Mesalamine
MESALAMINE Delayed-Release Tablets, USP These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. MESALAMINE Delayed-Release Tablets, for oral use Initial U.S. Approval: 1987
Approved
Approval ID
9703f92d-1d15-4376-8b2b-51502c266012
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 27, 2023
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
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 Code62135-714
Application NumberANDA217337
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 27, 2023
Generic NameMesalamine
INGREDIENTS (16)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive
Code: 5KY68S2577
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MESALAMINEActive
Quantity: 1.2 g in 1 1
Code: 4Q81I59GXC
Classification: ACTIB