FDAsafety guidance66% confidence
FDA AP — MEPERIDINE HYDROCHLORIDE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Annora Pharma; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA040331. Sponsor: EPIC PHARMA LLC. Submission status: AP. Submission type: SUPPL. Active ingredients: MEPERIDINE HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Allergy · Antihistamine
- Sub-indication
- General
Related signal: FDA Grants Approval for Diphenhydramine Hydrochloride ANDA219470