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

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01 AMOXICILLIN SODIUM STERILE (1)

02 AMPICILLIN SODIUM STERILE (1)

03 AMPICILLIN SODIUM/SULBACTAM SODIUM (1)

04 AMPICILLIN TRIHYDRATE STERILE (1)

05 ANASTROZOLE (1)

06 BENDAMUSTINE HYDROCHLORIDE (1)

07 BICALUTAMIDE (1)

08 BUFFERED CEFTAZIDIME PENTAHYDRATE, STERILE (1)

09 BUFFERED NAFCILLIN SODIUM STERILE (1)

10 BUFFERED OXACILLIN SODIUM STERILE (1)

11 BUFFERED PENICILLIN G POTASSIUM STERILE (1)

12 BUPIVACAINE HYDROCHLORIDE (1)

13 BUSULFAN (1)

14 CALCITONIN SALMON (1)

15 CARBOPLATIN (1)

16 CEFEPIME ARGININE STERILE (1)

17 CEFOXITIN SODIUM (STERILE) DRUG SUBSTANCE (1)

18 CEFTAZIDIME PENTAHYDRATE STERILE BUFFERED / AVIBACTAM SODIUM STERILE (4:1) (1)

19 CEFTRIAXONE SODIUM STERILE (1)

20 CEFUROXIME SODIUM STERILE (1)

21 CEPHAPIRIN BENZATHINE STERILE (1)

22 CEPHAPIRIN SODIUM STERILE (1)

23 CLOXACILLIN BENZATHINE STERILE (1)

24 CLOXACILLIN SODIUM (1)

25 DECITABINE (1)

26 DISODIUM PAMIDRONATE (1)

27 DOCETAXEL (1)

28 GEMCITABINE HYDROCHLORIDE (1)

29 GLUCAGON (1)

30 HETACILLIN POTASSIUM STERILE (1)

31 IRINOTECAN HYDROCHLORIDE TRIHYDRATE (1)

32 LETROZOLE (1)

33 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CANTON, MASSACHUSETTS. (1)

34 MCT LIPID EMULSION (1)

35 OCTREOTIDE ACETATE (1)

36 OXALIPLATIN (1)

37 PACLITAXEL SEMISYNTHETIC (1)

38 PIPERACILLIN SODIUM/ TAZOBACTAM SODIUM (8:1) STERILE LYOPHILIZED (1)

39 ROPIVACAINE HYDROCHLORIDE (1)

40 TEMSIROLIMUS (1)

41 TOPOTECAN HYDROCHLORIDE (1)

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01 FRESENIUS KABI ANTI INFECTIVES SRL (4)

02 FRESENIUS KABI CLAYTON L P (1)

03 FRESENIUS KABI IPSUM SRL (18)

04 FRESENIUS KABI ONCOLOGY LTD (17)

05 FRESENIUS USA INC (1)

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01 Germany (2)

02 Sweden (37)

03 U.S.A (2)

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01 Active (26)

02 Inactive (15)

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01 Complete (12)

02 Blank (29)

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FRESENIUS KABI IPSUM ...
Active
38349
N/A
2023-05-17
II
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FRESENIUS KABI IPSUM ...
Active
23287
N/A
2009-11-20
II
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FRESENIUS KABI IPSUM ...
Active
25477
N/A
2011-11-03
II
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FRESENIUS KABI IPSUM ...
Active
23699
N/A
2010-04-07
II
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FRESENIUS KABI ONCOLO...
Inactive
20660
N/A
2007-07-06
II
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FRESENIUS KABI ONCOLO...
Inactive
26656
N/A
2012-12-21
II
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FRESENIUS KABI ONCOLO...
Inactive
20099
N/A
2006-12-28
II
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FRESENIUS KABI IPSUM ...
Active
20985
Complete
2014-05-16
2014-05-05
2007-10-31
II
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FRESENIUS KABI IPSUM ...
Active
25387
Complete
2014-01-03
2013-12-17
2011-09-01
II
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FRESENIUS KABI IPSUM ...
Active
24941
Complete
2014-06-23
2013-12-20
2011-05-11
II
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