APPLICATION
ANDA090331
TYPE
ANDA
ORIGINAL APPROVAL
2010-04-23
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
LANSOPRAZOLEDiscontinued
LANSOPRAZOLE 30MG · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2022-09-02Labeling · Supplement 26 · standardAP
2021-10-15Labeling · Supplement 24 · standardAP
2021-10-15Labeling · Supplement 25 · standardAP
2019-06-28Labeling · Supplement 18 · standardAP
2019-06-28Labeling · Supplement 16 · standardAP
2019-06-28Labeling · Supplement 19 · standardAP
2015-03-05Labeling · Supplement 14 · standardAP
2015-03-05Manufacturing (CMC) · Supplement 7 · unknownAP
2013-08-27Labeling · Supplement 12 · standardAP
2013-04-03Labeling · Supplement 4 · standardAP
2013-04-03Labeling · Supplement 5 · standardAP
2012-01-31Labeling · Supplement 2AP
2012-01-31Labeling · Supplement 1AP
2010-04-23OriginalAP
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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