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FDA ANDA · ANDA203290

OMEPRAZOLE AND SODIUM BICARBONATE

Sponsor: ZYDUS PHARMS

APPLICATION
ANDA203290
TYPE
ANDA
ORIGINAL APPROVAL
2018-05-25
LATEST ACTION
2023-05-15
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

2023-05-15Labeling · Supplement 1 · standardAP
2023-05-15Labeling · Supplement 4 · standardAP
2023-05-15Labeling · Supplement 3 · standardAP
2018-05-25UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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