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    Sete Casas 2674 – 506 Loures, Portugal
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    +351 219 829 000
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    • FDA
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    Fluticasone Propionate

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    USDMF

    Found USDMF

    16334
    Active
    FLUTICASONE PROPIONATE
    2002-12-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-160 - Rev 02
    Valid
    Fluticasone propionate
    2019-02-27
    Japanese DMF

    Found JDMF

    223MF10176
    Fluticasone propionate at Sete Casa...
    2011-12-27
    Written Confirmation

    Close WC

    Application Number
    16334
    R1-CEP 2005-160 - Rev 02
    223MF10176
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    FLUTICASONE PROPIONATE
    Fluticasone propionate
    Fluticasone propionate at Sete Casa...
    Issue/Submission Date
    2002-12-20
    2019-02-27
    2011-12-27
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    Ivermectin

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    USDMF

    Found USDMF

    21395
    Active
    IVERMECTIN USP
    2008-03-05
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-138 - Rev 05
    Valid
    Ivermectin
    2020-02-28
    Japanese DMF

    Found JDMF

    304MF10006
    Ivermectin at Estrada Coronel Nicol...
    2022-01-11
    Written Confirmation

    Close WC

    Application Number
    21395
    R1-CEP 1998-138 - Rev 05
    304MF10006
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    IVERMECTIN USP
    Ivermectin
    Ivermectin at Estrada Coronel Nicol...
    Issue/Submission Date
    2008-03-05
    2020-02-28
    2022-01-11
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    • FDA
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    Minocycline Hydrochloride

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    USDMF

    Found USDMF

    13738
    Active
    MINOCYCLINE HYDROCHLORIDE
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 1997-078 - Rev 08
    Valid
    Minocycline hydrochloride dihydrate...
    2022-09-13
    Japanese DMF

    Found JDMF

    219MF10124
    Minocycline hydrochloride at Sete C...
    2007-04-18
    Written Confirmation

    Close WC

    Application Number
    13738
    R1-CEP 1997-078 - Rev 08
    219MF10124
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MINOCYCLINE HYDROCHLORIDE
    Minocycline hydrochloride dihydrate...
    Minocycline hydrochloride at Sete C...
    Issue/Submission Date
    1998-09-01
    2022-09-13
    2007-04-18
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    • FDA
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    Doxycycline Hyclate

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    USDMF

    Caution USDMF

    13636
    Inactive
    DOXYCYCLINE HYCLATE
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 1996-066 - Rev 06
    Valid
    Doxycycline hyclate
    2020-10-05
    Japanese DMF

    Found JDMF

    224MF10204
    Doxycycline hyclate at Estrada Coro...
    2012-10-09
    Written Confirmation

    Close WC

    Application Number
    13636
    R1-CEP 1996-066 - Rev 06
    224MF10204
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    DOXYCYCLINE HYCLATE
    Doxycycline hyclate
    Doxycycline hyclate at Estrada Coro...
    Issue/Submission Date
    1998-09-01
    2020-10-05
    2012-10-09
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    • FDA
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    Betamethasone Sodium Phosphate

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    USDMF

    Found USDMF

    6687
    Active
    BETAMETHASONE SODIUM PHOSPHATE
    1986-11-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    220MF10125
    Betamethasone ester sodium at Sete ...
    2008-05-15
    Written Confirmation

    Close WC

    Application Number
    6687
    220MF10125
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BETAMETHASONE SODIUM PHOSPHATE
    Betamethasone ester sodium at Sete ...
    Issue/Submission Date
    1986-11-18
    2008-05-15
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    • FDA
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    Doxycycline

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    USDMF

    Found USDMF

    13710
    Active
    DOXYCYCLINE MONOHYDRATE
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 1997-115 - Rev 07
    Valid
    Doxycycline monohydrate
    2021-09-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13710
    R1-CEP 1997-115 - Rev 07
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DOXYCYCLINE MONOHYDRATE
    Doxycycline monohydrate
    Issue/Submission Date
    1998-09-01
    2021-09-10
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    • FDA
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    Fluticasone Propionate

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    USDMF

    Found USDMF

    24791
    Active
    FLUTICASONE PROPIONATE INHALATION G...
    2011-03-25
    CEP/COS

    Found CEP/COS

    CEP 2011-103 - Rev 05
    Valid
    Fluticasone propionate, Process I
    2024-03-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24791
    CEP 2011-103 - Rev 05
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    FLUTICASONE PROPIONATE INHALATION G...
    Fluticasone propionate, Process I
    Issue/Submission Date
    2011-03-25
    2024-03-07
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    Minocycline Hydrochloride

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    USDMF

    Found USDMF

    29003
    Active
    MINOCYCLINE HYDROCHLORIDE MICRONIZE...
    2015-01-08
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-299 - Rev 00
    Valid
    Minocycline hydrochloride dihydrate...
    2022-10-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29003
    R0-CEP 2022-299 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MINOCYCLINE HYDROCHLORIDE MICRONIZE...
    Minocycline hydrochloride dihydrate...
    Issue/Submission Date
    2015-01-08
    2022-10-11
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    • FDA
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    Mometasone Furoate

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    USDMF

    Found USDMF

    14991
    Active
    MOMETASONE 17-FUROATE
    2000-05-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-111 - Rev 02
    Valid
    Mometasone furoate
    2021-10-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14991
    R1-CEP 2004-111 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MOMETASONE 17-FUROATE
    Mometasone furoate
    Issue/Submission Date
    2000-05-26
    2021-10-29
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    Mometasone Furoate

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    USDMF

    Found USDMF

    25987
    Active
    MOMETASONE FUROATE MONOHYDRATE INHA...
    2012-04-23
    CEP/COS

    Found CEP/COS

    CEP 2018-121 - Rev 03
    Valid
    Mometasone furoate monohydrate, Pro...
    2023-10-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25987
    CEP 2018-121 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MOMETASONE FUROATE MONOHYDRATE INHA...
    Mometasone furoate monohydrate, Pro...
    Issue/Submission Date
    2012-04-23
    2023-10-23
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    • FDA
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    Salmeterol Xinafoate

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    USDMF

    Found USDMF

    31795
    Active
    SALMETEROL XINAFOATE INHALATION GRA...
    2017-06-22
    CEP/COS

    Found CEP/COS

    CEP 2018-057 - Rev 03
    Valid
    Salmeterol xinafoate, Process II
    2024-03-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31795
    CEP 2018-057 - Rev 03
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    SALMETEROL XINAFOATE INHALATION GRA...
    Salmeterol xinafoate, Process II
    Issue/Submission Date
    2017-06-22
    2024-03-20
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    Salmeterol Xinafoate

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    USDMF

    Found USDMF

    32785
    Active
    SALMETEROL XINAFOATE MICRONIZED
    2018-05-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2017-055 - Rev 01
    Valid
    Salmeterol xinafoate, Process I
    2023-03-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32785
    R1-CEP 2017-055 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    SALMETEROL XINAFOATE MICRONIZED
    Salmeterol xinafoate, Process I
    Issue/Submission Date
    2018-05-30
    2023-03-01
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    • FDA
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    Avacopan

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    303MF10022
    Abakopan drug substance at 40 Lake ...
    2021-01-28
    Written Confirmation

    Close WC

    Application Number
    303MF10022
    Status
     
    Filing Details
    Abakopan drug substance at 40 Lake ...
    Issue/Submission Date
    2021-01-28
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    • FDA
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    Betamethasone Acetate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    6713
    Active
    BETAMETHASONE 21-ACETATE
    1986-11-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6713
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BETAMETHASONE 21-ACETATE
    Issue/Submission Date
    1986-11-28
    ASK
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    • FDA
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    Doxycycline

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    23638
    Active
    DOXYCYCLINE MONOHYDRATE MICRONIZED
    2010-03-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23638
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DOXYCYCLINE MONOHYDRATE MICRONIZED
    Issue/Submission Date
    2010-03-18
    ASK
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    • FDA
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    Doxycycline Hyclate

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    13714
    Active
    DOXYCYCLINE HYCLATE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13714
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DOXYCYCLINE HYCLATE
    Issue/Submission Date
    1998-09-01
    ASK
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    • FDA
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    Fluticasone Furoate

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    31713
    Active
    FLUTICASONE FUROATE INHALATION GRAD...
    2017-05-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31713
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FLUTICASONE FUROATE INHALATION GRAD...
    Issue/Submission Date
    2017-05-31
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    • FDA
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    Glycopyrronium Bromide

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    USDMF

    Found USDMF

    31206
    Active
    GLYCOPYRROLATE INHALATION GRADE
    2016-11-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31206
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    GLYCOPYRROLATE INHALATION GRADE
    Issue/Submission Date
    2016-11-29
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    • FDA
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    Halobetasol

    PDF Supplier PDF
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    USDMF

    Found USDMF

    16953
    Active
    HALOBETASOL PROPIONATE
    2003-11-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16953
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    HALOBETASOL PROPIONATE
    Issue/Submission Date
    2003-11-13
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    • FDA
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    Iohexol

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    23148
    Inactive
    IOHEXOL
    2009-10-02
    CEP/COS

    Caution CEP/COS

    R1-CEP 1999-044 - Rev 02
    Withdrawn by Holder
    Iohexol
    2013-01-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23148
    R1-CEP 1999-044 - Rev 02
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    IOHEXOL
    Iohexol
    Issue/Submission Date
    2009-10-02
    2013-01-17
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    • FDA
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    Iopamidol

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    11245
    Inactive
    IOPAMIDOL
    1994-12-13
    CEP/COS

    Caution CEP/COS

    R1-CEP 1997-107 - Rev 03
    Withdrawn by Holder
    Iopamidol, free from bacterial endo...
    2008-02-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11245
    R1-CEP 1997-107 - Rev 03
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    IOPAMIDOL
    Iopamidol, free from bacterial endo...
    Issue/Submission Date
    1994-12-13
    2008-02-08
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    • FDA
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    Ivermectin

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    221MF10281
    Ivermectin at Estrada Coronel Nicol...
    2009-12-18
    Written Confirmation

    Close WC

    Application Number
    221MF10281
    Status
     
    Filing Details
    Ivermectin at Estrada Coronel Nicol...
    Issue/Submission Date
    2009-12-18
    ASK
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    • FDA
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    Minocycline Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    34217
    Active
    MINOCYCLINE
    2019-11-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34217
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MINOCYCLINE
    Issue/Submission Date
    2019-11-14
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    Roxithromycin

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 1999-045 - Rev 02
    Valid
    Roxithromycin
    2008-09-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1999-045 - Rev 02
    Status
    Valid
     
    Filing Details
    Roxithromycin
    Issue/Submission Date
    2008-09-26
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    05ST03P

    PDF Supplier PDF
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    USDMF

    Found USDMF

    21775
    Active
    05ST03P
    2008-07-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21775
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    05ST03P
    Issue/Submission Date
    2008-07-08
    ASK
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    • FDA
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    KB01

    PDF Supplier PDF
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    USDMF

    Found USDMF

    22670
    Active
    KB01
    2009-03-27
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    22670
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    KB01
    Issue/Submission Date
    2009-03-27
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    Aclidinium Bromide

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    USDMF

    Caution USDMF

    34231
    Inactive
    ACLIDINIUM BROMIDE MICRONIZED
    2019-12-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    34231
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ACLIDINIUM BROMIDE MICRONIZED
    Issue/Submission Date
    2019-12-20
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    Beclomethasone Dipropionate

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    USDMF

    Caution USDMF

    6254
    Inactive
    BECLOMETHASONE 17,21-DIPROPIONATE
    1986-04-01
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    6254
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    BECLOMETHASONE 17,21-DIPROPIONATE
    Issue/Submission Date
    1986-04-01
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    Beclomethasone Dipropionate

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    USDMF

    Caution USDMF

    9782
    Inactive
    BECLOMETHASONE 17,21-DIPROPIONATE M...
    1992-07-15
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    9782
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    BECLOMETHASONE 17,21-DIPROPIONATE M...
    Issue/Submission Date
    1992-07-15
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    Beclomethasone Dipropionate

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    USDMF

    Caution USDMF

    27196
    Inactive
    BECLOMETHASONE DIPROPIONATE MONOHYD...
    2013-05-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    27196
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    BECLOMETHASONE DIPROPIONATE MONOHYD...
    Issue/Submission Date
    2013-05-30
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    Betamethasone Dipropionate

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    USDMF

    Caution USDMF

    5274
    Inactive
    BETAMETHASONE 17,21-DIPROPIONATE
    1984-03-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    5274
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    BETAMETHASONE 17,21-DIPROPIONATE
    Issue/Submission Date
    1984-03-01
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    Betamethasone Valerate

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    USDMF

    Caution USDMF

    4397
    Inactive
    BETAMETHASONE 17-VALERATE
    1981-12-22
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    4397
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    BETAMETHASONE 17-VALERATE
    Issue/Submission Date
    1981-12-22
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    Clobetasol Propionate

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    USDMF

    Caution USDMF

    9781
    Inactive
    CLOBETASOL 17-PROPIONATE
    1992-07-14
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    9781
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CLOBETASOL 17-PROPIONATE
    Issue/Submission Date
    1992-07-14
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    Danazol

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    USDMF

    Caution USDMF

    6287
    Inactive
    DANAZOL
    1986-03-17
    CEP/COS

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    Japanese DMF

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    Application Number
    6287
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    DANAZOL
    Issue/Submission Date
    1986-03-17
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    Flumethasone

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    USDMF

    Caution USDMF

    19981
    Inactive
    FLUMETHASONE
    2006-11-17
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    19981
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    FLUMETHASONE
    Issue/Submission Date
    2006-11-17
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    Methacycline Hydrochloride

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    USDMF

    Caution USDMF

    13649
    Inactive
    METHACYCLINE HYDROCHLORIDE
    1998-09-01
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    13649
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    METHACYCLINE HYDROCHLORIDE
    Issue/Submission Date
    1998-09-01
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    Simvastatin

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    USDMF

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    CEP/COS

    Caution CEP/COS

    R0-CEP 2003-240 - Rev 00
    Withdrawn by Holder
    Simvastatin
    2005-04-28
    Japanese DMF

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    Application Number
    R0-CEP 2003-240 - Rev 00
    Status
    Withdrawn by Holder
     
    Filing Details
    Simvastatin
    Issue/Submission Date
    2005-04-28
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    Sumatriptan

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    USDMF

    Caution USDMF

    24642
    Inactive
    SUMATRIPTAN USP
    2011-02-15
    CEP/COS

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    Written Confirmation

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    Application Number
    24642
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    SUMATRIPTAN USP
    Issue/Submission Date
    2011-02-15
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    Tamsulosin

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    USDMF

    Caution USDMF

    21803
    Inactive
    TAMSULOSIN HYDROCHLORIDE
    2008-07-17
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    21803
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    TAMSULOSIN HYDROCHLORIDE
    Issue/Submission Date
    2008-07-17
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    T-3811A15 (17TY01)

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    USDMF

    Caution USDMF

    16375
    Inactive
    T-3811A15 (17TY01)
    2003-01-21
    CEP/COS

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    Application Number
    16375
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    T-3811A15 (17TY01)
    Issue/Submission Date
    2003-01-21
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    17ST75030

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    USDMF

    Caution USDMF

    17328
    Inactive
    17ST75030
    2004-04-23
    CEP/COS

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    Application Number
    17328
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    17ST75030
    Issue/Submission Date
    2004-04-23
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    Hydrocortisone Aceponate

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    USDMF

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    CEP/COS

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    Application Number
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    Filing Details
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    Lefamulin Acetate

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    USDMF

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    CEP/COS

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    Japanese DMF

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    Pentetic Acid

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    USDMF

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    CEP/COS

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    Application Number
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    Umeclidinium Bromide

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    USDMF

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    CEP/COS

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    Vilanterol Trifenatate

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    USDMF

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    CEP/COS

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