APPLICATION
ANDA206858
TYPE
ANDA
ORIGINAL APPROVAL
2020-07-06
LATEST ACTION
2023-03-15
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
DALFAMPRIDINEDiscontinued
DALFAMPRIDINE 10MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2023-03-15Labeling · Supplement 3 · standardAP
2021-09-08Labeling · Supplement 1 · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.