APPLICATION
ANDA203957
TYPE
ANDA
ORIGINAL APPROVAL
2016-10-14
LATEST ACTION
2025-08-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Discontinued
Products
LANSOPRAZOLEDiscontinued
LANSOPRAZOLE 15MG · CAPSULE, DELAYED REL PELLETS · ORAL
LANSOPRAZOLEDiscontinued
LANSOPRAZOLE 30MG · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2025-08-15Labeling · Supplement 17 · standardAP
2025-03-12Labeling · Supplement 15 · standardAP
2021-11-09Labeling · Supplement 6 · standardAP
2021-11-09Labeling · Supplement 2 · standardAP
2021-11-09Labeling · Supplement 7 · standardAP
2021-11-09Labeling · Supplement 5 · standardAP
2021-11-09Labeling · Supplement 12 · standardAP
2021-11-09Labeling · Supplement 10 · standardAP
2016-10-14UNKNOWN · OriginalAP
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.
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