Basic Information
Dimethyl Fumarate
69539-043
Regulatory Information
69539-043
ANDA210460
C73584
May 13, 2021
USA
These highlights do not include all the information needed to use DIMETHYL FUMARATE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DIMETHYL FUMARATE DELAYED-RELEASE CAPSULES. DIMETHYL FUMARATE delayed-release capsules, for oral use Initial U.S. Approval: 2013
Human Prescription Drug Label
6
Company Information
650786952
Active Ingredients
CROSCARMELLOSE SODIUM
Code: M28OL1HH48
Class Code: IACT
CELLULOSE, MICROCRYSTALLINE
Code: OP1R32D61U
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
Code: NX76LV5T8J
Class Code: IACT
TRIETHYL CITRATE
Code: 8Z96QXD6UM
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
GELATIN
Code: 2G86QN327L
Class Code: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)
Code: 74G4R6TH13
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
SODIUM LAURYL SULFATE
Code: 368GB5141J
Class Code: IACT
SHELLAC
Code: MB5IUD6JUA
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
POTASSIUM HYDROXIDE
Code: WZH3C48M4T
Class Code: IACT
POLYSORBATE 80
Code: 6OZP39ZG8H
Class Code: IACT
Active Moieties
monomethyl fumarate
Code: 45IUB1PX8R