APPLICATION
ANDA091269
TYPE
ANDA
ORIGINAL APPROVAL
2010-10-15
LATEST ACTION
2022-09-02
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
2022-09-02Labeling · Supplement 20 · standardAP
2021-10-15Labeling · Supplement 18 · standardAP
2021-10-15Labeling · Supplement 17 · standardAP
2019-05-10Labeling · Supplement 16 · standardAP
2019-05-10Labeling · Supplement 8 · standardAP
2019-05-10Labeling · Supplement 14 · standardAP
2019-05-10Labeling · Supplement 12 · standardAP
2019-05-10Labeling · Supplement 13 · standardAP
2015-04-03Labeling · Supplement 6 · standardAP
2013-07-31Labeling · Supplement 5 · standardAP
2013-05-02Labeling · Supplement 4 · standardAP
2012-05-11Manufacturing (CMC) · Supplement 3AP
2012-01-31Labeling · Supplement 2AP
2012-01-31Labeling · Supplement 1AP
2010-10-15OriginalAP
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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