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

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01 ENALAPRIL MALEATE (1)

02 ENALAPRILA USP (1)

03 FOR THE NOVO MESTO PLANT (1)

04 LANSOPRAZOLE ACTIVE SUBSTANCE (1)

05 NIFEDIPINE (1)

06 OXYTETRACYCLINE (1)

07 PIROXICAM (1)

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01 KRKA DD NOVO MESTO (4)

02 KRKA PHARMACEUTICAL AND CHEMICAL WORKS (3)

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01 Slovenia (7)

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01 Inactive (7)

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01 Blank (7)

URL Supplier Web Content
KRKA DD NOVO MESTO
Inactive
12809
N/A
1997-12-29
II
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KRKA DD NOVO MESTO
Inactive
15005
N/A
2000-08-21
II
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KRKA DD NOVO MESTO
Inactive
22321
N/A
2008-12-17
II
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KRKA PHARMACEUTICAL A...
Inactive
5295
N/A
1984-03-18
II
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KRKA DD NOVO MESTO
Inactive
13507
N/A
1998-09-01
II
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KRKA PHARMACEUTICAL A...
Inactive
8055
N/A
1989-05-04
II
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FOR THE NOVO MESTO PLANT

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KRKA PHARMACEUTICAL A...
Inactive
5428
N/A
1984-06-29
II
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