Rowasa
ROWASA®(mesalamine)Rectal Suspension Enema4.0 grams/unit (60 mL)Rx only
Approved
Approval ID
e505ab99-1943-4216-a178-4d5dbe64e3b2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 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 Code0037-0066
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 (8)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
POTASSIUM ACETATEInactive
Code: M911911U02
Classification: IACT
MESALAMINEActive
Quantity: 4 g in 60 mL
Code: 4Q81I59GXC
Classification: ACTIB
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31
Classification: IACT
POTASSIUM METABISULFITEInactive
Code: 65OE787Q7W
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT