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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
December 21, 2009
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.

Physicians Total Care, Inc.

Physicians Total Care, Inc.

194123980

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
54868-0610
Application Number
NDA020222
Marketing Category
NDA authorized generic (C73605)
Route of Administration
ORAL
Effective Date
October 19, 2010
Code: X7D10K905GClass: ACTIBQuantity: 1 g in 1 1
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
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