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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Sandoz B2B to the U.S. FDA. Original Data : FDA Website

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    3-DESACETYl-7-AMINOCEPHALOSPORANIC ...

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    6-APA (6 AMINOPENICILLANIC ACID)

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    SANDOZ GMBH
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    8757
    N/A
    1990-09-25
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    6-METHYLERGOLENE-8-CARBOXYLIC ACID

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    SANDOZ GMBH
    Inactive
    5892
    N/A
    1985-06-03
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    6-METHYLERGOLINE-8B-CARBOXYLIC ACID

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    SANDOZ LTD PHARMACEUT...
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    5944
    N/A
    1985-07-17
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    7-ACT

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    SANDOZ GMBH
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    4996
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    1983-06-21
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    7-AMCA

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    SANDOZ GMBH
    Active
    17683
    N/A
    2004-09-10
    II
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    7-AMINO-CEPHALOSPORANIC ACID (7-ACA...

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    SANDOZ GMBH
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    4990
    N/A
    1983-06-21
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    7-PACA (7-AMINO-3-PROPENYL-CEPHALOS...

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    SANDOZ GMBH
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    10838
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    1994-03-29
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    AMLODIPINE BESYLATE

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    16887
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    2003-10-02
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    AMLODIPINE BESYLATE (PROCESS 2)

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    NOVARTIS PHARMACEUTIC...
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    22964
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    2009-07-21
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    AMOXCILLIN TRIHYDRATE USP

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    SANDOZ INDUSTRIAL PRO...
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    13764
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    2019-08-13
    2019-08-09
    1998-09-01
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    AMOXICILLIN SODIUM (NON-STERILE BUL...

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    SANDOZ INDUSTRIAL PRO...
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    18044
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    2005-02-01
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    AMOXICILLIN TRIHYDRATE

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    SANDOZ GMBH
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    38086
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    2023-06-23
    2023-05-22
    2023-06-02
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    AMPICILLIN ANHYDROUS

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    SANDOZ INDUSTRIAL PRO...
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    13212
    N/A
    1998-04-30
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    AMPICILLIN SODIUM (STERILE)

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    SANDOZ GMBH
    Active
    13754
    Complete
    2023-04-20
    2023-04-17
    1998-09-01
    II
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    AMPICILLIN TRIHYDRATE

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    SANDOZ INDUSTRIAL PRO...
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    13765
    N/A
    1998-09-01
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    APREMILAST

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    LEK PHARMACEUTICALS D...
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    31809
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    2017-11-16
    2017-09-11
    2017-09-27
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    ASCOMYCIN

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    SANDOZ GMBH
    Active
    15113
    N/A
    2000-10-30
    II
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    ATORVASTATIN ATV-44 INTERMEDIATE

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    SANDOZ SYNTEK ILAC HA...
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    22723
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    2009-04-15
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    ATORVASTATIN CALCIUM

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    LEK PHARMACEUTICALS D...
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    18082
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    2005-02-01
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    AURANOFIN

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    LEK PHARMACEUTICAL AN...
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    8292
    N/A
    1989-11-16
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    AZITHROMYCIN MONOHYDRATE (NON-STERI...

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    SANDOZ INDUSTRIAL PRO...
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    16390
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    2003-01-30
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    BOPINDOLOL

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    SANDOZ LTD PHARMACEUT...
    Inactive
    5452
    N/A
    1984-07-02
    II
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    BROMOCRIPTINE MESYLATE USP

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    LEK PHARMACEUTICALS D...
    Active
    6827
    N/A
    1987-02-13
    II
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    BUTALBITAL

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    SANDOZ PHARMACEUTICAL...
    Inactive
    5610
    N/A
    1984-12-03
    II
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    BUTALBITAL

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    SANDOZ LTD PHARMACEUT...
    Inactive
    5645
    N/A
    1984-12-07
    II
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    CALCIUM (GLUCOHYTONATE) GLUCEPTATE

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    LEK PHARMACEUTICAL AN...
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    4289
    N/A
    1981-09-29
    II
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    CANDESARTAN CILEXETIL

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    LEK PHARMACEUTICALS D...
    Inactive
    20053
    N/A
    2006-12-18
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    CASPOFUNGIN ACETATE

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    LEK PHARMACEUTICALS D...
    Inactive
    23222
    N/A
    2009-10-28
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    CEFAZOLIN SODIUM (STERILE)

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    SANDOZ GMBH
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    14133
    N/A
    1999-05-03
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    CEFDINIR

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    SANDOZ GMBH
    Active
    18457
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    2005-06-27
    II
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    CEFEPIME / L-ARGININE STERILE MIXTU...

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    SANDOZ INDUSTRIAL PRO...
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    21150
    N/A
    2007-12-17
    II
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    Cefepime, unsterile

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    SANDOZ GMBH
    Inactive
    21139
    N/A
    2007-12-14
    II
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    CEFIXIME

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    SANDOZ PRIVATE LTD
    Inactive
    16313
    N/A
    2002-12-17
    II
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    CEFIXIME

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    SANDOZ GMBH
    Active
    27527
    Complete
    2013-11-27
    2013-09-19
    2013-09-27
    II
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    CEFOTAXIME SODIUM STERILE

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    SANDOZ GMBH
    Active
    21202
    N/A
    2007-12-27
    II
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    CEFPODOXIME PROXETIL

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    SANDOZ PRIVATE LTD
    Inactive
    16542
    N/A
    2003-04-15
    II
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    CEFPODOXIME PROXETIL

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    SANDOZ GMBH
    Active
    20076
    N/A
    2006-12-26
    II
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    CEFPROZIL

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    SANDOZ PRIVATE LTD
    Inactive
    17453
    N/A
    2004-06-07
    II
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    CEFTAZIDIME FOR INJECTION

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    SANDOZ GMBH
    Active
    16082
    N/A
    2002-08-06
    II
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    CEFTRIAXONE SODIUM (STERILE)

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    SANDOZ GMBH
    Active
    16467
    N/A
    2003-03-12
    II
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    CEFTRIAXONE SODIUM STERILE

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    SANDOZ INDUSTRIAL PRO...
    Inactive
    24412
    N/A
    2010-12-01
    II
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    CEFUROXIME AXETIL

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    SANDOZ PRIVATE LTD
    Inactive
    15815
    N/A
    2002-01-21
    II
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    CEPHALOSPORIN C SODIUM

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    SANDOZ GMBH
    Active
    9437
    N/A
    1991-12-02
    II
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    CHLORPHENIRAMINE BASE

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    SANDOZ PHARMACEUTICAL...
    Inactive
    6598
    N/A
    1986-09-24
    II
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    CHLORPHENIRAMINE MALEATE

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    SANDOZ PHARM CORP
    Inactive
    5386
    N/A
    1984-05-03
    II
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    CHLORTHALIDONE

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    SANDOZ LTD PHARMACEUT...
    Inactive
    5109
    N/A
    1983-09-02
    II
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    CILASTATIN SODIUM STERILE

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    SANDOZ GMBH
    Inactive
    23307
    N/A
    2009-11-24
    II
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    CIMETIDINE HCL

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    LEK PHARMACEUTICAL AN...
    Inactive
    7863
    N/A
    1988-12-13
    II
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    CLARITHROMYCIN (NON-STERILE BULK)

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    SANDOZ INDUSTRIAL PRO...
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    16083
    N/A
    2002-08-06
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