MedPath

CHOLESTYRAMINE

Cholestyramine for Oral Suspension, USP

Approved
Approval ID

d82647da-465b-4e2e-8cf8-72d50f047b3e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 17, 2023

Manufacturers
FDA

PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS

DUNS: 080210964

Products 1

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

cholestyramine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code24658-266
Application NumberANDA074557
Product Classification
M
Marketing Category
C73584
G
Generic Name
cholestyramine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 17, 2023
FDA Product Classification

INGREDIENTS (12)

CHOLESTYRAMINEActive
Quantity: 4 g in 9 g
Code: 4B33BGI082
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FRUCTOSEInactive
Code: 6YSS42VSEV
Classification: IACT
PECTINInactive
Code: 89NA02M4RX
Classification: IACT
AMMONIUM GLYCYRRHIZATEInactive
Code: 3VRD35U26C
Classification: IACT
ORANGEInactive
Code: 5EVU04N5QU
Classification: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0C
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT

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CHOLESTYRAMINE - FDA Drug Approval Details