← FDA DRUG APPROVALS
FDA ANDA · ANDA211532
DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATE
Sponsor: LUPIN LTD
APPLICATION
ANDA211532
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)
Products
DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATENone (Tentative Approval)
DAPAGLIFLOZIN, SAXAGLIPTIN MONOHYDRATE 5MG · TABLET · ORAL
DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATENone (Tentative Approval)
DAPAGLIFLOZIN, SAXAGLIPTIN MONOHYDRATE 10MG · TABLET · ORAL
Approval history
2024-01-03UNKNOWN · Original · standardTA
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.