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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Pliva Hrvatska

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    Pliva Hrvatska
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    Croatia
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    PLIVA HRVATSKA d.o.o.Prilaz baruna Filipovića 2510000 Zagreb, Croatia
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    385 1 37 24 863
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    Azithromycin

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2010-131 - Rev 02
    Valid
    Azithromycin, Monohydrate
    2021-10-27
    Japanese DMF

    Found JDMF

    219MF10049
    Azithromycin hydrate at Prilaz baru...
    2007-02-13
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2010-131 - Rev 02
    219MF10049
    Status
    Valid
     
    Filing Details
    Azithromycin, Monohydrate
    Azithromycin hydrate at Prilaz baru...
    Issue/Submission Date
    2021-10-27
    2007-02-13
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    Oxaliplatin

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    USDMF

    Found USDMF

    19594
    Active
    OXALIPLATIN
    2006-07-11
    CEP/COS

    Caution CEP/COS

    R0-CEP 2008-082 - Rev 00
    Withdrawn by Holder
    Oxaliplatin
    2009-10-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19594
    R0-CEP 2008-082 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    OXALIPLATIN
    Oxaliplatin
    Issue/Submission Date
    2006-07-11
    2009-10-20
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    Azithromycin Dihydrate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2007-072 - Rev 02
    Valid
    Azithromycin, Dihydrate
    2021-10-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2007-072 - Rev 02
    Status
    Valid
     
    Filing Details
    Azithromycin, Dihydrate
    Issue/Submission Date
    2021-10-25
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    Carboplatin

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    USDMF

    Caution USDMF

    16280
    Inactive
    CARBOPLATIN
    2002-12-02
    CEP/COS

    Caution CEP/COS

    R0-CEP 2005-157 - Rev 00
    Withdrawn by Holder
    Carboplatin
    2007-10-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16280
    R0-CEP 2005-157 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    CARBOPLATIN
    Carboplatin
    Issue/Submission Date
    2002-12-02
    2007-10-02
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    Carboplatin

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10412
    Carboplatin at Kara(´)sek 1,621 33...
    2006-04-14
    Written Confirmation

    Close WC

    Application Number
    218MF10412
    Status
     
    Filing Details
    Carboplatin at Kara(´)sek 1,621 33...
    Issue/Submission Date
    2006-04-14
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    Donepezil

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10184
    Donepezil hydrochloride \"Teva\" at...
    2010-06-28
    Written Confirmation

    Close WC

    Application Number
    222MF10184
    Status
     
    Filing Details
    Donepezil hydrochloride \"Teva\" at...
    Issue/Submission Date
    2010-06-28
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    Eszopiclone

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10074
    Eszopiclone \"Teva / PLIVA\" at Pri...
    2016-03-24
    Written Confirmation

    Close WC

    Application Number
    228MF10074
    Status
     
    Filing Details
    Eszopiclone \"Teva / PLIVA\" at Pri...
    Issue/Submission Date
    2016-03-24
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    Etodolac

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10244
    Etodolac \"Teva / PLIVA2\" at Prila...
    2015-10-07
    Written Confirmation

    Close WC

    Application Number
    227MF10244
    Status
     
    Filing Details
    Etodolac \"Teva / PLIVA2\" at Prila...
    Issue/Submission Date
    2015-10-07
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    Hydrochlorothiazide

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    229MF10218
    Hydrochlorothiazide \"Teva / Pliva\...
    2017-12-12
    Written Confirmation

    Close WC

    Application Number
    229MF10218
    Status
     
    Filing Details
    Hydrochlorothiazide \"Teva / Pliva\...
    Issue/Submission Date
    2017-12-12
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    Imatinib Mesylate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    224MF10188
    Imatinib mesylate \"Teva\" at Prila...
    2012-09-03
    Written Confirmation

    Close WC

    Application Number
    224MF10188
    Status
     
    Filing Details
    Imatinib mesylate \"Teva\" at Prila...
    Issue/Submission Date
    2012-09-03
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    Irinotecan Hydrochloride

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    USDMF

    Found USDMF

    19050
    Active
    IRINOTECAN HYDROCHLORIDE TRIHYDRATE
    2005-12-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19050
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    IRINOTECAN HYDROCHLORIDE TRIHYDRATE
    Issue/Submission Date
    2005-12-20
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    Mesalazine

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    USDMF

    Caution USDMF

    10645
    Inactive
    MESALAZINE
    1993-01-03
    CEP/COS

    Caution CEP/COS

    R1-CEP 2004-276 - Rev 01
    Withdrawn by Holder
    Mesalazine
    2013-03-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10645
    R1-CEP 2004-276 - Rev 01
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    MESALAZINE
    Mesalazine
    Issue/Submission Date
    1993-01-03
    2013-03-21
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    Omeprazole

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10127
    Omeprazole \"Teva\" at Prilaz barun...
    2013-07-02
    Written Confirmation

    Close WC

    Application Number
    225MF10127
    Status
     
    Filing Details
    Omeprazole \"Teva\" at Prilaz barun...
    Issue/Submission Date
    2013-07-02
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    Sugammadex Sodium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10026
    Sugammadex sodium at Prilaz baruna...
    2023-02-08
    Written Confirmation

    Close WC

    Application Number
    305MF10026
    Status
     
    Filing Details
    Sugammadex sodium at Prilaz baruna...
    Issue/Submission Date
    2023-02-08
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    Chlorhexidine

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    USDMF

    Caution USDMF

    8349
    Inactive
    CHLORHEXIDINE BASE
    1989-12-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8349
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CHLORHEXIDINE BASE
    Issue/Submission Date
    1989-12-29
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    Chlorhexidine Gluconate

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    USDMF

    Caution USDMF

    8363
    Inactive
    CHLORHEXIDINE GLUCONATE SOLUTION
    1989-12-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8363
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CHLORHEXIDINE GLUCONATE SOLUTION
    Issue/Submission Date
    1989-12-18
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    Chlorothiazide

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    USDMF

    Caution USDMF

    4610
    Inactive
    CHLOROTHIAZIDE
    1982-06-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4610
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CHLOROTHIAZIDE
    Issue/Submission Date
    1982-06-16
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    Chlorpropamide

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    USDMF

    Caution USDMF

    2885
    Inactive
    CHLORPROPAMIDE
    1977-03-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    2885
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CHLORPROPAMIDE
    Issue/Submission Date
    1977-03-17
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    Dacarbazine

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    16326
    Inactive
    DACARBAZINE
    2002-12-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16326
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    DACARBAZINE
    Issue/Submission Date
    2002-12-19
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    Glutethimide

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    USDMF

    Caution USDMF

    4168
    Inactive
    GLUTETHIMIDE (CHEM NAME: 2-ETHYL-...
    1981-05-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4168
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    GLUTETHIMIDE (CHEM NAME: 2-ETHYL-...
    Issue/Submission Date
    1981-05-07
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    Ketoprofen

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    8551
    Inactive
    KETOPROFEN
    1990-04-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8551
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    KETOPROFEN
    Issue/Submission Date
    1990-04-23
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    Meclizine Hydrochloride

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    USDMF

    Caution USDMF

    2847
    Inactive
    MECLIZINE HCL
    1977-02-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    2847
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MECLIZINE HCL
    Issue/Submission Date
    1977-02-04
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    Metoprolol Tartrate

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    USDMF

    Caution USDMF

    9539
    Inactive
    METOPROLOL TARTRATE
    1992-02-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    9539
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    METOPROLOL TARTRATE
    Issue/Submission Date
    1992-02-13
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    Oxytetracycline Dihydrate

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    USDMF

    Caution USDMF

    13350
    Inactive
    OXYTETRACYCLINE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13350
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    OXYTETRACYCLINE
    Issue/Submission Date
    1998-09-01
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    Oxytetracycline Hydrochloride

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    USDMF

    Caution USDMF

    13349
    Inactive
    OXYTETRACYCLINE HYDROCHLORIDE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13349
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    OXYTETRACYCLINE HYDROCHLORIDE
    Issue/Submission Date
    1998-09-01
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    Pemoline

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    USDMF

    Caution USDMF

    13919
    Inactive
    PEMOLINE
    1998-12-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13919
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    PEMOLINE
    Issue/Submission Date
    1998-12-29
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    Sulfisoxazole

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    USDMF

    Caution USDMF

    2739
    Inactive
    SULFISOXAZOLE
    1976-08-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    2739
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    SULFISOXAZOLE
    Issue/Submission Date
    1976-08-30
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    FACILITY FOR AZITHROMICIN DIHYDRATE MFG. IN ZAGREB, YUG...

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    USDMF

    Caution USDMF

    8408
    Inactive
    FACILITY FOR AZITHROMICIN DIHYDRATE...
    1990-01-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8408
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    FACILITY FOR AZITHROMICIN DIHYDRATE...
    Issue/Submission Date
    1990-01-29
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    MANUFACTURING SITE, PERSONNEL, AND OPERATING PROCEDURES...

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    14079
    Inactive
    MANUFACTURING SITE, PERSONNEL, AND ...
    1999-04-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14079
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MANUFACTURING SITE, PERSONNEL, AND ...
    Issue/Submission Date
    1999-04-15
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