APPLICATION
ANDA202294
TYPE
ANDA
ORIGINAL APPROVAL
2017-04-19
LATEST ACTION
2025-08-14
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
DEXLANSOPRAZOLEPrescription
DEXLANSOPRAZOLE 30MG · CAPSULE, DELAYED RELEASE · ORAL
DEXLANSOPRAZOLEPrescription
DEXLANSOPRAZOLE 60MG · CAPSULE, DELAYED RELEASE · ORAL
Approval history
2025-08-14Labeling · Supplement 13 · standardAP
2025-08-14Labeling · Supplement 16 · standardAP
2022-08-03Labeling · Supplement 9 · standardAP
2022-06-16Manufacturing (CMC) · Supplement 6 · unknownAP
2022-05-03Labeling · Supplement 2 · standardAP
2022-05-03Labeling · Supplement 3 · standardAP
2020-10-01Labeling · Supplement 1 · standardAP
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.