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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Boehringer Ingelheim GmbH

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    Boehringer Ingelheim GmbH
    Germany Flag
    Country
    Country
    Germany
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    Address
    Corporate Division Communications, Binger Strasse 173, 55216 Ingelheim am Rhein
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    Telephone
    +49 - 6132 - 77 0
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    Email
    enquiries@pharmacompass.com
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    Website
    https://www.boehringer-ingelheim.com/
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    • FDA
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    Epinastine Hydrochloride

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    USDMF

    Found USDMF

    15003
    Active
    EPINASTINE HYDROCHLORIDE
    2000-09-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-311 - Rev 01
    Valid
    Epinastine hydrochloride
    2021-03-17
    Japanese DMF

    Found JDMF

    224MF10100
    Epinastine hydrochloride at Binger ...
    2012-05-23
    Written Confirmation

    Close WC

    Application Number
    15003
    R1-CEP 2011-311 - Rev 01
    224MF10100
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    EPINASTINE HYDROCHLORIDE
    Epinastine hydrochloride
    Epinastine hydrochloride at Binger ...
    Issue/Submission Date
    2000-09-11
    2021-03-17
    2012-05-23
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    Ipratropium Bromide

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    USDMF

    Found USDMF

    14259
    Active
    IPRATROPIUM BROMIDE MONOHYDRATE
    1999-06-25
    CEP/COS

    Found CEP/COS

    R1-CEP 1996-005 - Rev 05
    Valid
    Ipratropium bromide
    2015-10-08
    Japanese DMF

    Found JDMF

    220MF10081
    Ipratropium bromide hydrate at Bing...
    2008-03-14
    Written Confirmation

    Close WC

    Application Number
    14259
    R1-CEP 1996-005 - Rev 05
    220MF10081
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    IPRATROPIUM BROMIDE MONOHYDRATE
    Ipratropium bromide
    Ipratropium bromide hydrate at Bing...
    Issue/Submission Date
    1999-06-25
    2015-10-08
    2008-03-14
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    Repaglinide

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    USDMF

    Found USDMF

    19620
    Active
    REPAGLINIDE
    2006-07-24
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-123 - Rev 00
    Valid
    Repaglinide
    2012-09-25
    Japanese DMF

    Found JDMF

    221MF10144
    Repaglinide at Binger Strasse 173,5...
    2009-07-09
    Written Confirmation

    Close WC

    Application Number
    19620
    R1-CEP 2006-123 - Rev 00
    221MF10144
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    REPAGLINIDE
    Repaglinide
    Repaglinide at Binger Strasse 173,5...
    Issue/Submission Date
    2006-07-24
    2012-09-25
    2009-07-09
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    Ketoprofen

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    USDMF

    Caution USDMF

    18148
    Inactive
    KETOPROFEN
    2005-02-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-010 - Rev 02
    Valid
    Ketoprofen
    2010-07-08
    Japanese DMF

    Found JDMF

    218MF10395
    Ketoprofen at S. S. 11 Padana Super...
    2006-03-20
    Written Confirmation

    Close WC

    Application Number
    18148
    R1-CEP 2002-010 - Rev 02
    218MF10395
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    KETOPROFEN
    Ketoprofen
    Ketoprofen at S. S. 11 Padana Super...
    Issue/Submission Date
    2005-02-21
    2010-07-08
    2006-03-20
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    Ambroxol Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2002-142 - Rev 03
    Valid
    Ambroxol hydrochloride
    2011-02-10
    Japanese DMF

    Found JDMF

    220MF10085
    Ambroxol hydrochloride at S. S. 11 ...
    2008-03-18
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2002-142 - Rev 03
    220MF10085
    Status
    Valid
     
    Filing Details
    Ambroxol hydrochloride
    Ambroxol hydrochloride at S. S. 11 ...
    Issue/Submission Date
    2011-02-10
    2008-03-18
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    Atropine Sulfate

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    USDMF

    Caution USDMF

    5494
    Inactive
    ATROPINE SULFATE
    1984-01-11
    CEP/COS

    Caution CEP/COS

    R1-CEP 2000-299 - Rev 02
    Withdrawn by Holder
    Atropine sulfate
    2011-02-18
    Japanese DMF

    Found JDMF

    218MF10482
    Atropine sulfate at Binger Strasse ...
    2006-05-15
    Written Confirmation

    Close WC

    Application Number
    5494
    R1-CEP 2000-299 - Rev 02
    218MF10482
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    ATROPINE SULFATE
    Atropine sulfate
    Atropine sulfate at Binger Strasse ...
    Issue/Submission Date
    1984-01-11
    2011-02-18
    2006-05-15
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    Crotamiton

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    USDMF

    Caution USDMF

    15285
    Inactive
    CROTAMITON
    2001-02-08
    CEP/COS

    Caution CEP/COS

    R1-CEP 1999-131 - Rev 03
    Withdrawn by Holder
    Crotamiton
    2012-05-11
    Japanese DMF

    Found JDMF

    221MF10127
    Crotamiton at S. S. 11 Padana Super...
    2009-06-23
    Written Confirmation

    Close WC

    Application Number
    15285
    R1-CEP 1999-131 - Rev 03
    221MF10127
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    CROTAMITON
    Crotamiton
    Crotamiton at S. S. 11 Padana Super...
    Issue/Submission Date
    2001-02-08
    2012-05-11
    2009-06-23
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    Digoxin

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    USDMF

    Caution USDMF

    6926
    Inactive
    DIGOXIN
    1987-04-06
    CEP/COS

    Caution CEP/COS

    R1-CEP 2000-147 - Rev 04
    Withdrawn by Holder
    Digoxin
    2015-09-25
    Japanese DMF

    Found JDMF

    218MF10484
    Digoxin at Binger Strasse 173,55216...
    2006-05-15
    Written Confirmation

    Close WC

    Application Number
    6926
    R1-CEP 2000-147 - Rev 04
    218MF10484
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    DIGOXIN
    Digoxin
    Digoxin at Binger Strasse 173,55216...
    Issue/Submission Date
    1987-04-06
    2015-09-25
    2006-05-15
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    Epinephrine

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    USDMF

    Caution USDMF

    5822
    Inactive
    EPINEPHRINE
    1985-05-29
    CEP/COS

    Caution CEP/COS

    R1-CEP 2009-274 - Rev 00
    Withdrawn by Holder
    Adrenaline
    2016-03-17
    Japanese DMF

    Found JDMF

    218MF10483
    Epinephrine at Binger Strasse 173, ...
    2006-05-15
    Written Confirmation

    Close WC

    Application Number
    5822
    R1-CEP 2009-274 - Rev 00
    218MF10483
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    EPINEPHRINE
    Adrenaline
    Epinephrine at Binger Strasse 173, ...
    Issue/Submission Date
    1985-05-29
    2016-03-17
    2006-05-15
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    Epinephrine Bitartrate

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    USDMF

    Caution USDMF

    5779
    Inactive
    EPINEPHRINE HYDROGENTARTRATE
    1984-05-04
    CEP/COS

    Caution CEP/COS

    R1-CEP 1999-193 - Rev 02
    Withdrawn by Holder
    Adrenaline tartrate
    2009-11-17
    Japanese DMF

    Found JDMF

    221MF10015
    Epinephrine bitartrate at Binger St...
    2009-01-13
    Written Confirmation

    Close WC

    Application Number
    5779
    R1-CEP 1999-193 - Rev 02
    221MF10015
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    EPINEPHRINE HYDROGENTARTRATE
    Adrenaline tartrate
    Epinephrine bitartrate at Binger St...
    Issue/Submission Date
    1984-05-04
    2009-11-17
    2009-01-13
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    Pramipexole Dihydrochloride

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    USDMF

    Found USDMF

    21413
    Active
    PRAMIPEXOLE DIHYDROCHLORIDE MONOHYD...
    2008-03-12
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-171 - Rev 00
    Valid
    Pramipexole dihydrochloride monohyd...
    2019-01-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21413
    R1-CEP 2011-171 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    PRAMIPEXOLE DIHYDROCHLORIDE MONOHYD...
    Pramipexole dihydrochloride monohyd...
    Issue/Submission Date
    2008-03-12
    2019-01-24
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    Salbutamol Sulphate

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    USDMF

    Found USDMF

    14258
    Active
    ALBUTEROL SULFATE (UNMICRONIZED)
    1999-06-25
    CEP/COS

    Found CEP/COS

    R1-CEP 1997-004 - Rev 04
    Valid
    Salbutamol sulfate
    2010-06-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14258
    R1-CEP 1997-004 - Rev 04
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ALBUTEROL SULFATE (UNMICRONIZED)
    Salbutamol sulfate
    Issue/Submission Date
    1999-06-25
    2010-06-23
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    Scopolamine Hydrobromide

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    USDMF

    Caution USDMF

    3622
    Inactive
    SCOPOLAMINE AMINOXIDE HYDROBROMIDE
    1979-08-23
    CEP/COS

    Caution CEP/COS

    R1-CEP 2000-064 - Rev 01
    Withdrawn by Holder
    Hyoscine hydrobromide
    2008-09-09
    Japanese DMF

    Found JDMF

    221MF10105
    Scopolamine hydrobromide hydrate at...
    2009-05-27
    Written Confirmation

    Close WC

    Application Number
    3622
    R1-CEP 2000-064 - Rev 01
    221MF10105
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    SCOPOLAMINE AMINOXIDE HYDROBROMIDE
    Hyoscine hydrobromide
    Scopolamine hydrobromide hydrate at...
    Issue/Submission Date
    1979-08-23
    2008-09-09
    2009-05-27
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    Sodium Picosulfate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2003-068 - Rev 00
    Valid
    Sodium picosulfate
    2009-11-04
    Japanese DMF

    Found JDMF

    220MF10132
    Picosulfate sodium hydrate at S. S....
    2008-05-20
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2003-068 - Rev 00
    220MF10132
    Status
    Valid
     
    Filing Details
    Sodium picosulfate
    Picosulfate sodium hydrate at S. S....
    Issue/Submission Date
    2009-11-04
    2008-05-20
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    Digoxin

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    USDMF

    Caution USDMF

    21559
    Inactive
    DIGOXIN 20 MICROMETER
    2008-04-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10278
    Digoxin (crystal) at Binger Strasse...
    2010-12-17
    Written Confirmation

    Close WC

    Application Number
    21559
    222MF10278
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    DIGOXIN 20 MICROMETER
    Digoxin (crystal) at Binger Strasse...
    Issue/Submission Date
    2008-04-15
    2010-12-17
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    Dipyridamole

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    USDMF

    Found USDMF

    13870
    Active
    DIPYRIDAMOLE
    1998-11-27
    CEP/COS

    Caution CEP/COS

    R1-CEP 1999-089 - Rev 03
    Withdrawn by Holder
    Dipyridamole
    2009-11-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13870
    R1-CEP 1999-089 - Rev 03
    Status
    Active
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    DIPYRIDAMOLE
    Dipyridamole
    Issue/Submission Date
    1998-11-27
    2009-11-12
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    Doxapram Hydrochloride

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    USDMF

    Caution USDMF

    6114
    Inactive
    DOXAPRAM HYDROCHLORIDE
    1985-12-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10495
    Hydrochloric acid doxapram at 2820 ...
    2006-05-15
    Written Confirmation

    Close WC

    Application Number
    6114
    218MF10495
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    DOXAPRAM HYDROCHLORIDE
    Hydrochloric acid doxapram at 2820 ...
    Issue/Submission Date
    1985-12-02
    2006-05-15
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    Hyoscine Butyl Bromide

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    USDMF

    Caution USDMF

    11679
    Inactive
    SCOPOLAMINE-N-BUTLYBROMIDE (BUSCOPA...
    1995-09-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-063 - Rev 02
    Valid
    Hyoscine butylbromide
    2018-05-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11679
    R1-CEP 2000-063 - Rev 02
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    SCOPOLAMINE-N-BUTLYBROMIDE (BUSCOPA...
    Hyoscine butylbromide
    Issue/Submission Date
    1995-09-20
    2018-05-11
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    Tiotropium Bromide

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    USDMF

    Caution USDMF

    18135
    Inactive
    TIOTROPIUM BROMIDE MONOHYDRATE
    2005-03-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-359 - Rev 00
    Valid
    Tiotropium bromide monohydrate
    2016-10-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18135
    R1-CEP 2010-359 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    TIOTROPIUM BROMIDE MONOHYDRATE
    Tiotropium bromide monohydrate
    Issue/Submission Date
    2005-03-03
    2016-10-06
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    Atropine

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    USDMF

    Caution USDMF

    5791
    Inactive
    ATROPINE
    1985-03-27
    CEP/COS

    Caution CEP/COS

    R1-CEP 2010-150 - Rev 00
    Withdrawn by Holder
    Atropine
    2017-03-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5791
    R1-CEP 2010-150 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    ATROPINE
    Atropine
    Issue/Submission Date
    1985-03-27
    2017-03-17
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    Bisacodyl

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2003-067 - Rev 00
    Valid
    Bisacodyl
    2010-01-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2003-067 - Rev 00
    Status
    Valid
     
    Filing Details
    Bisacodyl
    Issue/Submission Date
    2010-01-07
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    Bisacodyl

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2004-037 - Rev 00
    Valid
    Bisacodyl, Powder
    2010-01-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2004-037 - Rev 00
    Status
    Valid
     
    Filing Details
    Bisacodyl, Powder
    Issue/Submission Date
    2010-01-07
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    Bromhexine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2002-025 - Rev 02
    Valid
    Bromhexine hydrochloride
    2015-12-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2002-025 - Rev 02
    Status
    Valid
     
    Filing Details
    Bromhexine hydrochloride
    Issue/Submission Date
    2015-12-14
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    Brotizolam

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2008-063 - Rev 00
    Valid
    Brotizolam, Micronised
    2014-10-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2008-063 - Rev 00
    Status
    Valid
     
    Filing Details
    Brotizolam, Micronised
    Issue/Submission Date
    2014-10-31
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    Clenbuterol Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2000-122 - Rev 03
    Valid
    Clenbuterol Hydrochloride
    2014-10-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2000-122 - Rev 03
    Status
    Valid
     
    Filing Details
    Clenbuterol Hydrochloride
    Issue/Submission Date
    2014-10-10
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    Clonidine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2003-038 - Rev 00
    Valid
    Clonidine hydrochloride
    2009-05-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2003-038 - Rev 00
    Status
    Valid
     
    Filing Details
    Clonidine hydrochloride
    Issue/Submission Date
    2009-05-14
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    Dihydroergotamine Mesylate

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    USDMF

    Caution USDMF

    10242
    Inactive
    DIHYDROERGOTAMINE MESYLATE
    1993-04-26
    CEP/COS

    Caution CEP/COS

    R1-CEP 2001-268 - Rev 01
    Withdrawn by Holder
    Dihydroergotamine mesilate
    2015-11-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10242
    R1-CEP 2001-268 - Rev 01
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    DIHYDROERGOTAMINE MESYLATE
    Dihydroergotamine mesilate
    Issue/Submission Date
    1993-04-26
    2015-11-03
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    Ergotamine Tartrate

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    USDMF

    Caution USDMF

    5765
    Inactive
    ERGOTAMINE TARTRATE
    1985-03-27
    CEP/COS

    Caution CEP/COS

    R0-CEP 2001-255 - Rev 01
    Withdrawn by Holder
    Ergotamine Tartrate
    2004-10-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5765
    R0-CEP 2001-255 - Rev 01
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    ERGOTAMINE TARTRATE
    Ergotamine Tartrate
    Issue/Submission Date
    1985-03-27
    2004-10-13
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    Etilefrine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2000-011 - Rev 01
    Valid
    Etilefrine Hydrochloride
    2006-04-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2000-011 - Rev 01
    Status
    Valid
     
    Filing Details
    Etilefrine Hydrochloride
    Issue/Submission Date
    2006-04-26
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    Fenoterol Hydrobromide

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 1996-062 - Rev 06
    Valid
    Fenoterol hydrobromide
    2018-05-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1996-062 - Rev 06
    Status
    Valid
     
    Filing Details
    Fenoterol hydrobromide
    Issue/Submission Date
    2018-05-23
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    Homatropine Hydrobromide

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    USDMF

    Caution USDMF

    12067
    Inactive
    HOMATROPINE HYDROBROMIDE
    1996-07-23
    CEP/COS

    Caution CEP/COS

    R1-CEP 2001-176 - Rev 01
    Withdrawn by Holder
    Homatropine Hydrobromide
    2007-11-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12067
    R1-CEP 2001-176 - Rev 01
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    HOMATROPINE HYDROBROMIDE
    Homatropine Hydrobromide
    Issue/Submission Date
    1996-07-23
    2007-11-15
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    Homatropine Methylbromide

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    USDMF

    Caution USDMF

    5441
    Inactive
    HOMATROPINE METHYLBROMIDE
    1984-05-24
    CEP/COS

    Caution CEP/COS

    R1-CEP 2001-175 - Rev 02
    Withdrawn by Holder
    Homatropine Methylbromide
    2012-03-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5441
    R1-CEP 2001-175 - Rev 02
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    HOMATROPINE METHYLBROMIDE
    Homatropine Methylbromide
    Issue/Submission Date
    1984-05-24
    2012-03-16
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    Hyoscyamine Sulfate

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    USDMF

    Caution USDMF

    9351
    Inactive
    HYOSCYAMINE SULFATE
    1991-09-06
    CEP/COS

    Caution CEP/COS

    R1-CEP 2000-298 - Rev 01
    Withdrawn by Holder
    Hyoscyamine sulfate
    2007-10-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    9351
    R1-CEP 2000-298 - Rev 01
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    HYOSCYAMINE SULFATE
    Hyoscyamine sulfate
    Issue/Submission Date
    1991-09-06
    2007-10-05
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    Meloxicam

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    USDMF

    Found USDMF

    13846
    Active
    MELOXICAM
    1998-10-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13846
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MELOXICAM
    Issue/Submission Date
    1998-10-29
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    Metaproterenol Hemisulfate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2004-217 - Rev 00
    Valid
    Orciprenaline sulfate
    2012-03-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2004-217 - Rev 00
    Status
    Valid
     
    Filing Details
    Orciprenaline sulfate
    Issue/Submission Date
    2012-03-07
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    Methocarbamol

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    USDMF

    Found USDMF

    5954
    Active
    METHOCARBAMOL
    1985-07-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5954
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    METHOCARBAMOL
    Issue/Submission Date
    1985-07-09
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    Methylphenidate Hydrochloride

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    USDMF

    Caution USDMF

    15485
    Inactive
    METHYLPHENIDATE HYDROCHLORIDE
    2001-06-20
    CEP/COS

    Caution CEP/COS

    R1-CEP 2009-254 - Rev 00
    Withdrawn by Holder
    Methylphenidate hydrochloride
    2015-11-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15485
    R1-CEP 2009-254 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    METHYLPHENIDATE HYDROCHLORIDE
    Methylphenidate hydrochloride
    Issue/Submission Date
    2001-06-20
    2015-11-25
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    Moxonidine

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    USDMF

    Caution USDMF

    12863
    Inactive
    MOXONIDINE
    1998-02-13
    CEP/COS

    Caution CEP/COS

    R1-CEP 2003-139 - Rev 00
    Withdrawn by Holder
    Moxonidine
    2009-07-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12863
    R1-CEP 2003-139 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    MOXONIDINE
    Moxonidine
    Issue/Submission Date
    1998-02-13
    2009-07-29
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    Phenylephrine Hydrochloride

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    USDMF

    Caution USDMF

    5912
    Inactive
    PHENYLEPHRINE HYDROCHLORIDE
    1985-05-15
    CEP/COS

    Caution CEP/COS

    R1-CEP 2003-167 - Rev 00
    Withdrawn by Holder
    Phenylephrine
    2009-07-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5912
    R1-CEP 2003-167 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    PHENYLEPHRINE HYDROCHLORIDE
    Phenylephrine
    Issue/Submission Date
    1985-05-15
    2009-07-20
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    Phenylephrine Hydrochloride

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    USDMF

    Caution USDMF

    23007
    Inactive
    PHENYLEPHRINE HYDROCHLORIDE 150 MES...
    2009-08-03
    CEP/COS

    Caution CEP/COS

    R1-CEP 1996-065 - Rev 05
    Withdrawn by Holder
    Phenylephrine hydrochloride
    2014-11-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23007
    R1-CEP 1996-065 - Rev 05
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    PHENYLEPHRINE HYDROCHLORIDE 150 MES...
    Phenylephrine hydrochloride
    Issue/Submission Date
    2009-08-03
    2014-11-18
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    Pramipexole Dihydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-186 - Rev 00
    Valid
    Pramipexole dihydrochloride monohyd...
    2020-04-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2019-186 - Rev 00
    Status
    Valid
     
    Filing Details
    Pramipexole dihydrochloride monohyd...
    Issue/Submission Date
    2020-04-02
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    Scopolamine

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    USDMF

    Caution USDMF

    8723
    Inactive
    SCOPOLAMINE
    1990-08-31
    CEP/COS

    Caution CEP/COS

    R1-CEP 2006-216 - Rev 00
    Withdrawn by Holder
    Hyoscine
    2014-06-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8723
    R1-CEP 2006-216 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    SCOPOLAMINE
    Hyoscine
    Issue/Submission Date
    1990-08-31
    2014-06-05
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    Tramazoline Hydrochloride Monohydrate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2004-045 - Rev 00
    Valid
    Tramazoline hydrochloride monohydra...
    2010-01-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2004-045 - Rev 00
    Status
    Valid
     
    Filing Details
    Tramazoline hydrochloride monohydra...
    Issue/Submission Date
    2010-01-21
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    Trospium Chloride

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    USDMF

    Caution USDMF

    14967
    Inactive
    TROSPIUM CHLORIDE
    2000-07-20
    CEP/COS

    Caution CEP/COS

    R1-CEP 2004-316 - Rev 00
    Withdrawn by Holder
    Trospium chloride
    2011-09-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14967
    R1-CEP 2004-316 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    TROSPIUM CHLORIDE
    Trospium chloride
    Issue/Submission Date
    2000-07-20
    2011-09-22
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    Zolpidem Tartrate

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    USDMF

    Caution USDMF

    16940
    Inactive
    ZOLPIDEM TARTRATE
    2003-10-31
    CEP/COS

    Caution CEP/COS

    R0-CEP 2003-279 - Rev 00
    Withdrawn by Holder
    Zolpidem tartrate
    2005-03-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16940
    R0-CEP 2003-279 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    ZOLPIDEM TARTRATE
    Zolpidem tartrate
    Issue/Submission Date
    2003-10-31
    2005-03-03
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    Beperuminogen per plasmid

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    230MF10030
    Beperuminogen per plasmid at Dr. Bo...
    2018-02-19
    Written Confirmation

    Close WC

    Application Number
    230MF10030
    Status
     
    Filing Details
    Beperuminogen per plasmid at Dr. Bo...
    Issue/Submission Date
    2018-02-19
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    Medium / Medium Additives ・ F-Media

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    230MF40022
    Medium / Medium Additives ・ F-Med...
    2018-05-25
    Written Confirmation

    Close WC

    Application Number
    230MF40022
    Status
     
    Filing Details
    Medium / Medium Additives ・ F-Med...
    Issue/Submission Date
    2018-05-25
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    Medium / Medium Additives / G-Medium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    230MF40020
    Medium / Medium Additives / G-Mediu...
    2018-05-25
    Written Confirmation

    Close WC

    Application Number
    230MF40020
    Status
     
    Filing Details
    Medium / Medium Additives / G-Mediu...
    Issue/Submission Date
    2018-05-25
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    Medium / Medium Additives-P-Media

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    230MF40021
    Medium / Medium Additives-P-Media a...
    2018-05-25
    Written Confirmation

    Close WC

    Application Number
    230MF40021
    Status
     
    Filing Details
    Medium / Medium Additives-P-Media a...
    Issue/Submission Date
    2018-05-25
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    Medium / Medium Additives-I-Medium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    230MF40023
    Medium / Medium Additives-I-Medium ...
    2018-05-25
    Written Confirmation

    Close WC

    Application Number
    230MF40023
    Status
     
    Filing Details
    Medium / Medium Additives-I-Medium ...
    Issue/Submission Date
    2018-05-25
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