dimethyl fumarate capsule delayed release dimethyl fumarate kit
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)
amneal pharmaceuticals ny llc
CAPSULE GREEN AN 1318
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dimethyl fumarate capsule delayed release dimethyl fumarate kit
amneal pharmaceuticals ny llc
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16 HOW SUPPLIED/STORAGE AND HANDLING
DIMETHYL FUMARATE delayed-release capsules are available as hard gelatin delayed-release capsules in two strengths containing either 120 mg or 240 mg of
DIMETHYL FUMARATE.
DIMETHYL FUMARATE Delayed-Release capsules, 120 mg are supplied as opaque green cap printed "AN" on cap with black ink and opaque white body printed "1318" on body with black ink. They are available as follows: 7-day bottle of 14 capsules: NDC 69238-1318-4
DIMETHYL FUMARATE Delayed-Release capsules, 240 mg are supplied as opaque green cap printed "AN" on cap with black ink and opaque green body printed "1319" on body with black ink. They are available as follows: 30-day bottle of 60 capsules: NDC 69238-1319-6
DIMETHYL FUMARATE Delayed-Release capsules are also supplied as 30-day Starter Pack which contain 14 capsules of 120 mg as starter dose for 7 days and 46 capsules of 240 mg as regular dose for 23 days. 30-day Starter Pack: (7-day bottle of 120 mg capsules, quantity 14) (23-day bottle of 240 mg capsules, quantity 46) Carton of 60 capsules: NDC 69238-1626-3 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect the capsules from light. Store in original container.
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