APPLICATION
ANDA207363
TYPE
ANDA
ORIGINAL APPROVAL
2019-04-23
LATEST ACTION
2020-08-07
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
RUFINAMIDEPrescription
RUFINAMIDE 40MG/ML · SUSPENSION · ORAL
Approval history
2020-08-07Labeling · 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.
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