Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
A-S Medication Solutions
A-S Medication Solutions
830016429
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ezetimibe and Simvastatin
Product Details
NDC Product Code
50090-4772Application Number
ANDA209222Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 30, 2021HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
EzetimibeActive
Code: EOR26LQQ24Class: ACTIBQuantity: 10 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
SimvastatinActive
Code: AGG2FN16EVClass: ACTIBQuantity: 40 mg in 1 1
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT