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FDA ANDA · ANDA205545
OMEPRAZOLE AND SODIUM BICARBONATE
Sponsor: AJANTA PHARMA LTD
APPLICATION
ANDA205545
TYPE
ANDA
ORIGINAL APPROVAL
2016-07-27
LATEST ACTION
2024-10-07
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
2024-10-07Labeling · Supplement 24 · standardAP
2023-12-26Labeling · Supplement 19 · standardAP
2023-12-26Labeling · Supplement 15 · standardAP
2023-12-26Labeling · Supplement 22 · standardAP
2020-04-06Labeling · Supplement 7 · standardAP
2020-04-06Labeling · Supplement 1 · standardAP
2020-04-06Labeling · Supplement 4 · standardAP
2016-07-27UNKNOWN · Original · 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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