MedPath
FDA Approval

Rilutek

December 9, 2022

HUMAN PRESCRIPTION DRUG LABEL

Riluzole(50 mg in 1 1)

Products (1)

Rilutek

70515-700

NDA020599

NDA (C73594)

ORAL

March 31, 2020

silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
RiluzoleActive
Code: 7LJ087RS6FClass: ACTIBQuantity: 50 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
polyethylene glycol 6000Inactive
Code: 30IQX730WEClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
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