01 1BELINOSTAT
02 2LEVOLEUCOVORIN
03 3LEVOLEUCOVORIN CALCIUM
04 1MELPHALAN HYDROCHLORIDE
05 2PRALATREXATE
06 1VINCRISTINE SULFATE
01 1ACROTECH
02 9ACROTECH BIOPHARMA
01 1INJECTABLE, LIPOSOMAL;INTRAVENOUS
02 5POWDER;INTRAVENOUS
03 4SOLUTION;INTRAVENOUS
01 1175MG/VIAL
02 120MG/ML (20MG/ML)
03 1300MG/VIAL
04 140MG/2ML (20MG/ML)
05 1500MG/VIAL
06 15MG/5ML (1MG/ML)
07 1EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
08 1EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
09 2EQ 50MG BASE/VIAL
01 10USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : POWDER;INTRAVENOUS
Brand Name : BELEODAQ
Dosage Strength : 500MG/VIAL
Packaging :
Approval Date : 2014-07-03
Application Number : 206256
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : POWDER;INTRAVENOUS
Brand Name : KHAPZORY
Dosage Strength : 175MG/VIAL
Packaging :
Approval Date : 2018-10-19
Application Number : 211226
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : POWDER;INTRAVENOUS
Brand Name : KHAPZORY
Dosage Strength : 300MG/VIAL
Packaging :
Approval Date : 2018-10-19
Application Number : 211226
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : POWDER;INTRAVENOUS
Brand Name : FUSILEV
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2008-03-07
Application Number : 20140
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : SOLUTION;INTRAVENOUS
Brand Name : FUSILEV
Dosage Strength : EQ 175MG BASE/17.5ML (...
Packaging :
Approval Date : 2011-04-29
Application Number : 20140
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : SOLUTION;INTRAVENOUS
Brand Name : FUSILEV
Dosage Strength : EQ 250MG BASE/25ML (EQ...
Packaging :
Approval Date : 2011-04-29
Application Number : 20140
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : POWDER;INTRAVENOUS
Brand Name : EVOMELA
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2016-03-10
Application Number : 207155
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : SOLUTION;INTRAVENOUS
Brand Name : FOLOTYN
Dosage Strength : 20MG/ML (20MG/ML)
Packaging :
Approval Date : 2009-09-24
Application Number : 22468
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : SOLUTION;INTRAVENOUS
Brand Name : FOLOTYN
Dosage Strength : 40MG/2ML (20MG/ML)
Packaging :
Approval Date : 2009-09-24
Application Number : 22468
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : INJECTABLE, LIPOSOMAL;IN...
Brand Name : MARQIBO KIT
Dosage Strength : 5MG/5ML (1MG/ML)
Packaging :
Approval Date : 2012-08-09
Application Number : 202497
Regulatory Info : DISCN
Registration Country : USA
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