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Colestipol Hydrochloride

Micronized Colestipol Hydrochloride Tablets

Approved
Approval ID

fbd848be-fb6a-495c-80bc-a9e9ed18e15f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 6, 2016

Manufacturers
FDA

Carilion Materials Management

DUNS: 079239644

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 Code68151-4361
Application NumberNDA020222
Product Classification
M
Marketing Category
C73605
G
Generic Name
Colestipol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 11, 2016
FDA Product Classification

INGREDIENTS (7)

COLESTIPOL HYDROCHLORIDEActive
Quantity: 1 g in 1 1
Code: X7D10K905G
Classification: ACTIB
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT

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Colestipol Hydrochloride - FDA Drug Approval Details