Canasa
Approved
Approval ID
357e0e6b-cfbd-454c-82d7-cfc460dc0d68
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 23, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-6147
Application NumberNDA021252
Product Classification
M
Marketing Category
C73594
G
Generic Name
mesalamine
Product Specifications
Route of AdministrationRECTAL
Effective DateAugust 23, 2010
FDA Product Classification
INGREDIENTS (2)
MESALAMINEActive
Quantity: 1000 mg in 1 1
Code: 4Q81I59GXC
Classification: ACTIB
FAT, HARDInactive
Code: 8334LX7S21
Classification: IACT