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    +34 934 393 009
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    • FDA
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    Erythromycin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    13466
    Active
    ERYTHROMYCIN BASE
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-129 - Rev 02
    Valid
    Erythromycin, Micronised, powder
    2021-03-26
    Japanese DMF

    Found JDMF

    218MF10942
    erythromycin at Paseo del Deleite, ...
    2006-11-24
    Written Confirmation

    Close WC

    Application Number
    13466
    R1-CEP 2003-129 - Rev 02
    218MF10942
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ERYTHROMYCIN BASE
    Erythromycin, Micronised, powder
    erythromycin at Paseo del Deleite, ...
    Issue/Submission Date
    1998-09-01
    2021-03-26
    2006-11-24
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    Erythromycin Ethyl Succinate

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    USDMF

    Found USDMF

    13654
    Active
    ERYTHROMYCIN ETHYLSUCCINATE
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-136 - Rev 07
    Valid
    Erythromycin ethylsuccinate, Powder...
    2019-11-21
    Japanese DMF

    Found JDMF

    225MF10104
    Erythromycin ethyl succinate at Pas...
    2013-05-15
    Written Confirmation

    Close WC

    Application Number
    13654
    R1-CEP 2002-136 - Rev 07
    225MF10104
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ERYTHROMYCIN ETHYLSUCCINATE
    Erythromycin ethylsuccinate, Powder...
    Erythromycin ethyl succinate at Pas...
    Issue/Submission Date
    1998-09-01
    2019-11-21
    2013-05-15
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    • FDA
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    Clarithromycin

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2005-014 - Rev 04
    Valid
    Clarithromycin
    2021-03-01
    Japanese DMF

    Found JDMF

    220MF10030
    Clarithromycin at Paseo del Deleite...
    2008-01-23
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2005-014 - Rev 04
    220MF10030
    Status
    Valid
     
    Filing Details
    Clarithromycin
    Clarithromycin at Paseo del Deleite...
    Issue/Submission Date
    2021-03-01
    2008-01-23
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    • FDA
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    Famotidine

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    USDMF

    Found USDMF

    13086
    Active
    FAMOTIDINE
    1998-07-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    226MF10186
    Famotidine at Paseo del Deleite, s/...
    2014-09-30
    Written Confirmation

    Close WC

    Application Number
    13086
    226MF10186
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FAMOTIDINE
    Famotidine at Paseo del Deleite, s/...
    Issue/Submission Date
    1998-07-21
    2014-09-30
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    Fosfomycin

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    USDMF

    Found USDMF

    11582
    Active
    FOSFOMYCIN PHENYLAMMONIUM SALT
    1995-07-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10649
    [Japanese Pharmacopoeia] fosfomycin...
    2006-07-20
    Written Confirmation

    Close WC

    Application Number
    11582
    218MF10649
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FOSFOMYCIN PHENYLAMMONIUM SALT
    [Japanese Pharmacopoeia] fosfomycin...
    Issue/Submission Date
    1995-07-10
    2006-07-20
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    Fosfomycin Sodium

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    USDMF

    Found USDMF

    14341
    Active
    FOSFOMYCIN SODIUM
    1999-08-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    301MF10083
    Fosfomycin Sodium at Paseo del Dele...
    2019-10-25
    Written Confirmation

    Close WC

    Application Number
    14341
    301MF10083
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FOSFOMYCIN SODIUM
    Fosfomycin Sodium at Paseo del Dele...
    Issue/Submission Date
    1999-08-04
    2019-10-25
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    • FDA
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    Fusidic Acid

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    USDMF

    Found USDMF

    20479
    Active
    FUSIDIC ACID
    2007-04-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-121 - Rev 02
    Valid
    Fusidic acid, Powder, Micronised
    2021-11-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20479
    R1-CEP 2006-121 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    FUSIDIC ACID
    Fusidic acid, Powder, Micronised
    Issue/Submission Date
    2007-04-27
    2021-11-17
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    Sodium Fusidate

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    USDMF

    Found USDMF

    20405
    Active
    SODIUM FUSIDATE
    2007-03-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-120 - Rev 02
    Valid
    Sodium fusidate, Powder, Micronised
    2022-02-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20405
    R1-CEP 2006-120 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    SODIUM FUSIDATE
    Sodium fusidate, Powder, Micronised
    Issue/Submission Date
    2007-03-29
    2022-02-18
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    • FDA
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    Erythromycin Stearate

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    13467
    Inactive
    ERYTHROMYCIN STEARATE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10103
    Erythromycin stearate at Paseo del ...
    2013-05-15
    Written Confirmation

    Close WC

    Application Number
    13467
    225MF10103
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ERYTHROMYCIN STEARATE
    Erythromycin stearate at Paseo del ...
    Issue/Submission Date
    1998-09-01
    2013-05-15
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    • FDA
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    Azithromycin

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    224MF10053
    Azithromycin hydrate at Paseo del D...
    2012-03-12
    Written Confirmation

    Close WC

    Application Number
    224MF10053
    Status
     
    Filing Details
    Azithromycin hydrate at Paseo del D...
    Issue/Submission Date
    2012-03-12
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    Azithromycin

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10462
    Azithromycin hydrate at Paseo del D...
    2006-04-27
    Written Confirmation

    Close WC

    Application Number
    218MF10462
    Status
     
    Filing Details
    Azithromycin hydrate at Paseo del D...
    Issue/Submission Date
    2006-04-27
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    Azithromycin Dihydrate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2007-206 - Rev 03
    Valid
    Azithromycin, Dihydrate
    2022-02-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2007-206 - Rev 03
    Status
    Valid
     
    Filing Details
    Azithromycin, Dihydrate
    Issue/Submission Date
    2022-02-04
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    Clarithromycin

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10685
    Clarithromycin at Paseo del Deleite...
    2006-08-11
    Written Confirmation

    Close WC

    Application Number
    218MF10685
    Status
     
    Filing Details
    Clarithromycin at Paseo del Deleite...
    Issue/Submission Date
    2006-08-11
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    • FDA
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    Erythromycin

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    37397
    Active
    ERYTHROMYCIN BASE DIHYDRATE
    2022-09-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37397
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ERYTHROMYCIN BASE DIHYDRATE
    Issue/Submission Date
    2022-09-14
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    • FDA
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    Fosfomycin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    31195
    Active
    FOSFOMYCIN TROMETHAMINE
    2017-02-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31195
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FOSFOMYCIN TROMETHAMINE
    Issue/Submission Date
    2017-02-24
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    Fosfomycin Calcium

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    221MF10079
    Fosfomycin calcium hydrate at Paseo...
    2009-04-17
    Written Confirmation

    Close WC

    Application Number
    221MF10079
    Status
     
    Filing Details
    Fosfomycin calcium hydrate at Paseo...
    Issue/Submission Date
    2009-04-17
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    Fusidic Acid

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2023-222 - Rev 00
    Valid
    Fusidic acid, Sterile Powder and St...
    2023-09-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2023-222 - Rev 00
    Status
    Valid
     
    Filing Details
    Fusidic acid, Sterile Powder and St...
    Issue/Submission Date
    2023-09-28
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    • FDA
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    Terbinafine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10830
    Terbinafine hydrochloride at Paseo ...
    2006-10-20
    Written Confirmation

    Close WC

    Application Number
    218MF10830
    Status
     
    Filing Details
    Terbinafine hydrochloride at Paseo ...
    Issue/Submission Date
    2006-10-20
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    • FDA
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    Erythromycin Estolate

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    13468
    Inactive
    ERYTHROMYCIN ESTOLATE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13468
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ERYTHROMYCIN ESTOLATE
    Issue/Submission Date
    1998-09-01
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    • FDA
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    Lovastatin

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Caution USDMF

    16901
    Inactive
    LOVASTATIN (TECHNICAL GRADE)
    2003-10-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16901
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    LOVASTATIN (TECHNICAL GRADE)
    Issue/Submission Date
    2003-10-13
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    Lovastatin

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    USDMF

    Caution USDMF

    17069
    Inactive
    LOVASTATIN
    2004-01-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17069
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    LOVASTATIN
    Issue/Submission Date
    2004-01-05
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    Mevastatin

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    19411
    Inactive
    COMPACTIN
    2006-04-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19411
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    COMPACTIN
    Issue/Submission Date
    2006-04-26
    ASK
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    • FDA
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    Formaldehyde

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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