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

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01 APIXABAN (1)

02 BEMPEDOIC ACID (1)

03 BILASTINE (1)

04 BRIVARACETAM (1)

05 CARIPRAZINE HYDROCHLORIDE (1)

06 DABIGATRAN ETEXILATE MESYLATE (1)

07 DAPAGLIFLOZIN (1)

08 DEXLANSOPRAZOLE SESQUIHYDRATE (1)

09 Dapagliflozin Propanediol Monohydrate (1)

10 EMPAGLIFLOZIN (1)

11 ESOMEPRAZOLE MAGNESIUM TRIHYDRATE USP (1)

12 LANSOPRAZOLE USP (1)

13 LINAGLIPTIN (1)

14 LINEZOLID USP (1)

15 LURASIDONE HYDROCHLORIDE (1)

16 MIROGABALIN BESYLATE (1)

17 OLANZAPINE (FORM-I) (1)

18 OMEPRAZOLE (1)

19 RALTEGRAVIR INTERMEDIATE "BENZYL (2-(4-(4-FLUOROBENZYL) CARBAMOYL)-5-HYDROXY-1-METHYL-6-OXO-1, 6-DIHYDRO- PYRIMIDIN-2-YL) PROPAN-2-YL) CARBAMATE" (1)

20 RELUGOLIX (1)

21 RIVAROXABAN (1)

22 ROSUVASTATIN CALCIUM USP (1)

23 SERTRALINE HYDROCHLORIDE FORM-II (1)

24 SITAGLIPTIN PHOSPHATE USP (1)

25 SITAGLIPTIN PHOSPHATE USP (ROUTE-1) (1)

26 TEGOPRAZAN (1)

27 TEGOPRAZAN CRYSTALLINE (1)

28 TOFACITINIB CITRATE (1)

29 VARENICLINE BASE (INTERMEDIATE OF VARENICLINE) (1)

30 VARENICLINE TARTRATE (1)

31 VILDAGLIPTIN (1)

32 VONOPRAZAN FUMARATE (1)

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01 LEE PHARMA LIMITED (1)

02 LEE PHARMA LTD (31)

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01 India (32)

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01 Active (32)

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01 Complete (8)

02 Blank (24)

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LEE PHARMA LTD
Active
37040
Complete
2022-12-12
2022-11-23
2022-08-25
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LEE PHARMA LTD
Active
36010
N/A
2021-06-28
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LEE PHARMA LTD
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36288
N/A
2021-09-16
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LEE PHARMA LTD
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39008
N/A
2023-10-09
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LEE PHARMA LIMITED
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38749
N/A
2023-09-14
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LEE PHARMA LTD
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36181
N/A
2021-11-17
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LEE PHARMA LTD
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36994
N/A
2023-06-12
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LEE PHARMA LTD
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35792
N/A
2021-07-22
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LEE PHARMA LTD
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38183
N/A
2023-04-03
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LEE PHARMA LTD
Active
36162
Complete
2024-02-27
2024-01-13
2022-08-16
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