Cholestyramine
Cholestyramine for Oral Suspension, USP Rx only
Approved
Approval ID
a0b64dfe-49bc-45d7-9281-9e9d6e296c40
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 23, 2021
Manufacturers
FDA
Ajanta Pharma USA Inc.
DUNS: 557554156
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 Code27241-134
Application NumberANDA211119
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cholestyramine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 23, 2021
FDA Product Classification
INGREDIENTS (9)
CHOLESTYRAMINEActive
Quantity: 4 g in 9 g
Code: 4B33BGI082
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0C
Classification: IACT
ORANGEInactive
Code: 5EVU04N5QU
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT