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    01 1ALOGLIPTIN BENZOATE

    02 1APIXABAN

    03 1ATOGEPANT MONOHYDRATE

    04 1AVANAFIL

    05 1AZILSARTAN KAMEDOXOMIL

    06 1BEMPEDOIC ACID

    07 1BOSENTAN MONOHYDRATE

    08 1BREXPIPRAZOLE

    09 1BRIVARACETAM

    10 1BRIVARACETAM (PROCESS-II)

    11 1CABOTEGRAVIR SODIUM

    12 1CHLORTHALIDONE

    13 1CLOBAZAM

    14 1CLORAZEPATE DIPOTASSIUM

    15 1COBICISTAT ON COLLOIDAL SILICON DIOXIDE

    16 1COLCHICINE (FORM-A)

    17 1CRISABOROLE

    18 1DAPAGLIFLOZIN (AMORPHOUS)

    19 1DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE

    20 1DIATRIZOATE MEGLUMINE

    21 1DIATRIZOATE SODIUM

    22 1DICYCLOMINE HYDROCHLORIDE

    23 1DIMETHYL FUMARATE

    24 1DIROXIMEL FUMARATE

    25 1DOXYLAMINE SUCCINATE

    26 1EDOXABAN TOSYLATE MONOHYDRATE

    27 1ELUXADOLINE

    28 1EMPAGLIFLOZIN

    29 1EMPAGLIFLOZIN (AMORPHOUS)

    30 1EMPAGLIFLOZIN (PROCESS-II)

    31 1ERTUGLIFLOZIN L-PYROGLUTAMIC ACID

    32 1FINGOLIMOD HYDROCHLORIDE

    33 1FOSFOMYCIN TROMETHAMINE

    34 1ISAVUCONAZONIUM SULFATE

    35 1LETERMOVIR (AMORPHOUS)

    36 1LINAGLIPTIN

    37 1LINAGLIPTIN PREMIX

    38 1LITHIUM CARBONATE

    39 1MACITENTAN

    40 1MARALIXIBAT CHLORIDE

    41 1MARIBAVIR

    42 1MOLNUPIRAVIR

    43 1MONOMETHYL FUMARATE

    44 1NEBIVOLOL HYDROCHLORIDE

    45 1NIRMATRELVIR

    46 1OSPEMIFENE

    47 1PIRFENIDONE

    48 1PIRFENIDONE (PROCESS-II)

    49 1POSACONAZOLE (FORM-I)

    50 1PYRIDOXINE HYDROCHLORIDE

    51 1REMDESIVIR

    52 1SACUBITRIL VALSARTAN SODIUM HYDRATE

    53 1SACUBITRIL VALSARTAN SODIUM ON COLLOIDAL SILICON DIOXIDE

    54 1SAPROPTERIN DIHYDROCHLORIDE

    55 1SELEXIPAG (AMORPHOUS)

    56 1SITAGLIPTIN PHOSPHATE ANHYDROUS

    57 1SITAGLIPTIN PHOSPHATE MONOHYDRATE

    58 1SUGAMMADEX SODIUM

    59 1TADALAFIL USP

    60 1TAFAMIDIS MEGLUMINE

    61 1TAVABOROLE

    62 1TERIFLUNOMIDE

    63 1TICAGRELOR

    64 1TICAGRELOR (PROCESS-II)

    65 1TOFACITINIB CITRATE

    66 1UBROGEPANT

    67 1VIBEGRON

    68 1VILDAGLIPTIN

    69 1VONOPRAZAN FUMARATE

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    Alogliptin Benzoate

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2016-09-02

    Pay. Date : 2016-06-13

    DMF Number : 30577

    Submission : 2016-07-18

    Status : Active

    Type : II

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    Apixaban

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    DMF Review : Complete

    Rev. Date : 2016-07-05

    Pay. Date : 2016-04-26

    DMF Number : 30461

    Submission : 2016-05-18

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    Atogepant Monohydrate

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    DMF Review : Complete

    Rev. Date : 2025-09-07

    Pay. Date : 2025-07-09

    DMF Number : 42258

    Submission : 2025-07-31

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    Avanafil

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    DMF Review : Complete

    Rev. Date : 2016-02-05

    Pay. Date : 2015-12-03

    DMF Number : 30024

    Submission : 2015-12-15

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    Azilsartan Kamedoxomil

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    DMF Review : Complete

    Rev. Date : 2018-01-04

    Pay. Date : 2017-08-08

    DMF Number : 31895

    Submission : 2017-11-28

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    Bempedoic Acid

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    DMF Review : Complete

    Rev. Date : 2023-12-20

    Pay. Date : 2023-11-29

    DMF Number : 38785

    Submission : 2023-09-30

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    Bosentan Monohydrate

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    DMF Review : N/A

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    DMF Number : 36018

    Submission : 2021-09-09

    Status : Active

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    Brexpiprazole

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    DMF Review : Complete

    Rev. Date : 2018-07-10

    Pay. Date : 2018-03-27

    DMF Number : 32532

    Submission : 2018-06-04

    Status : Active

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    09

    Brivaracetam

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    DMF Review : Complete

    Rev. Date : 2020-03-20

    Pay. Date : 2020-01-30

    DMF Number : 34569

    Submission : 2020-02-18

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    Brivaracetam (process-ii)

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    DMF Review : Complete

    Rev. Date : 2025-12-08

    Pay. Date : 2025-09-15

    DMF Number : 42544

    Submission : 2025-09-23

    Status : Active

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