MedPath
FDA Approval

COLESEVELAM HYDROCHLORIDE

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

FDA Approval Summary

Company
Effective Date
December 28, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Colesevelam(625 mg in 1 1)

Manufacturing Establishments1

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

A-S Medication Solutions

A-S Medication Solutions

830016429

Products1

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

COLESEVELAM HYDROCHLORIDE

Product Details

NDC Product Code
50090-6995
Application Number
NDA021176
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
September 12, 2022
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Code: P4SG24WI5QClass: ACTIBQuantity: 625 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
© Copyright 2025. All Rights Reserved by MedPath