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FDA Approval

Colestid

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
November 29, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Colestipol(5 g in 7.5 g)

Manufacturing Establishments1

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

Pharmacia & Upjohn Company LLC

Pharmacia & Upjohn Company LLC

618054084

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Flavored Colestid

Product Details

NDC Product Code
0009-0370
Application Number
NDA017563
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
November 29, 2023
Code: X7D10K905GClass: ACTIBQuantity: 5 g in 7.5 g
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
MALTOLInactive
Code: 3A9RD92BS4Class: IACT
BETA CAROTENEInactive
Code: 01YAE03M7JClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT

Colestid

Product Details

NDC Product Code
0009-0260
Application Number
NDA017563
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
November 29, 2023
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Code: X7D10K905GClass: ACTIBQuantity: 5 g in 5 g
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