Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bryant Ranch Prepack
171714327
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
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
63629-8860Application Number
ANDA210316Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 13, 2022ColesevelamActive
Code: P4SG24WI5QClass: ACTIBQuantity: 3.75 g in 1 1
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7UClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM TRISILICATEInactive
Code: C2E1CI501TClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
LEMONInactive
Code: 24RS0A988OClass: IACT
ORANGEInactive
Code: 5EVU04N5QUClass: IACT
ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0CClass: IACT