CHOLESTYRAMINE
Cholestyramine for Oral Suspension, USP Rx only
Approved
Approval ID
a86715e3-741f-47c6-9682-1413f0f8ff0c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
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 Code70771-1105
Application NumberANDA202901
Product Classification
M
Marketing Category
C73584
G
Generic Name
CHOLESTYRAMINE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (9)
CHOLESTYRAMINEActive
Quantity: 4 g in 9 g
Code: 4B33BGI082
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0C
Classification: IACT
ORANGEInactive
Code: 5EVU04N5QU
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
VANILLAInactive
Code: Q74T35078H
Classification: IACT