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FDA ANDA · ANDA078966
OMEPRAZOLE AND SODIUM BICARBONATE
Sponsor: STRIDES PHARMA INTL
APPLICATION
ANDA078966
TYPE
ANDA
ORIGINAL APPROVAL
2010-05-25
LATEST ACTION
2023-12-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
OMEPRAZOLE AND SODIUM BICARBONATEDiscontinued
OMEPRAZOLE 40MG, SODIUM BICARBONATE 1.1GM · CAPSULE · ORAL
OMEPRAZOLE AND SODIUM BICARBONATEDiscontinued
OMEPRAZOLE 20MG, SODIUM BICARBONATE 1.1GM · CAPSULE · ORAL
Approval history
2023-12-19Labeling · Supplement 11 · standardAP
2023-12-19Labeling · Supplement 12 · standardAP
2020-07-20Labeling · Supplement 9 · standardAP
2015-04-09Labeling · Supplement 8 · standardAP
2012-08-27Labeling · Supplement 6 · standardAP
2012-03-13Labeling · Supplement 5AP
2012-03-13Labeling · Supplement 3AP
2012-03-13Labeling · Supplement 4AP
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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