Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
EPIC PHARMA, LLC
827915443
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
EPIC PHARMA, LLC
EPIC PHARMA, LLC
EPIC PHARMA, LLC
827915443
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CHOLESTYRAMINE
Product Details
NDC Product Code
42806-266Application Number
ANDA074557Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 27, 2023CholestyramineActive
Code: 4B33BGI082Class: ACTIBQuantity: 4 g in 9 g
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
FRUCTOSEInactive
Code: 6YSS42VSEVClass: IACT
ORANGEInactive
Code: 5EVU04N5QUClass: IACT
PECTINInactive
Code: 89NA02M4RXClass: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0CClass: IACT
AMMONIUM GLYCYRRHIZATEInactive
Code: 3VRD35U26CClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT