OMEPRAZOLE (OMEPRAZOLE MAGNESIUM)
Summary
FDA approved OMEPRAZOLE (OMEPRAZOLE MAGNESIUM) by DEXCEL. ANDA (Generic) approval (Manufacturing (CMC)) on 2025-06-05. CAPSULE, DELAYED RELEASE, ORAL.
Details
Source
Drug Approval
External ID
ANDA216096-5
Action Date
2025-06-05
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
OMEPRAZOLE (generic: OMEPRAZOLE MAGNESIUM), CAPSULE, DELAYED RELEASE, ORAL. Application: ANDA216096
Company
Context & Analysis
DEXCEL has 6 FDA actions in our database.
Frequently Asked Questions
How often does DEXCEL have FDA actions?
DEXCEL has 6 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 "ANDA216096-5" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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