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 )
camber pharmaceuticals, inc.
CAPSULE BLUE H D12
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dimethyl fumarate capsule delayed release dimethyl fumarate kit
camber pharmaceuticals, inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
DIMETHYL FUMARATE is available as hard gelatin delayed-release capsules in two strengths containing either 120 mg or 240 mg of
DIMETHYL FUMARATE. The 120 mg capsules are light blue opaque size '0' hard gelatin capsules imprinted with 'H' on cap and 'D12' on body filled with white to off white tablets. They are available as follows: 30-day Starter Pack NDC 31722-680-60 7-day bottle 120 mg capsules, quantity 14 23-day bottle 240 mg capsules, quantity 46 120 mg capsules: 7-day bottle of 14 capsules NDC 31722-657-31 Blister Pack of 100 (10x10) unit dose capsules NDC 31722-657-32 The 240 mg capsules are white opaque size '0el' hard gelatin capsules imprinted with 'H' on cap and 'D15' on body filled with white to off white tablets. They are available as follows: 240 mg capsules: 23-day bottle of 46 capsules NDC 31722-658-31 30-day bottle of 60 capsules NDC 31722-658-32 Blister Pack of 100 (10x10) unit dose capsules NDC 31722-658-33 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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