IRBESARTAN
Summary
FDA approved IRBESARTAN by MACLEODS PHARMS LTD. ANDA (Generic) approval (Labeling) on 2025-11-25. TABLET, ORAL.
Details
Source
Drug Approval
External ID
ANDA202254-62
Action Date
2025-11-25
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
IRBESARTAN, TABLET, ORAL. Application: ANDA202254
Company
Context & Analysis
MACLEODS PHARMS LTD has 63 FDA actions in our database.
Frequently Asked Questions
How often does MACLEODS PHARMS LTD have FDA actions?
MACLEODS PHARMS LTD has 63 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 "ANDA202254-62" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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