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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Apotex Pharmachem Inc to the U.S. FDA. Original Data : FDA Website

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    Apotex Pharmachem
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    11, 34, 50 Spalding Drive, Brantford, Ontario, Canada N3T 6B8
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    +1-519-756-8942
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    ADEFOVIR DIPIVOXIL

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    APOTEX PHARMACHEM INC
    Active
    26630
    Complete
    2013-08-26
    2012-12-06
    2012-12-07
    II
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    ALFUZOSIN HYDROCHLORIDE USP

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    APOTEX PHARMACHEM INC
    Active
    20595
    N/A
    2007-06-08
    II
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    ALMOTRIPTAN MALATE

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    APOTEX PHARMACHEM IND...
    Inactive
    25225
    N/A
    2011-08-16
    II
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    ALPRAZOLAM USP

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    APOTEX PHARMACHEM IND...
    Inactive
    25074
    N/A
    2011-06-24
    II
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    ANASTROZOLE USP

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    APOTEX PHARMACHEM INC
    Active
    23326
    N/A
    2009-12-01
    II
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    APIXABAN

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    APOTEX PHARMACHEM IND...
    Inactive
    30499
    N/A
    2016-06-20
    II
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    ARIPIPRAZOLE USP

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    APOTEX PHARMACHEM INC
    Active
    19957
    N/A
    2006-11-13
    II
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    ATOMOXETINE HYDROCHLORIDE USP

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    APOTEX PHARMACHEM INC
    Active
    20070
    N/A
    2007-05-18
    II
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    ATORVASTATIN CALCIUM GRANULATION

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    APOTEX PHARMACHEM INC
    Inactive
    20117
    N/A
    2006-12-15
    II
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    BICALUTAMIDE USP

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    SIGNA SA DE CV
    Inactive
    22784
    N/A
    2009-05-15
    II
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    BUDESONIDE USP

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    APOTEX PHARMACHEM INC
    Active
    27451
    Complete
    2013-12-18
    2013-09-19
    2013-11-01
    II
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    BUSPIRONE HYDROCHLORIDE

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    APOTEX PHARMACHEM INC
    Inactive
    8928
    N/A
    1991-01-11
    II
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    CABERGOLINE USP

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    APOTEX PHARMACHEM IND...
    Inactive
    22620
    N/A
    2009-03-13
    II
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    CABERGOLINE USP

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    APOTEX PHARMACHEM IND...
    Inactive
    26235
    N/A
    2012-07-13
    II
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    CANDESARTAN CILEXETIL USP

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    APOTEX PHARMACHEM IND...
    Inactive
    23941
    N/A
    2010-07-02
    II
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    CAPECITABINE USP

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    APOTEX PHARMACHEM IND...
    Inactive
    25720
    N/A
    2012-01-19
    II
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    CARVEDILOL DIHYDROGEN PHOSPHATE

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    APOTEX PHARMACHEM IND...
    Inactive
    30112
    N/A
    2016-01-12
    II
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    CEVIMELINE HYDROCHLORIDE HEMIHYDRAT...

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    APOTEX PHARMACHEM INC
    Active
    22509
    N/A
    2009-02-06
    II
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    CIMETIDINE

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    APOTEX PHARMACHEM INC
    Inactive
    8021
    N/A
    1989-04-20
    II
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    CLONAZEPAM USP

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    APOTEX PHARMACHEM IND...
    Active
    22167
    N/A
    2008-11-11
    II
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    CYCLOSPORINE USP (BULK)

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    APOTEX PHARMACHEM INC
    Active
    13929
    Complete
    2014-11-11
    2014-05-08
    1999-01-04
    II
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    CYTARABINE USP XXI

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    APOTEX PHARMACHEM INC
    Inactive
    7364
    N/A
    1988-03-04
    II
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    DABIGATRAN ETEXILATE MESYLATE

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    APOTEX PHARMACHEM INC
    Active
    28029
    Complete
    2014-08-25
    2014-03-28
    2014-03-28
    II
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    DARIFENACIN HYDROBROMIDE

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    APOTEX PHARMACHEM INC
    Active
    26824
    Complete
    2014-01-14
    2013-03-26
    2013-08-23
    II
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    DEFERASIROX

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    APOTEX PHARMACHEM IND...
    Inactive
    28379
    N/A
    2014-06-30
    II
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    DEFERIPRONE

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    APOTEX PHARMACHEM IND...
    Active
    10867
    N/A
    1994-04-12
    II
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    DESVENLAFAXINE SUCCINATE MONOHYDRAT...

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    APOTEX PHARMACHEM INC
    Active
    25777
    N/A
    2012-02-13
    II
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    DEXLANSOPRAZOLE ANHYDRATE

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    APOTEX PHARMACHEM INC
    Active
    29035
    Complete
    2015-06-11
    2015-03-19
    2015-03-30
    II
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    DOLASETRON MESYLATE MONOHYDRATE USP

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    APOTEX PHARMACHEM IND...
    Inactive
    24531
    N/A
    2011-01-06
    II
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    DONEPEZIL HYDROCHLORIDE MONOHYDRRAT...

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    APOTEX PHARMACHEM IND...
    Inactive
    23008
    N/A
    2009-08-04
    II
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    DOXAZOSIN MESYLATE USP

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    APOTEX PHARMACHEM IND...
    Active
    13039
    N/A
    1998-06-22
    II
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    DRONEDARONE HYDROCHLORIDE

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    APOTEX PHARMACHEM IND...
    Inactive
    27088
    N/A
    2013-05-08
    II
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    ELETRIPTAN HYDROBROMIDE

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    APOTEX PHARMACHEM IND...
    Inactive
    23651
    N/A
    2010-03-25
    II
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    ELIGLUSTAT TARTRATE (1:0.5)

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    APOTEX PHARMACHEM INC
    Active
    32724
    Complete
    2018-05-31
    2018-04-20
    2018-05-01
    II
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    ENALAPRIL MALEATE USP

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    APOTEX PHARMACHEM IND...
    Inactive
    19058
    N/A
    2005-12-21
    II
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    ENTECAVIR USP

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    APOTEX PHARMACHEM IND...
    Inactive
    24305
    N/A
    2010-10-19
    II
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    EPLERENONE MEK HEMISOLVATE (1:0.5)

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    APOTEX PHARMACHEM INC
    Inactive
    19796
    N/A
    2006-09-25
    II
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    ERLOTINIB HYDROCHLORIDE

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    APOTEX PHARMACHEM INC
    Active
    26631
    Complete
    2014-10-28
    2012-12-12
    2013-01-22
    II
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    ESZOPICLONE USP

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    APOTEX PHARMACHEM IND...
    Inactive
    26829
    N/A
    2013-02-13
    II
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    ETRAVIRINE

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    APOTEX PHARMACHEM IND...
    Inactive
    27923
    N/A
    2014-03-07
    II
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    EXEMESTANE

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    APOTEX PHARMACHEM IND...
    Inactive
    27167
    N/A
    2013-05-31
    II
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    FAMOTIDINE USP

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    APOTEX PHARMACHEM INC
    Inactive
    18254
    N/A
    2005-04-06
    II
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    FEBUXOSTAT

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    SIGNA SA DE CV
    Inactive
    26741
    N/A
    2012-12-31
    II
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    FESOTERODINE FUMARATE

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    SIGNA SA DE CV
    Active
    26345
    Complete
    2013-04-23
    2012-11-23
    2012-08-17
    II
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    FINGOLIMOD HYDROCHLORIDE

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    APOTEX PHARMACHEM IND...
    Active
    27983
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    2014-08-07
    2014-03-28
    2014-03-28
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    FLUTICASONE PROPIONATE USP (MICRONI...

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    APOTEX PHARMACHEM INC
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    35393
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    2021-02-10
    2020-12-07
    2020-12-30
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    FLUVOXAMINE MALEATE USP

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    APOTEX PHARMACHEM IND...
    Active
    14529
    Complete
    2015-09-15
    2014-06-05
    1999-11-12
    II
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    GAMMA-HYDROXYBUTYRATE

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    APOTEX PHARMACHEM INC
    Inactive
    7249
    N/A
    1987-12-11
    II
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    GATIFLOXACIN HEMIHYDRATE

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    APOTEX PHARMACHEM IND...
    Active
    20685
    N/A
    2007-07-13
    II
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    IBANDRONATE SODIUM

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    APOTEX PHARMACHEM INC
    Active
    20525
    N/A
    2007-05-11
    II
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