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FDA Approval

Cholestyramine

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

FDA Approval Summary

Company
Bryant Ranch Prepack
DUNS: 171714327
Effective Date
December 1, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Cholestyramine(4 g in 5 g)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Bryant Ranch Prepack

171714327

Manufacturing Establishments1

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

Bryant Ranch Prepack

Bryant Ranch Prepack

Bryant Ranch Prepack

171714327

Products1

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

Cholestyramine

Product Details

NDC Product Code
63629-2162
Application Number
ANDA077203
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 26, 2022
ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0CClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
Code: 4B33BGI082Class: ACTIBQuantity: 4 g in 5 g
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
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