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

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01 AT-4140 (1)

02 DROXIDOPA (1)

03 ENOXACIN SESQUIHYDRATE (1)

04 MEROPENEM (1)

05 MEROPENEM BULK BLEND (1)

06 MEROPENEM/SODIUM CARBONATE (1)

07 RANIRESTAT (AS-3201) (1)

08 SM-13496 (1)

09 SM-5887 (AMRUBICIN HYDROCHLORIDE) (1)

10 SMP-028 (1)

11 SMP-114 (1)

12 SMP-601 DRUG SUBSTANCE (1)

13 SMP-797 DRUG SUBSTANCE (1)

14 SMP-986 (1)

15 ZONISAMIDE DRUG SUBSTANCE (1)

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01 DAINIPPON PHARMACEUTICAL CO LTD (2)

02 DAINIPPON SUMITOMO PHARMA CO LTD (5)

03 SUMITOMO DAINIPPON PHARMA CO LTD (6)

04 SUMITOMO PHARMA CO LTD (2)

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01 Japan (15)

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01 Active (2)

02 Inactive (13)

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01 Blank (15)

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DAINIPPON PHARMACEUTI...
Inactive
8375
N/A
1990-01-16
II
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SUMITOMO DAINIPPON PH...
Inactive
20556
N/A
2007-05-23
II
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DAINIPPON PHARMACEUTI...
Inactive
7252
N/A
1987-12-09
II
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SUMITOMO DAINIPPON PH...
Inactive
10322
N/A
1993-06-25
II
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SUMITOMO DAINIPPON PH...
Inactive
18102
N/A
2005-02-16
II
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DAINIPPON SUMITOMO PH...
Inactive
10321
N/A
1993-06-25
II
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SUMITOMO DAINIPPON PH...
Inactive
21445
N/A
2008-03-19
II
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SUMITOMO PHARMA CO LT...
Active
16059
N/A
2002-07-15
II
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SUMITOMO DAINIPPON PH...
Inactive
18990
N/A
2005-11-30
II
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DAINIPPON SUMITOMO PH...
Inactive
18571
N/A
2005-08-08
II
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