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

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01 PENICILLIN G POTASSIUM (1)

02 PENICILLIN G PROCAINE (1)

03 PENICILLIN V POTASSIUM (1)

04 POLYMYXIN B SULFATE (1)

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01 BIOTIKA AS (3)

02 BIOTIKA SA (1)

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01 Slovakia (4)

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01 Active (2)

02 Inactive (2)

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01 Complete (1)

02 Blank (3)

URL Supplier Web Content
BIOTIKA SA
Inactive
16837
N/A
2003-09-15
II
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BIOTIKA AS
Inactive
14400
N/A
1999-09-10
II
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BIOTIKA AS
Active
13963
N/A
1999-01-29
II
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BIOTIKA AS
Active
23876
Complete
2014-09-29
2013-12-11
2010-05-31
II
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