APPLICATION
ANDA207394
TYPE
ANDA
ORIGINAL APPROVAL
2019-01-18
LATEST ACTION
2024-12-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Prescription
Products
LANSOPRAZOLEPrescription
LANSOPRAZOLE 30MG · CAPSULE, DELAYED REL PELLETS · ORAL
LANSOPRAZOLEPrescription
LANSOPRAZOLE 15MG · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2024-12-19Labeling · Supplement 11 · standardAP
2024-02-23Labeling · Supplement 10 · standardAP
2024-02-23Labeling · Supplement 8 · standardAP
2024-02-23Labeling · Supplement 6 · standardAP
2019-01-18UNKNOWN · Original · 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.