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

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    Apotex Inc
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    150 Signet Drive, Toronto, Ontario, M9L 1T9
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    ABACAVIR SULFATE USP

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    SIGNA SA DE CV
    Active
    23644
    Complete
    2014-07-15
    2014-07-07
    2010-03-19
    II
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    ACYCLOVIR USP

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    SIGNA SA DE CV
    Active
    22949
    Complete
    2014-01-03
    2013-12-11
    2009-07-16
    II
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    ADEFOVIR DIPIVOXIL

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    APOTEX PHARMACHEM INC
    Active
    26630
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    2013-08-26
    2012-12-06
    2012-12-07
    II
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    ALENDRONATE SODIUM TRIHYDRATE USP

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    SIGNA SA DE CV
    Inactive
    16129
    N/A
    2002-09-10
    II
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    ALENDRONATE SODIUM TRIHYDRATE USP

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    APOTEX PHARMACHEM INC
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    15409
    N/A
    2001-04-30
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    ALFUZOSIN HYDROCHLORIDE USP

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    APOTEX PHARMACHEM INC
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    20595
    N/A
    2007-06-08
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    ALLOPURINOL USP

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    SIGNA SA DE CV
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    15841
    N/A
    2002-02-04
    II
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    ALMOTRIPTAN MALATE

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    25225
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    2011-08-16
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    ALPHA METHYL DOPA USP

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    6363
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    1986-05-16
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    ALPRAZOLAM USP

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    APOTEX PHARMACHEM IND...
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    25074
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    2011-06-24
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    ANASTROZOLE USP

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    APOTEX PHARMACHEM INC
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    23326
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    2009-12-01
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    APIXABAN

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    APOTEX PHARMACHEM IND...
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    30499
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    2016-06-20
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    ARIPIPRAZOLE USP

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    APOTEX PHARMACHEM INC
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    ASENAPINE MALEATE

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    SIGNA SA DE CV
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    27316
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    2013-07-26
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    ATAZANAVIR SULFATE

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    SIGNA SA DE CV
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    28565
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    2015-01-28
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    ATOMOXETINE HYDROCHLORIDE USP

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

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    APOTEX PHARMACHEM INC
    Inactive
    20117
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    2006-12-15
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    ATORVASTATIN CALCIUM PROPYLENE GLYC...

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    SIGNA SA DE CV
    Active
    21574
    Complete
    2012-11-23
    2012-11-05
    2008-04-29
    II
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    AZT (ZIDOVUDINE)

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    SIGNA SA DE CV
    Inactive
    8818
    N/A
    1990-11-07
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    BALSALAZIDE DISODIUM DIHYDRATE USP

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    SIGNA SA DE CV
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    18894
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    2014-06-24
    2013-04-30
    2005-10-21
    II
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    BICALUTAMIDE USP

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    SIGNA SA DE CV
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    22784
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    2009-05-15
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    BREXPIPRAZOLE

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    SIGNA SA DE CV
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    33560
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    2019-05-03
    2019-02-15
    2019-03-11
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    BUDESONIDE USP

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    APOTEX PHARMACHEM INC
    Active
    27451
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    2013-12-18
    2013-09-19
    2013-11-01
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    BULK EVEROLIMUS

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    APOTEX PHARMACHEM INC
    Active
    31073
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    2017-03-30
    2016-10-24
    2016-10-27
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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
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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...
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    23941
    N/A
    2010-07-02
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    CAPECITABINE USP

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    APOTEX PHARMACHEM IND...
    Inactive
    25720
    N/A
    2012-01-19
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    CAPECITABINE USP

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    SIGNA SA DE CV
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    30543
    N/A
    2016-06-23
    II
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    CARVEDILOL DIHYDROGEN PHOSPHATE

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    APOTEX PHARMACHEM IND...
    Inactive
    30112
    N/A
    2016-01-12
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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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    CLOPIDOGREL BISULPHATE USP

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    SIGNA SA DE CV
    Active
    15721
    N/A
    2001-11-13
    II
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    CRUDE METRONIDAZOLE

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    SIGNA SA
    Inactive
    4025
    N/A
    1981-01-06
    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
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    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
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    2014-01-14
    2013-03-26
    2013-08-23
    II
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    DEFERASIROX

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

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    APOTEX PHARMACHEM IND...
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    10867
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    1994-04-12
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    DESVENLAFAXINE SUCCINATE MONOHYDRAT...

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    APOTEX PHARMACHEM INC
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    25777
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    2012-02-13
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    DEXLANSOPRAZOLE ANHYDRATE

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    APOTEX PHARMACHEM INC
    Active
    29035
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    2015-06-11
    2015-03-19
    2015-03-30
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    DIDEOXYINOSINE

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    SIGNA SA DE CV
    Inactive
    17413
    N/A
    2004-05-26
    II
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    DOLASETRON MESYLATE MONOHYDRATE USP

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

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    23008
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    2009-08-04
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    DOXAZOSIN MESYLATE USP

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    APOTEX PHARMACHEM IND...
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    13039
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    1998-06-22
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    DRONEDARONE HYDROCHLORIDE

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    APOTEX PHARMACHEM IND...
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    27088
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    2013-05-08
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    DULOXETINE HYDROCHLORIDE USP

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    SIGNA SA DE CV
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    21833
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    2017-06-16
    2017-05-19
    2008-07-30
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