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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
Greenstone LLC
DUNS: 825560733
Effective Date
September 29, 2023
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.

Pharmacia & Upjohn Company LLC

Greenstone LLC

618054084

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
59762-0450
Application Number
NDA020222
Marketing Category
NDA authorized generic (C73605)
Route of Administration
ORAL
Effective Date
November 18, 2022
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Code: X7D10K905GClass: ACTIBQuantity: 1 g in 1 1
TRIACETINInactive
Code: XHX3C3X673Class: IACT
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