fingolimod capsule
1 INDICATIONS AND USAGE Fingolimod 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 patients 10 years of age and older. Fingolimod is a sphingosine 1-phosphate receptor modulator 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 patients 10 years of age and older. ( 1 )
dr. reddy's laboratories inc
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 0.5 mg
FINGOLIMOD capsules are supplied as follows:
FINGOLIMOD capsules 0.5 mg are white to off-white powder filled in size ‘3’ hard gelatin capsules with dark yellow opaque colored cap imprinted ‘FGM’ with black ink and white opaque colored body imprinted ‘0.5mg’ with black ink. Bottles of 30 NDC 43598-285-30 Carton of 7 capsules containing 1 blister card of 7 capsules per blister card NDC 43598-285-70 Carton of 30 capsules containing 3 blister cards of 10 capsules per blister card NDC 43598-285-31 16.2 Storage and Handling
FINGOLIMOD capsules should be stored at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.
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