Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Preferred Pharmaceuticals Inc.
791119022
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals Inc.
791119022
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ezetimibe
Product Details
NDC Product Code
68788-8297Application Number
ANDA209234Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 25, 2023EzetimibeActive
Code: EOR26LQQ24Class: ACTIBQuantity: 10 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT