Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Amneal Pharmaceuticals Private Limited
Amneal Pharmaceuticals LLC
915076126
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Linezolid
Product Details
NDC Product Code
65162-777Application Number
ANDA204536Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 17, 2023LinezolidActive
Code: ISQ9I6J12JClass: ACTIBQuantity: 600 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4BClass: IACT
DIETHYL PHTHALATEInactive
Code: UF064M00AFClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT