MedPath
FDA Approval

Welchol

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

FDA Approval Summary

Company
Effective Date
September 7, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Colesevelam(625 mg in 1 1)

Products2

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

Welchol

Product Details

NDC Product Code
0713-0879
Application Number
NDA021176
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
September 7, 2022
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
Code: P4SG24WI5QClass: ACTIBQuantity: 625 mg in 1 1

Welchol

Product Details

NDC Product Code
0713-0880
Application Number
NDA022362
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
September 7, 2022
MAGNESIUM TRISILICATEInactive
Code: C2E1CI501TClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
GLYCERYL MONO AND DICAPRYLOCAPRATEInactive
Code: U72Q2I8C85Class: IACT
ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
Code: P4SG24WI5QClass: ACTIBQuantity: 3.75 g in 1 1
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0CClass: IACT
© Copyright 2025. All Rights Reserved by MedPath