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Colestipol Hydrochloride

Colestipol Hydrochloride for Oral Suspension

Approved
Approval ID

4e89bf6e-c78a-402e-9cb2-8d02f6047d68

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 18, 2022

Manufacturers
FDA

Greenstone LLC

DUNS: 825560733

FDA

Mylan Pharmaceuticals Inc.

DUNS: 059295980

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 Code59762-0260
Application NumberNDA017563
Product Classification
M
Marketing Category
C73605
G
Generic Name
Colestipol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 18, 2022
FDA Product Classification

INGREDIENTS (2)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
COLESTIPOL HYDROCHLORIDEActive
Quantity: 5 g in 5 g
Code: X7D10K905G
Classification: ACTIB

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Colestipol Hydrochloride - FDA Drug Approval Details