COLESTIPOL HYDROCHLORIDE
Colestipol Hydrochloride Tablets USP
Approved
Approval ID
3d380b5e-e346-4a47-ac95-faa37c6f2a51
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 26, 2023
Manufacturers
FDA
ANI Pharmaceuticals, Inc.
DUNS: 145588013
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
COLESTIPOL HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62559-395
Application NumberANDA216517
Product Classification
M
Marketing Category
C73584
G
Generic Name
COLESTIPOL HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateApril 26, 2023
FDA Product Classification
INGREDIENTS (9)
COLESTIPOL HYDROCHLORIDEActive
Quantity: 1 g in 1 1
Code: X7D10K905G
Classification: ACTIB
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MICROCRYSTALLINE CELLULOSE 105Inactive
Code: KO5GYV0DCB
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLACEFATEInactive
Code: F2O5O2OI9F
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT