Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Annora Pharma Private Limited
American Health Packaging
650980746
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
60687-754Application Number
ANDA211813Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 18, 2023ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
AMMONIUM GLYCYRRHIZATEInactive
Code: 3VRD35U26CClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
LinezolidActive
Code: ISQ9I6J12JClass: ACTIBQuantity: 100 mg in 5 mL