Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Ajanta Pharma Limited
918594859
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Ajanta Pharma Ltd., Dahej
Ajanta Pharma USA Inc.
Ajanta Pharma Limited
862199968
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
27241-134Application Number
ANDA211119Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 23, 2021CholestyramineActive
Code: 4B33BGI082Class: ACTIBQuantity: 4 g in 9 g
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0CClass: IACT
ORANGEInactive
Code: 5EVU04N5QUClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT