Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Alkem Laboratories Limited
Ascend Laboratories, LLC
677605851
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Choleystyramine Light
Product Details
NDC Product Code
67877-422Application Number
ANDA211799Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 20, 2021ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
CholestyramineActive
Code: 4B33BGI082Class: ACTIBQuantity: 4 g in 5.718 g
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0CClass: IACT
FRUCTOSEInactive
Code: 6YSS42VSEVClass: IACT
PECTINInactive
Code: 89NA02M4RXClass: IACT
ORANGEInactive
Code: 5EVU04N5QUClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT