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FDA ANDA · ANDA210309

DIMETHYL FUMARATE

dimethyl-fumarate

Sponsor: GLENMARK PHARMS LTD

APPLICATION
ANDA210309
TYPE
ANDA
ORIGINAL APPROVAL
2020-10-06
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

DIMETHYL FUMARATEPrescription
DIMETHYL FUMARATE 240MG · CAPSULE, DELAYED RELEASE · ORAL
DIMETHYL FUMARATEPrescription
DIMETHYL FUMARATE 120MG · CAPSULE, DELAYED RELEASE · ORAL

Approval history

2025-01-22Labeling · Supplement 6 · standardAP
2024-02-08Labeling · Supplement 4 · standardAP
2024-02-08Labeling · Supplement 2 · standardAP
2024-02-08Labeling · Supplement 5 · standardAP
2024-02-08Labeling · Supplement 3 · standardAP
2024-02-08Labeling · Supplement 1 · standardAP
2020-10-06UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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