Dipentum
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Approved
Approval ID
8512d0c6-db4e-4673-b3b4-28975c18413f
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.
olsalazine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0037-6860
Application NumberNDA019715
Product Classification
M
Marketing Category
C73594
G
Generic Name
olsalazine sodium
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2022
FDA Product Classification
INGREDIENTS (6)
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
OLSALAZINE SODIUMActive
Quantity: 250 mg in 1 1
Code: Y7JEW0XG7I
Classification: ACTIB
CARAMELInactive
Code: T9D99G2B1R
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT