MedPath
FDA Approval

SIVEXTRO

March 10, 2023

HUMAN PRESCRIPTION DRUG LABEL

Tedizolid(200 mg in 1 1)

Products (2)

SIVEXTRO

67919-041

NDA205435

NDA (C73594)

ORAL

March 10, 2023

titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
TedizolidActive
Code: O7DRJ6R4DWClass: ACTIBQuantity: 200 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
mannitolInactive
Code: 3OWL53L36AClass: IACT
crospovidone (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
ferric oxide yellowInactive
Code: EX438O2MRTClass: IACT

SIVEXTRO

67919-040

NDA205436

NDA (C73594)

INTRAVENOUS

March 10, 2023

hydrochloric acidInactive
Code: QTT17582CBClass: IACT
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
TedizolidActive
Code: O7DRJ6R4DWClass: ACTIBQuantity: 200 mg in 4 mL
mannitolInactive
Code: 3OWL53L36AClass: IACTQuantity: 105 mg in 4 mL

Drug Labeling Information

RECENT MAJOR CHANGES SECTION


USE IN SPECIFIC POPULATIONS SECTION


ADVERSE REACTIONS SECTION


SPL UNCLASSIFIED SECTION


© Copyright 2025. All Rights Reserved by MedPath