FDA
Sitagliptin and Metformin Hydrochloride
The FDA lists this product in 2 strengths and forms.
Composition
- Active ingredients
- SITAGLIPTIN AND METFORMIN HYDROCHLORIDE 500MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- SITAGLIPTIN AND METFORMIN HYDROCHLORIDE 1000MG · TabletANDA214859-003 · Tentative approval
- SITAGLIPTIN AND METFORMIN HYDROCHLORIDE 500MG · TabletThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA214859.
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
- Sitagliptin and Metformin Hydrochloride
- Dosage form
- Tablet
- Applicant
- Aurobindo Pharma Limited
- Status
- Tentative approval
- FDA approval
- 24 Feb 2026
- Application
- ANDA214859-002