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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

Effective Date
May 11, 2021
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
0115-2142
Application Number
ANDA077510
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
November 11, 2023
Code: X7D10K905GClass: ACTIBQuantity: 1 g in 1 1
COPOVIDONE K25-31Inactive
Code: D9C330MD8BClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
CELLACEFATEInactive
Code: F2O5O2OI9FClass: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNYClass: IACT
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