APPLICATION
ANDA210531
TYPE
ANDA
ORIGINAL APPROVAL
2020-08-17
LATEST ACTION
2024-04-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Discontinued
Products
DIMETHYL FUMARATEDiscontinued
DIMETHYL FUMARATE 120MG · CAPSULE, DELAYED RELEASE · ORAL
DIMETHYL FUMARATEDiscontinued
DIMETHYL FUMARATE 240MG · CAPSULE, DELAYED RELEASE · ORAL
Approval history
2024-04-30Labeling · Supplement 6 · standardAP
2024-04-30Labeling · Supplement 12 · standardAP
2024-04-30Labeling · Supplement 10 · standardAP
2024-04-30Labeling · Supplement 3 · standardAP
2024-04-30Labeling · Supplement 13 · standardAP
2021-06-17Manufacturing (CMC) · Supplement 1 · unknownAP
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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