OMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE, SODIUM BICARBONATE)
Summary
FDA approved OMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE, SODIUM BICARBONATE) by SALIX. NDA (New Drug) approval (Labeling) on 2023-07-18. FOR SUSPENSION, ORAL.
Details
Source
Drug Approval
External ID
NDA021636-25
Action Date
2023-07-18
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
OMEPRAZOLE AND SODIUM BICARBONATE (generic: OMEPRAZOLE, SODIUM BICARBONATE), FOR SUSPENSION, ORAL. Application: NDA021636
Company
Context & Analysis
SALIX has 3 FDA actions in our database.
Frequently Asked Questions
How often does SALIX have FDA actions?
SALIX has 3 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 "NDA021636-25" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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