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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Euticals Group SpA

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    Cytarabine

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    USDMF

    Found USDMF

    25267
    Active
    CYTARABINE
    2011-09-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-048 - Rev 04
    Valid
    Cytarabine
    2020-10-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25267
    R1-CEP 2000-048 - Rev 04
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CYTARABINE
    Cytarabine
    Issue/Submission Date
    2011-09-07
    2020-10-16
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    Diacerein

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    USDMF

    Found USDMF

    23960
    Active
    DIACEREIN (PROCESS I)
    2010-07-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-247 - Rev 00
    Valid
    Diacerein
    2021-06-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23960
    R1-CEP 2014-247 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    DIACEREIN (PROCESS I)
    Diacerein
    Issue/Submission Date
    2010-07-13
    2021-06-24
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    Hydroxyurea

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    USDMF

    Found USDMF

    12754
    Active
    HYDROXYUREA
    1997-11-14
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-120 - Rev 03
    Valid
    Hydroxycarbamide
    2020-09-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12754
    R1-CEP 2003-120 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    HYDROXYUREA
    Hydroxycarbamide
    Issue/Submission Date
    1997-11-14
    2020-09-18
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    Diacerein

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    USDMF

    Found USDMF

    23961
    Active
    DIACEREIN (PROCESS II)
    2010-07-13
    CEP/COS

    Caution CEP/COS

    R0-CEP 2014-248 - Rev 00
    Expired
    Diacerein
    2016-07-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23961
    R0-CEP 2014-248 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Expired
     
    Filing Details
    DIACEREIN (PROCESS II)
    Diacerein
    Issue/Submission Date
    2010-07-13
    2016-07-21
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    Fludarabine Phosphate

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    USDMF

    Caution USDMF

    17374
    Inactive
    FLUDARABINE PHOSPHATE
    2004-05-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-282 - Rev 00
    Valid
    Fludarabine phosphate
    2016-10-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17374
    R1-CEP 2009-282 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    FLUDARABINE PHOSPHATE
    Fludarabine phosphate
    Issue/Submission Date
    2004-05-13
    2016-10-14
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    Hydralazine Hydrochloride

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    USDMF

    Found USDMF

    22169
    Active
    HYDRALAZINE HYDROCHLORIDE
    2008-10-31
    CEP/COS

    Caution CEP/COS

    R0-CEP 2015-161 - Rev 01
    Expired
    Hydralazine hydrochloride
    2020-10-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22169
    R0-CEP 2015-161 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Expired
     
    Filing Details
    HYDRALAZINE HYDROCHLORIDE
    Hydralazine hydrochloride
    Issue/Submission Date
    2008-10-31
    2020-10-29
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    Adenosine

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    USDMF

    Found USDMF

    22232
    Active
    ADENOSINE
    2008-11-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22232
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ADENOSINE
    Issue/Submission Date
    2008-11-25
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    Bromfenac

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    USDMF

    Found USDMF

    23704
    Active
    BROENAC SODIUM
    2010-04-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23704
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BROENAC SODIUM
    Issue/Submission Date
    2010-04-12
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    Capecitabine

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    USDMF

    Found USDMF

    25266
    Active
    CAPECITABINE
    2011-09-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25266
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CAPECITABINE
    Issue/Submission Date
    2011-09-07
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    Cytarabine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2023-289 - Rev 00
    Valid
    Cytarabine, Process 2
    2024-02-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2023-289 - Rev 00
    Status
    Valid
     
    Filing Details
    Cytarabine, Process 2
    Issue/Submission Date
    2024-02-06
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    Disopyramide

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    USDMF

    Found USDMF

    14204
    Active
    DISOPYRAMIDE PHOSPHATE
    1999-06-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14204
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DISOPYRAMIDE PHOSPHATE
    Issue/Submission Date
    1999-06-11
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    Lithium Carbonate

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    USDMF

    Found USDMF

    23175
    Active
    LITHIUM CARBONATE PHARMA GRADE
    2009-10-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23175
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LITHIUM CARBONATE PHARMA GRADE
    Issue/Submission Date
    2009-10-07
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    Oxcarbazepine

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    USDMF

    Found USDMF

    16588
    Active
    OXCARBAZEPINE
    2003-05-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16588
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    OXCARBAZEPINE
    Issue/Submission Date
    2003-05-15
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    Pirenzepine

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    USDMF

    Found USDMF

    13831
    Active
    PIRENZEPINE DIHYDROCHLORIDE
    1998-11-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13831
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PIRENZEPINE DIHYDROCHLORIDE
    Issue/Submission Date
    1998-11-05
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    Pirenzepine

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    USDMF

    Found USDMF

    33591
    Active
    PIRENZEPINE BASE PURE
    2019-06-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33591
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PIRENZEPINE BASE PURE
    Issue/Submission Date
    2019-06-06
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    Sucralfate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    16589
    Active
    SUCRALFATE
    2003-05-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16589
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SUCRALFATE
    Issue/Submission Date
    2003-05-13
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    Sulfapyridine

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    USDMF

    Found USDMF

    6658
    Active
    SULFAPYRIDINE
    1986-10-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6658
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SULFAPYRIDINE
    Issue/Submission Date
    1986-10-29
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    Vidarabine

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10026
    Vidarabine at Viale Bianca Maria 25...
    2015-01-23
    Written Confirmation

    Close WC

    Application Number
    227MF10026
    Status
     
    Filing Details
    Vidarabine at Viale Bianca Maria 25...
    Issue/Submission Date
    2015-01-23
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    Vidarabine

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10132
    \"Outsider Regulations\" vidarabine...
    2006-01-30
    Written Confirmation

    Close WC

    Application Number
    218MF10132
    Status
     
    Filing Details
    \"Outsider Regulations\" vidarabine...
    Issue/Submission Date
    2006-01-30
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    2-Nitro-4,5-Dihydro-1,3-Thiazole

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    USDMF

    Caution USDMF

    10531
    Inactive
    NITRO-THIAZOLINEBULK
    1993-10-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10531
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    NITRO-THIAZOLINEBULK
    Issue/Submission Date
    1993-10-19
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    Amrinone

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    USDMF

    Caution USDMF

    13193
    Inactive
    AMRINONE, USP
    1998-09-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13193
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    AMRINONE, USP
    Issue/Submission Date
    1998-09-22
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    Atenolol

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    USDMF

    Caution USDMF

    8834
    Inactive
    ATENOLOL
    1990-10-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8834
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ATENOLOL
    Issue/Submission Date
    1990-10-10
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    Azacitidine

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    USDMF

    Caution USDMF

    25265
    Inactive
    AZACITIDINE
    2011-09-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25265
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    AZACITIDINE
    Issue/Submission Date
    2011-09-07
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    Bendamustine Hydrochloride

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    USDMF

    Caution USDMF

    25394
    Inactive
    BENDAMUSTINE HYDROCHLORIDE HYDRATE
    2011-10-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25394
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    BENDAMUSTINE HYDROCHLORIDE HYDRATE
    Issue/Submission Date
    2011-10-18
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    Benzocaine

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    16638
    Inactive
    BENZOCAINE USP-EP
    2003-06-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16638
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    BENZOCAINE USP-EP
    Issue/Submission Date
    2003-06-06
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    Buspirone Hydrochloride

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    USDMF

    Caution USDMF

    10414
    Inactive
    BUSPIRONE HYDROCHLORIDE
    1993-08-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10414
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    BUSPIRONE HYDROCHLORIDE
    Issue/Submission Date
    1993-08-09
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    Busulfan

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    25393
    Inactive
    BUSULFAN
    2011-10-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25393
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    BUSULFAN
    Issue/Submission Date
    2011-10-18
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    Carbaspirin Calcium

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2003-106 - Rev 01
    Withdrawn by Holder
    Carbasalate calcium
    2006-08-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2003-106 - Rev 01
    Status
    Withdrawn by Holder
     
    Filing Details
    Carbasalate calcium
    Issue/Submission Date
    2006-08-30
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    Desipramine Hydrochloride

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    7216
    Inactive
    DESIPRAMINE HYDROCHLORIDE USP
    1987-10-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    7216
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    DESIPRAMINE HYDROCHLORIDE USP
    Issue/Submission Date
    1987-10-28
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    Doxylamine Succinate

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    7215
    Inactive
    DOXYLAMINE SUCCINATE USP
    1987-10-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    7215
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    DOXYLAMINE SUCCINATE USP
    Issue/Submission Date
    1987-10-28
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    Erythromycin Ethyl Succinate

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    USDMF

    Caution USDMF

    13600
    Inactive
    ERYTHROMYCIN ETHYLSUCCINATE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13600
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ERYTHROMYCIN ETHYLSUCCINATE
    Issue/Submission Date
    1998-09-01
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    Erythromycin Stearate

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    USDMF

    Caution USDMF

    13478
    Inactive
    ERYTHROMYCIN STEARATE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13478
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ERYTHROMYCIN STEARATE
    Issue/Submission Date
    1998-09-01
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    Ethyl 4-Butylamino-Benzoate

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    USDMF

    Caution USDMF

    8970
    Inactive
    ETHYL-4-N(n-BUTYLAMINO) BENZOATE
    1991-02-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    8970
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ETHYL-4-N(n-BUTYLAMINO) BENZOATE
    Issue/Submission Date
    1991-02-21
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    Gemcitabine

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    USDMF

    Caution USDMF

    23516
    Inactive
    GEMCITABINE HYDROCHLORIDE
    2010-02-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    23516
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    GEMCITABINE HYDROCHLORIDE
    Issue/Submission Date
    2010-02-12
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    Hydralazine Hydrochloride

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    USDMF

    Caution USDMF

    22682
    Inactive
    HYDRALAZINE HYDROCHLORIDE INJECTABL...
    2009-03-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22682
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    HYDRALAZINE HYDROCHLORIDE INJECTABL...
    Issue/Submission Date
    2009-03-20
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    Imipramine Hydrochloride

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    USDMF

    Caution USDMF

    7190
    Inactive
    IMIPRAMINE HYDROCHLORIDE
    1987-10-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    7190
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    IMIPRAMINE HYDROCHLORIDE
    Issue/Submission Date
    1987-10-18
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    Propofol

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    USDMF

    Caution USDMF

    11596
    Inactive
    BULK CRUDE PROPOFOL
    1995-07-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    11596
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    BULK CRUDE PROPOFOL
    Issue/Submission Date
    1995-07-25
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    Ribavirin

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    USDMF

    Caution USDMF

    23004
    Inactive
    RIBAVIRIN
    2009-08-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    23004
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    RIBAVIRIN
    Issue/Submission Date
    2009-08-03
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    Sancycline

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    USDMF

    Caution USDMF

    11842
    Inactive
    SANCYCLINE
    1996-01-26
    CEP/COS

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    Japanese DMF

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    Application Number
    11842
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    SANCYCLINE
    Issue/Submission Date
    1996-01-26
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    Terazosin HCl

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    USDMF

    Caution USDMF

    19480
    Inactive
    TERAZOSIN HYDROCHLORIDE
    2006-05-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    19480
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    TERAZOSIN HYDROCHLORIDE
    Issue/Submission Date
    2006-05-25
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    Tetracycline

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    USDMF

    Caution USDMF

    13465
    Inactive
    TETRACYCLINE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    13465
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    TETRACYCLINE
    Issue/Submission Date
    1998-09-01
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    Tetracycline Hydrochloride

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    USDMF

    Caution USDMF

    13456
    Inactive
    TETRACYCLINE HYDROCHLORIDE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13456
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    TETRACYCLINE HYDROCHLORIDE
    Issue/Submission Date
    1998-09-01
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    Triclocarban

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    USDMF

    Caution USDMF

    215
    Inactive
    TCC TRICLOCARBAN (3,4,4'-TRICHLORO...
    1965-05-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Application Number
    215
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    TCC TRICLOCARBAN (3,4,4'-TRICHLORO...
    Issue/Submission Date
    1965-05-21
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    FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES...

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    USDMF

    Caution USDMF

    6743
    Inactive
    FACILITIES, PERSONNEL, AND GENERAL ...
    1986-12-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    6743
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    FACILITIES, PERSONNEL, AND GENERAL ...
    Issue/Submission Date
    1986-12-19
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    2-CHLORO-4.5-DIFLUOROPHENYL-B-KETOESTER (SOL.) - VARESE...

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    USDMF

    Caution USDMF

    8261
    Inactive
    2-CHLORO-4.5-DIFLUOROPHENYL-B-KETOE...
    1989-10-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8261
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    2-CHLORO-4.5-DIFLUOROPHENYL-B-KETOE...
    Issue/Submission Date
    1989-10-12
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    2-CHLORO-4.5-DIFLUOROPHENYL-B-KETOESTER - VARESE, ITAL...

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    USDMF

    Caution USDMF

    8262
    Inactive
    2-CHLORO-4.5-DIFLUOROPHENYL-B-KETOE...
    1989-10-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8262
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    2-CHLORO-4.5-DIFLUOROPHENYL-B-KETOE...
    Issue/Submission Date
    1989-10-12
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    FACILITY IN ORIGGIO (VARESE), ITALY

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    USDMF

    Caution USDMF

    10048
    Inactive
    FACILITY IN ORIGGIO (VARESE), ITALY
    1993-01-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Close WC

    Application Number
    10048
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    FACILITY IN ORIGGIO (VARESE), ITALY
    Issue/Submission Date
    1993-01-21
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    OP 3300/15

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    USDMF

    Caution USDMF

    11760
    Inactive
    OP 3300/15
    1995-11-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    11760
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    OP 3300/15
    Issue/Submission Date
    1995-11-28
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    Citicoline Sodium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    Gold Sodium Thiomalate

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    USDMF

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    CEP/COS

    Close CEP/COS

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    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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