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

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    Krka
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    Slovenia
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    Smarjeska cesta 6, 8501 Novo mesto
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    +386 7 331 21 11
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    • FDA
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    Enalapril Maleate

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    USDMF

    Caution USDMF

    12809
    Inactive
    ENALAPRIL MALEATE
    1997-12-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-212 - Rev 02
    Valid
    Enalapril maleate
    2010-09-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12809
    R1-CEP 2000-212 - Rev 02
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    ENALAPRIL MALEATE
    Enalapril maleate
    Issue/Submission Date
    1997-12-29
    2010-09-10
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    Amlodipine Besylate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2022-449 - Rev 00
    Valid
    Amlodipine besilate, 311302
    2023-01-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2022-449 - Rev 00
    Status
    Valid
     
    Filing Details
    Amlodipine besilate, 311302
    Issue/Submission Date
    2023-01-19
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    Amlodipine Besylate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2014-243 - Rev 01
    Valid
    Amlodipine besilate
    2021-05-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2014-243 - Rev 01
    Status
    Valid
     
    Filing Details
    Amlodipine besilate
    Issue/Submission Date
    2021-05-11
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    Atorvastatin

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2023-270 - Rev 01
    Valid
    Atorvastatin calcium, 317500
    2024-02-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2023-270 - Rev 01
    Status
    Valid
     
    Filing Details
    Atorvastatin calcium, 317500
    Issue/Submission Date
    2024-02-06
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    Atorvastatin

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2013-024 - Rev 01
    Valid
    Atorvastatin calcium
    2020-05-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2013-024 - Rev 01
    Status
    Valid
     
    Filing Details
    Atorvastatin calcium
    Issue/Submission Date
    2020-05-28
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    Atorvastatin

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-105 - Rev 01
    Valid
    Atorvastatin calcium, 315313
    2022-01-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2021-105 - Rev 01
    Status
    Valid
     
    Filing Details
    Atorvastatin calcium, 315313
    Issue/Submission Date
    2022-01-28
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    Candesartan Cilexetil

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2016-132 - Rev 01
    Valid
    Candesartan cilexetil
    2024-02-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2016-132 - Rev 01
    Status
    Valid
     
    Filing Details
    Candesartan cilexetil
    Issue/Submission Date
    2024-02-19
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    Carvedilol

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2001-294 - Rev 04
    Valid
    Carvedilol
    2015-01-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2001-294 - Rev 04
    Status
    Valid
     
    Filing Details
    Carvedilol
    Issue/Submission Date
    2015-01-28
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    Clopidogrel

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2014-027 - Rev 03
    Valid
    Clopidogrel hydrogen sulfate
    2023-12-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2014-027 - Rev 03
    Status
    Valid
     
    Filing Details
    Clopidogrel hydrogen sulfate
    Issue/Submission Date
    2023-12-12
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    Clopidogrel Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2018-251 - Rev 00
    Valid
    Clopidogrel hydrochloride
    2020-01-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2018-251 - Rev 00
    Status
    Valid
     
    Filing Details
    Clopidogrel hydrochloride
    Issue/Submission Date
    2020-01-10
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    Clopidogrel Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2020-254 - Rev 01
    Valid
    Clopidogrel hydrochloride, 313814
    2022-12-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2020-254 - Rev 01
    Status
    Valid
     
    Filing Details
    Clopidogrel hydrochloride, 313814
    Issue/Submission Date
    2022-12-20
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    Duloxetine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2015-246 - Rev 00
    Valid
    Duloxetine hydrochloride
    2022-03-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2015-246 - Rev 00
    Status
    Valid
     
    Filing Details
    Duloxetine hydrochloride
    Issue/Submission Date
    2022-03-01
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    Esomeprazole Magnesium

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2018-035 - Rev 02
    Valid
    Esomeprazole magnesium dihydrate
    2023-01-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2018-035 - Rev 02
    Status
    Valid
     
    Filing Details
    Esomeprazole magnesium dihydrate
    Issue/Submission Date
    2023-01-05
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    Losartan Potassium

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-275 - Rev 00
    Valid
    Losartan potassium
    2022-03-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2019-275 - Rev 00
    Status
    Valid
     
    Filing Details
    Losartan potassium
    Issue/Submission Date
    2022-03-17
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    Losartan Potassium

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2023-323 - Rev 00
    Valid
    Losartan potassium, 318642
    2024-02-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2023-323 - Rev 00
    Status
    Valid
     
    Filing Details
    Losartan potassium, 318642
    Issue/Submission Date
    2024-02-16
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    Norfloxacin

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2021-141 - Rev 01
    Valid
    Norfloxacin, Product code 312025
    2024-02-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2021-141 - Rev 01
    Status
    Valid
     
    Filing Details
    Norfloxacin, Product code 312025
    Issue/Submission Date
    2024-02-06
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    Norfloxacin

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-140 - Rev 00
    Valid
    Norfloxacin, Product code 312008
    2022-12-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2021-140 - Rev 00
    Status
    Valid
     
    Filing Details
    Norfloxacin, Product code 312008
    Issue/Submission Date
    2022-12-20
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    Olmesartan Medoxomil

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2015-259 - Rev 00
    Valid
    Olmesartan medoxomil
    2021-09-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2015-259 - Rev 00
    Status
    Valid
     
    Filing Details
    Olmesartan medoxomil
    Issue/Submission Date
    2021-09-15
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    Oxytetracycline Dihydrate

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    USDMF

    Caution USDMF

    13507
    Inactive
    OXYTETRACYCLINE
    1998-09-01
    CEP/COS

    Caution CEP/COS

    R0-CEP 2003-274 - Rev 00
    Withdrawn by Holder
    Oxytetracycline dihydrate
    2005-09-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13507
    R0-CEP 2003-274 - Rev 00
    Status
    Inactive
    Fees Unpaid
    N/A
    Withdrawn by Holder
     
    Filing Details
    OXYTETRACYCLINE
    Oxytetracycline dihydrate
    Issue/Submission Date
    1998-09-01
    2005-09-30
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    Pantoprazole Sodium

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2013-227 - Rev 01
    Valid
    Pantoprazole sodium sesquihydrate
    2023-07-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2013-227 - Rev 01
    Status
    Valid
     
    Filing Details
    Pantoprazole sodium sesquihydrate
    Issue/Submission Date
    2023-07-13
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    Perindopril Erbumine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-235 - Rev 00
    Valid
    Perindopril tert-butylamine, Code 3...
    2021-09-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2019-235 - Rev 00
    Status
    Valid
     
    Filing Details
    Perindopril tert-butylamine, Code 3...
    Issue/Submission Date
    2021-09-22
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    Perindopril Erbumine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-245 - Rev 01
    Valid
    Perindopril tert-butylamine, Code 3...
    2022-03-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2019-245 - Rev 01
    Status
    Valid
     
    Filing Details
    Perindopril tert-butylamine, Code 3...
    Issue/Submission Date
    2022-03-07
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    Rabeprazole

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2018-140 - Rev 01
    Valid
    Rabeprazole sodium hydrate
    2022-10-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2018-140 - Rev 01
    Status
    Valid
     
    Filing Details
    Rabeprazole sodium hydrate
    Issue/Submission Date
    2022-10-17
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    Rivaroxaban

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-232 - Rev 01
    Valid
    Rivaroxaban
    2023-05-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2021-232 - Rev 01
    Status
    Valid
     
    Filing Details
    Rivaroxaban
    Issue/Submission Date
    2023-05-11
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    Rivaroxaban

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2021-231 - Rev 01
    Valid
    Rivaroxaban
    2023-11-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2021-231 - Rev 01
    Status
    Valid
     
    Filing Details
    Rivaroxaban
    Issue/Submission Date
    2023-11-07
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    Rosuvastatin Calcium

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2018-077 - Rev 02
    Valid
    Rosuvastatin calcium
    2023-02-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2018-077 - Rev 02
    Status
    Valid
     
    Filing Details
    Rosuvastatin calcium
    Issue/Submission Date
    2023-02-10
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    Telmisartan

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2015-307 - Rev 01
    Valid
    Telmisartan
    2023-05-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2015-307 - Rev 01
    Status
    Valid
     
    Filing Details
    Telmisartan
    Issue/Submission Date
    2023-05-30
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    Telmisartan

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-254 - Rev 00
    Valid
    Telmisartan, 315519
    2021-12-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2021-254 - Rev 00
    Status
    Valid
     
    Filing Details
    Telmisartan, 315519
    Issue/Submission Date
    2021-12-08
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    Telmisartan

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-280 - Rev 00
    Valid
    Telmisartan, 315780
    2021-11-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2021-280 - Rev 00
    Status
    Valid
     
    Filing Details
    Telmisartan, 315780
    Issue/Submission Date
    2021-11-30
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    Valsartan

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2011-148 - Rev 04
    Valid
    Valsartan
    2023-01-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2011-148 - Rev 04
    Status
    Valid
     
    Filing Details
    Valsartan
    Issue/Submission Date
    2023-01-27
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    Venlafaxine Hydrochloride

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2005-264 - Rev 03
    Valid
    Venlafaxine hydrochloride
    2018-09-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2005-264 - Rev 03
    Status
    Valid
     
    Filing Details
    Venlafaxine hydrochloride
    Issue/Submission Date
    2018-09-20
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    Ticagrelor, Micronized

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    USDMF

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    CEP/COS

    Found CEP/COS

    CEP 2022-437 - Rev 00
    Valid
    Ticagrelor, Micronized
    2024-03-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2022-437 - Rev 00
    Status
    Valid
     
    Filing Details
    Ticagrelor, Micronized
    Issue/Submission Date
    2024-03-01
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    Bacitracin Zinc

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    USDMF

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    CEP/COS

    Caution CEP/COS

    R0-CEP 2006-052 - Rev 00
    Withdrawn by Holder
    Bacitracin zinc
    2008-11-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2006-052 - Rev 00
    Status
    Withdrawn by Holder
     
    Filing Details
    Bacitracin zinc
    Issue/Submission Date
    2008-11-07
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    Enalapril Maleate

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    USDMF

    Caution USDMF

    15005
    Inactive
    ENALAPRILA USP
    2000-08-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15005
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    ENALAPRILA USP
    Issue/Submission Date
    2000-08-21
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    Lansoprazole

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    USDMF

    Caution USDMF

    22321
    Inactive
    LANSOPRAZOLE ACTIVE SUBSTANCE
    2008-12-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22321
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    LANSOPRAZOLE ACTIVE SUBSTANCE
    Issue/Submission Date
    2008-12-17
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    Lovastatin

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    USDMF

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    CEP/COS

    Caution CEP/COS

    R1-CEP 2004-191 - Rev 01
    Withdrawn by Holder
    Lovastatin
    2010-12-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2004-191 - Rev 01
    Status
    Withdrawn by Holder
     
    Filing Details
    Lovastatin
    Issue/Submission Date
    2010-12-02
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    Nifedipine

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    USDMF

    Caution USDMF

    5295
    Inactive
    NIFEDIPINE
    1984-03-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5295
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    NIFEDIPINE
    Issue/Submission Date
    1984-03-18
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    Norfloxacin

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    USDMF

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    CEP/COS

    Caution CEP/COS

    R1-CEP 2000-270 - Rev 04
    Withdrawn by Holder
    Norfloxacin
    2013-03-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2000-270 - Rev 04
    Status
    Withdrawn by Holder
     
    Filing Details
    Norfloxacin
    Issue/Submission Date
    2013-03-14
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    Oxytetracycline Dihydrate

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    USDMF

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    CEP/COS

    Caution CEP/COS

    R1-CEP 1999-133 - Rev 01
    Withdrawn by Holder
    Oxytetracycline dihydrate
    2007-07-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1999-133 - Rev 01
    Status
    Withdrawn by Holder
     
    Filing Details
    Oxytetracycline dihydrate
    Issue/Submission Date
    2007-07-31
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    Piroxicam

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    USDMF

    Caution USDMF

    8055
    Inactive
    PIROXICAM
    1989-05-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8055
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    PIROXICAM
    Issue/Submission Date
    1989-05-04
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    Simvastatin

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    USDMF

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    CEP/COS

    Caution CEP/COS

    R1-CEP 2001-212 - Rev 00
    Withdrawn by Holder
    Simvastatin
    2007-04-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2001-212 - Rev 00
    Status
    Withdrawn by Holder
     
    Filing Details
    Simvastatin
    Issue/Submission Date
    2007-04-10
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    Simvastatin

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    USDMF

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    CEP/COS

    Caution CEP/COS

    R1-CEP 2006-298 - Rev 00
    Withdrawn by Holder
    Simvastatin
    2012-10-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2006-298 - Rev 00
    Status
    Withdrawn by Holder
     
    Filing Details
    Simvastatin
    Issue/Submission Date
    2012-10-08
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    FOR THE NOVO MESTO PLANT

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    USDMF

    Caution USDMF

    5428
    Inactive
    FOR THE NOVO MESTO PLANT
    1984-06-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5428
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    FOR THE NOVO MESTO PLANT
    Issue/Submission Date
    1984-06-29
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