APPLICATION
ANDA202637
TYPE
ANDA
ORIGINAL APPROVAL
2013-09-13
LATEST ACTION
2022-09-02
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Discontinued
Products
LANSOPRAZOLEDiscontinued
LANSOPRAZOLE 15MG · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2022-09-02Labeling · Supplement 18 · standardAP
2020-10-20Labeling · Supplement 6 · standardAP
2020-10-20Labeling · Supplement 15 · standardAP
2020-10-20Labeling · Supplement 9 · standardAP
2020-10-20Labeling · Supplement 8 · standardAP
2015-03-17Labeling · Supplement 5 · standardAP
2013-09-13UNKNOWN · 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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