FDA
Irbesartan; Hydrochlorothiazide
The FDA lists this product in 4 strengths and forms.
Composition
- Active ingredients
- IRBESARTAN 300MG; HYDROCHLOROTHIAZIDE 12.5MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- IRBESARTAN 300MG; HYDROCHLOROTHIAZIDE 25MG · TabletANDA201524-003 · Tentative approval
- IRBESARTAN 300MG; HYDROCHLOROTHIAZIDE 25MG · TabletANDA090815-003 · Tentative approval
- IRBESARTAN 150MG; HYDROCHLOROTHIAZIDE 12.5MG · TabletANDA090815-001 · Tentative approval
- IRBESARTAN 300MG; HYDROCHLOROTHIAZIDE 12.5MG · TabletThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA090815.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.