FDAsafety guidance77% confidence
FDA AP — OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (ORIG)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Upsher Smith Labs; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA206371. Sponsor: MICRO LABS. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL.
Supporting Context
- Therapeutic area
- Immunology · Corticosteroid
- Sub-indication
- General
Related signal: FDA Approves Deflazacort Supplement Application by Upsher Smith Labs