Dimethyl Fumerate Delayed-Release Capsules

Route
Oral
Dosage form
Delayed-Release Capsules
Strength
120mg and 240mg
Rx/OTC
Rx
Indication
Indicated for the treatment of relapsing forms of Multiple Sclerosis (MS).
TE Rating
AB
Reference Listed Drug
TECFIDERA TM
ANDA#
210382
Strength Form Product Description Imprint Image How Supplied NDC Number HDMA
Sheets
PI SDS
120mg Delayed-Release Capsules Hard gelatin delayed-release capsule. The 120 mg capsules have a green cap and white body, printed with “T127 120 mg” in black ink on the body. T127 120 mg 14 24979-127-21
240mg Delayed-Release Capsules Hard gelatin delayed-release capsule. The 240 mg capsules have a green cap and a green body, printed with “T128 240 mg” in black ink on the body. T128 240 mg 60 24979-128-04

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