Mesalamine Rectal
These highlights do not include all the information needed to use MESALAMINE RECTAL SUPPOSITORIES safely and effectively. See full prescribing information for MESALAMINE RECTAL SUPPOSITORIES. MESALAMINE suppositories, for rectal use Initial U.S. Approval: 1987
Approved
Approval ID
87de237c-febb-42ca-b2a4-b444396f8640
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2023
Manufacturers
FDA
Amring Pharmaceuticals Inc.
DUNS: 079843051
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Mesalamine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69918-560
Application NumberANDA208362
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mesalamine
Product Specifications
Route of AdministrationRECTAL
Effective DateNovember 15, 2023
FDA Product Classification
INGREDIENTS (2)
FAT, HARDInactive
Code: 8334LX7S21
Classification: IACT
MESALAMINEActive
Quantity: 1000 mg in 1 1
Code: 4Q81I59GXC
Classification: ACTIB