APPLICATION
ANDA206836
TYPE
ANDA
ORIGINAL APPROVAL
2017-01-23
LATEST ACTION
2023-04-19
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
DALFAMPRIDINEPrescription
DALFAMPRIDINE 10MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2023-04-19Labeling · Supplement 4 · standardAP
2021-09-08Labeling · Supplement 2 · standardAP
2020-09-10Labeling · Supplement 1 · standardAP
2017-01-23UNKNOWN · 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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