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ZERBAXA (nda206829)- (EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL)

CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM CUBIST PHARMS LLC
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL
No Yes
2035-Aug-14 2019-Dec-19
None None
2024-Dec-19 No
ZERBAXA (ceftolozane and tazobactam) is a combination of ceftolozane, a cephalosporin antibacterial, and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of the following infections caused by designated susceptible microorganisms: • Complicated Intra-abdominal Infections (cIAI), used in combination with metronidazole, in adult and pediatric patients (birth to less than 18 years old). • Complicated Urinary Tract Infections (cUTI), Including Pyelonephritis, in adult and pediatric patients (birth to less than 18 years old). • Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP), in adult patients 18 years and older.
0 0 0
Total Other Developers None
Drugs with Suitability No
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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