dimethyl fumarate capsule delayed release
1 INDICATIONS AND USAGE Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ( 1 )
mylan pharmaceuticals inc.
CAPSULE WHITE Mylan DF 120
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dimethyl fumarate capsule delayed release
mylan pharmaceuticals inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
DIMETHYL FUMARATE Delayed-Release capsules, USP are available containing 120 mg or 240 mg of
DIMETHYL FUMARATE, USP. The 120 mg capsules are hard-shell gelatin capsules with a blue-green opaque cap and a white opaque body filled with white to off-white enteric coated pellets with no markings. The capsules are axially printed with MYLAN over DF 120 in black ink on both the cap and body. They are available as follows: NDC 0378-0396-14 bottles of 14 capsules The 240 mg capsules are hard-shell gelatin capsules with a blue-green opaque cap and a blue-green opaque body filled with white to off-white enteric coated pellets with no markings. The capsules are axially printed with MYLAN over DF 240 in black ink on both the cap and body. They are available as follows: NDC 0378-0399-91 bottles of 60 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect the capsules from light. Store in original container.
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