Composition
- Active ingredients
- SITAGLIPTIN 50MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- SITAGLIPTIN 50MG · TabletANDA216337-002 · Tentative approval
- SITAGLIPTIN 100MG · TabletANDA216337-003 · Tentative approval
- SITAGLIPTIN 25MG · TabletANDA216337-001 · Tentative approval
- SITAGLIPTIN 50MG · TabletThis page
- SITAGLIPTIN 100MG · TabletANDA216057-003 · Tentative approval
- SITAGLIPTIN 25MG · TabletANDA216057-001 · Tentative approval
- SITAGLIPTIN 100MG · TabletANDA218441-003 · Tentative approval
- SITAGLIPTIN 50MG · TabletANDA218441-002 · Tentative approval
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA216057.
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
- Dosage form
- Tablet
- Applicant
- Laurus Labs LTD
- Status
- Tentative approval
- FDA approval
- 12 Nov 2025
- Application
- ANDA216057-002