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    • FDA
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    Colchicine

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    USDMF

    Found USDMF

    10088
    Active
    COLCHICINE USP
    1993-02-10
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-182 - Rev 03
    Valid
    Colchicine
    2021-11-08
    Japanese DMF

    Found JDMF

    218MF10226
    Colchicine at Viale Ortles 12 Milan...
    2006-02-16
    Written Confirmation

    Close WC

    Application Number
    10088
    R1-CEP 2004-182 - Rev 03
    218MF10226
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    COLCHICINE USP
    Colchicine
    Colchicine at Viale Ortles 12 Milan...
    Issue/Submission Date
    1993-02-10
    2021-11-08
    2006-02-16
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    Docetaxel

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    USDMF

    Found USDMF

    23884
    Active
    N-DEBOC-DOCETAXEL (N-DEBENZOYL-10-D...
    2010-06-08
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-094 - Rev 01
    Valid
    Docetaxel trihydrate
    2020-08-25
    Japanese DMF

    Found JDMF

    301MF10103
    Docetaxel at Viale Ortles 12 Milan ...
    2019-12-10
    Written Confirmation

    Close WC

    Application Number
    23884
    R0-CEP 2018-094 - Rev 01
    301MF10103
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    N-DEBOC-DOCETAXEL (N-DEBENZOYL-10-D...
    Docetaxel trihydrate
    Docetaxel at Viale Ortles 12 Milan ...
    Issue/Submission Date
    2010-06-08
    2020-08-25
    2019-12-10
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    Paclitaxel

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    USDMF

    Found USDMF

    16242
    Active
    PACLITAXEL P.I.
    2002-11-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-102 - Rev 03
    Valid
    Paclitaxel, produced by semi-synthe...
    2022-10-19
    Japanese DMF

    Found JDMF

    221MF10053
    Paclitaxel / S at Viale Ortles 12 M...
    2009-03-16
    Written Confirmation

    Close WC

    Application Number
    16242
    R1-CEP 2008-102 - Rev 03
    221MF10053
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    PACLITAXEL P.I.
    Paclitaxel, produced by semi-synthe...
    Paclitaxel / S at Viale Ortles 12 M...
    Issue/Submission Date
    2002-11-13
    2022-10-19
    2009-03-16
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    Paclitaxel

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    USDMF

    Caution USDMF

    12757
    Inactive
    PACLITAXEL, DRUG SUBSTANCE
    1997-11-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-320 - Rev 02
    Valid
    Paclitaxel, Isolated from natural s...
    2020-11-19
    Japanese DMF

    Found JDMF

    218MF10269
    Paclitaxel / PI at Viale Ortles 12 ...
    2006-05-22
    Written Confirmation

    Close WC

    Application Number
    12757
    R1-CEP 2006-320 - Rev 02
    218MF10269
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    PACLITAXEL, DRUG SUBSTANCE
    Paclitaxel, Isolated from natural s...
    Paclitaxel / PI at Viale Ortles 12 ...
    Issue/Submission Date
    1997-11-20
    2020-11-19
    2006-05-22
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    Paclitaxel

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    USDMF

    Caution USDMF

    12876
    Inactive
    PACLITAXEL
    1998-02-23
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-346 - Rev 05
    Valid
    Paclitaxel, Produced by a semi-synt...
    2023-07-11
    Japanese DMF

    Found JDMF

    226MF10210
    Paclitaxel / S at Viale Ortles 12 M...
    2014-10-27
    Written Confirmation

    Close WC

    Application Number
    12876
    R0-CEP 2019-346 - Rev 05
    226MF10210
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    PACLITAXEL
    Paclitaxel, Produced by a semi-synt...
    Paclitaxel / S at Viale Ortles 12 M...
    Issue/Submission Date
    1998-02-23
    2023-07-11
    2014-10-27
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    Docetaxel

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    USDMF

    Found USDMF

    23886
    Active
    DOCETAXEL
    2010-08-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-216 - Rev 01
    Valid
    Docetaxel
    2020-08-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23886
    R1-CEP 2012-216 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DOCETAXEL
    Docetaxel
    Issue/Submission Date
    2010-08-30
    2020-08-25
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    Colchicine

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    USDMF

    Caution USDMF

    22115
    Inactive
    IDN 5404 (THIOCOLCHICINE DERIVATIVE...
    2008-10-29
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-118 - Rev 00
    Valid
    Colchicine, Micronised
    2021-08-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22115
    R0-CEP 2021-118 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    IDN 5404 (THIOCOLCHICINE DERIVATIVE...
    Colchicine, Micronised
    Issue/Submission Date
    2008-10-29
    2021-08-13
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    Paclitaxel

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    USDMF

    Found USDMF

    20977
    Active
    PACLITAXEL/S
    2007-10-22
    CEP/COS

    Caution CEP/COS

    R1-CEP 2006-319 - Rev 00
    Withdrawn by Holder
    Paclitaxel, isolated from natural s...
    2013-03-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20977
    R1-CEP 2006-319 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    PACLITAXEL/S
    Paclitaxel, isolated from natural s...
    Issue/Submission Date
    2007-10-22
    2013-03-26
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    10-Deacetylbaccatin- III

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    USDMF

    Found USDMF

    10462
    Active
    10-DEACETYLBACCATIN III/R
    1993-08-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10462
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    10-DEACETYLBACCATIN III/R
    Issue/Submission Date
    1993-08-25
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    Bilberry

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2009-158 - Rev 01
    Valid
    Fresh bilberry fruit dry extract, r...
    2020-11-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2009-158 - Rev 01
    Status
    Valid
     
    Filing Details
    Fresh bilberry fruit dry extract, r...
    Issue/Submission Date
    2020-11-19
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    Cabazitaxel

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    USDMF

    Found USDMF

    34809
    Active
    CABAZITAXEL
    2020-04-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34809
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CABAZITAXEL
    Issue/Submission Date
    2020-04-17
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    Cannabidiol

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    USDMF

    Found USDMF

    35648
    Active
    CANNABIDIOL
    2021-02-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35648
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CANNABIDIOL
    Issue/Submission Date
    2021-02-16
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    Docetaxel

    PDF Supplier PDF
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    USDMF

    Found USDMF

    33209
    Active
    DOCETAXEL TRIHYDRATE
    2018-09-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33209
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DOCETAXEL TRIHYDRATE
    Issue/Submission Date
    2018-09-28
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    Galantamine Hydrobromide

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2011-288 - Rev 01
    Valid
    Galantamine hydrobromide, Isolated ...
    2020-11-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2011-288 - Rev 01
    Status
    Valid
     
    Filing Details
    Galantamine hydrobromide, Isolated ...
    Issue/Submission Date
    2020-11-19
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    Ginkgo Biloba Extract

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2012-267 - Rev 00
    Valid
    Ginkgo dry extract, refined and qua...
    2018-08-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2012-267 - Rev 00
    Status
    Valid
     
    Filing Details
    Ginkgo dry extract, refined and qua...
    Issue/Submission Date
    2018-08-27
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    Paclitaxel

    PDF Supplier PDF
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    USDMF

    Found USDMF

    27162
    Active
    PACLITAXEL/S SEMISYNTHETIC PROCESS,...
    2013-08-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27162
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PACLITAXEL/S SEMISYNTHETIC PROCESS,...
    Issue/Submission Date
    2013-08-06
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    Paclitaxel

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    USDMF

    Found USDMF

    34200
    Active
    PACLITAXEL/SW
    2019-10-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34200
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PACLITAXEL/SW
    Issue/Submission Date
    2019-10-25
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    Perforate St John wort

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2011-163 - Rev 02
    Valid
    St. John\'s wort dry extract, quant...
    2024-03-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2011-163 - Rev 02
    Status
    Valid
     
    Filing Details
    St. John\'s wort dry extract, quant...
    Issue/Submission Date
    2024-03-15
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    Reserpine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    4942
    Active
    RESERPINE USP
    1983-04-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4942
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    RESERPINE USP
    Issue/Submission Date
    1983-04-29
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    Resiniferatoxin

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    USDMF

    Found USDMF

    34626
    Active
    RESINIFERATOXIN
    2020-03-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34626
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    RESINIFERATOXIN
    Issue/Submission Date
    2020-03-11
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    saw palmetto

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2022-484 - Rev 00
    Valid
    Saw palmetto extract, DER: 7-11:1 -...
    2023-04-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2022-484 - Rev 00
    Status
    Valid
     
    Filing Details
    Saw palmetto extract, DER: 7-11:1 -...
    Issue/Submission Date
    2023-04-12
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    saw palmetto

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2014-116 - Rev 00
    Valid
    Saw palmetto extract, DER:6.5-9:1
    2020-05-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2014-116 - Rev 00
    Status
    Valid
     
    Filing Details
    Saw palmetto extract, DER:6.5-9:1
    Issue/Submission Date
    2020-05-28
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    Silybum Marianum L.

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2014-265 - Rev 00
    Valid
    Milk thistle dry extract, refined a...
    2021-04-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2014-265 - Rev 00
    Status
    Valid
     
    Filing Details
    Milk thistle dry extract, refined a...
    Issue/Submission Date
    2021-04-19
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    Thiocolchicoside

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2015-294 - Rev 00
    Valid
    Thiocolchicoside hydrate, Code 3064...
    2022-02-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2015-294 - Rev 00
    Status
    Valid
     
    Filing Details
    Thiocolchicoside hydrate, Code 3064...
    Issue/Submission Date
    2022-02-03
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    Thiocolchicoside

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2015-333 - Rev 00
    Valid
    Thiocolchicoside hydrate, Indena In...
    2022-04-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2015-333 - Rev 00
    Status
    Valid
     
    Filing Details
    Thiocolchicoside hydrate, Indena In...
    Issue/Submission Date
    2022-04-14
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    Thiocolchicoside

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2016-055 - Rev 01
    Valid
    Thiocolchicoside crystallised from ...
    2023-03-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2016-055 - Rev 01
    Status
    Valid
     
    Filing Details
    Thiocolchicoside crystallised from ...
    Issue/Submission Date
    2023-03-29
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    Thiocolchicoside

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2015-298 - Rev 00
    Valid
    Thiocolchicoside crystallised from ...
    2022-02-07
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R1-CEP 2015-298 - Rev 00
    Status
    Valid
     
    Filing Details
    Thiocolchicoside crystallised from ...
    Issue/Submission Date
    2022-02-07
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    Thiocolchicoside

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2015-285 - Rev 00
    Valid
    Thiocolchicoside hydrate, Code 3064...
    2022-02-23
    Japanese DMF

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    Written Confirmation

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    Application Number
    R1-CEP 2015-285 - Rev 00
    Status
    Valid
     
    Filing Details
    Thiocolchicoside hydrate, Code 3064...
    Issue/Submission Date
    2022-02-23
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    Thiotepa

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    USDMF

    Found USDMF

    33037
    Active
    THIOTEPA
    2019-05-24
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    33037
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    THIOTEPA
    Issue/Submission Date
    2019-05-24
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    Cascara

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    USDMF

    Caution USDMF

    3085
    Inactive
    CASANTHRANOL (THIS D FORMERLY HELD...
    1977-11-21
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    3085
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CASANTHRANOL (THIS D FORMERLY HELD...
    Issue/Submission Date
    1977-11-21
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    Deserpidine

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    USDMF

    Caution USDMF

    4808
    Inactive
    DESERPIDINE USP
    1983-02-18
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    4808
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    DESERPIDINE USP
    Issue/Submission Date
    1983-02-18
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    Ingenol Mebutate

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    USDMF

    Caution USDMF

    28747
    Inactive
    INGENOL MEBUTATE
    2014-12-22
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    28747
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    INGENOL MEBUTATE
    Issue/Submission Date
    2014-12-22
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    MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

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    USDMF

    Caution USDMF

    5344
    Inactive
    MANUFACTURING SITE, FACILITIES, PER...
    1984-05-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5344
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MANUFACTURING SITE, FACILITIES, PER...
    Issue/Submission Date
    1984-05-01
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    FACILITY AND OPERATING PROCEDURES IN SETTALA (MI), ITAL...

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    USDMF

    Caution USDMF

    10463
    Inactive
    FACILITY AND OPERATING PROCEDURES I...
    1993-08-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10463
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    FACILITY AND OPERATING PROCEDURES I...
    Issue/Submission Date
    1993-08-25
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    IDN 5109

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    USDMF

    Caution USDMF

    15872
    Inactive
    IDN 5109
    2002-02-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15872
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    IDN 5109
    Issue/Submission Date
    2002-02-19
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    Boldine

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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    Enoxolone

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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