FDA
Dapagliflozin and Metformin
The FDA lists this product in 4 strengths and forms.
Composition
- Active ingredients
- DAPAGLIFLOZIN || METFORMIN 500MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA218091.
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
- Dapagliflozin and Metformin
- Active substance
- dapagliflozin || metformin
- Dosage form
- Tablet
- Applicant
- Sinotherapeutics Inc
- Status
- Tentative approval
- FDA approval
- 8 May 2025
- Application
- ANDA218091-004