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    UQUIFA
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    C/ Mallorca 262, 3rd floor, Barcelona 08008
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    +34 934 674 810
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    Ciprofloxacin

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    USDMF

    Found USDMF

    17279
    Active
    CIPROFLOXACIN
    2004-03-31
    CEP/COS

    Found CEP/COS

    CEP 2004-173 - Rev 01
    Valid
    Ciprofloxacin
    2024-02-15
    Japanese DMF

    Found JDMF

    219MF10080
    Ciprofloxacin at Calle 37 Este No. ...
    2007-03-14
    Written Confirmation

    Close WC

    Application Number
    17279
    CEP 2004-173 - Rev 01
    219MF10080
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CIPROFLOXACIN
    Ciprofloxacin
    Ciprofloxacin at Calle 37 Este No. ...
    Issue/Submission Date
    2004-03-31
    2024-02-15
    2007-03-14
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    Clindamycin Phosphate

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    USDMF

    Found USDMF

    14412
    Active
    CLINDAMYCIN PHOSPHATE USP
    1999-09-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-097 - Rev 05
    Valid
    Clindamycin phosphate
    2023-06-09
    Japanese DMF

    Found JDMF

    226MF10069
    Clindamycin phosphate ester hydrate...
    2014-03-11
    Written Confirmation

    Close WC

    Application Number
    14412
    R1-CEP 2000-097 - Rev 05
    226MF10069
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CLINDAMYCIN PHOSPHATE USP
    Clindamycin phosphate
    Clindamycin phosphate ester hydrate...
    Issue/Submission Date
    1999-09-23
    2023-06-09
    2014-03-11
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    Ketoconazole

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    USDMF

    Found USDMF

    16212
    Active
    KETOCONAZOLE
    2002-10-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-138 - Rev 04
    Valid
    Ketoconazole
    2021-04-21
    Japanese DMF

    Found JDMF

    218MF10434
    Ketoconazole at Calle 37 Este No. 1...
    2006-04-27
    Written Confirmation

    Close WC

    Application Number
    16212
    R1-CEP 2005-138 - Rev 04
    218MF10434
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    KETOCONAZOLE
    Ketoconazole
    Ketoconazole at Calle 37 Este No. 1...
    Issue/Submission Date
    2002-10-17
    2021-04-21
    2006-04-27
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    Lansoprazole

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    USDMF

    Found USDMF

    17787
    Active
    LANSOPRAZOLE
    2004-10-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-001 - Rev 00
    Valid
    Lansoprazole
    2019-04-24
    Japanese DMF

    Found JDMF

    220MF10103
    Lansoprazole at Mallorca, 262, 3rd ...
    2008-04-11
    Written Confirmation

    Close WC

    Application Number
    17787
    R1-CEP 2011-001 - Rev 00
    220MF10103
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    LANSOPRAZOLE
    Lansoprazole
    Lansoprazole at Mallorca, 262, 3rd ...
    Issue/Submission Date
    2004-10-28
    2019-04-24
    2008-04-11
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    • FDA
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    Metformin

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    USDMF

    Found USDMF

    16047
    Active
    METFORMIN HYDROCHLORIDE
    2002-07-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-063 - Rev 03
    Valid
    Metformin Hydrochloride
    2020-10-29
    Japanese DMF

    Found JDMF

    218MF10349
    Metformin hydrochloride at Calle 37...
    2006-03-17
    Written Confirmation

    Close WC

    Application Number
    16047
    R1-CEP 2003-063 - Rev 03
    218MF10349
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    METFORMIN HYDROCHLORIDE
    Metformin Hydrochloride
    Metformin hydrochloride at Calle 37...
    Issue/Submission Date
    2002-07-11
    2020-10-29
    2006-03-17
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    Omeprazole

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    USDMF

    Caution USDMF

    11551
    Inactive
    OMEPRAZOLE
    1995-06-09
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-120 - Rev 00
    Valid
    Omeprazole, Site II - Micronised an...
    2022-09-26
    Japanese DMF

    Found JDMF

    219MF10283
    Omeprazole (production only) at Tor...
    2007-09-10
    Written Confirmation

    Close WC

    Application Number
    11551
    R0-CEP 2022-120 - Rev 00
    219MF10283
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    OMEPRAZOLE
    Omeprazole, Site II - Micronised an...
    Omeprazole (production only) at Tor...
    Issue/Submission Date
    1995-06-09
    2022-09-26
    2007-09-10
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    • FDA
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    Aciclovir

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    USDMF

    Found USDMF

    11896
    Active
    ACYCLOVIR
    1996-03-18
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-148 - Rev 05
    Valid
    Aciclovir
    2016-12-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11896
    R1-CEP 1998-148 - Rev 05
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ACYCLOVIR
    Aciclovir
    Issue/Submission Date
    1996-03-18
    2016-12-08
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    Allopurinol

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    USDMF

    Found USDMF

    16472
    Active
    ALLOPURINOL
    2003-03-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-004 - Rev 02
    Valid
    Allopurinol
    2017-12-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16472
    R1-CEP 2003-004 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ALLOPURINOL
    Allopurinol
    Issue/Submission Date
    2003-03-19
    2017-12-15
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    Cimetidine

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    USDMF

    Found USDMF

    10982
    Active
    CIMETIDINE USP
    1994-07-11
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-023 - Rev 06
    Valid
    Cimetidine
    2019-09-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10982
    R1-CEP 1998-023 - Rev 06
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CIMETIDINE USP
    Cimetidine
    Issue/Submission Date
    1994-07-11
    2019-09-03
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    Doxylamine Succinate

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    USDMF

    Found USDMF

    5399
    Active
    DOXYLAMINE SUCCINATE USP
    1984-05-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-089 - Rev 06
    Valid
    Doxylamine hydrogen succinate
    2020-10-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5399
    R1-CEP 2004-089 - Rev 06
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DOXYLAMINE SUCCINATE USP
    Doxylamine hydrogen succinate
    Issue/Submission Date
    1984-05-22
    2020-10-21
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    Famotidine

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    USDMF

    Found USDMF

    19911
    Active
    FAMOTIDINE USP
    2006-10-30
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-182 - Rev 00
    Valid
    Famotidine
    2023-06-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19911
    R0-CEP 2021-182 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    FAMOTIDINE USP
    Famotidine
    Issue/Submission Date
    2006-10-30
    2023-06-08
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    Nimodipine

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    USDMF

    Found USDMF

    16951
    Active
    NIMODIPINE (MICRONIZED)
    2003-11-03
    CEP/COS

    Found CEP/COS

    CEP 2004-272 - Rev 03
    Valid
    Nimodipine
    2023-10-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16951
    CEP 2004-272 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    NIMODIPINE (MICRONIZED)
    Nimodipine
    Issue/Submission Date
    2003-11-03
    2023-10-04
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    Pantoprazole Sodium

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    USDMF

    Found USDMF

    18480
    Active
    PANTOPRAZOLE SODIUM
    2005-07-06
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-058 - Rev 03
    Valid
    Pantoprazole sodium sesquihydrate
    2020-01-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18480
    R1-CEP 2011-058 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    PANTOPRAZOLE SODIUM
    Pantoprazole sodium sesquihydrate
    Issue/Submission Date
    2005-07-06
    2020-01-09
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    • FDA
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    Quetiapine Hemifumarate

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    USDMF

    Found USDMF

    31074
    Active
    QUETIAPINE FUMARATE
    2016-11-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-110 - Rev 00
    Valid
    Quetiapine Fumarate
    2021-06-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31074
    R1-CEP 2014-110 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    QUETIAPINE FUMARATE
    Quetiapine Fumarate
    Issue/Submission Date
    2016-11-28
    2021-06-22
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    Sitagliptin Phosphate

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    USDMF

    Found USDMF

    37448
    Active
    SITAGLIPTIN PHOSPHATE
    2023-02-21
    CEP/COS

    Found CEP/COS

    R0-CEP 2017-252 - Rev 00
    Valid
    Sitagliptin phosphate monohydrate
    2021-01-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37448
    R0-CEP 2017-252 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SITAGLIPTIN PHOSPHATE
    Sitagliptin phosphate monohydrate
    Issue/Submission Date
    2023-02-21
    2021-01-28
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    Solifenacin Succinate

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    USDMF

    Found USDMF

    29581
    Active
    SOLIFENACIN SUCCINATE
    2015-07-22
    CEP/COS

    Found CEP/COS

    R0-CEP 2017-094 - Rev 00
    Valid
    Solifenacin succinate
    2019-03-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29581
    R0-CEP 2017-094 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SOLIFENACIN SUCCINATE
    Solifenacin succinate
    Issue/Submission Date
    2015-07-22
    2019-03-12
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    Terbinafine Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    16187
    Active
    TERBINAFINE HYDROCHLORIDE
    2002-10-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10711
    Terbinafine HCl at Calle 37 Este No...
    2006-08-14
    Written Confirmation

    Close WC

    Application Number
    16187
    218MF10711
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TERBINAFINE HYDROCHLORIDE
    Terbinafine HCl at Calle 37 Este No...
    Issue/Submission Date
    2002-10-04
    2006-08-14
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    Tolterodine Tartrate

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    USDMF

    Found USDMF

    20096
    Active
    TOLTERODINE TARTRATE
    2006-12-28
    CEP/COS

    Found CEP/COS

    CEP 2021-381 - Rev 00
    Valid
    Tolterodine tartrate
    2023-10-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20096
    CEP 2021-381 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    TOLTERODINE TARTRATE
    Tolterodine tartrate
    Issue/Submission Date
    2006-12-28
    2023-10-13
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    Tropicamide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    17800
    Active
    TROPICAMIDE
    2004-10-15
    CEP/COS

    Found CEP/COS

    R0-CEP 2016-330 - Rev 01
    Valid
    Tropicamide
    2021-02-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17800
    R0-CEP 2016-330 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TROPICAMIDE
    Tropicamide
    Issue/Submission Date
    2004-10-15
    2021-02-09
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    Zolpidem Tartrate

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    USDMF

    Found USDMF

    15131
    Active
    ZOLPIDEM TARTRATE
    2000-11-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-144 - Rev 03
    Valid
    Zolpidem tartrate
    2020-06-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15131
    R1-CEP 2003-144 - Rev 03
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ZOLPIDEM TARTRATE
    Zolpidem tartrate
    Issue/Submission Date
    2000-11-08
    2020-06-17
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    Carisoprodol

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    USDMF

    Found USDMF

    17444
    Active
    CARISOPRODOL USP
    2004-06-03
    CEP/COS

    Caution CEP/COS

    R0-CEP 2004-128 - Rev 00
    Expired
    Carisoprodol - Monograph Text delet...
    2008-05-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17444
    R0-CEP 2004-128 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Expired
     
    Filing Details
    CARISOPRODOL USP
    Carisoprodol - Monograph Text delet...
    Issue/Submission Date
    2004-06-03
    2008-05-14
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    Esomeprazole Magnesium

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    USDMF

    Found USDMF

    30036
    Active
    ESOMEPRAZOLE MAGNESIUM DIHYDRATE
    2016-04-15
    CEP/COS

    Caution CEP/COS

    R0-CEP 2016-088 - Rev 00
    Withdrawn by Holder
    Esomeprazole magnesium dihydrate
    2018-02-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30036
    R0-CEP 2016-088 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Withdrawn by Holder
     
    Filing Details
    ESOMEPRAZOLE MAGNESIUM DIHYDRATE
    Esomeprazole magnesium dihydrate
    Issue/Submission Date
    2016-04-15
    2018-02-09
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    Esomeprazole Sodium

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    USDMF

    Caution USDMF

    30667
    Inactive
    ESOMEPRAZOLE SODIUM
    2016-07-20
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-192 - Rev 00
    Valid
    Esomeprazole sodium
    2022-08-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30667
    R0-CEP 2022-192 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ESOMEPRAZOLE SODIUM
    Esomeprazole sodium
    Issue/Submission Date
    2016-07-20
    2022-08-08
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    Lamotrigine

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    18439
    Inactive
    LAMOTRIGINE
    2005-06-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-382 - Rev 04
    Valid
    Lamotrigine
    2022-10-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18439
    R1-CEP 2010-382 - Rev 04
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    LAMOTRIGINE
    Lamotrigine
    Issue/Submission Date
    2005-06-20
    2022-10-28
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    Minocycline Hydrochloride

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    15171
    Inactive
    MINOCYCLINE HYDROCHLORIDE USP
    2000-12-01
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-152 - Rev 02
    Valid
    Minocycline hydrochloride dihydrate
    2009-12-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15171
    R1-CEP 1998-152 - Rev 02
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    MINOCYCLINE HYDROCHLORIDE USP
    Minocycline hydrochloride dihydrate
    Issue/Submission Date
    2000-12-01
    2009-12-11
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    Quetiapine Hemifumarate

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    20311
    Inactive
    QUETIAPINE FUMARATE
    2007-02-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-271 - Rev 00
    Valid
    Quetiapine Fumarate, Code 1378
    2022-03-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20311
    R1-CEP 2016-271 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    QUETIAPINE FUMARATE
    Quetiapine Fumarate, Code 1378
    Issue/Submission Date
    2007-02-23
    2022-03-02
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    Ranitidine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    8288
    Active
    RANITIDINE HCL
    1989-11-17
    CEP/COS

    Caution CEP/COS

    R1-CEP 1996-102 - Rev 04
    Withdrawn by Holder
    Ranitidine hydrochloride
    2016-06-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8288
    R1-CEP 1996-102 - Rev 04
    Status
    Active
    Fees Paid
    Reviewed
    Withdrawn by Holder
     
    Filing Details
    RANITIDINE HCL
    Ranitidine hydrochloride
    Issue/Submission Date
    1989-11-17
    2016-06-23
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    Albendazole

    PDF Supplier PDF
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    USDMF

    Found USDMF

    25914
    Active
    ALBENDAZOLE
    2012-03-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25914
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ALBENDAZOLE
    Issue/Submission Date
    2012-03-27
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    Bicalutamide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    21103
    Active
    Bicalutamide
    2007-11-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21103
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    Bicalutamide
    Issue/Submission Date
    2007-11-30
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    Cinacalcet Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29494
    Active
    CINACALCET HYDROCHLORIDE
    2015-06-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29494
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CINACALCET HYDROCHLORIDE
    Issue/Submission Date
    2015-06-24
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    Ciprofloxacin Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    14474
    Active
    CIPROFLAXIN HCL
    1999-10-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14474
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CIPROFLAXIN HCL
    Issue/Submission Date
    1999-10-19
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    Ciprofloxacin Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    17061
    Active
    CIPROFLOXACIN HYDROCHLORIDE, USP
    2003-12-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17061
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CIPROFLOXACIN HYDROCHLORIDE, USP
    Issue/Submission Date
    2003-12-08
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    Clindamycin Phosphate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Caution USDMF

    18533
    Inactive
    CLINDAMYCIN PHOSPHATE USP (AR)
    2005-07-22
    CEP/COS

    Caution CEP/COS

    R0-CEP 2003-177 - Rev 01
    Expired
    Clindamycin phosphate, Product code...
    2010-01-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18533
    R0-CEP 2003-177 - Rev 01
    Status
    Inactive
    Fees Paid
    N/A
    Expired
     
    Filing Details
    CLINDAMYCIN PHOSPHATE USP (AR)
    Clindamycin phosphate, Product code...
    Issue/Submission Date
    2005-07-22
    2010-01-14
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    Cyclopentolate Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    7272
    Active
    CYCLOPENTOLATE HYDROCHLORIDE
    1987-12-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    7272
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CYCLOPENTOLATE HYDROCHLORIDE
    Issue/Submission Date
    1987-12-31
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    Duloxetine

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-003 - Rev 00
    Valid
    Duloxetine hydrochloride, Process B
    2022-10-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2021-003 - Rev 00
    Status
    Valid
     
    Filing Details
    Duloxetine hydrochloride, Process B
    Issue/Submission Date
    2022-10-04
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    Ketorolac Trometamol

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Caution USDMF

    14209
    Inactive
    KETOROLAC TROMETHAMINE USP
    1999-06-17
    CEP/COS

    Caution CEP/COS

    R0-CEP 2015-190 - Rev 02
    Withdrawn by Holder
    Ketorolac trometamol
    2021-05-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14209
    R0-CEP 2015-190 - Rev 02
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    KETOROLAC TROMETHAMINE USP
    Ketorolac trometamol
    Issue/Submission Date
    1999-06-17
    2021-05-12
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    Levofloxacin

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    18159
    Active
    LEVOFLOXACIN HEMIHYDRATE
    2005-03-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18159
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LEVOFLOXACIN HEMIHYDRATE
    Issue/Submission Date
    2005-03-08
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    Mivacurium Chloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    28415
    Active
    MIVACURIUM CHLORIDE
    2014-06-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28415
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MIVACURIUM CHLORIDE
    Issue/Submission Date
    2014-06-19
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    Nitrendipine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2017-032 - Rev 00
    Valid
    Nitrendipine
    2023-03-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2017-032 - Rev 00
    Status
    Valid
     
    Filing Details
    Nitrendipine
    Issue/Submission Date
    2023-03-24
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    Omeprazole

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    17255
    Active
    OMEPRAZOLE
    2004-03-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17255
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    OMEPRAZOLE
    Issue/Submission Date
    2004-03-23
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    Omeprazole Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    221MF10170
    Omeprazole sodium (production only)...
    2009-07-30
    Written Confirmation

    Close WC

    Application Number
    221MF10170
    Status
     
    Filing Details
    Omeprazole sodium (production only)...
    Issue/Submission Date
    2009-07-30
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    Pyrantel Pamoate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    19815
    Active
    PYRANTEL PAMOATE USP
    2006-09-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19815
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PYRANTEL PAMOATE USP
    Issue/Submission Date
    2006-09-29
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    Pyrantel Pamoate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    23040
    Active
    PYRANTEL PAMOATE
    2009-08-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23040
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PYRANTEL PAMOATE
    Issue/Submission Date
    2009-08-14
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    Pyrantel Tartrate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    20114
    Active
    PYRANTEL TARTRATE ZEOLEX
    2007-01-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20114
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PYRANTEL TARTRATE ZEOLEX
    Issue/Submission Date
    2007-01-04
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    Pyrantel Tartrate

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    USDMF

    Found USDMF

    23080
    Active
    PYRANTEL TARTRATE ZEOLEX
    2009-08-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23080
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PYRANTEL TARTRATE ZEOLEX
    Issue/Submission Date
    2009-08-31
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    Ranolazine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    31940
    Active
    RANOLAZINE
    2017-08-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31940
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    RANOLAZINE
    Issue/Submission Date
    2017-08-01
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    Rivaroxaban

    PDF Supplier PDF
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    USDMF

    Found USDMF

    32827
    Active
    RIVAROXABAN
    2018-05-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32827
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    RIVAROXABAN
    Issue/Submission Date
    2018-05-24
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    Telmisartan

    PDF Supplier PDF
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    USDMF

    Found USDMF

    31706
    Active
    TELMISARTAN
    2017-05-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31706
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TELMISARTAN
    Issue/Submission Date
    2017-05-10
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    Ciprofloxacin Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Caution USDMF

    11602
    Inactive
    CIPROFLOXACIN HYDROCHLORIDE
    1996-02-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11602
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CIPROFLOXACIN HYDROCHLORIDE
    Issue/Submission Date
    1996-02-05
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    Ranitidine Hydrochloride

    PDF Supplier PDF
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    See Less

    USDMF

    Caution USDMF

    10273
    Inactive
    RANITIDINE HYDROCHLORIDE (CRYSTALLI...
    1993-05-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10273
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    RANITIDINE HYDROCHLORIDE (CRYSTALLI...
    Issue/Submission Date
    1993-05-27
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