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

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01 KAD-1229 (1)

02 KLH-2109 CHOLINE DRUG SUBSTANCE (1)

03 KMD-3213 (SILODOSIN) DRUG SUBSTANCE (1)

04 KUR-1246 DRUG SUBSTANCE (1)

05 LINZAGOLIX CHOLINE (1)

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01 KISSEI PHARMACEUTICAL CO LTD (1)

02 KISSEI PHARMACEUTICALS CO LTD (3)

03 MEDICI NOVA INC (1)

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01 Japan (5)

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01 Active (3)

02 Inactive (2)

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01 Blank (5)

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KISSEI PHARMACEUTICAL...
Inactive
12834
N/A
1998-01-30
II
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KISSEI PHARMACEUTICAL...
Active
13030
N/A
1998-06-18
II
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MEDICI NOVA INC
Active
17734
N/A
2004-10-07
II
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KISSEI PHARMACEUTICAL...
Active
35700
N/A
2021-06-03
II
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KLH-2109 CHOLINE DRUG SUBSTANCE

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KISSEI PHARMACEUTICAL...
Inactive
30160
N/A
2016-01-12
II
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