APPLICATION
ANDA203203
TYPE
ANDA
ORIGINAL APPROVAL
2016-07-25
LATEST ACTION
2023-04-06
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
2023-04-06Labeling · Supplement 11 · standardAP
2023-04-06Labeling · Supplement 14 · standardAP
2023-04-06Labeling · Supplement 10 · standardAP
2020-08-20Labeling · Supplement 6 · standardAP
2020-08-20Labeling · Supplement 4 · standardAP
2020-08-20Labeling · Supplement 2 · standardAP
2020-08-20Labeling · Supplement 5 · standardAP
2016-07-25UNKNOWN · 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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