DALFAMPRIDINE
Summary
FDA approved DALFAMPRIDINE by ALKEM LABS LTD. ANDA (Generic) approval (Labeling) on 2025-11-21. TABLET, EXTENDED RELEASE, ORAL.
Details
Source
Drug Approval
External ID
ANDA206765-16
Action Date
2025-11-21
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
DALFAMPRIDINE, TABLET, EXTENDED RELEASE, ORAL. Application: ANDA206765
Company
Context & Analysis
ALKEM LABS LTD has 50 FDA actions in our database.
Frequently Asked Questions
How often does ALKEM LABS LTD have FDA actions?
ALKEM LABS LTD has 50 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 "ANDA206765-16" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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