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    HEC Pharm
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    Dong Yang Guang Park, Zhenan Road No.368, Shang Sha Village, Changan Town, Dongguan, Guangdong, Chi
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    86 769 853 15888
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    • FDA
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    Erythromycin

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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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    • FDA
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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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    • FDA
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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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    • FDA
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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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    • FDA
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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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    • FDA
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    Azithromycin Dihydrate

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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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    • FDA
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    Entacapone

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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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    • FDA
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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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    • FDA
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    Metoprolol Succinate

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    USDMF

    Found USDMF

    27915
    Active
    METOPROLOL SUCCINATE NON-STERILE BU...
    2014-03-11
    CEP/COS

    Found CEP/COS

    CEP 2014-038 - Rev 01
    Valid
    Metoprolol succinate
    2023-11-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27915
    CEP 2014-038 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    METOPROLOL SUCCINATE NON-STERILE BU...
    Metoprolol succinate
    Issue/Submission Date
    2014-03-11
    2023-11-17
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    • FDA
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    Moxifloxacin Hydrochloride

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    USDMF

    Found USDMF

    27394
    Active
    MOXIFLOXACIN HYDROCHLORIDE NON-STER...
    2013-08-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-225 - Rev 01
    Valid
    Moxifloxacin hydrochloride
    2021-08-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27394
    R1-CEP 2013-225 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MOXIFLOXACIN HYDROCHLORIDE NON-STER...
    Moxifloxacin hydrochloride
    Issue/Submission Date
    2013-08-07
    2021-08-26
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    • FDA
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    Olanzapine

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    USDMF

    Found USDMF

    26763
    Active
    OLANZAPINE NON-STERILE BULK DRUG SU...
    2012-12-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-406 - Rev 01
    Valid
    Olanzapine
    2023-07-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26763
    R1-CEP 2012-406 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    OLANZAPINE NON-STERILE BULK DRUG SU...
    Olanzapine
    Issue/Submission Date
    2012-12-28
    2023-07-20
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    • FDA
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    Olmesartan Medoxomil

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    USDMF

    Found USDMF

    30171
    Active
    OLMESARTAN MEDOXOMIL NON-STERILE BU...
    2016-01-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-032 - Rev 00
    Valid
    Olmesartan medoxomil
    2022-01-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30171
    R1-CEP 2016-032 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    OLMESARTAN MEDOXOMIL NON-STERILE BU...
    Olmesartan medoxomil
    Issue/Submission Date
    2016-01-28
    2022-01-05
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    • FDA
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    Rivaroxaban

    PDF Supplier PDF
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    USDMF

    Found USDMF

    28786
    Active
    RIVAROXABAN, NON-STERILE BULK DRUG ...
    2015-01-08
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-029 - Rev 00
    Valid
    Rivaroxaban
    2022-03-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28786
    R0-CEP 2021-029 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    RIVAROXABAN, NON-STERILE BULK DRUG ...
    Rivaroxaban
    Issue/Submission Date
    2015-01-08
    2022-03-28
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    • FDA
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    Rosuvastatin Calcium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29397
    Active
    ROSUVASTATIN CALCIUM NON-STERILE BU...
    2015-07-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-356 - Rev 00
    Valid
    Rosuvastatin calcium
    2022-10-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29397
    R1-CEP 2015-356 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ROSUVASTATIN CALCIUM NON-STERILE BU...
    Rosuvastatin calcium
    Issue/Submission Date
    2015-07-03
    2022-10-25
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    • FDA
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    Sitagliptin Phosphate

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    USDMF

    Found USDMF

    30170
    Active
    SITAGLIPTIN PHOSPHATE MONOHYDRATE N...
    2016-01-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-015 - Rev 01
    Valid
    Sitagliptin phosphate monohydrate
    2022-07-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30170
    R1-CEP 2016-015 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SITAGLIPTIN PHOSPHATE MONOHYDRATE N...
    Sitagliptin phosphate monohydrate
    Issue/Submission Date
    2016-01-19
    2022-07-01
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    Solifenacin Succinate

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    USDMF

    Found USDMF

    35140
    Active
    SOLIFENACIN SUCCINATE NON-STERILE B...
    2020-08-28
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-263 - Rev 00
    Valid
    Solifenacin succinate
    2021-09-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35140
    R0-CEP 2020-263 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SOLIFENACIN SUCCINATE NON-STERILE B...
    Solifenacin succinate
    Issue/Submission Date
    2020-08-28
    2021-09-14
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    Tadalafil

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    USDMF

    Found USDMF

    32453
    Active
    TADALAFIL NON-STERILE BULK DRUG SUB...
    2018-01-31
    CEP/COS

    Found CEP/COS

    R1-CEP 2018-005 - Rev 00
    Valid
    Tadalafil
    2023-08-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32453
    R1-CEP 2018-005 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TADALAFIL NON-STERILE BULK DRUG SUB...
    Tadalafil
    Issue/Submission Date
    2018-01-31
    2023-08-24
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    Atorvastatin

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    USDMF

    Found USDMF

    27664
    Active
    ATORVASTATIN CALCIUM NON-STERILE BU...
    2013-10-25
    CEP/COS

    Caution CEP/COS

    R0-CEP 2012-382 - Rev 01
    Withdrawn by Holder
    Atorvastatin calcium
    2015-11-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27664
    R0-CEP 2012-382 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    ATORVASTATIN CALCIUM NON-STERILE BU...
    Atorvastatin calcium
    Issue/Submission Date
    2013-10-25
    2015-11-23
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    Azithromycin

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    USDMF

    Found USDMF

    28453
    Active
    AZITHROMYCIN MONOHYDRATE NON-STERIL...
    2014-10-23
    CEP/COS

    Caution CEP/COS

    R0-CEP 2017-154 - Rev 00
    Withdrawn by Holder
    Azithromycin, PII
    2017-10-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28453
    R0-CEP 2017-154 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Withdrawn by Holder
     
    Filing Details
    AZITHROMYCIN MONOHYDRATE NON-STERIL...
    Azithromycin, PII
    Issue/Submission Date
    2014-10-23
    2017-10-26
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    Alogliptin Benzoate

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    USDMF

    Found USDMF

    30913
    Active
    ALOGLIPTIN BENZOATE NON-STERILE BUL...
    2016-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30913
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ALOGLIPTIN BENZOATE NON-STERILE BUL...
    Issue/Submission Date
    2016-09-30
    ASK
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    • FDA
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    Apixaban

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    USDMF

    Found USDMF

    30874
    Active
    APIXABAN NON-STERILE BULK DRUG SUBS...
    2016-08-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30874
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    APIXABAN NON-STERILE BULK DRUG SUBS...
    Issue/Submission Date
    2016-08-31
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    Apremilast

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    USDMF

    Found USDMF

    34088
    Active
    APREMILAST NON-STERILE BULK DRUG SU...
    2019-08-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34088
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    APREMILAST NON-STERILE BULK DRUG SU...
    Issue/Submission Date
    2019-08-31
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    Azilsartan

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    USDMF

    Found USDMF

    28452
    Active
    AZILSARTAN KAMEDOXOMIL NON-STERILE ...
    2014-08-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28452
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    AZILSARTAN KAMEDOXOMIL NON-STERILE ...
    Issue/Submission Date
    2014-08-14
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    Brivaracetam

    PDF Supplier PDF
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    USDMF

    Found USDMF

    34398
    Active
    BRIVARACETAM NON-STERILE BULK DRUG ...
    2020-01-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34398
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BRIVARACETAM NON-STERILE BULK DRUG ...
    Issue/Submission Date
    2020-01-17
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    Brivaracetam

    PDF Supplier PDF
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    USDMF

    Found USDMF

    35405
    Active
    (R)-4-PROPYLDIHYDROFURAN-2(3H)-ONE ...
    2020-12-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35405
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    (R)-4-PROPYLDIHYDROFURAN-2(3H)-ONE ...
    Issue/Submission Date
    2020-12-01
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    Clopidogrel

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    27917
    Inactive
    CLOPIDOGREL BISULFATE NON-STERILE B...
    2014-04-10
    CEP/COS

    Caution CEP/COS

    R0-CEP 2013-259 - Rev 01
    Withdrawn by Holder
    Clopidogrel hydrogen sulfate
    2015-11-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27917
    R0-CEP 2013-259 - Rev 01
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    CLOPIDOGREL BISULFATE NON-STERILE B...
    Clopidogrel hydrogen sulfate
    Issue/Submission Date
    2014-04-10
    2015-11-23
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    Duloxetine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    30172
    Active
    DULOXETINE HYDROCHLORIDE, NON-STERI...
    2016-02-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30172
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DULOXETINE HYDROCHLORIDE, NON-STERI...
    Issue/Submission Date
    2016-02-02
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    • FDA
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    Erythromycin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    19444
    Active
    ERYTHROMYCIN USP, NON-STERILE BULK ...
    2006-03-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19444
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ERYTHROMYCIN USP, NON-STERILE BULK ...
    Issue/Submission Date
    2006-03-20
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    Erythromycin Thiocyanate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10168
    Erythromycin thiocyanate at No. 62 ...
    2016-08-19
    Written Confirmation

    Close WC

    Application Number
    228MF10168
    Status
     
    Filing Details
    Erythromycin thiocyanate at No. 62 ...
    Issue/Submission Date
    2016-08-19
    ASK
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    • FDA
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    Escitalopram Oxalate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    35183
    Active
    ESCITALOPRAM OXALATE NON-STERILE BU...
    2020-09-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35183
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ESCITALOPRAM OXALATE NON-STERILE BU...
    Issue/Submission Date
    2020-09-27
    ASK
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    • FDA
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    Febuxostat

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    31838
    Active
    FEBUXOSTAT NON-STERILE BULK DRUG SU...
    2017-07-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31838
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FEBUXOSTAT NON-STERILE BULK DRUG SU...
    Issue/Submission Date
    2017-07-03
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    • FDA
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    Levofloxacin

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    26295
    Active
    LEVOFLOXACIN NON-STERILE BULK DRUG ...
    2012-08-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26295
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LEVOFLOXACIN NON-STERILE BULK DRUG ...
    Issue/Submission Date
    2012-08-09
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    Linagliptin

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    28785
    Active
    LINAGLIPTIN, NON-STERILE BULK DRUG ...
    2014-12-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28785
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LINAGLIPTIN, NON-STERILE BULK DRUG ...
    Issue/Submission Date
    2014-12-22
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    Lincomycin Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2018-038 - Rev 02
    Valid
    Lincomycin hydrochloride
    2023-11-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2018-038 - Rev 02
    Status
    Valid
     
    Filing Details
    Lincomycin hydrochloride
    Issue/Submission Date
    2023-11-29
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    Metronidazole

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Caution USDMF

    19442
    Inactive
    METRONIDAZOLE USP, NON-STERILE BULK...
    2006-03-10
    CEP/COS

    Caution CEP/COS

    R1-CEP 2005-002 - Rev 00
    Withdrawn by Holder
    Metronidazole
    2011-06-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19442
    R1-CEP 2005-002 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    METRONIDAZOLE USP, NON-STERILE BULK...
    Metronidazole
    Issue/Submission Date
    2006-03-10
    2011-06-01
    ASK
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    • FDA
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    Moxifloxacin Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-396 - Rev 00
    Valid
    Moxifloxacin hydrochloride, Site 3
    2021-12-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2021-396 - Rev 00
    Status
    Valid
     
    Filing Details
    Moxifloxacin hydrochloride, Site 3
    Issue/Submission Date
    2021-12-20
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    Moxifloxacin Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2020-402 - Rev 00
    Valid
    Moxifloxacin hydrochloride, Site 2
    2021-03-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2020-402 - Rev 00
    Status
    Valid
     
    Filing Details
    Moxifloxacin hydrochloride, Site 2
    Issue/Submission Date
    2021-03-01
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    Prasugrel Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    26769
    Active
    PRASUGREL HYDROCHLORIDE NON-STERILE...
    2012-12-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26769
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PRASUGREL HYDROCHLORIDE NON-STERILE...
    Issue/Submission Date
    2012-12-28
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    • FDA
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    Ritonavir

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    36673
    Active
    RITONAVIR NON-STERILE BULK DRUG SUB...
    2022-01-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36673
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    RITONAVIR NON-STERILE BULK DRUG SUB...
    Issue/Submission Date
    2022-01-23
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    Rosuvastatin

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    35343
    Active
    Rosuvastatin intermediate RSV01
    2020-11-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35343
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    Rosuvastatin intermediate RSV01
    Issue/Submission Date
    2020-11-05
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    Roxithromycin

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2018-207 - Rev 00
    Valid
    Roxithromycin
    2020-05-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2018-207 - Rev 00
    Status
    Valid
     
    Filing Details
    Roxithromycin
    Issue/Submission Date
    2020-05-29
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    Sugammadex Sodium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    33790
    Active
    SUGAMMADEX SODIUM NON STERILE BULK ...
    2019-04-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33790
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SUGAMMADEX SODIUM NON STERILE BULK ...
    Issue/Submission Date
    2019-04-26
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    Sultopride HCl

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    303MF10003
    Sultopride Hydrochloride at Xiaba D...
    2021-01-07
    Written Confirmation

    Close WC

    Application Number
    303MF10003
    Status
     
    Filing Details
    Sultopride Hydrochloride at Xiaba D...
    Issue/Submission Date
    2021-01-07
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    Tenofovir Alafenamide Fumarate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    33805
    Active
    TENOFOVIR ALAFENAMIDE FUMARATE NON-...
    2019-04-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33805
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TENOFOVIR ALAFENAMIDE FUMARATE NON-...
    Issue/Submission Date
    2019-04-30
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    Ticagrelor

    PDF Supplier PDF
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    USDMF

    Found USDMF

    28787
    Active
    TICAGRELOR NON-STERILE BULK DRUG SU...
    2015-01-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28787
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TICAGRELOR NON-STERILE BULK DRUG SU...
    Issue/Submission Date
    2015-01-30
    ASK
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    • FDA
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    Zidovudine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    23762
    Active
    ZIDOVUDINE, NON-STERILE DRUG SUBSTA...
    2010-04-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23762
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ZIDOVUDINE, NON-STERILE DRUG SUBSTA...
    Issue/Submission Date
    2010-04-20
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    • FDA
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    OSELTAMIVIR PHOSPHATE NON-STERILE BULK DRUG SUBSTANCE

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

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    USDMF

    Found USDMF

    38716
    Active
    OSELTAMIVIR PHOSPHATE NON-STERILE B...
    2023-08-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38716
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    OSELTAMIVIR PHOSPHATE NON-STERILE B...
    Issue/Submission Date
    2023-08-30
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    • FDA
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    CHUS01

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    302MF10103
    CHUS01 at Xiaba Development Zone, R...
    2020-08-24
    Written Confirmation

    Close WC

    Application Number
    302MF10103
    Status
     
    Filing Details
    CHUS01 at Xiaba Development Zone, R...
    Issue/Submission Date
    2020-08-24
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