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FDA NDA · NDA213593

KONVOMEP

omeprazole and sodium bicarbonate

Sponsor: AZURITY

APPLICATION
NDA213593
TYPE
NDA
ORIGINAL APPROVAL
2022-08-30
LATEST ACTION
2022-08-30
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription

Products

KONVOMEP · ReferencePrescription
OMEPRAZOLE 2MG/ML, SODIUM BICARBONATE 84MG/ML · FOR SUSPENSION · ORAL

Approval history

2022-08-30Type 5 - New Formulation or New Manufacturer · Original · standardLetterAP
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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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