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    Azaperone

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2002-215 - Rev 04
    Valid
    Azaperone for veterinary use
    2013-11-05
    Japanese DMF

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    Written Confirmation

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    Application Number
    R1-CEP 2002-215 - Rev 04
    Status
    Valid
     
    Filing Details
    Azaperone for veterinary use
    Issue/Submission Date
    2013-11-05
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    Caninsulin

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    USDMF

    Caution USDMF

    2912
    Inactive
    ZINC INSULIN CRYSTALS--ARGENTINA D-...
    1976-12-22
    CEP/COS

    Caution CEP/COS

    R0-CEP 2000-313 - Rev 02
    Withdrawn by Holder
    Zinc insulin crystals, Product numb...
    2005-02-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    2912
    R0-CEP 2000-313 - Rev 02
    Status
    Inactive
    Fees Unpaid
    N/A
    Withdrawn by Holder
     
    Filing Details
    ZINC INSULIN CRYSTALS--ARGENTINA D-...
    Zinc insulin crystals, Product numb...
    Issue/Submission Date
    1976-12-22
    2005-02-28
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    Diclazuril

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2003-107 - Rev 03
    Valid
    Diclazuril for veterinary use
    2013-02-26
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R1-CEP 2003-107 - Rev 03
    Status
    Valid
     
    Filing Details
    Diclazuril for veterinary use
    Issue/Submission Date
    2013-02-26
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    Enilconazole

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2004-029 - Rev 02
    Valid
    Enilconazole for veterinary use
    2013-02-14
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R1-CEP 2004-029 - Rev 02
    Status
    Valid
     
    Filing Details
    Enilconazole for veterinary use
    Issue/Submission Date
    2013-02-14
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    Gemcitabine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2007-063 - Rev 00
    Valid
    Gemcitabine hydrochloride
    2014-11-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2007-063 - Rev 00
    Status
    Valid
     
    Filing Details
    Gemcitabine hydrochloride
    Issue/Submission Date
    2014-11-07
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    Insulin (Human) Recombinant

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10167
    Insulin human (recombinant) at Lill...
    2015-06-18
    Written Confirmation

    Close WC

    Application Number
    227MF10167
    Status
     
    Filing Details
    Insulin human (recombinant) at Lill...
    Issue/Submission Date
    2015-06-18
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    Insulin Lispro

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    303MF10175
    Insulin lispro (genetical recombina...
    2021-12-09
    Written Confirmation

    Close WC

    Application Number
    303MF10175
    Status
     
    Filing Details
    Insulin lispro (genetical recombina...
    Issue/Submission Date
    2021-12-09
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    Insulin Lispro

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF10534
    Insulin lispro (recombinant) at Lil...
    2005-09-09
    Written Confirmation

    Close WC

    Application Number
    217MF10534
    Status
     
    Filing Details
    Insulin lispro (recombinant) at Lil...
    Issue/Submission Date
    2005-09-09
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    Insulin Lispro

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10053
    Insulin lispro (recombinant) at 65t...
    2007-03-05
    Written Confirmation

    Close WC

    Application Number
    219MF10053
    Status
     
    Filing Details
    Insulin lispro (recombinant) at 65t...
    Issue/Submission Date
    2007-03-05
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    Insulin Lispro

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    226MF10225
    Insulin lispro (recombinant) at Lil...
    2014-12-08
    Written Confirmation

    Close WC

    Application Number
    226MF10225
    Status
     
    Filing Details
    Insulin lispro (recombinant) at Lil...
    Issue/Submission Date
    2014-12-08
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    Insulin Lispro

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    229MF10064
    Insulin lispro (recombinant) at 65t...
    2017-03-13
    Written Confirmation

    Close WC

    Application Number
    229MF10064
    Status
     
    Filing Details
    Insulin lispro (recombinant) at 65t...
    Issue/Submission Date
    2017-03-13
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    Olanzapine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF10535
    Olanzapine \"Lily\" at Dunderrow, K...
    2005-09-09
    Written Confirmation

    Close WC

    Application Number
    217MF10535
    Status
     
    Filing Details
    Olanzapine \"Lily\" at Dunderrow, K...
    Issue/Submission Date
    2005-09-09
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    Tylosin Tartrate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2001-016 - Rev 03
    Valid
    Tylosin tartrate for veterinary use
    2019-05-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2001-016 - Rev 03
    Status
    Valid
     
    Filing Details
    Tylosin tartrate for veterinary use
    Issue/Submission Date
    2019-05-09
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    Vincristine Sulfate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 1995-027 - Rev 02
    Valid
    Vincristine sulfate
    2006-07-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1995-027 - Rev 02
    Status
    Valid
     
    Filing Details
    Vincristine sulfate
    Issue/Submission Date
    2006-07-15
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    Aspirin

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    USDMF

    Caution USDMF

    1774
    Inactive
    ASPIRIN CAPSULES 325MG
    1971-08-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    1774
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    ASPIRIN CAPSULES 325MG
    Issue/Submission Date
    1971-08-02
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    Capreomycin

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    USDMF

    Caution USDMF

    15288
    Inactive
    CAPREOMYCIN SULFATE, STERILE BULK (...
    2001-02-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15288
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    CAPREOMYCIN SULFATE, STERILE BULK (...
    Issue/Submission Date
    2001-02-27
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    • FDA
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    Cefaclor

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    USDMF

    Caution USDMF

    13598
    Inactive
    CEFACLOR
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13598
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    CEFACLOR
    Issue/Submission Date
    1998-09-01
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    Cefaclor

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    USDMF

    Caution USDMF

    13622
    Inactive
    CEFACLOR
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13622
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    CEFACLOR
    Issue/Submission Date
    1998-09-01
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    Cefaclor

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    USDMF

    Caution USDMF

    13647
    Inactive
    CEFACLOR
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13647
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    CEFACLOR
    Issue/Submission Date
    1998-09-01
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    • FDA
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    Cefalotin sodium Sterile

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    USDMF

    Caution USDMF

    13384
    Inactive
    CEPHALOTHIN SODIUM
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13384
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    CEPHALOTHIN SODIUM
    Issue/Submission Date
    1998-09-01
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    Cefamandole Nafate

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    USDMF

    Caution USDMF

    13565
    Inactive
    CEFAMANDOLE NAFATE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13565
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    CEFAMANDOLE NAFATE
    Issue/Submission Date
    1998-09-01
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    Cefamandole Nafate

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    USDMF

    Caution USDMF

    13594
    Inactive
    CEFAMANDOLE NAFATE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13594
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    CEFAMANDOLE NAFATE
    Issue/Submission Date
    1998-09-01
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    Cefamandole Sodium Salt

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    USDMF

    Caution USDMF

    13619
    Inactive
    CEFAMANDOLE SODIUM
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13619
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    CEFAMANDOLE SODIUM
    Issue/Submission Date
    1998-09-01
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    Cefuroxime Sodium

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    USDMF

    Caution USDMF

    13675
    Inactive
    CEFUROXIME SODIUM
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13675
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    CEFUROXIME SODIUM
    Issue/Submission Date
    1998-09-01
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    Cephalexin

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    13610
    Inactive
    CEPHALEXIN
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13610
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    CEPHALEXIN
    Issue/Submission Date
    1998-09-01
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    Cephalexin Monohydrate

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    USDMF

    Caution USDMF

    13385
    Inactive
    CEPHALEXIN MONOHYDRATE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13385
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    CEPHALEXIN MONOHYDRATE
    Issue/Submission Date
    1998-09-01
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    Cycloserine

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    USDMF

    Caution USDMF

    13686
    Inactive
    CYCLOSERINE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13686
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    CYCLOSERINE
    Issue/Submission Date
    1998-09-01
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    Erythromycin

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    13515
    Inactive
    ERYTHROMYCIN
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13515
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    ERYTHROMYCIN
    Issue/Submission Date
    1998-09-01
    ASK
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    Erythromycin Estolate

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    13204
    Inactive
    ERYTHROMYCIN ESTOLATE
    1998-04-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13204
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    ERYTHROMYCIN ESTOLATE
    Issue/Submission Date
    1998-04-30
    ASK
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    Erythromycin Estolate

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    USDMF

    Caution USDMF

    13331
    Inactive
    ERYTHROMYCIN ESTOLATE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13331
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    ERYTHROMYCIN ESTOLATE
    Issue/Submission Date
    1998-09-01
    ASK
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    Erythromycin Estolate

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    USDMF

    Caution USDMF

    13333
    Inactive
    ERYTHROMYCIN ESTOLATE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13333
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    ERYTHROMYCIN ESTOLATE
    Issue/Submission Date
    1998-09-01
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    Erythromycin Estolate

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    USDMF

    Caution USDMF

    13676
    Inactive
    ERYTHROMYCIN ESTOLATE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    13676
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    ERYTHROMYCIN ESTOLATE
    Issue/Submission Date
    1998-09-01
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    H-Arg-Pro-Pna

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    USDMF

    Caution USDMF

    13890
    Inactive
    DIPEPTIDYLAMINOPEPTIDASE (DDAP)
    1998-12-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13890
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    DIPEPTIDYLAMINOPEPTIDASE (DDAP)
    Issue/Submission Date
    1998-12-08
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    H-Arg-Pro-Pna

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    USDMF

    Caution USDMF

    15466
    Inactive
    DIPEPTIDYLAMINOPEPTIDASE (DDAP)
    2001-06-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15466
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    DIPEPTIDYLAMINOPEPTIDASE (DDAP)
    Issue/Submission Date
    2001-06-05
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    Methadone Hydrochloride

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    USDMF

    Caution USDMF

    1526
    Inactive
    MANUF AND CONTROL INFOR. FOR METHAD...
    1970-05-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    1526
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    MANUF AND CONTROL INFOR. FOR METHAD...
    Issue/Submission Date
    1970-05-27
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    Nitroglycerin

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    USDMF

    Caution USDMF

    1923
    Inactive
    NITROGLYCERIN AMPOULES
    1972-05-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    1923
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    NITROGLYCERIN AMPOULES
    Issue/Submission Date
    1972-05-01
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    Penicillin G Procaine

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    USDMF

    Caution USDMF

    13291
    Inactive
    PENICILLIN G PROCAINE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    13291
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    PENICILLIN G PROCAINE
    Issue/Submission Date
    1998-09-01
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    Penicillin V Potassium

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    USDMF

    Caution USDMF

    13332
    Inactive
    PENICILLIN V POTASSIUM
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    13332
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    PENICILLIN V POTASSIUM
    Issue/Submission Date
    1998-09-01
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    Penicillin V Potassium

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    USDMF

    Caution USDMF

    13417
    Inactive
    PENICILLIN V POTASSIUM
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    13417
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    PENICILLIN V POTASSIUM
    Issue/Submission Date
    1998-09-01
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    Tobramycin Sulfate

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    USDMF

    Caution USDMF

    13513
    Inactive
    TOBRAMYCIN SULFATE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    13513
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    TOBRAMYCIN SULFATE
    Issue/Submission Date
    1998-09-01
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    Trypsin

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    USDMF

    Caution USDMF

    15047
    Inactive
    RECOMBINANT BOVINE TRYPSIN (RTRYPSI...
    2000-09-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15047
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    RECOMBINANT BOVINE TRYPSIN (RTRYPSI...
    Issue/Submission Date
    2000-09-18
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    Vancomycin Hydrochloride

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    USDMF

    Caution USDMF

    13652
    Inactive
    VANCOMYCIN HYDROCHLORIDE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    13652
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    VANCOMYCIN HYDROCHLORIDE
    Issue/Submission Date
    1998-09-01
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    TOPICAL ANESTHETIC COMPOUND C-10

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    USDMF

    Caution USDMF

    185
    Inactive
    TOPICAL ANESTHETIC COMPOUND C-10
    1955-12-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    185
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    TOPICAL ANESTHETIC COMPOUND C-10
    Issue/Submission Date
    1955-12-22
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    CHLORDIETHYLNOL (DIETHYL CHLORO ETHYNYL CARBINOL)

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    USDMF

    Caution USDMF

    227
    Inactive
    CHLORDIETHYLNOL (DIETHYL CHLORO ETH...
    1957-04-08
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    227
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    CHLORDIETHYLNOL (DIETHYL CHLORO ETH...
    Issue/Submission Date
    1957-04-08
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    1 - CYCLOPPENTYL - 2 - AMINO PROPANE

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    USDMF

    Caution USDMF

    303
    Inactive
    1 - CYCLOPPENTYL - 2 - AMINO PROPAN...
    1958-08-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    303
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    1 - CYCLOPPENTYL - 2 - AMINO PROPAN...
    Issue/Submission Date
    1958-08-29
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    MYRISTYL - 3 - HYDROXYBUTYLAMINE HCL - COMPOUND 06537

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    USDMF

    Caution USDMF

    334
    Inactive
    MYRISTYL - 3 - HYDROXYBUTYLAMINE HC...
    1959-04-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    334
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    MYRISTYL - 3 - HYDROXYBUTYLAMINE HC...
    Issue/Submission Date
    1959-04-20
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    VORTEL TABLETS

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    USDMF

    Caution USDMF

    352
    Inactive
    VORTEL TABLETS
    1959-11-16
    CEP/COS

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    Application Number
    352
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    VORTEL TABLETS
    Issue/Submission Date
    1959-11-16
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    ROTOWEIGH (TM) CAPSULE WEIGHING MACHINE AT USED IN THE ...

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    USDMF

    Caution USDMF

    3518
    Inactive
    ROTOWEIGH (TM) CAPSULE WEIGHING MAC...
    1979-03-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    3518
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    ROTOWEIGH (TM) CAPSULE WEIGHING MAC...
    Issue/Submission Date
    1979-03-14
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    RECOMBINANT PORCINE CARBOXYPEPTIDASE B (RCPB)

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    USDMF

    Caution USDMF

    15046
    Inactive
    RECOMBINANT PORCINE CARBOXYPEPTIDAS...
    2000-09-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    15046
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    RECOMBINANT PORCINE CARBOXYPEPTIDAS...
    Issue/Submission Date
    2000-09-18
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    MDX-068 (HUMANIZED ANTI-B-AMYLOID MONOCLONAL ANTIBODY)

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    USDMF

    Caution USDMF

    18686
    Inactive
    MDX-068 (HUMANIZED ANTI-B-AMYLOID M...
    2004-03-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    18686
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    MDX-068 (HUMANIZED ANTI-B-AMYLOID M...
    Issue/Submission Date
    2004-03-15
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