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
NDC Product Code0037-0022
Application NumberNDA019618
Marketing CategoryC73594
Route of AdministrationRECTAL
Effective DateNovember 15, 2021
Generic Namemesalamine
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