APPLICATION
ANDA077255
TYPE
ANDA
ORIGINAL APPROVAL
2009-11-10
LATEST ACTION
2021-10-15
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
2021-10-15Labeling · Supplement 22 · standardAP
2019-07-01Labeling · Supplement 17 · standardAP
2019-07-01Labeling · Supplement 15 · standardAP
2019-07-01Labeling · Supplement 18 · standardAP
2019-07-01Labeling · Supplement 16 · standardAP
2015-04-02Labeling · Supplement 14 · standardAP
2013-04-30Labeling · Supplement 11 · standardAP
2013-04-30Labeling · Supplement 12 · standardAP
2012-04-18Labeling · Supplement 8AP
2012-04-18Labeling · Supplement 6AP
2012-04-18Labeling · Supplement 4AP
2012-04-18Labeling · Supplement 2AP
2012-04-16Labeling · Supplement 10AP
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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