NDC 72000-320

SIVEXTRO

Tedizolid Phosphate

SIVEXTRO is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Nabriva Therapeutics Us, Inc.. The primary component is Tedizolid Phosphate.

Product ID72000-320_2769a04d-5479-4341-93ca-ce9d323ada89
NDC72000-320
Product TypeHuman Prescription Drug
Proprietary NameSIVEXTRO
Generic NameTedizolid Phosphate
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2014-06-20
Marketing CategoryNDA /
Application NumberNDA205436
Labeler NameNabriva Therapeutics US, Inc.
Substance NameTEDIZOLID PHOSPHATE
Active Ingredient Strength200 mg/4mL
Pharm ClassesOxazolidinone Antibacterial [EPC],Oxazolidinones [CS],Breast Cancer Resistance Protein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 72000-320-10

10 VIAL, GLASS in 1 CARTON (72000-320-10) > 4 mL in 1 VIAL, GLASS
Marketing Start Date2014-06-20
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "SIVEXTRO" or generic name "Tedizolid Phosphate"

NDCBrand NameGeneric Name
67919-040SIVEXTROtedizolid phosphate
67919-041SIVEXTROtedizolid phosphate
72000-310SIVEXTROtedizolid phosphate
72000-320SIVEXTROtedizolid phosphate

Trademark Results [SIVEXTRO]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SIVEXTRO
SIVEXTRO
85750866 4597817 Live/Registered
MERCK SHARP & DOHME CORP.
2012-10-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.