Cholestyramine
Cholestyramine for Oral Suspension, USP
Approved
Approval ID
06261db5-1435-4b91-8b54-71bfcfb1368c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 12, 2021
Manufacturers
FDA
TAGI Pharma, Inc.
DUNS: 963322560
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 Code51224-011
Application NumberANDA209597
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cholestyramine
Product Specifications
Route of AdministrationORAL
Effective DateMay 12, 2021
FDA Product Classification
INGREDIENTS (8)
CholestyramineActive
Quantity: 4 g in 8.3 g
Code: 4B33BGI082
Classification: ACTIB
sucroseInactive
Code: C151H8M554
Classification: IACT
propylene glycol alginateInactive
Code: 26CD3J2R0C
Classification: IACT
orangeInactive
Code: 5EVU04N5QU
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
anhydrous citric acidInactive
Code: XF417D3PSL
Classification: IACT
FD&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
aluminum oxideInactive
Code: LMI26O6933
Classification: IACT