APPLICATION
ANDA210440
TYPE
ANDA
ORIGINAL APPROVAL
2020-09-24
LATEST ACTION
2024-10-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
DIMETHYL FUMARATEPrescription
DIMETHYL FUMARATE 120MG · CAPSULE, DELAYED RELEASE · ORAL
DIMETHYL FUMARATEPrescription
DIMETHYL FUMARATE 240MG · CAPSULE, DELAYED RELEASE · ORAL
Approval history
2024-10-11Labeling · Supplement 7 · standardAP
2024-10-11Labeling · Supplement 5 · standardAP
2024-10-11Labeling · Supplement 8 · standardAP
2024-10-11Labeling · Supplement 10 · standardAP
2024-10-11Labeling · Supplement 4 · standardAP
2024-10-11Labeling · Supplement 2 · 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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