FDA
Dapagliflozin
The FDA lists this product in 41 strengths and forms.
Composition
- Active ingredients
- DAPAGLIFLOZIN 10MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- DAPAGLIFLOZIN 10MG · TabletANDA216119-002 · Tentative approval
- DAPAGLIFLOZIN 5MG · TabletANDA216119-001 · Tentative approval
- DAPAGLIFLOZIN 5MG · TabletANDA211312-001 · Prescription
- DAPAGLIFLOZIN 10MG · TabletANDA211312-002 · Prescription
- DAPAGLIFLOZIN 5MG · TabletANDA211468-001 · Prescription
- DAPAGLIFLOZIN 10MG · TabletANDA211468-002 · Prescription
- DAPAGLIFLOZIN 10MG · TabletANDA211564-002 · Tentative approval
- DAPAGLIFLOZIN 5MG · TabletANDA211564-001 · Tentative approval
- DAPAGLIFLOZIN 10MG · TabletANDA220679-002 · Tentative approval
- DAPAGLIFLOZIN 5MG · TabletANDA211482-001 · Prescription
- DAPAGLIFLOZIN 10MG · TabletANDA211482-002 · Prescription
- DAPAGLIFLOZIN 5MG · TabletANDA211545-001 · Prescription
- DAPAGLIFLOZIN 10MG · TabletANDA211545-002 · Prescription
At a glance
- Brand name
- Dapagliflozin
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Micro Labs
- Status
- Prescription
- FDA approval
- 6 Apr 2026
- Application
- ANDA211467-002