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Colestid

Colestid Flavored Colestid colestipol hydrochloride for oral suspension

Approved
Approval ID

21b37725-fc0c-4365-a7dc-1a473d42502d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 29, 2023

Manufacturers
FDA

Pharmacia & Upjohn Company LLC

DUNS: 618054084

Products 2

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 Code0009-0370
Application NumberNDA017563
Product Classification
M
Marketing Category
C73594
G
Generic Name
Colestipol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 29, 2023
FDA Product Classification

INGREDIENTS (7)

COLESTIPOL HYDROCHLORIDEActive
Quantity: 5 g in 7.5 g
Code: X7D10K905G
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
MALTOLInactive
Code: 3A9RD92BS4
Classification: IACT
BETA CAROTENEInactive
Code: 01YAE03M7J
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT

Colestipol Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0009-0260
Application NumberNDA017563
Product Classification
M
Marketing Category
C73594
G
Generic Name
Colestipol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 29, 2023
FDA Product Classification

INGREDIENTS (2)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
COLESTIPOL HYDROCHLORIDEActive
Quantity: 5 g in 5 g
Code: X7D10K905G
Classification: ACTIB

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Colestid - FDA Drug Approval Details