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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Micro Labs Limited

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    MICRO LABS LIMITED

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    Micro Labs Limited
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    Country
    Country
    India
    Address
    Address
    27, RACE COURSE ROAD, BANGALORE-560 001
    Telephone
    Telephone
    +91-80-2237 0451-57
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    http://www.microlabsltd.com/
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    Brimonidine Tartrate

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    USDMF

    Found USDMF

    34362
    Active
    BRIMONIDINE TARTRATE USP
    2019-12-21
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-335 - Rev 01
    Valid
    Brimonidine tartrate
    2022-02-07
    Japanese DMF

    Found JDMF

    301MF10111
    Brimonidine Tartrate at 31, Race Co...
    2019-12-20
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225
    Expired
    Brimonidine Tartrate IH
    2019-08-16
    Application Number
    34362
    R0-CEP 2019-335 - Rev 01
    301MF10111
    Indian CDSCO WC-0225
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-08-15
    Filing Details
    BRIMONIDINE TARTRATE USP
    Brimonidine tartrate
    Brimonidine Tartrate at 31, Race Co...
    Brimonidine Tartrate IH
    Issue/Submission Date
    2019-12-21
    2022-02-07
    2019-12-20
    2019-08-16
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    Dorzolamide Hydrochloride

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    USDMF

    Found USDMF

    24753
    Active
    DORZOLAMIDE HYDROCHLORIDE USP
    2011-02-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-102 - Rev 06
    Valid
    Dorzolamide hydrochloride
    2021-01-07
    Japanese DMF

    Found JDMF

    304MF10044
    Dorzolamide Hydrochloride at 31, Ra...
    2022-02-24
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225
    Expired
    Dorzolamide Hydrochloride (Ph. Eur/...
    2019-08-16
    Application Number
    24753
    R1-CEP 2011-102 - Rev 06
    304MF10044
    Indian CDSCO WC-0225
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-08-15
    Filing Details
    DORZOLAMIDE HYDROCHLORIDE USP
    Dorzolamide hydrochloride
    Dorzolamide Hydrochloride at 31, Ra...
    Dorzolamide Hydrochloride (Ph. Eur/...
    Issue/Submission Date
    2011-02-28
    2021-01-07
    2022-02-24
    2019-08-16
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    Escitalopram Oxalate

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    USDMF

    Caution USDMF

    24684
    Inactive
    ESCITALOPRAM OXALATE
    2010-11-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-250 - Rev 00
    Valid
    Escitalopram oxalate
    2023-01-16
    Japanese DMF

    Found JDMF

    303MF10028
    Escitalopram Oxalate at 31, Race Co...
    2021-02-10
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225
    Expired
    Escitalopram Oxalate (IH/USP)
    2019-08-16
    Application Number
    24684
    R1-CEP 2016-250 - Rev 00
    303MF10028
    Indian CDSCO WC-0225
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-08-15
    Filing Details
    ESCITALOPRAM OXALATE
    Escitalopram oxalate
    Escitalopram Oxalate at 31, Race Co...
    Escitalopram Oxalate (IH/USP)
    Issue/Submission Date
    2010-11-30
    2023-01-16
    2021-02-10
    2019-08-16
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    Celecoxib

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    USDMF

    Found USDMF

    24686
    Active
    CELECOXIB USP
    2010-11-26
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-201 - Rev 00
    Valid
    Celecoxib, Process-IV
    2022-08-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225
    Expired
    Celecoxib (IH/Ph. Eur/USP)
    2019-08-16
    Application Number
    24686
    R0-CEP 2022-201 - Rev 00
    Indian CDSCO WC-0225
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-08-15
    Filing Details
    CELECOXIB USP
    Celecoxib, Process-IV
    Celecoxib (IH/Ph. Eur/USP)
    Issue/Submission Date
    2010-11-26
    2022-08-19
    2019-08-16
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    Clobazam

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    USDMF

    Found USDMF

    32059
    Active
    CLOBAZAM
    2017-11-30
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-168 - Rev 01
    Valid
    Clobazam
    2022-04-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225A3
    Expired
    Clobazam IH
    2020-01-16
    Application Number
    32059
    R0-CEP 2019-168 - Rev 01
    Indian CDSCO WC-0225A3
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-08-15
    Filing Details
    CLOBAZAM
    Clobazam
    Clobazam IH
    Issue/Submission Date
    2017-11-30
    2022-04-21
    2020-01-16
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    Irbesartan

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    USDMF

    Found USDMF

    24834
    Active
    IRBESARTAN USP
    2011-03-28
    CEP/COS

    Found CEP/COS

    CEP 2020-260 - Rev 03
    Valid
    Irbesartan, Process II
    2023-12-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225
    Expired
    Irbesartan (Ph. Eur/USP)
    2019-08-16
    Application Number
    24834
    CEP 2020-260 - Rev 03
    Indian CDSCO WC-0225
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-08-15
    Filing Details
    IRBESARTAN USP
    Irbesartan, Process II
    Irbesartan (Ph. Eur/USP)
    Issue/Submission Date
    2011-03-28
    2023-12-14
    2019-08-16
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    Naphazoline Hydrochloride

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    USDMF

    Found USDMF

    32465
    Active
    NAPHAZOLINE HYDROCHLORIDE USP
    2018-01-30
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-188 - Rev 01
    Valid
    Naphazoline Hydrochloride
    2021-06-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225N
    Expired
    Naphazoline Hydrochloride EP
    2019-09-03
    Application Number
    32465
    R0-CEP 2019-188 - Rev 01
    Indian CDSCO WC-0225N
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-08-15
    Filing Details
    NAPHAZOLINE HYDROCHLORIDE USP
    Naphazoline Hydrochloride
    Naphazoline Hydrochloride EP
    Issue/Submission Date
    2018-01-30
    2021-06-02
    2019-09-03
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    Olmesartan Medoxomil

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    USDMF

    Found USDMF

    27539
    Active
    OLMESARTAN MEDOXOMIL USP
    2013-09-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-251 - Rev 01
    Valid
    Olmesartan medoxomil
    2023-01-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225
    Expired
    Olmesartan medoximil EP
    2019-08-16
    Application Number
    27539
    R1-CEP 2014-251 - Rev 01
    Indian CDSCO WC-0225
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-08-15
    Filing Details
    OLMESARTAN MEDOXOMIL USP
    Olmesartan medoxomil
    Olmesartan medoximil EP
    Issue/Submission Date
    2013-09-26
    2023-01-03
    2019-08-16
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    Pirfenidone

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    USDMF

    Found USDMF

    32654
    Active
    PIRFENIDONE
    2018-04-03
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-155 - Rev 01
    Valid
    Pirfenidone
    2022-11-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225A3
    Expired
    Pirfenidone EP
    2020-01-16
    Application Number
    32654
    R0-CEP 2019-155 - Rev 01
    Indian CDSCO WC-0225A3
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-08-15
    Filing Details
    PIRFENIDONE
    Pirfenidone
    Pirfenidone EP
    Issue/Submission Date
    2018-04-03
    2022-11-16
    2020-01-16
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    Rivaroxaban

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    USDMF

    Found USDMF

    31418
    Active
    RIVAROXABAN
    2017-03-30
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-318 - Rev 01
    Valid
    Rivaroxaban
    2022-12-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225A6
    Expired
    Rivaroxaban IH
    2020-02-10
    Application Number
    31418
    R0-CEP 2021-318 - Rev 01
    Indian CDSCO WC-0225A6
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-08-15
    Filing Details
    RIVAROXABAN
    Rivaroxaban
    Rivaroxaban IH
    Issue/Submission Date
    2017-03-30
    2022-12-19
    2020-02-10
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    Solifenacin Succinate

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    USDMF

    Found USDMF

    31459
    Active
    SOLIFENACIN SUCCINATE
    2017-03-31
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-510 - Rev 00
    Valid
    Solifenacin succinate, Process-II
    2022-06-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225
    Expired
    Solifenacin Succinate IH
    2019-08-16
    Application Number
    31459
    R0-CEP 2021-510 - Rev 00
    Indian CDSCO WC-0225
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-08-15
    Filing Details
    SOLIFENACIN SUCCINATE
    Solifenacin succinate, Process-II
    Solifenacin Succinate IH
    Issue/Submission Date
    2017-03-31
    2022-06-20
    2019-08-16
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    Telmisartan

    PDF Supplier PDF
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    USDMF

    Found USDMF

    27538
    Active
    TELMISARTAN USP
    2013-09-23
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-388 - Rev 01
    Valid
    Telmisartan, Process-II
    2021-10-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225
    Expired
    Telmisartan EP
    2019-08-16
    Application Number
    27538
    R0-CEP 2020-388 - Rev 01
    Indian CDSCO WC-0225
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-08-15
    Filing Details
    TELMISARTAN USP
    Telmisartan, Process-II
    Telmisartan EP
    Issue/Submission Date
    2013-09-23
    2021-10-07
    2019-08-16
    ASK
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    • FDA
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    Ticagrelor

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29012
    Active
    TICAGRELOR
    2015-02-13
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-173 - Rev 00
    Valid
    Ticagrelor
    2023-04-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225A7
    Expired
    Ticagrelor IH
    2020-06-23
    Application Number
    29012
    R0-CEP 2021-173 - Rev 00
    Indian CDSCO WC-0225A7
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-08-15
    Filing Details
    TICAGRELOR
    Ticagrelor
    Ticagrelor IH
    Issue/Submission Date
    2015-02-13
    2023-04-19
    2020-06-23
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    • FDA
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    Celecoxib

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    37290
    Active
    CELECOXIB USP (PROCESS-II)
    2022-07-04
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-345 - Rev 00
    Valid
    Celecoxib, Process-V
    2022-10-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37290
    R0-CEP 2022-345 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CELECOXIB USP (PROCESS-II)
    Celecoxib, Process-V
    Issue/Submission Date
    2022-07-04
    2022-10-21
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    • FDA
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    Dorzolamide Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2020-308 - Rev 01
    Valid
    Dorzolamide hydrochloride, Process-...
    2022-02-23
    Japanese DMF

    Found JDMF

    229MF10037
    Dorzolamide Hydrochloride at 27, RA...
    2017-02-08
    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2020-308 - Rev 01
    229MF10037
    Status
    Valid
     
    Filing Details
    Dorzolamide hydrochloride, Process-...
    Dorzolamide Hydrochloride at 27, RA...
    Issue/Submission Date
    2022-02-23
    2017-02-08
    ASK
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    Losartan Potassium

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    USDMF

    Found USDMF

    24688
    Active
    LOSARTAN POTASSIUM USP
    2010-11-26
    CEP/COS

    Caution CEP/COS

    R1-CEP 2010-381 - Rev 03
    Withdrawn by Holder
    Losartan potassium
    2020-01-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225
    Expired
    Losartan Potassium (Ph. Eur/USP)
    2019-08-16
    Application Number
    24688
    R1-CEP 2010-381 - Rev 03
    Indian CDSCO WC-0225
    Status
    Active
    Fees Paid
    Reviewed
    Withdrawn by Holder
     
    Expired
    2022-08-15
    Filing Details
    LOSARTAN POTASSIUM USP
    Losartan potassium
    Losartan Potassium (Ph. Eur/USP)
    Issue/Submission Date
    2010-11-26
    2020-01-29
    2019-08-16
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    Meloxicam

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    25785
    Inactive
    MELOXICAM USP
    2012-01-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-077 - Rev 01
    Valid
    Meloxicam
    2019-10-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225
    Expired
    Meloxicam (Ph. Eur/USP/BP)
    2019-08-16
    Application Number
    25785
    R1-CEP 2012-077 - Rev 01
    Indian CDSCO WC-0225
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-08-15
    Filing Details
    MELOXICAM USP
    Meloxicam
    Meloxicam (Ph. Eur/USP/BP)
    Issue/Submission Date
    2012-01-30
    2019-10-28
    2019-08-16
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    Timolol Maleate

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    USDMF

    Found USDMF

    37228
    Active
    TIMOLOL MALEATE USP
    2022-06-29
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-322 - Rev 00
    Valid
    Timolol maleate
    2023-06-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37228
    R0-CEP 2022-322 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TIMOLOL MALEATE USP
    Timolol maleate
    Issue/Submission Date
    2022-06-29
    2023-06-28
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    Torsemide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    35901
    Active
    TORSEMIDE USP
    2021-05-06
    CEP/COS

    Found CEP/COS

    R0-CEP 2023-057 - Rev 00
    Valid
    Torasemide, Process II
    2023-04-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35901
    R0-CEP 2023-057 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TORSEMIDE USP
    Torasemide, Process II
    Issue/Submission Date
    2021-05-06
    2023-04-28
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    Torsemide

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    24687
    Inactive
    TORSEMIDE USP
    2010-11-26
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-167 - Rev 00
    Valid
    Torasemide
    2022-10-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225A3
    Expired
    Torsemide USP, TORASEMIDE EP
    2020-01-16
    Application Number
    24687
    R0-CEP 2021-167 - Rev 00
    Indian CDSCO WC-0225A3
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-08-15
    Filing Details
    TORSEMIDE USP
    Torasemide
    Torsemide USP, TORASEMIDE EP
    Issue/Submission Date
    2010-11-26
    2022-10-10
    2020-01-16
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    Apixaban

    PDF Supplier PDF
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    USDMF

    Found USDMF

    30619
    Active
    APIXABAN
    2016-08-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225A6
    Expired
    Apixaban IH
    2020-02-10
    Application Number
    30619
    Indian CDSCO WC-0225A6
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-08-15
    Filing Details
    APIXABAN
    Apixaban IH
    Issue/Submission Date
    2016-08-12
    2020-02-10
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    Brivaracetam

    PDF Supplier PDF
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    USDMF

    Found USDMF

    34585
    Active
    BRIVARACETAM
    2020-02-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225A10
    Expired
    Brivaracetam IH
    2021-07-20
    Application Number
    34585
    Indian CDSCO WC-0225A10
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-08-15
    Filing Details
    BRIVARACETAM
    Brivaracetam IH
    Issue/Submission Date
    2020-02-18
    2021-07-20
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    • FDA
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    Bromfenac Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    27800
    Active
    BROENAC SODIUM SESQUIHYDRATE
    2013-12-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225
    Expired
    Bromfenac Sodium Sesquihydrate IH
    2019-08-16
    Application Number
    27800
    Indian CDSCO WC-0225
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-08-15
    Filing Details
    BROENAC SODIUM SESQUIHYDRATE
    Bromfenac Sodium Sesquihydrate IH
    Issue/Submission Date
    2013-12-23
    2019-08-16
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    Cyclizine

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2010-355 - Rev 03
    Valid
    Cyclizine Hydrochloride
    2019-10-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225
    Expired
    Cyclizine Hydrochloride (Ph. Eur)
    2019-08-16
    Application Number
    R1-CEP 2010-355 - Rev 03
    Indian CDSCO WC-0225
    Status
    Valid
     
    Expired
    2022-08-15
    Filing Details
    Cyclizine Hydrochloride
    Cyclizine Hydrochloride (Ph. Eur)
    Issue/Submission Date
    2019-10-28
    2019-08-16
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    Dabigatran Etexilate Mesylate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29668
    Active
    DABIGATRAN ETEXILATE MESYLATE
    2015-09-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225
    Expired
    Dabigatran Etexilate Mesylate IH
    2019-08-16
    Application Number
    29668
    Indian CDSCO WC-0225
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-08-15
    Filing Details
    DABIGATRAN ETEXILATE MESYLATE
    Dabigatran Etexilate Mesylate IH
    Issue/Submission Date
    2015-09-29
    2019-08-16
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    • FDA
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    Dapagliflozin

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    32139
    Active
    DAPAGLIFLOZIN
    2017-11-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225A6
    Expired
    Dapagliflozin IH
    2020-02-10
    Application Number
    32139
    Indian CDSCO WC-0225A6
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-08-15
    Filing Details
    DAPAGLIFLOZIN
    Dapagliflozin IH
    Issue/Submission Date
    2017-11-06
    2020-02-10
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    Darunavir Ethanolate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29157
    Active
    DARUNAVIR ETHANOLATE
    2015-09-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225A7
    Expired
    Darunavir Ethanolate IH
    2020-06-23
    Application Number
    29157
    Indian CDSCO WC-0225A7
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-08-15
    Filing Details
    DARUNAVIR ETHANOLATE
    Darunavir Ethanolate IH
    Issue/Submission Date
    2015-09-17
    2020-06-23
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    Dimethyl Fumarate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    30863
    Active
    DIMETHYL FUMARATE
    2016-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225A6
    Expired
    Dimethyl Fumarate IH
    2020-02-10
    Application Number
    30863
    Indian CDSCO WC-0225A6
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-08-15
    Filing Details
    DIMETHYL FUMARATE
    Dimethyl Fumarate IH
    Issue/Submission Date
    2016-09-30
    2020-02-10
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    • FDA
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    Ebastine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2009-106 - Rev 03
    Valid
    Ebastine
    2023-07-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225
    Expired
    Ebastine (Ph. Eur)
    2019-08-16
    Application Number
    R1-CEP 2009-106 - Rev 03
    Indian CDSCO WC-0225
    Status
    Valid
     
    Expired
    2022-08-15
    Filing Details
    Ebastine
    Ebastine (Ph. Eur)
    Issue/Submission Date
    2023-07-13
    2019-08-16
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    • FDA
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    Escitalopram Oxalate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    34568
    Active
    ESCITALOPRAM OXALATE USP
    2020-11-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225A6
    Expired
    Escitalopram Oxalate EP
    2020-02-10
    Application Number
    34568
    Indian CDSCO WC-0225A6
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-08-15
    Filing Details
    ESCITALOPRAM OXALATE USP
    Escitalopram Oxalate EP
    Issue/Submission Date
    2020-11-30
    2020-02-10
    ASK
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    • FDA
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    Ezetimibe

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    37728
    Active
    EZETIMIBE USP
    2022-12-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225A7
    Expired
    Ezetimibe IH
    2020-06-23
    Application Number
    37728
    Indian CDSCO WC-0225A7
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-08-15
    Filing Details
    EZETIMIBE USP
    Ezetimibe IH
    Issue/Submission Date
    2022-12-29
    2020-06-23
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    • FDA
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    Isoproterenol Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    29732
    Active
    ISOPROTERENOL HYDROCHLORIDE USP
    2015-09-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225A7
    Expired
    Isoprenaline Hydrochloride EP
    2020-06-23
    Application Number
    29732
    Indian CDSCO WC-0225A7
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-08-15
    Filing Details
    ISOPROTERENOL HYDROCHLORIDE USP
    Isoprenaline Hydrochloride EP
    Issue/Submission Date
    2015-09-28
    2020-06-23
    ASK
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    • FDA
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    Mirabegron

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

    See Less

    USDMF

    Found USDMF

    29734
    Active
    MIRABEGRON
    2015-09-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225A6
    Expired
    Mirabegron IH
    2020-02-10
    Application Number
    29734
    Indian CDSCO WC-0225A6
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-08-15
    Filing Details
    MIRABEGRON
    Mirabegron IH
    Issue/Submission Date
    2015-09-28
    2020-02-10
    ASK
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    • FDA
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    Rasagiline Mesylate

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

    See Less

    USDMF

    Found USDMF

    27448
    Active
    RASAGILINE MESYLATE
    2013-09-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225
    Expired
    Rasagiline mesilate IH
    2019-08-16
    Application Number
    27448
    Indian CDSCO WC-0225
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-08-15
    Filing Details
    RASAGILINE MESYLATE
    Rasagiline mesilate IH
    Issue/Submission Date
    2013-09-10
    2019-08-16
    ASK
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    • FDA
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    Sodium Nitroprusside

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    29156
    Active
    SODIUM NITROPRUSSIDE USP
    2015-07-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225
    Expired
    Sodium Nitroprusside USP
    2019-08-16
    Application Number
    29156
    Indian CDSCO WC-0225
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-08-15
    Filing Details
    SODIUM NITROPRUSSIDE USP
    Sodium Nitroprusside USP
    Issue/Submission Date
    2015-07-14
    2019-08-16
    ASK
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    • FDA
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    Tofacitinib Citrate

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

    See Less

    USDMF

    Found USDMF

    30621
    Active
    TOFACITINIB CITRATE
    2016-08-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0225A7
    Expired
    Tofacitinib Citrate IH
    2020-06-23
    Application Number
    30621
    Indian CDSCO WC-0225A7
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-08-15
    Filing Details
    TOFACITINIB CITRATE
    Tofacitinib Citrate IH
    Issue/Submission Date
    2016-08-03
    2020-06-23
    ASK
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    • FDA
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    Aminocaproic Acid

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

    See Less

    USDMF

    Found USDMF

    35069
    Active
    AMINOCAPROIC ACID USP
    2020-08-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35069
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    AMINOCAPROIC ACID USP
    Issue/Submission Date
    2020-08-19
    ASK
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    • FDA
    • EDQM
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    Anagrelide Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    37180
    Active
    ANAGRELIDE HYDROCHLORIDE USP
    2022-06-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37180
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ANAGRELIDE HYDROCHLORIDE USP
    Issue/Submission Date
    2022-06-01
    ASK
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    your Marketing & Sales content
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    • FDA
    • EDQM
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    Artemether

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    27933
    Active
    ARTEMETHER
    2014-02-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27933
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ARTEMETHER
    Issue/Submission Date
    2014-02-04
    ASK
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    your Marketing & Sales content
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    • FDA
    • EDQM
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    Besifloxacin Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    31989
    Active
    BESIFLOXACIN HYDROCHLORIDE
    2017-11-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31989
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BESIFLOXACIN HYDROCHLORIDE
    Issue/Submission Date
    2017-11-30
    ASK
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    • FDA
    • EDQM
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    Dolutegravir Sodium

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

    See Less

    USDMF

    Found USDMF

    31222
    Active
    DOLUTEGRAVIR SODIUM
    2017-01-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31222
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DOLUTEGRAVIR SODIUM
    Issue/Submission Date
    2017-01-03
    ASK
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    your Marketing & Sales content
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    • FDA
    • EDQM
    • WHO-GMP
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    Fampridine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    33146
    Active
    DALFAMPRIDINE USP
    2018-09-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33146
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DALFAMPRIDINE USP
    Issue/Submission Date
    2018-09-27
    ASK
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    • FDA
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    Glimepiride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    37221
    Active
    GLIMEPIRIDE USP
    2022-06-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37221
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    GLIMEPIRIDE USP
    Issue/Submission Date
    2022-06-30
    ASK
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    • FDA
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    Lifitegrast

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

    See Less

    USDMF

    Found USDMF

    34735
    Active
    LIFITEGRAST
    2020-04-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34735
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LIFITEGRAST
    Issue/Submission Date
    2020-04-29
    ASK
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    your Marketing & Sales content
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    • FDA
    • EDQM
    • WHO-GMP
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    Lumefantrine

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

    See Less

    USDMF

    Found USDMF

    28108
    Active
    LUMEFANTRINE USP
    2014-03-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28108
    Status
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    Fees Paid
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    LUMEFANTRINE USP
    Issue/Submission Date
    2014-03-24
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    32514
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    METHAZOLAMIDE USP
    2018-03-01
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    Application Number
    32514
    Status
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    Fees Paid
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    METHAZOLAMIDE USP
    Issue/Submission Date
    2018-03-01
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    31988
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    METHENAMINE HIPPURATE USP
    2017-10-06
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    Application Number
    31988
    Status
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    METHENAMINE HIPPURATE USP
    Issue/Submission Date
    2017-10-06
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    USDMF

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    29733
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    LEVOMILNACIPRAN HYDROCHLORIDE
    2015-09-29
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    Application Number
    29733
    Status
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    Fees Paid
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    Filing Details
    LEVOMILNACIPRAN HYDROCHLORIDE
    Issue/Submission Date
    2015-09-29
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    36043
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    NETARSUDIL DIMESYLATE
    2021-07-27
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    Application Number
    36043
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    NETARSUDIL DIMESYLATE
    Issue/Submission Date
    2021-07-27
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    32726
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    TENOFOVIR ALAFENAMIDE HEMIFUMARATE
    2018-06-21
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    Application Number
    32726
    Status
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    TENOFOVIR ALAFENAMIDE HEMIFUMARATE
    Issue/Submission Date
    2018-06-21
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