APPLICATION
ANDA210465
TYPE
ANDA
ORIGINAL APPROVAL
2021-02-01
LATEST ACTION
2023-09-19
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
2023-09-19Labeling · Supplement 3 · standardAP
2023-09-19Labeling · Supplement 1 · standardAP
2021-02-01UNKNOWN · Original · standardAP
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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