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01 1CUBIST PHARMS INC
02 1MERCK CANADA INC
03 1MSD Pharmaceuticals
04 5Merck & Co
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01 1Ceftolozano+Tazobactam 1G+0,5G 10 Units Parenteral Use
02 1INF
03 1POWDER FOR SOLUTION
04 1POWDER;INTRAVENOUS
05 1Powder For Concentrate For Infusion Solution
06 2Powder For Concentrate For Solution For Infusion
07 1Powder to concentrate to the infusion fluid, resolution
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01 1Allowed
02 1Approved
03 1Authorized
04 1Originator
05 1Prescription
06 1RX
07 2Blank
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01 2ZERBAXA
02 6Zerbaxa
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01 1Canada
02 1Italy
03 1Norway
04 1South Africa
05 1Spain
06 1Sweden
07 1Switzerland
08 1USA
Regulatory Info : RX
Registration Country : USA
CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
Brand Name : ZERBAXA
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL
Packaging :
Approval Date : 2014-12-19
Application Number : 206829
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Italy
Ceftolozane Sulfate; Tazobactam
Brand Name : Zerbaxa
Dosage Form : Ceftolozano+Tazobactam 1G+0,5G 10 Units Parenteral Use
Dosage Strength : 10 bottles groun EV 1 g + 0 g
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Zerbaxa
Dosage Form : Powder to concentrate to the infusion fluid, resolution
Dosage Strength : 1 g/0.5 g
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Approved
Registration Country : Sweden
Ceftolozane Sulfate; Tazobactam Sodium
Brand Name : Zerbaxa
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength :
Packaging :
Approval Date : 18/09/2015
Application Number : 20140903000081
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Zerbaxa
Dosage Form : INF
Dosage Strength : 1000mg
Packaging : 20X10mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Authorized
Registration Country : Spain
Tazobactam Sodium; Ceftolozane Sulfate
Brand Name : Zerbaxa
Dosage Form : Powder For Concentrate For Infusion Solution
Dosage Strength : 1G; 0.5 G
Packaging :
Approval Date : 2015-10-08
Application Number : 1151032001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Prescription
Registration Country : Canada
CEFTOLOZANE (CEFTOLOZANE SULFATE)
Brand Name : ZERBAXA
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 1G/VIAL
Packaging : 11.4ML (RECONST.) (1.5G)
Approval Date :
Application Number : 2446901
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Zerbaxa
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength :
Packaging :
Approval Date : 03/03/2016
Application Number : 65472
Regulatory Info : Allowed
Registration Country : Switzerland