APPLICATION
ANDA201921
TYPE
ANDA
ORIGINAL APPROVAL
2012-12-18
LATEST ACTION
2024-05-02
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
2024-05-02Labeling · Supplement 8 · standardAP
2019-06-03Labeling · Supplement 6 · standardAP
2017-09-26Labeling · Supplement 3 · standardAP
2017-09-26Labeling · Supplement 2 · standardAP
2015-03-16Labeling · Supplement 1 · standardAP
2012-12-18UNKNOWN · 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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