APPLICATION
ANDA090763
TYPE
ANDA
ORIGINAL APPROVAL
2009-11-10
LATEST ACTION
2024-07-05
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Prescription
Products
LANSOPRAZOLEPrescription
LANSOPRAZOLE 15MG · CAPSULE, DELAYED REL PELLETS · ORAL
LANSOPRAZOLEPrescription
LANSOPRAZOLE 30MG · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2024-07-05Labeling · Supplement 19 · standardAP
2024-02-14Labeling · Supplement 16 · standardAP
2024-02-14Labeling · Supplement 12 · standardAP
2024-02-14Labeling · Supplement 10 · standardAP
2024-02-14Labeling · Supplement 17 · standardAP
2015-03-16Labeling · Supplement 8 · standardAP
2013-08-27Labeling · Supplement 4 · standardAP
2012-08-28Labeling · Supplement 2AP
2012-08-28Labeling · Supplement 3AP
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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