AVALIDE
HYDROCHLOROTHIAZIDE; IRBESARTAN
Approval overview AVALIDE is listed in Drugs@FDA under application 020758 (NDA).
Review priority: STANDARD Marketing status: Discontinued Active ingredient HYDROCHLOROTHIAZIDE; IRBESARTAN Form and strength TABLET;ORAL - 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor SANOFI AVENTIS US Submission history Latest submission status date: 2025-08-01 00:00:00.
Structured Monograph
Clinical summary
Approval overview AVALIDE is listed in Drugs@FDA under application 020758 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient HYDROCHLOROTHIAZIDE; IRBESARTAN Form and strength TABLET;ORAL - 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor SANOFI AVENTIS US Submission history Latest submission status date: 2025-08-01 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Discontinued
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.