KONVOMEP (OMEPRAZOLE AND SODIUM BICARBONATE)
Summary
FDA approved KONVOMEP (OMEPRAZOLE AND SODIUM BICARBONATE) by AZURITY. NDA (New Drug) approval (Type 5 - New Formulation or New Manufacturer) on 2022-08-30. FOR SUSPENSION, ORAL.
Details
Source
Drug Approval
External ID
NDA213593-1
Action Date
2022-08-30
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
KONVOMEP (generic: OMEPRAZOLE AND SODIUM BICARBONATE), FOR SUSPENSION, ORAL. Application: NDA213593
Company
Context & Analysis
AZURITY has 21 FDA actions in our database.
Frequently Asked Questions
How often does AZURITY have FDA actions?
AZURITY has 21 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA213593-1" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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