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01 1IMATINIB MESYLATE
02 4METHOTREXATE
03 2NELARABINE
04 2THIOTEPA
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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 6RX
02 3Blank
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RLD : Yes
TE Code :
Dosage Form : SOLUTION; ORAL
Proprietary Name : IMKELDI
Dosage Strength : EQ 80MG BASE/ML
Approval Date : 2024-11-22
Application Number : 219097
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
Dosage Form : SOLUTION; ORAL
Proprietary Name : JYLAMVO
Dosage Strength : 2MG/ML
Approval Date : 2022-11-29
Application Number : 212479
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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RLD :
TE Code :
Dosage Form : SOLUTION; ORAL
Proprietary Name : JYLAMVO
Dosage Strength : 2MG/ML
Approval Date :
Application Number : 212479
RX/OTC/DISCN :
RLD :
TE Code :

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RLD :
TE Code :
Dosage Form : SOLUTION; ORAL
Proprietary Name : JYLAMVO
Dosage Strength : 2MG/ML
Approval Date :
Application Number : 212479
RX/OTC/DISCN :
RLD :
TE Code :

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RLD :
TE Code :
Dosage Form : SOLUTION; ORAL
Proprietary Name : JYLAMVO
Dosage Strength : 2MG/ML
Approval Date :
Application Number : 212479
RX/OTC/DISCN :
RLD :
TE Code :

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RLD : No
TE Code : AP
Dosage Form : INJECTABLE; INTRAVENOUS
Proprietary Name : NELARABINE
Dosage Strength : 250MG/50ML (5MG/ML)
Approval Date : 2023-03-03
Application Number : 214809
RX/OTC/DISCN : RX
RLD : No
TE Code : AP

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RLD : No
TE Code :
Dosage Form : INJECTABLE; INTRAVENOUS
Proprietary Name : NELARABINE
Dosage Strength : 375MG/75ML (5MG/ML)
Approval Date : 2025-07-16
Application Number : 214809
RX/OTC/DISCN : RX
RLD : No
TE Code :

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RLD : Yes
TE Code :
Dosage Form : SOLUTION; INTRAVENOUS
Proprietary Name : TEPYLUTE
Dosage Strength : 15MG/1.5ML (10MG/ML)
Approval Date : 2024-06-25
Application Number : 216984
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
Dosage Form : SOLUTION; INTRAVENOUS
Proprietary Name : TEPYLUTE
Dosage Strength : 100MG/10ML (10MG/ML)
Approval Date : 2025-02-26
Application Number : 216984
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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