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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Bizen Chemical Co. - Ltd to the U.S. FDA. Original Data : FDA Website

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01 BIZEN EPA-70E (ICOSAPENT ETHYL) DRUG SUBSTANCE INTERMEDIATE (1)

02 BIZEN EPA-E (ICOSAPENT ETHYL) DRUG SUBSTANCE (1)

03 BIZEN EPA-EC (ICOSAPENT ETHYL) INTERMEDIATE (1)

04 BIZEN EPA-EC (ICOSAPENT ETHYL) DRUG SUBSTANCE INTERMEDIATE (1)

05 ICOSAPENTOSAN EQ (1)

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01 BIZEN CHEMICAL CO LTD (5)

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01 Japan (5)

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01 Active (5)

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01 Blank (5)

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BIZEN CHEMICAL CO LTD
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30122
N/A
2015-12-09
II
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BIZEN CHEMICAL CO LTD
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30007
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2015-11-04
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BIZEN CHEMICAL CO LTD
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32734
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2018-06-22
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BIZEN CHEMICAL CO LTD
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30025
N/A
2015-11-04
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BIZEN CHEMICAL CO LTD
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37279
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2022-07-29
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