APPLICATION
ANDA210226
TYPE
ANDA
ORIGINAL APPROVAL
2020-10-06
LATEST ACTION
2025-01-14
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
2025-01-14Labeling · Supplement 5 · standardAP
2024-02-16Labeling · Supplement 4 · standardAP
2024-02-16Labeling · Supplement 2 · standardAP
2024-02-16Labeling · Supplement 3 · standardAP
2024-02-16Labeling · Supplement 1 · standardAP
2020-10-06UNKNOWN · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.