APPLICATION
ANDA212587
TYPE
ANDA
ORIGINAL APPROVAL
2020-04-30
LATEST ACTION
2020-04-30
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
2020-04-30UNKNOWN · 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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