FDAsafety guidance65% confidence
FDA AP — OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (ORIG)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (cardiology) as Sandoz.
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
- Cardiovascular · Hypertension
- Sub-indication
- Hypertension
Related signal: Sandoz receives AP status for Irbesartan and Hydrochlorothiazide ANDA