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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
August 6, 2016
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Colestipol(1 g in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Carilion Materials Management

Carilion Materials Management

079239644

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
68151-4361
Application Number
NDA020222
Marketing Category
NDA authorized generic (C73605)
Route of Administration
ORAL
Effective Date
April 11, 2016
Code: X7D10K905GClass: ACTIBQuantity: 1 g in 1 1
TRIACETINInactive
Code: XHX3C3X673Class: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONESInactive
Code: FZ989GH94EClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
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