APPLICATION
ANDA208784
TYPE
ANDA
ORIGINAL APPROVAL
2017-09-21
LATEST ACTION
2023-06-30
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
2023-06-30Labeling · Supplement 1 · standardAP
2023-06-30Labeling · Supplement 8 · standardAP
2023-06-30Labeling · Supplement 6 · standardAP
2023-06-30Labeling · Supplement 2 · standardAP
2023-06-30Labeling · Supplement 9 · standardAP
2023-06-30Labeling · Supplement 7 · standardAP
2017-09-21UNKNOWN · 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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