APPLICATION
ANDA210158
TYPE
ANDA
ORIGINAL APPROVAL
2019-03-11
LATEST ACTION
2023-04-11
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
DALFAMPRIDINEPrescription
DALFAMPRIDINE 10MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2023-04-11Labeling · Supplement 5 · standardAP
2021-09-15Labeling · Supplement 4 · standardAP
2020-08-14Labeling · Supplement 3 · 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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