
Supporting Context
- Therapeutic area
- Pain Management · Analgesics
- Sub-indication
- Pain
Related signal: Aurobindo Pharma's ANDA218359 for Acetaminophen and Ibuprofen Receives AP Status