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FDA ANDA · ANDA204228
OMEPRAZOLE AND SODIUM BICARBONATE
Sponsor: AJANTA PHARMA LTD
APPLICATION
ANDA204228
TYPE
ANDA
ORIGINAL APPROVAL
2016-07-15
LATEST ACTION
2023-11-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
OMEPRAZOLE AND SODIUM BICARBONATEPrescription
OMEPRAZOLE 20MG, SODIUM BICARBONATE 1.1GM · CAPSULE · ORAL
OMEPRAZOLE AND SODIUM BICARBONATEPrescription
OMEPRAZOLE 40MG, SODIUM BICARBONATE 1.1GM · CAPSULE · ORAL
Approval history
2023-11-15Labeling · Supplement 21 · standardAP
2023-11-15Labeling · Supplement 14 · standardAP
2023-11-15Labeling · Supplement 19 · standardAP
2020-02-24Labeling · Supplement 9 · standardAP
2020-02-24Labeling · Supplement 1 · standardAP
2020-02-24Labeling · Supplement 6 · standardAP
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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