Mesalamine
These highlights do not include all the information needed to use Mesalamine safely and effectively. See full prescribing information for Mesalamine . M esalamine suppositor ies, for rectal use Initial U.S. Approval: 1987
Approved
Approval ID
3ef5c3f6-587e-48ea-a4b4-a7bf1bd749c6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 19, 2023
Manufacturers
FDA
Greenstone LLC
DUNS: 825560733
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 Code59762-0118
Application NumberNDA021252
Marketing CategoryC73605
Route of AdministrationRECTAL
Effective DateDecember 27, 2023
Generic Namemesalamine
INGREDIENTS (2)
MESALAMINEActive
Quantity: 1000 mg in 1 1
Code: 4Q81I59GXC
Classification: ACTIB
HARD FATInactive
Code: 8334LX7S21
Classification: IACT