FDA
Empagliflozin; Metformin Hydrochloride
The FDA lists this product in 6 strengths and forms.
Composition
- Active ingredients
- EMPAGLIFLOZIN 12.5MG; METFORMIN HYDROCHLORIDE 1000MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- EMPAGLIFLOZIN 12.5MG; METFORMIN HYDROCHLORIDE 500MG · TabletANDA212373-003 · Tentative approval
- EMPAGLIFLOZIN 5MG; METFORMIN HYDROCHLORIDE 500MG · TabletANDA212373-001 · Tentative approval
- EMPAGLIFLOZIN 12.5MG; METFORMIN HYDROCHLORIDE 1000MG · TabletANDA212373-004 · Tentative approval
- EMPAGLIFLOZIN 5MG; METFORMIN HYDROCHLORIDE 1000MG · TabletANDA212373-002 · Tentative approval
- EMPAGLIFLOZIN 12.5MG; METFORMIN HYDROCHLORIDE 1000MG · TabletThis page
- EMPAGLIFLOZIN 5MG; METFORMIN HYDROCHLORIDE 1000MG · Tablet, extended releaseANDA212243-001 · Tentative approval
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA218483.