APPLICATION
ANDA202487
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)
Products
SITAGLIPTIN PHOSPHATENone (Tentative Approval)
SITAGLIPTIN PHOSPHATE 100MG · TABLET · ORAL
SITAGLIPTIN PHOSPHATENone (Tentative Approval)
SITAGLIPTIN PHOSPHATE 25MG · TABLET · ORAL
SITAGLIPTIN PHOSPHATENone (Tentative Approval)
SITAGLIPTIN PHOSPHATE 50MG · TABLET · ORAL
Approval history
2015-02-23UNKNOWN · OriginalTA
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.