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

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01 AMORPHOUS ADEFOVIR DIPIVOXIL (11.6% COPOVIDONE DISPERSION) (1)

02 AMORPHOUS DOFETILIDE (1)

03 APIXABAN AMORPHOUS (6.58%) (1)

04 ASENAPINE MALEATE AMORPHOUS (31.2%) PREMIX (1)

05 L-TRYPTOPHAN ETHYL ESTER HCl (1)

06 VORTIOXETINE HYDROBROMIDE AMORPHOUS (24.12%) (1)

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01 SIGMA F AND D DIV LTD (1)

02 SIGMAPHARM LABORATORIES LLC (5)

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01 U.S.A (6)

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01 Active (5)

02 Inactive (1)

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01 Complete (4)

02 Blank (2)

URL Supplier Web Content
SIGMAPHARM LABORATORI...
Active
23844
N/A
2010-06-03
II
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SIGMAPHARM LABORATORI...
Active
28301
Complete
2014-08-22
2014-06-09
2014-06-05
II
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SIGMAPHARM LABORATORI...
Active
30774
Complete
2016-10-06
2016-08-15
2016-08-10
II
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SIGMAPHARM LABORATORI...
Active
27300
Complete
2013-09-22
2013-08-13
2013-08-08
II
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SIGMAPHARM LABORATORI...
Active
31898
Complete
2017-09-21
2017-08-18
2017-08-16
II
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L-TRYPTOPHAN ETHYL ESTER HCl

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SIGMA F AND D DIV LTD
Inactive
7278
N/A
1988-01-01
II
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