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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Apotex Pharmachem Inc

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    Apotex Pharmachem
    Canada Flag
    Country
    Country
    Canada
    Address
    Address
    11, 34, 50 Spalding Drive, Brantford, Ontario, Canada N3T 6B8
    Telephone
    Telephone
    +1-519-756-8942
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    Email
    enquiries@pharmacompass.com
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    Website
    https://www.apotex.com/
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    Perindopril Erbumine

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    USDMF

    Found USDMF

    21393
    Active
    PERINDOPRIL TERT-BUTYLAMINE
    2008-03-05
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-196 - Rev 01
    Valid
    Perindopril tert-butylamine, PER55L...
    2023-08-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0128
    Expired
    Perindopril tert-butylamine EP
    2014-03-06
    Application Number
    21393
    R0-CEP 2019-196 - Rev 01
    Indian CDSCO WC-0128
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2016-07-02
    Filing Details
    PERINDOPRIL TERT-BUTYLAMINE
    Perindopril tert-butylamine, PER55L...
    Perindopril tert-butylamine EP
    Issue/Submission Date
    2008-03-05
    2023-08-21
    2014-03-06
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    • FDA
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    Cabergoline

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    USDMF

    Caution USDMF

    22620
    Inactive
    CABERGOLINE USP
    2009-03-13
    CEP/COS

    Found CEP/COS

    CEP 2013-047 - Rev 02
    Valid
    Cabergoline
    2023-11-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0128
    Expired
    Cabergoline (USP/EP)
    2014-03-06
    Application Number
    22620
    CEP 2013-047 - Rev 02
    Indian CDSCO WC-0128
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2016-07-02
    Filing Details
    CABERGOLINE USP
    Cabergoline
    Cabergoline (USP/EP)
    Issue/Submission Date
    2009-03-13
    2023-11-08
    2014-03-06
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    • FDA
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    Mycophenolate Mofetil

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    USDMF

    Caution USDMF

    21227
    Inactive
    MYCOPHENOLATE MOFETIL USP
    2008-01-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-302 - Rev 01
    Valid
    Mycophenolate mofetil
    2018-11-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0128
    Expired
    Mycophenolate Mofetil (USP/EP) 
    2014-03-06
    Application Number
    21227
    R1-CEP 2010-302 - Rev 01
    Indian CDSCO WC-0128
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2016-07-02
    Filing Details
    MYCOPHENOLATE MOFETIL USP
    Mycophenolate mofetil
    Mycophenolate Mofetil (USP/EP) 
    Issue/Submission Date
    2008-01-11
    2018-11-20
    2014-03-06
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    Pramipexole Dihydrochloride

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    USDMF

    Caution USDMF

    21095
    Inactive
    PRAMIPEXOLE DIHYDROCHLORIDE MONOHYD...
    2007-11-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-112 - Rev 00
    Valid
    Pramipexole dihydrochloride monohyd...
    2018-02-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0128
    Expired
    Pramipexole Dihydrochloride Monohyd...
    2014-03-06
    Application Number
    21095
    R1-CEP 2011-112 - Rev 00
    Indian CDSCO WC-0128
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2016-07-02
    Filing Details
    PRAMIPEXOLE DIHYDROCHLORIDE MONOHYD...
    Pramipexole dihydrochloride monohyd...
    Pramipexole Dihydrochloride Monohyd...
    Issue/Submission Date
    2007-11-30
    2018-02-07
    2014-03-06
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    • FDA
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    Pravastatin

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    USDMF

    Found USDMF

    17023
    Active
    PRAVASTATIN SODIUM
    2003-12-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-101 - Rev 04
    Valid
    Pravastatin sodium
    2019-11-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17023
    R1-CEP 2003-101 - Rev 04
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    PRAVASTATIN SODIUM
    Pravastatin sodium
    Issue/Submission Date
    2003-12-11
    2019-11-05
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    • FDA
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    Raloxifene Hydrochloride

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    USDMF

    Caution USDMF

    24589
    Inactive
    RALOXIFENE HYDROCHLORIDE USP
    2011-02-01
    CEP/COS

    Found CEP/COS

    R0-CEP 2017-097 - Rev 00
    Valid
    Raloxifene hydrochloride
    2019-02-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0128
    Expired
    Raloxifene Hydrochloride (USP/EP) 
    2014-03-06
    Application Number
    24589
    R0-CEP 2017-097 - Rev 00
    Indian CDSCO WC-0128
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2016-07-02
    Filing Details
    RALOXIFENE HYDROCHLORIDE USP
    Raloxifene hydrochloride
    Raloxifene Hydrochloride (USP/EP) 
    Issue/Submission Date
    2011-02-01
    2019-02-06
    2014-03-06
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    Rizatriptan Benzoate

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    USDMF

    Caution USDMF

    24061
    Inactive
    RIZATRIPTAN BENZOATE USP
    2010-08-12
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-206 - Rev 00
    Valid
    Rizatriptan benzoate
    2020-11-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0128
    Expired
    Rizartriptan Benzoate (USPIEP) 
    2014-03-06
    Application Number
    24061
    R1-CEP 2013-206 - Rev 00
    Indian CDSCO WC-0128
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2016-07-02
    Filing Details
    RIZATRIPTAN BENZOATE USP
    Rizatriptan benzoate
    Rizartriptan Benzoate (USPIEP) 
    Issue/Submission Date
    2010-08-12
    2020-11-30
    2014-03-06
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    Anastrozole

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    USDMF

    Found USDMF

    23326
    Active
    ANASTROZOLE USP
    2009-12-01
    CEP/COS

    Caution CEP/COS

    R0-CEP 2014-296 - Rev 00
    Expired
    Anastrozole
    2016-01-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23326
    R0-CEP 2014-296 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Expired
     
    Filing Details
    ANASTROZOLE USP
    Anastrozole
    Issue/Submission Date
    2009-12-01
    2016-01-15
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    Dabigatran Etexilate Mesylate

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    USDMF

    Found USDMF

    28029
    Active
    DABIGATRAN ETEXILATE MESYLATE
    2014-03-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0128
    Expired
    Dabigatran Etexilate Mesylate
    2014-03-06
    Application Number
    28029
    Indian CDSCO WC-0128
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2016-07-02
    Filing Details
    DABIGATRAN ETEXILATE MESYLATE
    Dabigatran Etexilate Mesylate
    Issue/Submission Date
    2014-03-28
    2014-03-06
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    • FDA
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    Gatifloxacin

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    USDMF

    Found USDMF

    20685
    Active
    GATIFLOXACIN HEMIHYDRATE
    2007-07-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0128
    Expired
    Gatifloxacin Hemihydrate USP
    2014-03-06
    Application Number
    20685
    Indian CDSCO WC-0128
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2016-07-02
    Filing Details
    GATIFLOXACIN HEMIHYDRATE
    Gatifloxacin Hemihydrate USP
    Issue/Submission Date
    2007-07-13
    2014-03-06
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    Mycophenolate Mofetil

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Caution USDMF

    25746
    Inactive
    MYCOPHENOLATE MOFETIL USP
    2012-01-31
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-263 - Rev 00
    Valid
    Mycophenolate mofetil, MYM
    2019-02-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25746
    R1-CEP 2013-263 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    MYCOPHENOLATE MOFETIL USP
    Mycophenolate mofetil, MYM
    Issue/Submission Date
    2012-01-31
    2019-02-07
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    • FDA
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    Perindopril Arginine

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    30810
    Active
    PERINDOPRIL ARGININE
    2016-08-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0128
    Expired
    Perindopril Arginine 
    2014-03-06
    Application Number
    30810
    Indian CDSCO WC-0128
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2016-07-02
    Filing Details
    PERINDOPRIL ARGININE
    Perindopril Arginine 
    Issue/Submission Date
    2016-08-30
    2014-03-06
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    • FDA
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    Adefovir Dipivoxil

    PDF Supplier PDF
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    USDMF

    Found USDMF

    26630
    Active
    ADEFOVIR DIPIVOXIL
    2012-12-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26630
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ADEFOVIR DIPIVOXIL
    Issue/Submission Date
    2012-12-07
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    • FDA
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    Alfuzosin HCl

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    20595
    Active
    ALFUZOSIN HYDROCHLORIDE USP
    2007-06-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20595
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ALFUZOSIN HYDROCHLORIDE USP
    Issue/Submission Date
    2007-06-08
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    • FDA
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    Aripiprazole

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    19957
    Active
    ARIPIPRAZOLE USP
    2006-11-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19957
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ARIPIPRAZOLE USP
    Issue/Submission Date
    2006-11-13
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    • FDA
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    Atomoxetin Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    20070
    Active
    ATOMOXETINE HYDROCHLORIDE USP
    2007-05-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20070
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ATOMOXETINE HYDROCHLORIDE USP
    Issue/Submission Date
    2007-05-18
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    • FDA
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    Budesonide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    27451
    Active
    BUDESONIDE USP
    2013-11-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27451
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BUDESONIDE USP
    Issue/Submission Date
    2013-11-01
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    Cevimeline Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    22509
    Active
    CEVIMELINE HYDROCHLORIDE HEMIHYDRAT...
    2009-02-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22509
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CEVIMELINE HYDROCHLORIDE HEMIHYDRAT...
    Issue/Submission Date
    2009-02-06
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    • FDA
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    Clonazepam

    PDF Supplier PDF
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    USDMF

    Found USDMF

    22167
    Active
    CLONAZEPAM USP
    2008-11-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22167
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CLONAZEPAM USP
    Issue/Submission Date
    2008-11-11
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    Cyclosporine

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    USDMF

    Found USDMF

    13929
    Active
    CYCLOSPORINE USP (BULK)
    1999-01-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13929
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CYCLOSPORINE USP (BULK)
    Issue/Submission Date
    1999-01-04
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    Darifenacin Hydrobromide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    26824
    Active
    DARIFENACIN HYDROBROMIDE
    2013-08-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26824
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DARIFENACIN HYDROBROMIDE
    Issue/Submission Date
    2013-08-23
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    Deferiprone

    PDF Supplier PDF
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    USDMF

    Found USDMF

    10867
    Active
    DEFERIPRONE
    1994-04-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10867
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DEFERIPRONE
    Issue/Submission Date
    1994-04-12
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    Desvenlafaxine Succinate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    25777
    Active
    DESVENLAFAXINE SUCCINATE MONOHYDRAT...
    2012-02-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25777
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DESVENLAFAXINE SUCCINATE MONOHYDRAT...
    Issue/Submission Date
    2012-02-13
    ASK
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    Doxazosin Mesylate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    13039
    Active
    DOXAZOSIN MESYLATE USP
    1998-06-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13039
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DOXAZOSIN MESYLATE USP
    Issue/Submission Date
    1998-06-22
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    Erlotinib Hydrochloride

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    USDMF

    Found USDMF

    26631
    Active
    ERLOTINIB HYDROCHLORIDE
    2013-01-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26631
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ERLOTINIB HYDROCHLORIDE
    Issue/Submission Date
    2013-01-22
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    Fesoterodine

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    USDMF

    Found USDMF

    26345
    Active
    FESOTERODINE FUMARATE
    2012-08-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26345
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FESOTERODINE FUMARATE
    Issue/Submission Date
    2012-08-17
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    Fluvoxamine

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    USDMF

    Found USDMF

    14529
    Active
    FLUVOXAMINE MALEATE USP
    1999-11-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14529
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FLUVOXAMINE MALEATE USP
    Issue/Submission Date
    1999-11-12
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    Ibandronate Sodium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    20525
    Active
    IBANDRONATE SODIUM
    2007-05-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20525
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    IBANDRONATE SODIUM
    Issue/Submission Date
    2007-05-11
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    Levofloxacin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    19458
    Active
    LEVOFLOXACIN USP
    2006-05-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19458
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LEVOFLOXACIN USP
    Issue/Submission Date
    2006-05-19
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    Memantine Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    21199
    Active
    MEMANTINE HYDROCHLORIDE USP
    2007-12-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21199
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MEMANTINE HYDROCHLORIDE USP
    Issue/Submission Date
    2007-12-21
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    Methacholine Chloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    11758
    Active
    METHACHOLINE CHLORIDE USP
    1995-11-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11758
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    METHACHOLINE CHLORIDE USP
    Issue/Submission Date
    1995-11-28
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    Midodrine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    18470
    Active
    MIDODRINE HYDROCHLORIDE USP
    2005-06-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18470
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MIDODRINE HYDROCHLORIDE USP
    Issue/Submission Date
    2005-06-30
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    Moexipril

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

    See Less

    USDMF

    Found USDMF

    19113
    Active
    MOEXIPRIL HYDROCHLORIDE USP
    2006-01-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19113
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MOEXIPRIL HYDROCHLORIDE USP
    Issue/Submission Date
    2006-01-18
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    Montelukast Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    23495
    Active
    MONTELUKAST SODIUM USP
    2010-01-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23495
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MONTELUKAST SODIUM USP
    Issue/Submission Date
    2010-01-29
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    Mycophenolate Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    22819
    Active
    MYCOPHENOLATE SODIUM USP
    2009-05-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22819
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MYCOPHENOLATE SODIUM USP
    Issue/Submission Date
    2009-05-28
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    Olanzapine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    21980
    Active
    OLANZAPINE USP
    2008-09-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21980
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    OLANZAPINE USP
    Issue/Submission Date
    2008-09-17
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    Paliperidone

    PDF Supplier PDF
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    USDMF

    Found USDMF

    25073
    Active
    PALIPERIDONE USP
    2011-06-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25073
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PALIPERIDONE USP
    Issue/Submission Date
    2011-06-24
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    Paroxetine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    21440
    Active
    PAROXETINE HYDROCHLORIDE ANHYDROUS ...
    2008-03-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21440
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PAROXETINE HYDROCHLORIDE ANHYDROUS ...
    Issue/Submission Date
    2008-03-18
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    • FDA
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    Ramipril

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    20713
    Active
    RAMIPRIL USP
    2007-07-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20713
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    RAMIPRIL USP
    Issue/Submission Date
    2007-07-24
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    Risedronate Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    21819
    Active
    RISEDRONATE SODIUM HEMIPENTAHYDRATE...
    2008-07-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21819
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    RISEDRONATE SODIUM HEMIPENTAHYDRATE...
    Issue/Submission Date
    2008-07-18
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    Rivastigmine Tartrate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    22252
    Active
    RIVASTIGMINE TARTRATE
    2008-12-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22252
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    RIVASTIGMINE TARTRATE
    Issue/Submission Date
    2008-12-04
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    • FDA
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    Sitagliptin Phosphate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    24266
    Active
    SITAGLIPTIN PHOSPHATE MONOHYDRATE U...
    2010-10-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24266
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SITAGLIPTIN PHOSPHATE MONOHYDRATE U...
    Issue/Submission Date
    2010-10-08
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    • FDA
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    Tadalafil

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    25815
    Active
    TADALAFIL USP
    2012-02-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25815
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TADALAFIL USP
    Issue/Submission Date
    2012-02-22
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    • FDA
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    Tetrabenazine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    27135
    Active
    TETRABENAZINE
    2013-05-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27135
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TETRABENAZINE
    Issue/Submission Date
    2013-05-31
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    • FDA
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    Tolvaptan

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    27636
    Active
    TOLVAPTAN
    2013-12-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27636
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TOLVAPTAN
    Issue/Submission Date
    2013-12-04
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    Valacyclovir Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    21487
    Active
    VALACYCLOVIR HYDROCHLORIDE MONOHYDR...
    2008-04-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21487
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    VALACYCLOVIR HYDROCHLORIDE MONOHYDR...
    Issue/Submission Date
    2008-04-01
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    • FDA
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    Varenicline Tartrate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    23774
    Active
    VARENICLINE TARTRATE
    2010-05-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23774
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    VARENICLINE TARTRATE
    Issue/Submission Date
    2010-05-05
    ASK
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    • FDA
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    Venlafaxine Hydrochloride

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

    See Less

    USDMF

    Found USDMF

    21377
    Active
    VENLAFAXINE HYDROCHLORIDE USP
    2008-02-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21377
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    VENLAFAXINE HYDROCHLORIDE USP
    Issue/Submission Date
    2008-02-26
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    Warfarin Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    11387
    Active
    WARFARIN SODIUM CLATHRATE USP
    1995-03-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11387
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    WARFARIN SODIUM CLATHRATE USP
    Issue/Submission Date
    1995-03-15
    ASK
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    Ziprasidone Hydrochloride

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

    See Less

    USDMF

    Found USDMF

    18050
    Active
    ZIPRASIDONE HYDROCHLORIDE
    2005-02-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18050
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ZIPRASIDONE HYDROCHLORIDE
    Issue/Submission Date
    2005-02-03
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