Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Zydus Lifesciences Limited
918596198
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Zydus Lifesciences Limited
Zydus Lifesciences Limited
Zydus Lifesciences Limited
677605858
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
70771-1105Application Number
ANDA202901Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 9, 2024CholestyramineActive
Code: 4B33BGI082Class: ACTIBQuantity: 4 g in 9 g
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0CClass: IACT
ORANGEInactive
Code: 5EVU04N5QUClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
VANILLAInactive
Code: Q74T35078HClass: IACT