APPLICATION
ANDA206646
TYPE
ANDA
ORIGINAL APPROVAL
2018-10-24
LATEST ACTION
2023-05-01
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
DALFAMPRIDINEDiscontinued
DALFAMPRIDINE 10MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2023-05-01Labeling · Supplement 3 · standardAP
2023-05-01Labeling · Supplement 4 · standardAP
2020-08-13Labeling · Supplement 2 · standardAP
2018-10-24UNKNOWN · Original · 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.
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