APPLICATION
ANDA202384
TYPE
ANDA
ORIGINAL APPROVAL
2015-08-25
LATEST ACTION
2018-06-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Discontinued
Products
OMEPRAZOLEDiscontinued
OMEPRAZOLE 40MG · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2018-06-07Labeling · Supplement 2 · standardAP
2018-05-31Labeling · Supplement 1 · standardAP
2015-08-25UNKNOWN · 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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