FDAsafety guidance77% 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 (ophthalmology) as Mankind Pharma; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA040355. Sponsor: STRIDES PHARMA INTL. Submission status: AP. Submission type: SUPPL. Active ingredients: ACETAMINOPHEN, HYDROCODONE BITARTRATE.
Supporting Context
- Therapeutic area
- Ophthalmology · Glaucoma
- Sub-indication
- Ophthalmology
Related signal: FDA Grants Approval for Brimonidine Tartrate ANDA220398 by Mankind Pharma