IRBESARTAN
Summary
FDA approved IRBESARTAN by ALEMBIC PHARMS LTD. ANDA (Generic) approval (Labeling) on 2025-09-16. TABLET, ORAL.
Details
Source
Drug Approval
External ID
ANDA091236-29
Action Date
2025-09-16
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
IRBESARTAN, TABLET, ORAL. Application: ANDA091236
Company
Context & Analysis
ALEMBIC PHARMS LTD has 6 FDA actions in our database.
Frequently Asked Questions
How often does ALEMBIC PHARMS LTD have FDA actions?
ALEMBIC PHARMS LTD 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 "ANDA091236-29" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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