Fingolimod
These highlights do not include all the information needed to use FINGOLIMOD CAPSULES safely and effectively. See full prescribing information for FINGOLIMOD CAPSULES. FINGOLIMOD capsules, for oral use Initial U.S. Approval: 2010
Approved
Approval ID
c3199508-3d6a-4e44-96f0-bbde9969edcb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2023
Manufacturers
FDA
Camber Pharmaceuticals, Inc.
DUNS: 826774775
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fingolimod
PRODUCT DETAILS
NDC Product Code31722-889
Application NumberANDA207933
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 27, 2023
Generic NameFingolimod
INGREDIENTS (12)
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FINGOLIMOD HYDROCHLORIDEActive
Quantity: 0.5 mg in 1 1
Code: G926EC510T
Classification: ACTIM
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT