BAFIERTAM
These highlights do not include all the information needed to use BAFIERTAM safely and effectively. See full prescribing information for BAFIERTAM. BAFIERTAM (monomethyl fumarate) delayed-release capsules, for oral use Initial U.S. Approval: 2013
Approved
Approval ID
a161f9d4-70f1-4097-957a-eafb35d3274f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2023
Manufacturers
FDA
Banner Life Sciences LLC
DUNS: 079579273
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
monomethyl fumarate
PRODUCT DETAILS
NDC Product Code69387-001
Application NumberNDA210296
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJanuary 25, 2023
Generic Namemonomethyl fumarate
INGREDIENTS (22)
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type AInactive
Code: NX76LV5T8J
Classification: IACT
Triethyl CitrateInactive
Code: 8Z96QXD6UM
Classification: IACT
monomethyl fumarateActive
Quantity: 95 mg in 1 1
Code: 45IUB1PX8R
Classification: ACTIB
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
Hypromellose 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
polyethylene glycol 400Inactive
Code: B697894SGQ
Classification: IACT
Polyvinyl Alcohol, UnspecifiedInactive
Code: 532B59J990
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
Glyceryl MonocaprylocaprateInactive
Code: G7515SW10N
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
SorbitanInactive
Code: 6O92ICV9RU
Classification: IACT
SorbitolInactive
Code: 506T60A25R
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT
Isopropyl AlcoholInactive
Code: ND2M416302
Classification: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357
Classification: IACT
Butyl AlcoholInactive
Code: 8PJ61P6TS3
Classification: IACT
Propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
Lactic Acid, Unspecified FormInactive
Code: 33X04XA5AT
Classification: IACT
gelatin, unspecifiedInactive
Code: 2G86QN327L
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Glyceryl CaprylocaprateInactive
Code: U72Q2I8C85
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT