MedPath
FDA Approval

Dipentum

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

FDA Approval Summary

Company
Effective Date
December 26, 2017
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Olsalazine(250 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Carilion Materials Management

Carilion Materials Management

079239644

Products1

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

Dipentum

Product Details

NDC Product Code
68151-0312
Application Number
NDA019715
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
May 15, 2015
Code: Y7JEW0XG7IClass: ACTIBQuantity: 250 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
CARAMELInactive
Code: T9D99G2B1RClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
© Copyright 2025. All Rights Reserved by MedPath