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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Divis Laboratories

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    Divis Laboratories
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    Country
    Country
    India
    Address
    Address
    Divis Laboratories LimitedDivi Towers, 7-1-77/E/1/303,Dharam Karan Road, Ameerpet,HYDERABAD - 500 016.Andhra Pradesh, India.
    Telephone
    Telephone
    91 402 378 6322
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.divislabs.com/
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    • FDA
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    Dextromethorphan Hydrobromide

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    USDMF

    Found USDMF

    12356
    Active
    DEXTROMETHORPHAN HYDROBROMIDE USP
    1997-02-04
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-103 - Rev 06
    Valid
    Dextromethorphan hydrobromide
    2018-07-20
    Japanese DMF

    Found JDMF

    217MF10567
    Japanese Pharmacopoeia dextromethor...
    2005-09-09
    Written Confirmation

    Found WC

    Indian CDSCO WC-0031
    Valid
    Dextromethorphan HBr (BP/USPIPh.Eur...
    2022-06-16
    Application Number
    12356
    R1-CEP 1999-103 - Rev 06
    217MF10567
    Indian CDSCO WC-0031
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-06-16
    Filing Details
    DEXTROMETHORPHAN HYDROBROMIDE USP
    Dextromethorphan hydrobromide
    Japanese Pharmacopoeia dextromethor...
    Dextromethorphan HBr (BP/USPIPh.Eur...
    Issue/Submission Date
    1997-02-04
    2018-07-20
    2005-09-09
    2022-06-16
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    Levetiracetam

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    USDMF

    Found USDMF

    16894
    Active
    LEVETIRACETAM
    2003-10-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-079 - Rev 01
    Valid
    Levetiracetam, Process B
    2020-12-04
    Japanese DMF

    Found JDMF

    302MF10067
    Levetiracetam at 1-72/23(P)/DIVIS/3...
    2020-06-16
    Written Confirmation

    Found WC

    Indian CDSCO WC-0031
    Valid
    Levetiracetam (USP/Ph.Eur/BP)
    2022-06-16
    Application Number
    16894
    R1-CEP 2014-079 - Rev 01
    302MF10067
    Indian CDSCO WC-0031
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-06-16
    Filing Details
    LEVETIRACETAM
    Levetiracetam, Process B
    Levetiracetam at 1-72/23(P)/DIVIS/3...
    Levetiracetam (USP/Ph.Eur/BP)
    Issue/Submission Date
    2003-10-05
    2020-12-04
    2020-06-16
    2022-06-16
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    Nabumetone

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    USDMF

    Found USDMF

    15364
    Active
    NABUMETONE USP
    2001-04-02
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-055 - Rev 06
    Valid
    Nabumetone
    2018-08-23
    Japanese DMF

    Found JDMF

    228MF10204
    Nabumetone at 1-72/23(P)/DIVIS/303,...
    2016-10-31
    Written Confirmation

    Found WC

    Indian CDSCO WC-0031
    Valid
    Nabumetone (USP/Ph.Eur/BP)
    2022-06-16
    Application Number
    15364
    R1-CEP 1999-055 - Rev 06
    228MF10204
    Indian CDSCO WC-0031
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-06-16
    Filing Details
    NABUMETONE USP
    Nabumetone
    Nabumetone at 1-72/23(P)/DIVIS/303,...
    Nabumetone (USP/Ph.Eur/BP)
    Issue/Submission Date
    2001-04-02
    2018-08-23
    2016-10-31
    2022-06-16
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    • FDA
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    Carbidopa

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    USDMF

    Found USDMF

    17846
    Active
    CARBIDOPA USP
    2004-11-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-057 - Rev 05
    Valid
    Carbidopa
    2021-11-22
    Japanese DMF

    Found JDMF

    225MF10125
    Carbidopa at 1-72/23(P)/DIVIS/303, ...
    2013-07-02
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0030
    Expired
    Carbidopa (IP/BP/USP/Ph. Eur)
    2019-06-17
    Application Number
    17846
    R1-CEP 2005-057 - Rev 05
    225MF10125
    Indian CDSCO WC-0030
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-06-16
    Filing Details
    CARBIDOPA USP
    Carbidopa
    Carbidopa at 1-72/23(P)/DIVIS/303, ...
    Carbidopa (IP/BP/USP/Ph. Eur)
    Issue/Submission Date
    2004-11-20
    2021-11-22
    2013-07-02
    2019-06-17
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    Etilevodopa

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    USDMF

    Found USDMF

    17874
    Active
    LEVODOPA USP
    2004-12-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-161 - Rev 04
    Valid
    Levodopa
    2018-01-25
    Japanese DMF

    Found JDMF

    227MF10235
    Levodopa at 1-72/23(P)/DIVIS/303, D...
    2015-09-24
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0030
    Expired
    Levodopa (IP/BP/USP/Ph. Eur)
    2019-06-17
    Application Number
    17874
    R1-CEP 2005-161 - Rev 04
    227MF10235
    Indian CDSCO WC-0030
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-06-16
    Filing Details
    LEVODOPA USP
    Levodopa
    Levodopa at 1-72/23(P)/DIVIS/303, D...
    Levodopa (IP/BP/USP/Ph. Eur)
    Issue/Submission Date
    2004-12-03
    2018-01-25
    2015-09-24
    2019-06-17
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    Mesalazine

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    USDMF

    Found USDMF

    29998
    Active
    MESALAMINE USP
    2015-11-06
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-050 - Rev 01
    Valid
    Mesalazine
    2022-11-08
    Japanese DMF

    Found JDMF

    231MF10004
    Mesalazine at 1-72/23(P)/DIVIS/303,...
    2019-01-10
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0030
    Expired
    Mesalamine (IP/USP/BP/Ph.Eur)
    2019-06-17
    Application Number
    29998
    R1-CEP 2016-050 - Rev 01
    231MF10004
    Indian CDSCO WC-0030
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-06-16
    Filing Details
    MESALAMINE USP
    Mesalazine
    Mesalazine at 1-72/23(P)/DIVIS/303,...
    Mesalamine (IP/USP/BP/Ph.Eur)
    Issue/Submission Date
    2015-11-06
    2022-11-08
    2019-01-10
    2019-06-17
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    Valsartan

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    USDMF

    Found USDMF

    24797
    Active
    VALSARTAN USP
    2011-03-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-338 - Rev 01
    Valid
    Valsartan
    2020-05-25
    Japanese DMF

    Found JDMF

    302MF10044
    Valsartan at 1-72/23(P)/DIVIS/303, ...
    2020-04-14
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0030
    Expired
    Valsartan (USP/Ph. Eur/1P)
    2019-06-17
    Application Number
    24797
    R1-CEP 2012-338 - Rev 01
    302MF10044
    Indian CDSCO WC-0030
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-06-16
    Filing Details
    VALSARTAN USP
    Valsartan
    Valsartan at 1-72/23(P)/DIVIS/303, ...
    Valsartan (USP/Ph. Eur/1P)
    Issue/Submission Date
    2011-03-29
    2020-05-25
    2020-04-14
    2019-06-17
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    Dextromethorphan

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    USDMF

    Found USDMF

    22469
    Active
    DEXTROMETHORPHAN BASE USP
    2009-01-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    220MF10194
    Dextromethorphan base at 1-72/23(P)...
    2008-08-28
    Written Confirmation

    Found WC

    Indian CDSCO WC-0031
    Valid
    Dextromethorphan (USP)
    2022-06-16
    Application Number
    22469
    220MF10194
    Indian CDSCO WC-0031
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-06-16
    Filing Details
    DEXTROMETHORPHAN BASE USP
    Dextromethorphan base at 1-72/23(P)...
    Dextromethorphan (USP)
    Issue/Submission Date
    2009-01-28
    2008-08-28
    2022-06-16
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    • FDA
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    Diltiazem Hydrochloride

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    USDMF

    Found USDMF

    15267
    Active
    DILTIAZEM HYDROCHLORIDE USP
    2001-01-26
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-156 - Rev 10
    Valid
    Diltiazem hydrochloride
    2020-02-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0031
    Valid
    Diltiazem Hydrochloride (BP/USP/Ph....
    2022-06-16
    Application Number
    15267
    R1-CEP 1999-156 - Rev 10
    Indian CDSCO WC-0031
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-06-16
    Filing Details
    DILTIAZEM HYDROCHLORIDE USP
    Diltiazem hydrochloride
    Diltiazem Hydrochloride (BP/USP/Ph....
    Issue/Submission Date
    2001-01-26
    2020-02-24
    2022-06-16
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    • FDA
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    Iopamidol

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    USDMF

    Found USDMF

    18066
    Active
    IOPAMIDOL USP
    2005-02-06
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-038 - Rev 04
    Valid
    Iopamidol
    2018-12-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0031
    Valid
    Iopamidol (USP/Ph.Eur/BP)
    2022-06-16
    Application Number
    18066
    R1-CEP 2006-038 - Rev 04
    Indian CDSCO WC-0031
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-06-16
    Filing Details
    IOPAMIDOL USP
    Iopamidol
    Iopamidol (USP/Ph.Eur/BP)
    Issue/Submission Date
    2005-02-06
    2018-12-10
    2022-06-16
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    Naproxen

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    USDMF

    Found USDMF

    13866
    Active
    NAPROXEN USP
    1998-11-27
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-042 - Rev 08
    Valid
    Naproxen
    2018-02-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0031
    Valid
    Naproxen (BP/USP/Ph. Eur)
    2022-06-16
    Application Number
    13866
    R1-CEP 1999-042 - Rev 08
    Indian CDSCO WC-0031
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-06-16
    Filing Details
    NAPROXEN USP
    Naproxen
    Naproxen (BP/USP/Ph. Eur)
    Issue/Submission Date
    1998-11-27
    2018-02-28
    2022-06-16
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    Naproxen Sodium

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    USDMF

    Found USDMF

    13867
    Active
    NAPROXEN SODIUM USP
    1998-11-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-110 - Rev 04
    Valid
    Naproxen sodium
    2021-10-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0031
    Valid
    Naproxen Sodium (Ph. Eur/USP)
    2022-06-16
    Application Number
    13867
    R1-CEP 2007-110 - Rev 04
    Indian CDSCO WC-0031
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-06-16
    Filing Details
    NAPROXEN SODIUM USP
    Naproxen sodium
    Naproxen Sodium (Ph. Eur/USP)
    Issue/Submission Date
    1998-11-27
    2021-10-21
    2022-06-16
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    • FDA
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    Proguanil

    PDF Supplier PDF
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    USDMF

    Found USDMF

    18065
    Active
    PROGUANIL HYDROCHLORIDE
    2005-02-06
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-362 - Rev 02
    Valid
    Proguanil hydrochloride
    2018-02-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0031
    Valid
    Proguanil Hydrochloride (BP/USP/Ph....
    2022-06-16
    Application Number
    18065
    R1-CEP 2010-362 - Rev 02
    Indian CDSCO WC-0031
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-06-16
    Filing Details
    PROGUANIL HYDROCHLORIDE
    Proguanil hydrochloride
    Proguanil Hydrochloride (BP/USP/Ph....
    Issue/Submission Date
    2005-02-06
    2018-02-28
    2022-06-16
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    • FDA
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    Valacyclovir Hydrochloride

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    USDMF

    Found USDMF

    28936
    Active
    VALACYCLOVIR HYDROCHLORIDE USP (HYD...
    2014-12-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    224MF10172
    Valacyclovir hydrochloride at 1-72/...
    2012-08-17
    Written Confirmation

    Found WC

    Indian CDSCO WC-0031
    Valid
    Valacyclovir Hydrochloride (USP/BP/...
    2022-06-16
    Application Number
    28936
    224MF10172
    Indian CDSCO WC-0031
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-06-16
    Filing Details
    VALACYCLOVIR HYDROCHLORIDE USP (HYD...
    Valacyclovir hydrochloride at 1-72/...
    Valacyclovir Hydrochloride (USP/BP/...
    Issue/Submission Date
    2014-12-20
    2012-08-17
    2022-06-16
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    Capecitabine

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    USDMF

    Found USDMF

    22157
    Active
    CAPECITABINE
    2008-10-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-111 - Rev 00
    Valid
    Capecitabine
    2021-04-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0030
    Expired
    Capecitabine (USP/ Ph. Eur/IP)
    2019-06-17
    Application Number
    22157
    R1-CEP 2015-111 - Rev 00
    Indian CDSCO WC-0030
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-06-16
    Filing Details
    CAPECITABINE
    Capecitabine
    Capecitabine (USP/ Ph. Eur/IP)
    Issue/Submission Date
    2008-10-27
    2021-04-16
    2019-06-17
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    Gabapentin

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    USDMF

    Found USDMF

    19000
    Active
    GABAPENTIN USP
    2005-12-04
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-200 - Rev 00
    Valid
    Gabapentin, Alternative process
    2020-06-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0030
    Expired
    Gabapentin (USP/Ph. Eur)
    2019-06-17
    Application Number
    19000
    R0-CEP 2019-200 - Rev 00
    Indian CDSCO WC-0030
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-06-16
    Filing Details
    GABAPENTIN USP
    Gabapentin, Alternative process
    Gabapentin (USP/Ph. Eur)
    Issue/Submission Date
    2005-12-04
    2020-06-29
    2019-06-17
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    Irbesartan

    PDF Supplier PDF
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    USDMF

    Found USDMF

    26418
    Active
    IRBESARTAN USP
    2012-09-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-339 - Rev 03
    Valid
    Irbesartan
    2021-11-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0030
    Expired
    Irbesartan (USP/Ph. Eur)
    2019-06-17
    Application Number
    26418
    R1-CEP 2012-339 - Rev 03
    Indian CDSCO WC-0030
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-06-16
    Filing Details
    IRBESARTAN USP
    Irbesartan
    Irbesartan (USP/Ph. Eur)
    Issue/Submission Date
    2012-09-11
    2021-11-08
    2019-06-17
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    Lacosamide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    35724
    Active
    LACOSAMIDE
    2021-03-09
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-437 - Rev 02
    Valid
    Lacosamide
    2023-07-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0030A3
    Expired
    Lacosamide EP
    2021-04-01
    Application Number
    35724
    R0-CEP 2020-437 - Rev 02
    Indian CDSCO WC-0030A3
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-06-16
    Filing Details
    LACOSAMIDE
    Lacosamide
    Lacosamide EP
    Issue/Submission Date
    2021-03-09
    2023-07-27
    2021-04-01
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    Phenylephrine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    16918
    Active
    PHENYLEPHRINE HYDROCHLORIDE USP
    2003-10-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-291 - Rev 06
    Valid
    Phenylephrine hydrochloride
    2021-09-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0030
    Expired
    Phenylephrine HCI (IP/BP/USP/Ph. Eu...
    2019-06-17
    Application Number
    16918
    R1-CEP 2005-291 - Rev 06
    Indian CDSCO WC-0030
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-06-16
    Filing Details
    PHENYLEPHRINE HYDROCHLORIDE USP
    Phenylephrine hydrochloride
    Phenylephrine HCI (IP/BP/USP/Ph. Eu...
    Issue/Submission Date
    2003-10-19
    2021-09-15
    2019-06-17
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    • FDA
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    Venlafaxine Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    22470
    Active
    VENLAFAXINE HCL
    2009-01-28
    CEP/COS

    Found CEP/COS

    CEP 2011-080 - Rev 02
    Valid
    Venlafaxine hydrochloride
    2023-12-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0030
    Expired
    Venlafaxine Hydrochloride (Ph. Eur/...
    2019-06-17
    Application Number
    22470
    CEP 2011-080 - Rev 02
    Indian CDSCO WC-0030
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-06-16
    Filing Details
    VENLAFAXINE HCL
    Venlafaxine hydrochloride
    Venlafaxine Hydrochloride (Ph. Eur/...
    Issue/Submission Date
    2009-01-28
    2023-12-05
    2019-06-17
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    Levetiracetam

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    30185
    Active
    LEVETIRACETAM (PROCESS B)
    2016-01-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-219 - Rev 01
    Valid
    Levetiracetam
    2018-08-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30185
    R1-CEP 2011-219 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LEVETIRACETAM (PROCESS B)
    Levetiracetam
    Issue/Submission Date
    2016-01-08
    2018-08-01
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    Losartan Potassium

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    24183
    Active
    TRITYL LOSARTAN
    2010-09-15
    CEP/COS

    Caution CEP/COS

    R0-CEP 2016-196 - Rev 01
    Withdrawn by Holder
    Losartan potassium
    2020-01-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0030
    Expired
    Losartan Potassium (Ph. Eur/IP/USP)
    2019-06-17
    Application Number
    24183
    R0-CEP 2016-196 - Rev 01
    Indian CDSCO WC-0030
    Status
    Active
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Expired
    2022-06-16
    Filing Details
    TRITYL LOSARTAN
    Losartan potassium
    Losartan Potassium (Ph. Eur/IP/USP)
    Issue/Submission Date
    2010-09-15
    2020-01-17
    2019-06-17
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    Niacin

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    18481
    Active
    NIACIN USP
    2005-07-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0031
    Valid
    Niacin (BP/USPIPh.Eur)
    2022-06-16
    Application Number
    18481
    Indian CDSCO WC-0031
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-06-16
    Filing Details
    NIACIN USP
    Niacin (BP/USPIPh.Eur)
    Issue/Submission Date
    2005-07-05
    2022-06-16
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    Pregabalin

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    28306
    Inactive
    PREGABALIN
    2014-05-16
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-236 - Rev 00
    Valid
    Pregabalin
    2023-07-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0030
    Expired
    Pregabalin IH/USP/EP
    2019-06-17
    Application Number
    28306
    R1-CEP 2016-236 - Rev 00
    Indian CDSCO WC-0030
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-06-16
    Filing Details
    PREGABALIN
    Pregabalin
    Pregabalin IH/USP/EP
    Issue/Submission Date
    2014-05-16
    2023-07-03
    2019-06-17
    ASK
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    • FDA
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    Quetiapine Hemifumarate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    20983
    Active
    QUETIAPINE FUMARATE
    2007-10-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0031
    Valid
    Quetiapine Fumarate (IP)
    2022-06-16
    Application Number
    20983
    Indian CDSCO WC-0031
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-06-16
    Filing Details
    QUETIAPINE FUMARATE
    Quetiapine Fumarate (IP)
    Issue/Submission Date
    2007-10-25
    2022-06-16
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    Tamsulosin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    18971
    Active
    TAMSULOSIN HYDROCHLORIDE
    2005-11-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0031
    Valid
    Tamsulosin Hydrochloride (BP/USP/Ph...
    2022-06-16
    Application Number
    18971
    Indian CDSCO WC-0031
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-06-16
    Filing Details
    TAMSULOSIN HYDROCHLORIDE
    Tamsulosin Hydrochloride (BP/USP/Ph...
    Issue/Submission Date
    2005-11-25
    2022-06-16
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    Telmisartan

    PDF Supplier PDF
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    USDMF

    Found USDMF

    26028
    Active
    TELMISARTAN, USP
    2012-05-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-302 - Rev 00
    Valid
    Telmisartan
    2019-04-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26028
    R1-CEP 2012-302 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TELMISARTAN, USP
    Telmisartan
    Issue/Submission Date
    2012-05-05
    2019-04-01
    ASK
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    Ticagrelor

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    36701
    Active
    TICAGRELOR
    2022-01-27
    CEP/COS

    Found CEP/COS

    CEP 2022-072 - Rev 00
    Valid
    Ticagrelor
    2023-10-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36701
    CEP 2022-072 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TICAGRELOR
    Ticagrelor
    Issue/Submission Date
    2022-01-27
    2023-10-24
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    Zolpidem Tartrate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Caution USDMF

    18808
    Inactive
    ZOLPIDEM TARTRATE USP
    2005-09-25
    CEP/COS

    Caution CEP/COS

    R1-CEP 2006-105 - Rev 04
    Withdrawn by Holder
    Zolpidem tartrate
    2018-03-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0031
    Valid
    Zolpidem Tartrate (BP/USPIPh.Eur)
    2022-06-16
    Application Number
    18808
    R1-CEP 2006-105 - Rev 04
    Indian CDSCO WC-0031
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Valid
    2025-06-16
    Filing Details
    ZOLPIDEM TARTRATE USP
    Zolpidem tartrate
    Zolpidem Tartrate (BP/USPIPh.Eur)
    Issue/Submission Date
    2005-09-25
    2018-03-20
    2022-06-16
    ASK
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    • FDA
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    Desloratadine

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

    See Less

    USDMF

    Caution USDMF

    19441
    Inactive
    DESLORATADINE
    2006-05-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0031
    Valid
    Desloratadine (IH)
    2022-06-16
    Application Number
    19441
    Indian CDSCO WC-0031
    Status
    Inactive
    Fees Paid
    N/A
     
    Valid
    2025-06-16
    Filing Details
    DESLORATADINE
    Desloratadine (IH)
    Issue/Submission Date
    2006-05-17
    2022-06-16
    ASK
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    • FDA
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    Olmesartan Medoxomil

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    27950
    Active
    OLMESARTAN MEDOXOMIL USP
    2014-01-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0030
    Expired
    Olmesartan Medoxomil (USP/Ph. Eur)
    2019-06-17
    Application Number
    27950
    Indian CDSCO WC-0030
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-06-16
    Filing Details
    OLMESARTAN MEDOXOMIL USP
    Olmesartan Medoxomil (USP/Ph. Eur)
    Issue/Submission Date
    2014-01-28
    2019-06-17
    ASK
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    • FDA
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    Orlistat

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

    See Less

    USDMF

    Found USDMF

    35884
    Active
    ORLISTAT
    2021-04-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0030
    Expired
    Orlistate USP
    2019-06-17
    Application Number
    35884
    Indian CDSCO WC-0030
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-06-16
    Filing Details
    ORLISTAT
    Orlistate USP
    Issue/Submission Date
    2021-04-30
    2019-06-17
    ASK
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    • FDA
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    Sumatriptan

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    23624
    Active
    SUMATRIPTAN SUCCINATE AND SUMATRIPT...
    2010-03-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0030
    Expired
    Sumatriptan (IP)
    2019-06-17
    Application Number
    23624
    Indian CDSCO WC-0030
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-06-16
    Filing Details
    SUMATRIPTAN SUCCINATE AND SUMATRIPT...
    Sumatriptan (IP)
    Issue/Submission Date
    2010-03-10
    2019-06-17
    ASK
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    • FDA
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    Bupropion Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    18306
    Active
    BUPROPION HYDROCHLORIDE USP
    2005-04-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18306
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BUPROPION HYDROCHLORIDE USP
    Issue/Submission Date
    2005-04-24
    ASK
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    • FDA
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    Carvedilol

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

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0031
    Valid
    Carvedilol (Ph.Eur)
    2022-06-16
    Application Number
    Indian CDSCO WC-0031
    Status
     
    Valid
    2025-06-16
    Filing Details
    Carvedilol (Ph.Eur)
    Issue/Submission Date
    2022-06-16
    ASK
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    • FDA
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    Carvedilol

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

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0031A2
    Valid
    Carvedilol IH
    2022-06-14
    Application Number
    Indian CDSCO WC-0031A2
    Status
     
    Valid
    2025-06-16
    Filing Details
    Carvedilol IH
    Issue/Submission Date
    2022-06-14
    ASK
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    • FDA
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    Gabapentin

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2013-208 - Rev 00
    Valid
    Gabapentin
    2019-10-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2013-208 - Rev 00
    Status
    Valid
     
    Filing Details
    Gabapentin
    Issue/Submission Date
    2019-10-31
    ASK
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    your Marketing & Sales content
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    • FDA
    • EDQM
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    Iohexol

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

    See Less

    USDMF

    Found USDMF

    38195
    Active
    IOHEXOL
    2023-03-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38195
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    IOHEXOL
    Issue/Submission Date
    2023-03-20
    ASK
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    • FDA
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    Pregabalin

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    30790
    Active
    PREGABALIN (ALTERNATIVE PROCESS)
    2016-08-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30790
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PREGABALIN (ALTERNATIVE PROCESS)
    Issue/Submission Date
    2016-08-01
    ASK
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    • FDA
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    Quetiapine Hemifumarate

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

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0031A2
    Valid
    Quetiapine Fumarate USP/EP
    2022-06-14
    Application Number
    Indian CDSCO WC-0031A2
    Status
     
    Valid
    2025-06-16
    Filing Details
    Quetiapine Fumarate USP/EP
    Issue/Submission Date
    2022-06-14
    ASK
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    your Marketing & Sales content
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    • FDA
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    Succinate

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

    See Less

    USDMF

    Found USDMF

    20686
    Active
    BOC CORE SUCCINATE (INTERMEDIATE)
    2007-07-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20686
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BOC CORE SUCCINATE (INTERMEDIATE)
    Issue/Submission Date
    2007-07-15
    ASK
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    your Marketing & Sales content
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    • FDA
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    Sulfasalazine

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

    See Less

    USDMF

    Found USDMF

    16817
    Active
    SULPHAZINE
    2003-09-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16817
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SULPHAZINE
    Issue/Submission Date
    2003-09-03
    ASK
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    your Marketing & Sales content
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    • FDA
    • EDQM
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    Topiramate

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

    See Less

    USDMF

    Found USDMF

    21068
    Active
    Topiramate
    2007-11-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21068
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    Topiramate
    Issue/Submission Date
    2007-11-25
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    Vigabatrin

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    31953
    Active
    VIGABATRIN USP
    2017-07-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31953
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    VIGABATRIN USP
    Issue/Submission Date
    2017-07-29
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    Vigabatrin

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    USDMF

    Caution USDMF

    21579
    Inactive
    VIGABATRIN
    2008-04-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0030
    Expired
    Vigabatrin (BP)
    2019-06-17
    Application Number
    21579
    Indian CDSCO WC-0030
    Status
    Inactive
    Fees Paid
    N/A
     
    Expired
    2022-06-16
    Filing Details
    VIGABATRIN
    Vigabatrin (BP)
    Issue/Submission Date
    2008-04-29
    2019-06-17
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    A WINGS

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    USDMF

    Found USDMF

    14778
    Active
    A WINGS
    2000-03-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14778
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    A WINGS
    Issue/Submission Date
    2000-03-14
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    B WINGS

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    USDMF

    Found USDMF

    14779
    Active
    B WINGS
    2000-03-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14779
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    B WINGS
    Issue/Submission Date
    2000-03-14
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    KETOENAMINE

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    22065
    Active
    KETOENAMINE
    2008-10-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22065
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    KETOENAMINE
    Issue/Submission Date
    2008-10-05
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    2-4-WING ACTIVE ESTER

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    USDMF

    Found USDMF

    23990
    Active
    2-4-WING ACTIVE ESTER
    2010-07-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23990
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    2-4-WING ACTIVE ESTER
    Issue/Submission Date
    2010-07-23
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    IRBESARTAN USP

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    USDMF

    Found USDMF

    39096
    Active
    IRBESARTAN USP
    2023-11-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    39096
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    IRBESARTAN USP
    Issue/Submission Date
    2023-11-07
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