ISOSORBIDE MONONITRATE
Summary
FDA approved ISOSORBIDE MONONITRATE by DEXCEL LTD. ANDA (Generic) approval (Labeling) on 2025-07-14. TABLET, EXTENDED RELEASE, ORAL.
Details
Source
Drug Approval
External ID
ANDA210822-4
Action Date
2025-07-14
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
ISOSORBIDE MONONITRATE, TABLET, EXTENDED RELEASE, ORAL. Application: ANDA210822
Company
Context & Analysis
Frequently Asked Questions
How often does DEXCEL LTD have FDA actions?
This is the only FDA action we have on record for DEXCEL LTD in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "ANDA210822-4" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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