APPLICATION
ANDA203345
TYPE
ANDA
ORIGINAL APPROVAL
2018-03-16
LATEST ACTION
2020-07-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Over-the-counter
Products
OMEPRAZOLE AND SODIUM BICARBONATEOver-the-counter
OMEPRAZOLE 20MG, SODIUM BICARBONATE 1.1GM · CAPSULE · ORAL
Approval history
2020-07-23Labeling · Supplement 1 · standardAP
2018-03-16UNKNOWN · 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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