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Welchol

These highlights do not include all the information needed to use WELCHOL safely and effectively. See full prescribing information for WELCHOL. WELCHOL (colesevelam hydrochloride) tablets, for oral use WELCHOL (colesevelam hydrochloride) for oral suspension Initial U.S. Approval: 2000

Approved
Approval ID

89cbd0a3-2d1b-41db-8c97-35ec67b7b09f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 7, 2022

Manufacturers
FDA

Cosette Pharmaceuticals, Inc.

DUNS: 116918230

Products 2

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

colesevelam hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0713-0879
Application NumberNDA021176
Product Classification
M
Marketing Category
C73594
G
Generic Name
colesevelam hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 7, 2022
FDA Product Classification

INGREDIENTS (5)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
COLESEVELAM HYDROCHLORIDEActive
Quantity: 625 mg in 1 1
Code: P4SG24WI5Q
Classification: ACTIB

colesevelam hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0713-0880
Application NumberNDA022362
Product Classification
M
Marketing Category
C73594
G
Generic Name
colesevelam hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 7, 2022
FDA Product Classification

INGREDIENTS (7)

MAGNESIUM TRISILICATEInactive
Code: C2E1CI501T
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
GLYCERYL MONO AND DICAPRYLOCAPRATEInactive
Code: U72Q2I8C85
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
COLESEVELAM HYDROCHLORIDEActive
Quantity: 3.75 g in 1 1
Code: P4SG24WI5Q
Classification: ACTIB
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0C
Classification: IACT

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Welchol - FDA Drug Approval Details