OMEPRAZOLE
Summary
FDA approved OMEPRAZOLE by SANDOZ. ANDA (Generic) approval (Labeling) on 2023-10-11. CAPSULE, DELAYED REL PELLETS, ORAL.
Details
Source
Drug Approval
External ID
ANDA075757-56
Action Date
2023-10-11
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
OMEPRAZOLE, CAPSULE, DELAYED REL PELLETS, ORAL. Application: ANDA075757
Company
Context & Analysis
SANDOZ has 75 FDA actions in our database.
Frequently Asked Questions
How often does SANDOZ have FDA actions?
SANDOZ has 75 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 "ANDA075757-56" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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