APPLICATION
ANDA212364
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)
Products
EMPAGLIFLOZIN; LINAGLIPTINNone (Tentative Approval)
EMPAGLIFLOZIN 25MG, LINAGLIPTIN 5MG · TABLET · ORAL
EMPAGLIFLOZIN; LINAGLIPTINNone (Tentative Approval)
EMPAGLIFLOZIN 10MG, LINAGLIPTIN 5MG · TABLET · ORAL
Approval history
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.