FDA
Empagliflozin and Metformin Hydrochloride
The FDA lists this product in 4 strengths and forms.
Composition
- Active ingredients
- EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE 12.5MG/1000MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE 25MG/1000MG · Tablet, extended releaseANDA220511-004 · Tentative approval
- EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE 10MG/1000MG · Tablet, extended releaseANDA220511-002 · Tentative approval
- EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE 12.5MG/1000MG · Tablet, extended releaseThis page
- EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE 5MG/1000MG · Tablet, extended releaseANDA220511-001 · Tentative approval
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA220511.
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.



