Canasa
These highlights do not include all the information needed to use CANASA safely and effectively. See full prescribing information for CANASA. CANASA (mesalamine) suppositor ies, for rectal use Initial U.S. Approval: 1987
Approved
Approval ID
89d91601-152b-4398-bebe-af1c023e9935
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 24, 2023
Manufacturers
FDA
Allergan, Inc.
DUNS: 144796497
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 Code58914-501
Application NumberNDA021252
Product Classification
M
Marketing Category
C73594
G
Generic Name
Mesalamine
Product Specifications
Route of AdministrationRECTAL
Effective DateOctober 27, 2023
FDA Product Classification
INGREDIENTS (2)
fat, hardInactive
Code: 8334LX7S21
Classification: IACT
MESALAMINEActive
Quantity: 1000 mg in 1 1
Code: 4Q81I59GXC
Classification: ACTIB