DEXLANSOPRAZOLE
Summary
FDA approved DEXLANSOPRAZOLE by PH HEALTH. ANDA (Generic) approval (Labeling) on 2025-08-14. CAPSULE, DELAYED RELEASE, ORAL.
Details
Source
Drug Approval
External ID
ANDA202294-13
Action Date
2025-08-14
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
DEXLANSOPRAZOLE, CAPSULE, DELAYED RELEASE, ORAL. Application: ANDA202294
Company
Context & Analysis
PH HEALTH has 51 FDA actions in our database.
Frequently Asked Questions
How often does PH HEALTH have FDA actions?
PH HEALTH has 51 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 "ANDA202294-13" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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