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

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01 BUSPIRONE BASE (1)

02 BUSPIRONE HYDROCHLORIDE (1)

03 HYDROXYCHLOROQUINE SULFATE (1)

04 HYDROXYCHLOROQUINE SULFATE USP (1)

05 MEXILETINE HYDROCHLORIDE USP BULK (1)

06 PHENOBARBITAL SODIUM, USP (1)

07 PHENOBARBITAL USP (1)

08 TOPIRAMATE (1)

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01 ALKALOIDA CHEMICAL CO LTD (1)

02 ALKALOIDA CHEMICAL CO ZRT (6)

03 ICN HUNGARY COMPANY LTD (1)

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01 Hungary (7)

02 India (1)

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01 Active (3)

02 Inactive (5)

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01 Complete (2)

02 Blank (6)

URL Supplier Web Content
ALKALOIDA CHEMICAL CO...
Inactive
12135
N/A
1996-09-16
II
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ALKALOIDA CHEMICAL CO...
Inactive
12172
N/A
1996-10-16
II
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ALKALOIDA CHEMICAL CO...
Inactive
12762
N/A
1997-11-12
II
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ALKALOIDA CHEMICAL CO...
Active
23582
Complete
2018-05-11
2018-04-04
2010-03-25
II
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ICN HUNGARY COMPANY L...
Inactive
10376
N/A
1993-07-26
II
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ALKALOIDA CHEMICAL CO...
Active
34598
Complete
2020-03-31
2020-03-06
2020-03-10
II
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ALKALOIDA CHEMICAL CO...
Active
4642
N/A
1982-09-01
II
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ALKALOIDA CHEMICAL CO...
Inactive
16405
N/A
2003-01-30
II
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