APRISO
These highlights do not include all the information needed to use APRISO safely and effectively. See full prescribing information for APRISO. APRISO (mesalamine) extended-release capsules Initial U.S. Approval: 1987
Approved
Approval ID
7951139c-b271-45a4-b523-34b23800917b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
Salix Pharmaceuticals, Inc.
DUNS: 793108036
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
mesalamine
PRODUCT DETAILS
NDC Product Code65649-103
Application NumberNDA022301
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJanuary 9, 2024
Generic Namemesalamine
INGREDIENTS (12)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
MESALAMINEActive
Quantity: 375 mg in 1 1
Code: 4Q81I59GXC
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT