Composition
- Active ingredients
- HYDROCHLOROTHIAZIDE 25MG; IRBESARTAN 300MG
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA201505.
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.
At a glance
- Brand name
- Irbesartan Hydrochlorothiazide
- Active substance
- hydrochlorothiazide
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Apotex Inc
- Status
- Tentative approval
- FDA approval
- 15 Oct 2012
- Application
- ANDA201505-003