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FDA Approval

COLESTIPOL HYDROCHLORIDE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
April 26, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Colestipol(1 g in 1 1)

Products1

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
62559-395
Application Number
ANDA216517
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 26, 2023
Code: X7D10K905GClass: ACTIBQuantity: 1 g in 1 1
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
MICROCRYSTALLINE CELLULOSE 105Inactive
Code: KO5GYV0DCBClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLACEFATEInactive
Code: F2O5O2OI9FClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0WClass: IACT
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