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FDA ANDA · ANDA079182
OMEPRAZOLE/SODIUM BICARBONATE
omeprazole
Sponsor: STRIDES PHARMA INTL
APPLICATION
ANDA079182
TYPE
ANDA
ORIGINAL APPROVAL
2013-04-19
LATEST ACTION
2023-12-27
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription
Products
OMEPRAZOLE AND SODIUM BICARBONATEPrescription
OMEPRAZOLE 40MG/PACKET, SODIUM BICARBONATE 1.68GM/PACKET · FOR SUSPENSION · ORAL
OMEPRAZOLE AND SODIUM BICARBONATEPrescription
OMEPRAZOLE 20MG/PACKET, SODIUM BICARBONATE 1.68GM/PACKET · FOR SUSPENSION · ORAL
Approval history
2023-12-27Labeling · Supplement 10 · standardAP
2023-12-27Labeling · Supplement 7 · standardAP
2020-08-05Labeling · Supplement 4 · standardAP
2015-04-09Labeling · Supplement 2 · standardAP
2013-04-19OriginalAP
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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