Dipentum

Dipentum

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 051229602

Effective Date

October 15, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Olsalazine(250 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

0037-6860

Application Number

NDA019715

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

June 15, 2022

Ingredients

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

Code: Y7JEW0XG7IClass: ACTIBQuantity: 250 mg in 1 1

CARAMELInactive

Code: T9D99G2B1RClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT