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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by ALPS Pharmaceutical Ind. Co. Ltd.

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    ALPS PHARMACEUTICAL IND. CO. LTD.

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    ALPS Pharmaceutical Ind. Co. Ltd.
    japan Flag
    Country
    Country
    Japan
    Address
    Address
    2-10-50 Furukawa-cho Mukai-machi, Hida-shi, Gifu 509-4241 JAPAN
    Telephone
    Telephone
    81 577 732 021
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.alps-pharm.co.jp/english/
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    Enoxolone

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2022-388 - Rev 00
    Valid
    Enoxolone, New process
    2023-01-18
    Japanese DMF

    Found JDMF

    304MF10076
    Glycyrrhetinic Acid at 2-10-50 Muka...
    2022-05-18
    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2022-388 - Rev 00
    304MF10076
    Status
    Valid
     
    Filing Details
    Enoxolone, New process
    Glycyrrhetinic Acid at 2-10-50 Muka...
    Issue/Submission Date
    2023-01-18
    2022-05-18
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    Enoxolone

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2016-098 - Rev 01
    Expired
    Enoxolone
    2023-03-14
    Japanese DMF

    Found JDMF

    228MF10079
    Glycyrrhetinic acid at 2-10-50 Muka...
    2016-04-06
    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2016-098 - Rev 01
    228MF10079
    Status
    Expired
     
    Filing Details
    Enoxolone
    Glycyrrhetinic acid at 2-10-50 Muka...
    Issue/Submission Date
    2023-03-14
    2016-04-06
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    Aspartic Acid API

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF11041
    Potassium L- aspartic acid at 2-10-...
    2005-12-02
    Written Confirmation

    Close WC

    Application Number
    217MF11041
    Status
     
    Filing Details
    Potassium L- aspartic acid at 2-10-...
    Issue/Submission Date
    2005-12-02
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    Azulene

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF11057
    Azulene sodium sulfonate at 2-10-50...
    2005-12-02
    Written Confirmation

    Close WC

    Application Number
    217MF11057
    Status
     
    Filing Details
    Azulene sodium sulfonate at 2-10-50...
    Issue/Submission Date
    2005-12-02
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    Berberine Chloride Hydrate

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    221MF10207
    Japanese Pharmacopoeia berberine ch...
    2009-09-24
    Written Confirmation

    Close WC

    Application Number
    221MF10207
    Status
     
    Filing Details
    Japanese Pharmacopoeia berberine ch...
    Issue/Submission Date
    2009-09-24
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    Berberine Sulphate

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF11040
    Berberine sulfate at 2-10-50 Mukai-...
    2005-12-02
    Written Confirmation

    Close WC

    Application Number
    217MF11040
    Status
     
    Filing Details
    Berberine sulfate at 2-10-50 Mukai-...
    Issue/Submission Date
    2005-12-02
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    Calcium Sennoside

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    224MF10062
    SENNA GLYCOSIDES, CA 60% at 2-10-50...
    2012-04-01
    Written Confirmation

    Close WC

    Application Number
    224MF10062
    Status
     
    Filing Details
    SENNA GLYCOSIDES, CA 60% at 2-10-50...
    Issue/Submission Date
    2012-04-01
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    Calcium Sennoside

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF11063
    Sen\\\'nosaido calcium S (Alps) at ...
    2005-12-02
    Written Confirmation

    Close WC

    Application Number
    217MF11063
    Status
     
    Filing Details
    Sen\\\'nosaido calcium S (Alps) at ...
    Issue/Submission Date
    2005-12-02
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    Capsicum Annuum L.

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF11049
    Pepper extract -Z at 2-10-50 Mukai-...
    2005-12-02
    Written Confirmation

    Close WC

    Application Number
    217MF11049
    Status
     
    Filing Details
    Pepper extract -Z at 2-10-50 Mukai-...
    Issue/Submission Date
    2005-12-02
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    Cassia Senna L

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF11062
    Senna extract at 2-10-50 Mukai-cho,...
    2005-12-02
    Written Confirmation

    Close WC

    Application Number
    217MF11062
    Status
     
    Filing Details
    Senna extract at 2-10-50 Mukai-cho,...
    Issue/Submission Date
    2005-12-02
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    D-Panthenol

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF11027
    Panthenol at 2-10-50 Mukai-cho, Fur...
    2005-12-02
    Written Confirmation

    Close WC

    Application Number
    217MF11027
    Status
     
    Filing Details
    Panthenol at 2-10-50 Mukai-cho, Fur...
    Issue/Submission Date
    2005-12-02
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    Dextromethorphan Hydrobromide

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    220MF10121
    Japanese Pharmacopoeia dextromethor...
    2008-04-28
    Written Confirmation

    Close WC

    Application Number
    220MF10121
    Status
     
    Filing Details
    Japanese Pharmacopoeia dextromethor...
    Issue/Submission Date
    2008-04-28
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    Enoxolone

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF11025
    Glycyrrhetinic acid at 2-10-50 Muka...
    2005-12-02
    Written Confirmation

    Close WC

    Application Number
    217MF11025
    Status
     
    Filing Details
    Glycyrrhetinic acid at 2-10-50 Muka...
    Issue/Submission Date
    2005-12-02
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    Ephedrine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    221MF10172
    Japanese Pharmacopoeia dl- methyl e...
    2009-07-30
    Written Confirmation

    Close WC

    Application Number
    221MF10172
    Status
     
    Filing Details
    Japanese Pharmacopoeia dl- methyl e...
    Issue/Submission Date
    2009-07-30
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    Fluticasone Propionate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    224MF10093
    Fluticasone propionate at 2-10-50 M...
    2012-04-25
    Written Confirmation

    Close WC

    Application Number
    224MF10093
    Status
     
    Filing Details
    Fluticasone propionate at 2-10-50 M...
    Issue/Submission Date
    2012-04-25
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    Glycrrhizin

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF11022
    Japanese Pharmacopoeia licorice ext...
    2005-12-02
    Written Confirmation

    Close WC

    Application Number
    217MF11022
    Status
     
    Filing Details
    Japanese Pharmacopoeia licorice ext...
    Issue/Submission Date
    2005-12-02
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    Hyoscine Butyl Bromide

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10163
    Japanese Pharmacopoeia-butyl scopol...
    2007-05-21
    Written Confirmation

    Close WC

    Application Number
    219MF10163
    Status
     
    Filing Details
    Japanese Pharmacopoeia-butyl scopol...
    Issue/Submission Date
    2007-05-21
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    Hyoscyamine Sulfate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF11030
    Japanese Pharmacopoeia funnel extra...
    2005-12-02
    Written Confirmation

    Close WC

    Application Number
    217MF11030
    Status
     
    Filing Details
    Japanese Pharmacopoeia funnel extra...
    Issue/Submission Date
    2005-12-02
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    Magnesium Aspartate

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF11042
    Magnesium L- aspartic acid, potassi...
    2005-12-02
    Written Confirmation

    Close WC

    Application Number
    217MF11042
    Status
     
    Filing Details
    Magnesium L- aspartic acid, potassi...
    Issue/Submission Date
    2005-12-02
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    Methscopolamine Bromide

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF11029
    Methylsulfate N- methyl scopolamine...
    2005-12-02
    Written Confirmation

    Close WC

    Application Number
    217MF11029
    Status
     
    Filing Details
    Methylsulfate N- methyl scopolamine...
    Issue/Submission Date
    2005-12-02
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    Panipenem

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF11051
    Betamipron at 2-10-50 Mukai-cho, Fu...
    2005-12-02
    Written Confirmation

    Close WC

    Application Number
    217MF11051
    Status
     
    Filing Details
    Betamipron at 2-10-50 Mukai-cho, Fu...
    Issue/Submission Date
    2005-12-02
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    Pentoxiverine citrate

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10025
    Japanese Pharmacopoeia pentoxyverin...
    2013-02-13
    Written Confirmation

    Close WC

    Application Number
    225MF10025
    Status
     
    Filing Details
    Japanese Pharmacopoeia pentoxyverin...
    Issue/Submission Date
    2013-02-13
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    Pentoxiverine citrate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    221MF10228
    Japanese Pharmacopoeia pentoxyverin...
    2009-10-19
    Written Confirmation

    Close WC

    Application Number
    221MF10228
    Status
     
    Filing Details
    Japanese Pharmacopoeia pentoxyverin...
    Issue/Submission Date
    2009-10-19
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    • FDA
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    Plantago Lanceolata L.

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF11055
    Plantain extract at 2-10-50 Mukai-c...
    2005-12-02
    Written Confirmation

    Close WC

    Application Number
    217MF11055
    Status
     
    Filing Details
    Plantain extract at 2-10-50 Mukai-c...
    Issue/Submission Date
    2005-12-02
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    Potassium

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF11059
    Potassium cresol sulfonic acid at 2...
    2005-12-02
    Written Confirmation

    Close WC

    Application Number
    217MF11059
    Status
     
    Filing Details
    Potassium cresol sulfonic acid at 2...
    Issue/Submission Date
    2005-12-02
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    Prednisolone Valerate Acetate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    221MF10164
    Prednisolone valerate acetate at 2-...
    2009-07-23
    Written Confirmation

    Close WC

    Application Number
    221MF10164
    Status
     
    Filing Details
    Prednisolone valerate acetate at 2-...
    Issue/Submission Date
    2009-07-23
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    Protamine Sulfate

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    USDMF

    Found USDMF

    20538
    Active
    PROTAMINE SULFATE
    2007-05-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20538
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    PROTAMINE SULFATE
    Issue/Submission Date
    2007-05-11
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    Quinine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10105
    Japanese Pharmacopoeia quinine hydr...
    2010-03-19
    Written Confirmation

    Close WC

    Application Number
    222MF10105
    Status
     
    Filing Details
    Japanese Pharmacopoeia quinine hydr...
    Issue/Submission Date
    2010-03-19
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    Rutin

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2011-383 - Rev 00
    Valid
    Rutoside trihydrate, Uncaria
    2018-11-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2011-383 - Rev 00
    Status
    Valid
     
    Filing Details
    Rutoside trihydrate, Uncaria
    Issue/Submission Date
    2018-11-27
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    Rutin

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2006-129 - Rev 01
    Valid
    Rutoside trihydrate
    2019-08-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2006-129 - Rev 01
    Status
    Valid
     
    Filing Details
    Rutoside trihydrate
    Issue/Submission Date
    2019-08-01
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    Scopolamine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    303MF10050
    Scopolamine hydrobromide hydrate at...
    2021-03-22
    Written Confirmation

    Close WC

    Application Number
    303MF10050
    Status
     
    Filing Details
    Scopolamine hydrobromide hydrate at...
    Issue/Submission Date
    2021-03-22
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    • FDA
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    Scopolamine Hydrobromide

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10032
    Japanese Pharmacopoeia scopolamine ...
    2015-01-23
    Written Confirmation

    Close WC

    Application Number
    227MF10032
    Status
     
    Filing Details
    Japanese Pharmacopoeia scopolamine ...
    Issue/Submission Date
    2015-01-23
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    Tiotropium Bromide

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    221MF10173
    Japanese Pharmacopoeia Butoropiumu ...
    2009-07-30
    Written Confirmation

    Close WC

    Application Number
    221MF10173
    Status
     
    Filing Details
    Japanese Pharmacopoeia Butoropiumu ...
    Issue/Submission Date
    2009-07-30
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    Japanese Pharmacopoeia bellflower flow extract

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    USDMF

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    CEP/COS

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    Japanese DMF

    Found JDMF

    217MF11023
    Japanese Pharmacopoeia bellflower f...
    2005-12-02
    Written Confirmation

    Close WC

    Application Number
    217MF11023
    Status
     
    Filing Details
    Japanese Pharmacopoeia bellflower f...
    Issue/Submission Date
    2005-12-02
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    Ouhiekisu

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF11043
    Ouhiekisu at 2-10-50 Mukai-cho, Fur...
    2005-12-02
    Written Confirmation

    Close WC

    Application Number
    217MF11043
    Status
     
    Filing Details
    Ouhiekisu at 2-10-50 Mukai-cho, Fur...
    Issue/Submission Date
    2005-12-02
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    Peony root extract

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF11048
    Peony root extract at 2-10-50 Mukai...
    2005-12-02
    Written Confirmation

    Close WC

    Application Number
    217MF11048
    Status
     
    Filing Details
    Peony root extract at 2-10-50 Mukai...
    Issue/Submission Date
    2005-12-02
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    Phenylpropanolamine

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    USDMF

    Caution USDMF

    4255
    Inactive
    PHENYLPROPANOLAMINE HYDROCHLORIDE
    1981-07-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    4255
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    PHENYLPROPANOLAMINE HYDROCHLORIDE
    Issue/Submission Date
    1981-07-08
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    Sennosides

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    USDMF

    Caution USDMF

    13991
    Inactive
    SENNOSIDES USP
    1999-02-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13991
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    SENNOSIDES USP
    Issue/Submission Date
    1999-02-23
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    Sennosides

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    USDMF

    Caution USDMF

    14132
    Inactive
    SENNOSIDES(60)
    1999-05-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14132
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    SENNOSIDES(60)
    Issue/Submission Date
    1999-05-01
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    MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    9325
    Inactive
    MANUFACTURING SITE, FACILITIES, PER...
    1991-09-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    9325
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    MANUFACTURING SITE, FACILITIES, PER...
    Issue/Submission Date
    1991-09-03
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    MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

    PDF Supplier PDF
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    See Less

    USDMF

    Caution USDMF

    9326
    Inactive
    MANUFACTURING SITE, FACILITIES, PER...
    1991-09-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    9326
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    MANUFACTURING SITE, FACILITIES, PER...
    Issue/Submission Date
    1991-09-03
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    MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING...

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Caution USDMF

    13990
    Inactive
    MANUFACTURING SITE, FACILITIES, PER...
    1999-02-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13990
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    MANUFACTURING SITE, FACILITIES, PER...
    Issue/Submission Date
    1999-02-23
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