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

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01 ACETAZOLAMIDE (1)

02 APIXABAN (1)

03 APREMILAST (1)

04 ARIPIPRAZOLE (1)

05 ARIPIPRAZOLE LAUROXIL (1)

06 ARIPIPRAZOLE MONOHYDRATE (1)

07 AVANAFIL (1)

08 BACLOFEN (1)

09 BREXPIPRAZOLE (1)

10 CARBAMAZEPINE (1)

11 CARVEDILOL (1)

12 CARVEDILOL PHOSPHATE HEMIHYDRATE (1)

13 DAPAGLIFLOZIN (1)

14 DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (1)

15 EMPAGLIFLOZIN (1)

16 ETODOLAC (1)

17 HYDROCHLOROTHIAZIDE (1)

18 IBANDRONATE SODIUM MONOHYDRATE (1)

19 ISAVUCONAZONIUM SULFATE (1)

20 LAMOTRIGINE (1)

21 LINAGLIPTIN (1)

22 OXCARBAZEPINE (1)

23 PENTOXIFYLLINE (1)

24 PIMAVANSERIN TARTRATE (1)

25 RIVAROXABAN (1)

26 SACUBITRIL/VALSARTAN COMPLEX (1)

27 SAFINAMIDE METHANESULFONATE (1)

28 SILDENAFIL CITRATE (1)

29 SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE (1)

30 SODIUM ALENDRONATE (1)

31 SODIUM RISEDRONATE HEMI-PENTAHYDRATE (1)

32 SODIUM SALICYLATE (1)

33 SOLIFENACIN SUCCINATE (1)

34 TADALAFIL (1)

35 TICAGRELOR (1)

36 TOPIRAMATE (1)

37 VARDENAFIL HYDROCHLORIDE TRIHYDRATE (1)

38 ZOLEDRONIC ACID MONOHYDRATE (1)

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01 ZAKLADY FARMACEUTYCZNE POLPHARMA SA (38)

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01 Poland (38)

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01 Active (38)

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01 Complete (29)

02 Blank (9)

URL Supplier Web Content
ZAKLADY FARMACEUTYCZN...
Active
31531
Complete
2018-12-10
2018-08-21
2018-08-16
II
URL Supplier Web Content
ZAKLADY FARMACEUTYCZN...
Active
29689
N/A
2015-08-20
II
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