Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Amneal Pharmaceuticals Private Limited
Amneal Pharmaceuticals of New York LLC
915076126
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
0115-1864Application Number
ANDA212886Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 18, 2022ColesevelamActive
Code: P4SG24WI5QClass: ACTIBQuantity: 3.75 g in 1 1
LEMONInactive
Code: 24RS0A988OClass: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NCClass: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7UClass: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0CClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT