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    01 Alogliptin Benzoate (1)

    02 Apixaban (1)

    03 Apremilast (1)

    04 Aripiprazole (1)

    05 Atorvastatin (1)

    06 Azilsartan (1)

    07 Azithromycin (2)

    08 Azithromycin Dihydrate (1)

    09 Besifloxacin Hydrochloride (1)

    10 Brivaracetam (2)

    11 Clarithromycin (1)

    12 Clopidogrel (1)

    13 Duloxetine (1)

    14 Entacapone (1)

    15 Erythromycin (2)

    16 Erythromycin Thiocyanate (1)

    17 Escitalopram Oxalate (2)

    18 Esomeprazole Magnesium (1)

    19 Febuxostat (1)

    20 Felodipine (1)

    21 Fingolimod Hydrochloride (1)

    22 Irbesartan (1)

    23 Levofloxacin (1)

    24 Linagliptin (1)

    25 Lincomycin Hydrochloride (2)

    26 Metoprolol Succinate (1)

    27 Metronidazole (1)

    28 Moxifloxacin Hydrochloride (3)

    29 Olanzapine (1)

    30 Olmesartan Medoxomil (1)

    31 Prasugrel Hydrochloride (1)

    32 Ritonavir (1)

    33 Rivaroxaban (1)

    34 Rosuvastatin (1)

    35 Rosuvastatin Calcium (1)

    36 Roxithromycin (1)

    37 Simvastatin (2)

    38 Sitagliptin Phosphate (1)

    39 Solifenacin Succinate (1)

    40 Sugammadex Sodium (1)

    41 Sultopride HCl (1)

    42 Tadalafil (1)

    43 Tenofovir Alafenamide Fumarate (1)

    44 Ticagrelor (1)

    45 Zidovudine (1)

    46 Blank (2)

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    01 Active (40)

    02 Inactive (8)

    03 Blank (7)

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    01 Valid (23)

    02 Withdrawn by Holder (4)

    03 Blank (28)

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    01 224MF10166 (1)

    02 228MF10168 (1)

    03 231MF10067 (1)

    04 301MF10066 (1)

    05 302MF10103 (1)

    06 303MF10003 (1)

    07 304MF10011 (1)

    08 Blank (48)

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    Erythromycin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    19443
    Active
    ERYTHROMYCIN THIOCYANATE, PHARMACEU...
    2006-03-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-153 - Rev 02
    Valid
    Erythromycin
    2017-01-20
    Japanese DMF

    Found JDMF

    231MF10067
    Erythromycin at No. 62 Binjiang Roa...
    2019-03-11
    Written Confirmation

    Close WC

    Application Number
    19443
    R1-CEP 2007-153 - Rev 02
    231MF10067
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ERYTHROMYCIN THIOCYANATE, PHARMACEU...
    Erythromycin
    Erythromycin at No. 62 Binjiang Roa...
    Issue/Submission Date
    2006-03-20
    2017-01-20
    2019-03-11
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    Fingolimod Hydrochloride

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    USDMF

    Found USDMF

    28165
    Active
    FINGOLIMOD HYDROCHLORIDE NON-STERIL...
    2014-04-23
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-140 - Rev 00
    Valid
    Fingolimod hydrochloride, Form-I
    2021-07-15
    Japanese DMF

    Found JDMF

    304MF10011
    Fingolimod Hydrochloride at Xiaba D...
    2022-01-13
    Written Confirmation

    Close WC

    Application Number
    28165
    R0-CEP 2019-140 - Rev 00
    304MF10011
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    FINGOLIMOD HYDROCHLORIDE NON-STERIL...
    Fingolimod hydrochloride, Form-I
    Fingolimod Hydrochloride at Xiaba D...
    Issue/Submission Date
    2014-04-23
    2021-07-15
    2022-01-13
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    Lincomycin Hydrochloride

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    USDMF

    Found USDMF

    33500
    Active
    LINCOMYCIN HYDROCHLORIDE, NON-STERI...
    2019-01-24
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-136 - Rev 02
    Valid
    Lincomycin hydrochloride, Process I...
    2022-09-06
    Japanese DMF

    Found JDMF

    301MF10066
    Lincomycin hydrochloride hydrate at...
    2019-09-17
    Written Confirmation

    Close WC

    Application Number
    33500
    R0-CEP 2019-136 - Rev 02
    301MF10066
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LINCOMYCIN HYDROCHLORIDE, NON-STERI...
    Lincomycin hydrochloride, Process I...
    Lincomycin hydrochloride hydrate at...
    Issue/Submission Date
    2019-01-24
    2022-09-06
    2019-09-17
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    Azithromycin

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    USDMF

    Caution USDMF

    20852
    Inactive
    AZITHROMYCIN MONHYDRATE, NON-STERIL...
    2007-09-10
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-185 - Rev 00
    Valid
    Azithromycin, Monohydrate
    2020-08-28
    Japanese DMF

    Found JDMF

    224MF10166
    Azithromycin hydrate at No. 62 Binj...
    2012-08-16
    Written Confirmation

    Close WC

    Application Number
    20852
    R1-CEP 2014-185 - Rev 00
    224MF10166
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    AZITHROMYCIN MONHYDRATE, NON-STERIL...
    Azithromycin, Monohydrate
    Azithromycin hydrate at No. 62 Binj...
    Issue/Submission Date
    2007-09-10
    2020-08-28
    2012-08-16
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    Aripiprazole

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    USDMF

    Found USDMF

    30954
    Active
    ARIPIPRAZOLE NON-STERILE BULK DRUG ...
    2016-09-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-208 - Rev 00
    Valid
    Aripiprazole
    2023-06-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30954
    R1-CEP 2016-208 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ARIPIPRAZOLE NON-STERILE BULK DRUG ...
    Aripiprazole
    Issue/Submission Date
    2016-09-28
    2023-06-09
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    Azithromycin Dihydrate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    28837
    Active
    AZITHROMYCIN DIHYDRATE NON-STERILE ...
    2014-10-31
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-230 - Rev 04
    Valid
    Azithromycin, Dihydrate
    2022-01-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28837
    R1-CEP 2007-230 - Rev 04
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    AZITHROMYCIN DIHYDRATE NON-STERILE ...
    Azithromycin, Dihydrate
    Issue/Submission Date
    2014-10-31
    2022-01-04
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    Clarithromycin

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    USDMF

    Found USDMF

    24709
    Active
    CLARITHROMYCIN, NON-STERILE DRUG SU...
    2011-02-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-134 - Rev 02
    Valid
    Clarithromycin
    2021-02-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24709
    R1-CEP 2009-134 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CLARITHROMYCIN, NON-STERILE DRUG SU...
    Clarithromycin
    Issue/Submission Date
    2011-02-20
    2021-02-03
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    Entacapone

    PDF Supplier PDF
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    USDMF

    Found USDMF

    27109
    Active
    ENTACAPONE NON-STERILE BULK DRUG SU...
    2013-04-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-127 - Rev 02
    Valid
    Entacapone
    2022-07-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27109
    R1-CEP 2013-127 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ENTACAPONE NON-STERILE BULK DRUG SU...
    Entacapone
    Issue/Submission Date
    2013-04-20
    2022-07-06
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    Escitalopram Oxalate

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    USDMF

    Found USDMF

    28454
    Active
    ESCITALOPRAM OXALATE NON-STERILE BU...
    2014-09-28
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-258 - Rev 00
    Valid
    Escitalopram oxalate
    2021-10-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28454
    R0-CEP 2020-258 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ESCITALOPRAM OXALATE NON-STERILE BU...
    Escitalopram oxalate
    Issue/Submission Date
    2014-09-28
    2021-10-21
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    Esomeprazole Magnesium

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    USDMF

    Found USDMF

    27918
    Active
    ESOMEPRAZOLE MAGNESIUM DIHYDRATE NO...
    2014-04-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-159 - Rev 00
    Valid
    Esomeprazole magnesium dihydrate
    2020-05-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27918
    R1-CEP 2014-159 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ESOMEPRAZOLE MAGNESIUM DIHYDRATE NO...
    Esomeprazole magnesium dihydrate
    Issue/Submission Date
    2014-04-08
    2020-05-20
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