Composition
- Active ingredients
- SITAGLIPTIN PHOSPHATE 50MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- SITAGLIPTIN PHOSPHATE 50MG · TabletANDA216919-002 · Tentative approval
- SITAGLIPTIN PHOSPHATE 100MG · TabletANDA216919-003 · Tentative approval
- SITAGLIPTIN PHOSPHATE 25MG · TabletANDA216919-001 · Tentative approval
- SITAGLIPTIN PHOSPHATE 50MG · TabletThis page
- SITAGLIPTIN PHOSPHATE 100MG · TabletANDA216086-003 · Tentative approval
- SITAGLIPTIN PHOSPHATE 100MG · TabletANDA217041-003 · Tentative approval
- SITAGLIPTIN PHOSPHATE 50MG · TabletANDA217041-002 · Tentative approval
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA216086.
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
- Active substance
- sitagliptin phosphate
- Route
- Film coated
- Dosage form
- Tablet
- Applicant
- MSN Laboratories Private LTD
- Status
- Tentative approval
- FDA approval
- 23 Jul 2025
- Application
- ANDA216086-002