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

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01 ARMODAFINIL DRUG SUBSTANCE (1)

02 BROMOCRIPTINE MESYLATE (1)

03 CABERGOLINE (1)

04 CETIRIZINE HCI COATED GRANULES (1)

05 CYCLOSPORINE (1)

06 CYPROTERONE ACETATE (1)

07 DICLOFENAC SODIUM (2)

08 ELAGOLIX SODIUM (1)

09 ELTROMBOPAG CHOLINE (1)

10 ELTROMBOPAG OLAMINE (1)

11 ERGOTAMINE TARTRATE (1)

12 FACILITIES AND PERSONNEL IN PETAH TIKVA, ISRAEL (1)

13 FACILITIES LOCATED IN MINNEAPOLIS, MN (1)

14 FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES (1)

15 FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN QUEBEC, CANADA (1)

16 FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES FOR THE SCARBOROUGH, ONTARIO CANADA PLANT. (1)

17 FACILITIES, PERSONNEL,OPERATING PROC. AT ONTARIO, CANADA (1)

18 FEDRATINIB HYDROCHLORIDE (1)

19 FLUOROMETHOLONE (1)

20 FLUTICASONE FUROATE (1)

21 FORMOTEROL FUMARATE (1)

22 GLYCEROL PHENYLBUTYRATE (1)

23 GRADE B NOMAC (1)

24 IVOSIDENIB (1)

25 MANUFACTURE OF NITROFURANTOIN (1)

26 MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES AND PERSONNEL IN WINNIPEG MANITOBA, CANADA (1)

27 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN HAARLEM, HOLLAND. (1)

28 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN NETANYA, ISRAEL. (1)

29 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SCARBOROUGH, ONTARIO, CANADA. (1)

30 MEMANTINE HYDROCHLORIDE 7SM1037 (1)

31 METHYLPREDNISOLOME HEMISUCCINATE (FORMERLY HELD BY S.I.R.S.) (1)

32 MIDOSTAURIN (1)

33 MIGALASTAT HYDROCHLORIDE (1)

34 MODAFINIL DRUG SUBSTANCE (1)

35 MYCOPHENOLATE MOFETIL ID: 744010 (1)

36 MYCOPHENOLATE MOFETIL USP (1)

37 NERATINIB MALEATE MONOHYDRATE (1)

38 NILOTINIB TARTRATE (1)

39 NINTEDANIB ESYLATE (1)

40 NITROFURAZONE NF-BPC (PETAH TIQWA PLANT) (1)

41 NOMEGESTROL ACETATE, NOMAC GRADE B (1)

42 NOMEGESTROL ACTATE (1)

43 PERGOLIDE MESYLATE (1)

44 QUETIAPINE FUMARATE (1)

45 RANITIDINE HYDROCHLORIDE USP (1)

46 RIBOCICLIB SUCCINATE (1)

47 RIMEGEPANT SULFATE (1)

48 RISPERIDONE STERILE (1)

49 SAXAGLIPTIN HYDROCHLORIDE (DIHYDRATE) (1)

50 STERILE WATER FOR INJECTION USP (1)

51 TAFAMIDIS (1)

52 TRIAMTEREN AND TRIAMTERENE (1)

53 TUCATINIB (1)

54 VALBENAZINE TOSYLATE (1)

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01 ABIC LTD (1)

02 ASSIA CHEMICAL INDUSTRIES LTD (5)

03 CEPHALON INC (2)

04 CIMA LABORATORIES INC (2)

05 DURAMED PHARMACEUTICALS INC (1)

06 GALENA AS (3)

07 IVAX CR (1)

08 IVAX PHARMACEUTICALS SRO (2)

09 MONACHEM (2)

10 NOVOPHARM BIOTECH INC (1)

11 NOVOPHARM LTD (4)

12 NOVOPHARM QUEBEC (1)

13 PHARMACHEMIE BV (1)

14 PROSINTEX SPA (1)

15 SICOR DE MEXICO SA DE CV (1)

16 SICOR SPA (2)

17 SICOR SWISS BRANCH (1)

18 TEVA PARENTERAL MEDICINES INC (1)

19 TEVA PHARMACEUTICAL INDUSTRIES LTD (23)

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01 Canada (6)

02 Czech Republic (3)

03 India (7)

04 Israel (24)

05 Mexico (4)

06 Monaco (2)

07 Netherlands (1)

08 U.S.A (8)

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01 Active (27)

02 Inactive (28)

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01 Complete (17)

02 Blank (38)

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CEPHALON INC
Active
19685
N/A
2006-08-15
II
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GALENA AS
Inactive
11973
N/A
1996-05-06
II
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IVAX CR
Inactive
15933
N/A
2002-03-18
II
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CIMA LABORATORIES INC
Active
22680
N/A
2009-09-28
II
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GALENA AS
Inactive
11971
N/A
1996-05-13
II
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SICOR DE MEXICO SA DE...
Inactive
14078
N/A
1999-04-08
II
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ASSIA CHEMICAL INDUST...
Inactive
11499
N/A
1995-05-11
II
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PROSINTEX SPA
Inactive
8583
N/A
1990-05-28
II
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TEVA PHARMACEUTICAL I...
Active
36570
Complete
2022-02-28
2021-12-13
2022-02-08
II
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TEVA PHARMACEUTICAL I...
Active
35520
N/A
2021-02-18
II
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