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    01 7-Amino-3-Vinyl-3-Cephem-4-Carboxylic Acid (1)

    02 Albendazole (1)

    03 Armodafinil (1)

    04 Benazepril Hydrochloride (1)

    05 Buspirone Hydrochloride (1)

    06 Candesartan Cilexetil (1)

    07 Cefaclor (1)

    08 Cefixime (1)

    09 Cefprozil (1)

    10 Cefuroxime Axetil (1)

    11 Cephalexin (1)

    12 Cephalexin Monohydrate (1)

    13 Cilastatin (1)

    14 Cilastatin Sodium (1)

    15 Darifenacin Hydrobromide (1)

    16 Doripenem (2)

    17 Dronedarone Hydrochloride (1)

    18 Eszopiclone (1)

    19 Febuxostat (1)

    20 Flecainide (2)

    21 Ganciclovir (1)

    22 Hydroxychloroquine Sulphate (1)

    23 Imipenem (2)

    24 Lamotrigine (1)

    25 Lanthanum Carbonate (1)

    26 Lisinopril (1)

    27 Meloxicam (1)

    28 Meropenem (2)

    29 Montelukast Sodium (5)

    30 Moxifloxacin Hydrochloride (1)

    31 Nalidixic Acid (1)

    32 Nimesulide (1)

    33 Nitrofurantoin (4)

    34 Olmesartan Medoxomil (1)

    35 Paliperidone (1)

    36 Pimozide (1)

    37 Propofol (1)

    38 Ramipril (1)

    39 Rizatriptan Benzoate (1)

    40 Sodium Bicarbonate (1)

    41 Sodium Carbonate (1)

    42 Solifenacin Succinate (1)

    43 Tenofovir Disoproxil Fumarate (1)

    44 Tigecycline (1)

    45 Topiramate (2)

    filter

    01 Active (39)

    02 Inactive (13)

    03 Blank (5)

    filter

    01 Expired (2)

    02 Valid (12)

    03 Withdrawn by EDQM Failure to CEP procedure (6)

    04 Blank (37)

    filter

    01 Blank (57)

    filter

    01 WC-0170 (22)

    02 WC-0342 (4)

    03 Blank (31)

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    Benazepril Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    19479
    Active
    BENAZEPRIL HYDROCHLORIDE USP
    2006-05-31
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-273 - Rev 00
    Valid
    Benazepril hydrochloride
    2015-04-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0170
    Expired
    Benazepril Hydrochloride (EP/BP/USP...
    2019-07-22
    Application Number
    19479
    R1-CEP 2008-273 - Rev 00
    Indian CDSCO WC-0170
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-21
    Filing Details
    BENAZEPRIL HYDROCHLORIDE USP
    Benazepril hydrochloride
    Benazepril Hydrochloride (EP/BP/USP...
    Issue/Submission Date
    2006-05-31
    2015-04-15
    2019-07-22
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    Cefuroxime Axetil

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    USDMF

    Found USDMF

    20545
    Active
    CEFUROXIME AXETIL USP
    2007-05-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-198 - Rev 01
    Valid
    Cefuroxime axetil
    2015-07-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0342
    Expired
    Cefuroxime Axetil (USP)
    2015-08-25
    Application Number
    20545
    R1-CEP 2007-198 - Rev 01
    Indian CDSCO WC-0342
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2018-08-25
    Filing Details
    CEFUROXIME AXETIL USP
    Cefuroxime axetil
    Cefuroxime Axetil (USP)
    Issue/Submission Date
    2007-05-23
    2015-07-17
    2015-08-25
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    Flecainide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    19272
    Active
    FLECAINIDE ACETATE USP
    2006-03-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-289 - Rev 01
    Valid
    Flecainide acetate, Process A
    2015-03-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0170
    Expired
    Flecainide Acetate (BP/EP/USP)
    2019-07-22
    Application Number
    19272
    R1-CEP 2009-289 - Rev 01
    Indian CDSCO WC-0170
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-21
    Filing Details
    FLECAINIDE ACETATE USP
    Flecainide acetate, Process A
    Flecainide Acetate (BP/EP/USP)
    Issue/Submission Date
    2006-03-23
    2015-03-19
    2019-07-22
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    Lisinopril

    PDF Supplier PDF
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    USDMF

    Found USDMF

    17626
    Active
    LISINOPRIL USP
    2004-08-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-063 - Rev 04
    Valid
    Lisinopril dihydrate
    2020-03-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0170
    Expired
    Lisinopril (USP/IP/BP/EP)
    2019-07-22
    Application Number
    17626
    R1-CEP 2004-063 - Rev 04
    Indian CDSCO WC-0170
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-21
    Filing Details
    LISINOPRIL USP
    Lisinopril dihydrate
    Lisinopril (USP/IP/BP/EP)
    Issue/Submission Date
    2004-08-26
    2020-03-11
    2019-07-22
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    Meloxicam

    PDF Supplier PDF
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    USDMF

    Found USDMF

    18286
    Active
    MELOXICAM USP
    2005-04-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-301 - Rev 00
    Valid
    Meloxicam
    2015-07-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0170
    Expired
    Meloxicam (BP/USP)
    2019-07-22
    Application Number
    18286
    R1-CEP 2008-301 - Rev 00
    Indian CDSCO WC-0170
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-21
    Filing Details
    MELOXICAM USP
    Meloxicam
    Meloxicam (BP/USP)
    Issue/Submission Date
    2005-04-19
    2015-07-29
    2019-07-22
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    Nitrofurantoin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    23500
    Active
    NITROFURANTOIN ANHYDROUS USP
    2010-02-16
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-108 - Rev 01
    Valid
    Nitrofurantoin
    2020-09-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0170
    Expired
    Nitrofurantoin (IP/EP/USP)
    2019-07-22
    Application Number
    23500
    R1-CEP 2011-108 - Rev 01
    Indian CDSCO WC-0170
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-21
    Filing Details
    NITROFURANTOIN ANHYDROUS USP
    Nitrofurantoin
    Nitrofurantoin (IP/EP/USP)
    Issue/Submission Date
    2010-02-16
    2020-09-23
    2019-07-22
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    Albendazole

    PDF Supplier PDF
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    USDMF

    Found USDMF

    17754
    Active
    ALBENDAZOLE USP
    2004-11-08
    CEP/COS

    Caution CEP/COS

    R1-CEP 2001-448 - Rev 04
    Withdrawn by EDQM Failure to CEP procedure
    Albendazole
    2014-04-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0170
    Expired
    Albendazole IP/BP/EP/USP
    2019-07-22
    Application Number
    17754
    R1-CEP 2001-448 - Rev 04
    Indian CDSCO WC-0170
    Status
    Active
    Fees Paid
    N/A
    Withdrawn by EDQM Failure to CEP procedure
     
    Expired
    2022-07-21
    Filing Details
    ALBENDAZOLE USP
    Albendazole
    Albendazole IP/BP/EP/USP
    Issue/Submission Date
    2004-11-08
    2014-04-28
    2019-07-22
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    Buspirone Hydrochloride

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    USDMF

    Found USDMF

    25361
    Active
    BUSPIRONE HYDROCHLORIDE USP
    2011-11-16
    CEP/COS

    Caution CEP/COS

    R0-CEP 2012-361 - Rev 00
    Expired
    Buspirone hydrochloride
    2014-11-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0170
    Expired
    Busipirone Hydrochloride (IP/USP)
    2019-07-22
    Application Number
    25361
    R0-CEP 2012-361 - Rev 00
    Indian CDSCO WC-0170
    Status
    Active
    Fees Paid
    Reviewed
    Expired
     
    Expired
    2022-07-21
    Filing Details
    BUSPIRONE HYDROCHLORIDE USP
    Buspirone hydrochloride
    Busipirone Hydrochloride (IP/USP)
    Issue/Submission Date
    2011-11-16
    2014-11-13
    2019-07-22
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    Cefixime

    PDF Supplier PDF
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    USDMF

    Found USDMF

    26047
    Active
    CEFIXIME USP
    2012-06-08
    CEP/COS

    Caution CEP/COS

    R1-CEP 2008-124 - Rev 00
    Withdrawn by EDQM Failure to CEP procedure
    Cefixime
    2015-11-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0342
    Expired
    Cefixime (USP)
    2015-08-25
    Application Number
    26047
    R1-CEP 2008-124 - Rev 00
    Indian CDSCO WC-0342
    Status
    Active
    Fees Paid
    Reviewed
    Withdrawn by EDQM Failure to CEP procedure
     
    Expired
    2018-08-25
    Filing Details
    CEFIXIME USP
    Cefixime
    Cefixime (USP)
    Issue/Submission Date
    2012-06-08
    2015-11-20
    2015-08-25
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    Flecainide

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    USDMF

    Found USDMF

    23192
    Active
    FLECAINIDE ACETATE USP (PROCESS B)
    2009-10-14
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-005 - Rev 02
    Valid
    Flecainide acetate
    2020-08-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23192
    R1-CEP 2006-005 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    FLECAINIDE ACETATE USP (PROCESS B)
    Flecainide acetate
    Issue/Submission Date
    2009-10-14
    2020-08-13
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