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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by H. Lundbeck AS

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    H. Lundbeck AS
    Denmark Flag
    Country
    Country
    Denmark
    Address
    Address
    Ottiliavej 9 2500 Valby
    Telephone
    Telephone
    +45 3630 1311
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    Email
    enquiries@pharmacompass.com
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    Website
    https://www.lundbeck.com/global
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    • FDA
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    Citalopram Hydrobromide

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    USDMF

    Found USDMF

    12384
    Active
    CITALOPRAM HYDROBROMIDE
    1997-02-24
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-222 - Rev 00
    Valid
    Citalopram hydrobromide
    2017-01-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12384
    R1-CEP 2010-222 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CITALOPRAM HYDROBROMIDE
    Citalopram hydrobromide
    Issue/Submission Date
    1997-02-24
    2017-01-27
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    • FDA
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    Diazoxide

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    USDMF

    Found USDMF

    7031
    Active
    DIAZOXIDE
    1987-06-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10985
    Diazoxide at Via Quarta Strada, 2 P...
    2006-12-18
    Written Confirmation

    Close WC

    Application Number
    7031
    218MF10985
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DIAZOXIDE
    Diazoxide at Via Quarta Strada, 2 P...
    Issue/Submission Date
    1987-06-22
    2006-12-18
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    • FDA
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    Escitalopram Oxalate

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    USDMF

    Found USDMF

    14103
    Active
    ESCITALOPRAM OXALATE
    1999-04-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10216
    Escitalopram oxalate at Ottiliavej ...
    2010-08-10
    Written Confirmation

    Close WC

    Application Number
    14103
    222MF10216
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ESCITALOPRAM OXALATE
    Escitalopram oxalate at Ottiliavej ...
    Issue/Submission Date
    1999-04-29
    2010-08-10
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    • FDA
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    Trimipramine

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    USDMF

    Found USDMF

    5900
    Active
    TRIMIPRAMINE MALEATE
    1985-04-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-329 - Rev 00
    Valid
    Trimipramine maleate
    2018-01-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5900
    R1-CEP 2011-329 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TRIMIPRAMINE MALEATE
    Trimipramine maleate
    Issue/Submission Date
    1985-04-22
    2018-01-24
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    • FDA
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    Vortioxetine Hydrobromide

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    USDMF

    Found USDMF

    21224
    Active
    LU AA21004 HYDROBROMIDE
    2008-01-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    230MF10076
    Vortioxetine Hydrobromide at Via Qu...
    2018-07-03
    Written Confirmation

    Close WC

    Application Number
    21224
    230MF10076
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LU AA21004 HYDROBROMIDE
    Vortioxetine Hydrobromide at Via Qu...
    Issue/Submission Date
    2008-01-17
    2018-07-03
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    • FDA
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    Argatroban

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    USDMF

    Found USDMF

    21304
    Active
    ARGATROBAN
    2008-01-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21304
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ARGATROBAN
    Issue/Submission Date
    2008-01-30
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    Argatroban Monohydrate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10090
    Argatroban hydrate at Via Quarta St...
    2015-03-12
    Written Confirmation

    Close WC

    Application Number
    227MF10090
    Status
     
    Filing Details
    Argatroban hydrate at Via Quarta St...
    Issue/Submission Date
    2015-03-12
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    • FDA
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    Clomipramine Hydrochloride

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    USDMF

    Found USDMF

    8864
    Active
    CLOMIPRAMINE HYDROCHLORIDE
    1990-11-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8864
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CLOMIPRAMINE HYDROCHLORIDE
    Issue/Submission Date
    1990-11-19
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    Dapsone

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    USDMF

    Found USDMF

    15065
    Active
    DAPSONE
    2000-09-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15065
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DAPSONE
    Issue/Submission Date
    2000-09-29
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    Desipramine Hydrochloride

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    USDMF

    Found USDMF

    3374
    Active
    DESIPRAMINE HYDROCHLORIDE
    1978-10-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    3374
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DESIPRAMINE HYDROCHLORIDE
    Issue/Submission Date
    1978-10-04
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    Imipramine

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    USDMF

    Found USDMF

    22104
    Active
    IMIPRAMINE PAMOATE
    2008-10-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22104
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    IMIPRAMINE PAMOATE
    Issue/Submission Date
    2008-10-15
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    Indomethacin Sodium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10093
    Indomethacin sodium at Via Quarta S...
    2015-03-12
    Written Confirmation

    Close WC

    Application Number
    227MF10093
    Status
     
    Filing Details
    Indomethacin sodium at Via Quarta S...
    Issue/Submission Date
    2015-03-12
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    • FDA
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    Metoclopramide Hydrochloride

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    USDMF

    Found USDMF

    4877
    Active
    METOCLOPRAMIDE HCL MONOHYDRATE
    1983-03-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4877
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    METOCLOPRAMIDE HCL MONOHYDRATE
    Issue/Submission Date
    1983-03-26
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    • FDA
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    Nalmefene Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    229MF10109
    Nalmefene hydrochloride hydrate at ...
    2017-06-26
    Written Confirmation

    Close WC

    Application Number
    229MF10109
    Status
     
    Filing Details
    Nalmefene hydrochloride hydrate at ...
    Issue/Submission Date
    2017-06-26
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    Nalmefene Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    229MF10110
    Nalmefene hydrochloride hydrate at ...
    2017-06-26
    Written Confirmation

    Close WC

    Application Number
    229MF10110
    Status
     
    Filing Details
    Nalmefene hydrochloride hydrate at ...
    Issue/Submission Date
    2017-06-26
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    • FDA
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    Ritodrine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    224MF10226
    Ritodrine hydrochloride at Via Quar...
    2012-12-06
    Written Confirmation

    Close WC

    Application Number
    224MF10226
    Status
     
    Filing Details
    Ritodrine hydrochloride at Via Quar...
    Issue/Submission Date
    2012-12-06
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    Ritodrine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10513
    Ritodrine hydrochloride at Via Quar...
    2006-05-18
    Written Confirmation

    Close WC

    Application Number
    218MF10513
    Status
     
    Filing Details
    Ritodrine hydrochloride at Via Quar...
    Issue/Submission Date
    2006-05-18
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    • FDA
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    Thip Hydrochloride

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    USDMF

    Found USDMF

    18417
    Active
    GABOXADOL MONOHYDRATE
    2005-06-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18417
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    GABOXADOL MONOHYDRATE
    Issue/Submission Date
    2005-06-09
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    • FDA
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    Vortioxetine Hydrobromide

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    230MF10077
    Vortioxetine Hydrobromide at Ottili...
    2018-07-03
    Written Confirmation

    Close WC

    Application Number
    230MF10077
    Status
     
    Filing Details
    Vortioxetine Hydrobromide at Ottili...
    Issue/Submission Date
    2018-07-03
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    • FDA
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    Alfuzosin HCl

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    USDMF

    Caution USDMF

    20540
    Inactive
    ALFUZOSIN HYDROCHLORIDE
    2007-05-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20540
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ALFUZOSIN HYDROCHLORIDE
    Issue/Submission Date
    2007-05-15
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    • FDA
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    Calcium Amphomycin

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    USDMF

    Caution USDMF

    433
    Inactive
    CALCIUM - AMPHOMYCIN
    1961-05-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    433
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CALCIUM - AMPHOMYCIN
    Issue/Submission Date
    1961-05-12
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    • FDA
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    Ethotoin

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    25673
    Inactive
    ETHOTOIN
    2012-04-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25673
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ETHOTOIN
    Issue/Submission Date
    2012-04-10
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    Imipramine Hydrochloride

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    USDMF

    Caution USDMF

    1913
    Inactive
    IMIPRAMINE HYDROCHLORIDE
    1972-04-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    1913
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    IMIPRAMINE HYDROCHLORIDE
    Issue/Submission Date
    1972-04-05
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    • FDA
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    Melperone

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    20837
    Inactive
    MELPERONE HYDROCHLORIDE
    2007-07-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20837
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MELPERONE HYDROCHLORIDE
    Issue/Submission Date
    2007-07-27
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    Sertindole

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    USDMF

    Caution USDMF

    9414
    Inactive
    SERTINDOLE BULK DRUG SUBSTANCE
    1991-11-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    9414
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    SERTINDOLE BULK DRUG SUBSTANCE
    Issue/Submission Date
    1991-11-20
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    Tedatioxetine Hydrobromide

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    USDMF

    Caution USDMF

    21844
    Inactive
    LU AA24530 HYDROBROMIDE
    2008-09-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21844
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    LU AA24530 HYDROBROMIDE
    Issue/Submission Date
    2008-09-29
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    Tetrabenazine

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    USDMF

    Caution USDMF

    14323
    Inactive
    NITOMAN(TETRABENAZINE) TABLETS
    1999-07-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14323
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    NITOMAN(TETRABENAZINE) TABLETS
    Issue/Submission Date
    1999-07-25
    ASK
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    LU 3-010

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    1803
    Inactive
    LU 3-010
    1971-09-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    1803
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    LU 3-010
    Issue/Submission Date
    1971-09-27
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    FACILITY IN NYKOBING SJ., DENMARK

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    9413
    Inactive
    FACILITY IN NYKOBING SJ., DENMARK
    1991-11-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    9413
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    FACILITY IN NYKOBING SJ., DENMARK
    Issue/Submission Date
    1991-11-20
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    • FDA
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    LU-25-109-M DRUG SUBSTANCE

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    See Less

    USDMF

    Caution USDMF

    12257
    Inactive
    LU-25-109-M DRUG SUBSTANCE
    1996-12-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12257
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    LU-25-109-M DRUG SUBSTANCE
    Issue/Submission Date
    1996-12-09
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    USDMF

    Caution USDMF

    12381
    Inactive
    MANUFACTURING SITE, FACILITIES, PER...
    1997-02-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12381
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MANUFACTURING SITE, FACILITIES, PER...
    Issue/Submission Date
    1997-02-24
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    See Less

    USDMF

    Caution USDMF

    12382
    Inactive
    MANUFACTURING SITE, FACILITIES, PER...
    1997-02-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12382
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MANUFACTURING SITE, FACILITIES, PER...
    Issue/Submission Date
    1997-02-24
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    See Less

    USDMF

    Caution USDMF

    12383
    Inactive
    MANUFACTURING SITE, FACILITIES, PER...
    1997-02-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12383
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MANUFACTURING SITE, FACILITIES, PER...
    Issue/Submission Date
    1997-02-24
    ASK
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    your Marketing & Sales content
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    LU 28-179-C, DRUG SUBSTANCE

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    USDMF

    Caution USDMF

    13052
    Inactive
    LU 28-179-C, DRUG SUBSTANCE
    1998-07-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13052
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    LU 28-179-C, DRUG SUBSTANCE
    Issue/Submission Date
    1998-07-02
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    your Marketing & Sales content
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    LU 28-179-CAPSULES

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Caution USDMF

    13053
    Inactive
    LU 28-179-CAPSULES
    1998-07-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13053
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    LU 28-179-CAPSULES
    Issue/Submission Date
    1998-07-02
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