sfRowasa
sfROWASA (mesalamine) Rectal Suspension 4.0 g/60 mL Sulfite-Free Formulation R Only
Approved
Approval ID
aa273fdc-f7c4-4901-8f71-59ae03b8cdb1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 15, 2023
Manufacturers
FDA
Meda Pharmaceuticals Inc.
DUNS: 051229602
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 Code0037-0022
Application NumberNDA019618
Product Classification
M
Marketing Category
C73594
G
Generic Name
mesalamine
Product Specifications
Route of AdministrationRECTAL
Effective DateNovember 15, 2021
FDA Product Classification
INGREDIENTS (7)
MESALAMINEActive
Quantity: 4 g in 60 mL
Code: 4Q81I59GXC
Classification: ACTIB
POTASSIUM ACETATEInactive
Code: M911911U02
Classification: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED)Inactive
Code: K6MOM3T5YL
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT