APPLICATION
ANDA202396
TYPE
ANDA
ORIGINAL APPROVAL
2018-11-28
LATEST ACTION
2024-05-03
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
LANSOPRAZOLEPrescription
LANSOPRAZOLE 15MG · TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE · ORAL
LANSOPRAZOLEPrescription
LANSOPRAZOLE 30MG · TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE · ORAL
Approval history
2024-05-03Labeling · Supplement 6 · standardAP
2024-05-03Labeling · Supplement 4 · standardAP
2024-05-03Labeling · Supplement 3 · standardAP
2021-11-12Labeling · Supplement 2 · standardAP
2018-11-28UNKNOWN · 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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