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01 1IMATINIB MESYLATE
02 4METHOTREXATE
03 2NELARABINE
04 2THIOTEPA
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01 8SHORLA
02 1SHORLA ONCOLOGY
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01 2INJECTABLE;INTRAVENOUS
02 2SOLUTION;INTRAVENOUS
03 5SOLUTION;ORAL
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01 1100MG/10ML (10MG/ML)
02 115MG/1.5ML (10MG/ML)
03 1250MG/50ML (5MG/ML)
04 42MG/ML
05 1375MG/75ML (5MG/ML)
06 1EQ 80MG BASE/ML
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01 9USA
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Regulatory Info : RX
Registration Country : USA
Dosage Form : SOLUTION;ORAL
Brand Name : IMKELDI
Dosage Strength : EQ 80MG BASE/ML
Packaging :
Approval Date : 2024-11-22
Application Number : 219097
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : SOLUTION;ORAL
Brand Name : JYLAMVO
Dosage Strength : 2MG/ML
Packaging :
Approval Date : 2022-11-29
Application Number : 212479
Regulatory Info : RX
Registration Country : USA

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Regulatory Info :
Registration Country : USA
Dosage Form : SOLUTION;ORAL
Brand Name : JYLAMVO
Dosage Strength : 2MG/ML
Packaging :
Approval Date :
Application Number : 212479
Regulatory Info :
Registration Country : USA

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Regulatory Info :
Registration Country : USA
Dosage Form : SOLUTION;ORAL
Brand Name : JYLAMVO
Dosage Strength : 2MG/ML
Packaging :
Approval Date :
Application Number : 212479
Regulatory Info :
Registration Country : USA

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Regulatory Info :
Registration Country : USA
Dosage Form : SOLUTION;ORAL
Brand Name : JYLAMVO
Dosage Strength : 2MG/ML
Packaging :
Approval Date :
Application Number : 212479
Regulatory Info :
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : INJECTABLE;INTRAVENOUS
Brand Name : NELARABINE
Dosage Strength : 250MG/50ML (5MG/ML)
Packaging :
Approval Date : 2023-03-03
Application Number : 214809
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : INJECTABLE;INTRAVENOUS
Brand Name : NELARABINE
Dosage Strength : 375MG/75ML (5MG/ML)
Packaging :
Approval Date : 2025-07-16
Application Number : 214809
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : SOLUTION;INTRAVENOUS
Brand Name : TEPYLUTE
Dosage Strength : 15MG/1.5ML (10MG/ML)
Packaging :
Approval Date : 2024-06-25
Application Number : 216984
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : SOLUTION;INTRAVENOUS
Brand Name : TEPYLUTE
Dosage Strength : 100MG/10ML (10MG/ML)
Packaging :
Approval Date : 2025-02-26
Application Number : 216984
Regulatory Info : RX
Registration Country : USA

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