APPLICATION
ANDA217784
TYPE
ANDA
ORIGINAL APPROVAL
2024-05-09
LATEST ACTION
2024-05-09
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Over-the-counter
Products
OMEPRAZOLE AND SODIUM BICARBONATEOver-the-counter
OMEPRAZOLE 20MG/PACKET, SODIUM BICARBONATE 1.68GM/PACKET · FOR SUSPENSION · ORAL
Approval history
2024-05-09UNKNOWN · 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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