Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Amneal Pharmaceuticals of New York, LLC
Amneal Pharmaceuticals of New York LLC
123797875
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
COLESTIPOL HYDROCHLORIDE
Product Details
NDC Product Code
0115-5212Application Number
ANDA077277Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 30, 2023ColestipolActive
Code: X7D10K905GClass: ACTIBQuantity: 5 g in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
COLESTIPOL HYDROCHLORIDE
Product Details
NDC Product Code
0115-5213Application Number
ANDA077277Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 30, 2023ColestipolActive
Code: X7D10K905GClass: ACTIBQuantity: 5 g in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT