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01 2A. Menarini
02 2Melinta Therapeutics
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01 1POWDER;INTRAVENOUS
02 1Powder For Concentrate For Infusion Solution
03 1TABLET;ORAL
04 1Tablet
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01 2Authorized
02 2RX
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01 2BAXDELA
02 2Quofenix
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01 2Spain
02 2USA
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Quofenix
Dosage Form : Powder For Concentrate For Infusion Solution
Dosage Strength : 300MG
Packaging :
Approval Date : 2021-06-25
Application Number : 1191393001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Quofenix
Dosage Form : Tablet
Dosage Strength : 450MG
Packaging :
Approval Date : 2021-06-25
Application Number : 1191393002
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : RX
Registration Country : USA
Brand Name : BAXDELA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 450MG BASE
Packaging :
Approval Date : 2017-06-19
Application Number : 208610
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : BAXDELA
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : EQ 300MG BASE/VIAL
Packaging :
Approval Date : 2017-06-19
Application Number : 208611
Regulatory Info : RX
Registration Country : USA