01 1ALVIMOPAN
02 1CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
03 4DAPTOMYCIN
04 2FIDAXOMICIN
05 2TEDIZOLID PHOSPHATE
01 1CUBIST PHARMACEUTICALS LLC
02 1CUBIST PHARMS
03 8CUBIST PHARMS LLC
01 1CAPSULE;ORAL
02 1FOR SUSPENSION;ORAL
03 1POWDER FOR SOLUTION
04 5POWDER;INTRAVENOUS
05 2TABLET;ORAL
01 112MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
02 2200MG
03 1200MG/VIAL
04 1250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
05 140MG/ML
06 1500MG/VIAL
07 2500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
08 1EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL
01 1Canada
02 9USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : CAPSULE;ORAL
Brand Name : ENTEREG
Dosage Strength : 12MG **Federal Registe...
Packaging :
Approval Date : 2008-05-20
Application Number : 21775
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
Dosage Form : POWDER;INTRAVENOUS
Brand Name : ZERBAXA
Dosage Strength : EQ 1GM BASE/VIAL;EQ 0....
Packaging :
Approval Date : 2014-12-19
Application Number : 206829
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : POWDER;INTRAVENOUS
Brand Name : CUBICIN
Dosage Strength : 250MG/VIAL **Federal R...
Packaging :
Approval Date : 2003-09-12
Application Number : 21572
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : POWDER;INTRAVENOUS
Brand Name : CUBICIN
Dosage Strength : 500MG/VIAL **Federal R...
Packaging :
Approval Date : 2003-09-12
Application Number : 21572
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : POWDER;INTRAVENOUS
Brand Name : CUBICIN RF
Dosage Strength : 500MG/VIAL **Federal R...
Packaging :
Approval Date : 2016-07-06
Application Number : 21572
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : Canada
Dosage Form : POWDER FOR SOLUTION
Brand Name : CUBICIN RF
Dosage Strength : 500MG/VIAL
Packaging : 10ML
Approval Date :
Application Number : 2465493
Regulatory Info :
Registration Country : Canada
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : DIFICID
Dosage Strength : 200MG
Packaging :
Approval Date : 2011-05-27
Application Number : 201699
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : FOR SUSPENSION;ORAL
Brand Name : DIFICID
Dosage Strength : 40MG/ML
Packaging :
Approval Date : 2020-01-24
Application Number : 213138
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : SIVEXTRO
Dosage Strength : 200MG
Packaging :
Approval Date : 2014-06-20
Application Number : 205435
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : POWDER;INTRAVENOUS
Brand Name : SIVEXTRO
Dosage Strength : 200MG/VIAL
Packaging :
Approval Date : 2014-06-20
Application Number : 205436
Regulatory Info : RX
Registration Country : USA
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