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    Zydus Lifesciences
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    Country
    Country
    India
    Address
    Address
    Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, Sarkhej - Gandhinagar Hwy, Ahmedabad, 382481
    Telephone
    Telephone
    91 2262801310
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    Email
    enquiries@pharmacompass.com
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    https://www.zyduscadila.com/
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    • FDA
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    Mesalazine

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    USDMF

    Found USDMF

    22999
    Active
    MESALAMINE USP
    2009-07-31
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-009 - Rev 01
    Valid
    Mesalazine
    2022-07-07
    Japanese DMF

    Found JDMF

    303MF10044
    Mesalazine at Zydus Corporate Park,...
    2021-03-15
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0095
    Expired
    Mesalamine (USP) Etodolac (USP)
    2019-07-08
    Application Number
    22999
    R0-CEP 2019-009 - Rev 01
    303MF10044
    Indian CDSCO WC-0095
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-07
    Filing Details
    MESALAMINE USP
    Mesalazine
    Mesalazine at Zydus Corporate Park,...
    Mesalamine (USP) Etodolac (USP)
    Issue/Submission Date
    2009-07-31
    2022-07-07
    2021-03-15
    2019-07-08
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    • FDA
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    Paroxetine Hydrochloride

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    USDMF

    Found USDMF

    16680
    Active
    PAROXETINE HYDROCHLORIDE USP (HEMIH...
    2003-06-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-239 - Rev 06
    Valid
    Paroxetine hydrochloride hemihydrat...
    2022-07-08
    Japanese DMF

    Found JDMF

    222MF10207
    Paroxetine Hydrochloride Hydrate at...
    2010-07-26
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0084
    Expired
    Paroxetine Hydrochloride IH
    2019-07-15
    Application Number
    16680
    R1-CEP 2004-239 - Rev 06
    222MF10207
    Indian CDSCO WC-0084
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-14
    Filing Details
    PAROXETINE HYDROCHLORIDE USP (HEMIH...
    Paroxetine hydrochloride hemihydrat...
    Paroxetine Hydrochloride Hydrate at...
    Paroxetine Hydrochloride IH
    Issue/Submission Date
    2003-06-27
    2022-07-08
    2010-07-26
    2019-07-15
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    • FDA
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    Tramadol Hydrochloride

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    USDMF

    Found USDMF

    17037
    Active
    TRAMADOL HYDROCHLORIDE USP
    2004-02-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-098 - Rev 04
    Valid
    Tramadol hydrochloride
    2022-07-07
    Japanese DMF

    Found JDMF

    301MF10065
    Tramadol Hydrochloride at “Zydus ...
    2019-09-17
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0095
    Expired
    Tramadol Hydrochloride (EP/USP)
    2019-07-08
    Application Number
    17037
    R1-CEP 2004-098 - Rev 04
    301MF10065
    Indian CDSCO WC-0095
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-07
    Filing Details
    TRAMADOL HYDROCHLORIDE USP
    Tramadol hydrochloride
    Tramadol Hydrochloride at “Zydus ...
    Tramadol Hydrochloride (EP/USP)
    Issue/Submission Date
    2004-02-17
    2022-07-07
    2019-09-17
    2019-07-08
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    • FDA
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    Valsartan

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    USDMF

    Caution USDMF

    22684
    Inactive
    VALSARTAN USP
    2009-03-31
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-221 - Rev 00
    Valid
    Valsartan
    2023-04-04
    Japanese DMF

    Found JDMF

    225MF10140
    Valsartan at “Zydus Tower”, Sat...
    2013-07-23
    Written Confirmation

    Found WC

    Indian CDSCO WC-0080
    Valid
    Valsartan (EP/USP)
    2022-06-08
    Application Number
    22684
    R0-CEP 2020-221 - Rev 00
    225MF10140
    Indian CDSCO WC-0080
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    VALSARTAN USP
    Valsartan
    Valsartan at “Zydus Tower”, Sat...
    Valsartan (EP/USP)
    Issue/Submission Date
    2009-03-31
    2023-04-04
    2013-07-23
    2022-06-08
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    • FDA
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    Atomoxetin Hydrochloride

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    USDMF

    Found USDMF

    20364
    Active
    ATOMOXETINE HCL USP
    2007-03-22
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-236 - Rev 01
    Valid
    Atomoxetine hydrochloride
    2022-07-11
    Japanese DMF

    Found JDMF

    303MF10088
    Atomoxetine Hydrochloride at Zydus ...
    2021-06-07
    Written Confirmation

    Close WC

    Application Number
    20364
    R0-CEP 2019-236 - Rev 01
    303MF10088
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ATOMOXETINE HCL USP
    Atomoxetine hydrochloride
    Atomoxetine Hydrochloride at Zydus ...
    Issue/Submission Date
    2007-03-22
    2022-07-11
    2021-06-07
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    Atorvastatin

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    USDMF

    Found USDMF

    18822
    Active
    ATORVASTATIN PROTECTED DIOL
    2005-09-30
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-309 - Rev 01
    Valid
    Atorvastatin calcium, Process-III
    2022-07-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0080
    Valid
    Atorvastatin Calcium (USP)/Atorvast...
    2022-06-08
    Application Number
    18822
    R0-CEP 2020-309 - Rev 01
    Indian CDSCO WC-0080
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    ATORVASTATIN PROTECTED DIOL
    Atorvastatin calcium, Process-III
    Atorvastatin Calcium (USP)/Atorvast...
    Issue/Submission Date
    2005-09-30
    2022-07-26
    2022-06-08
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    Losartan Potassium

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    USDMF

    Caution USDMF

    18153
    Inactive
    LOSARTAN POTASSIUM USP
    2005-03-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-133 - Rev 08
    Valid
    Losartan potassium
    2023-03-23
    Japanese DMF

    Found JDMF

    223MF10140
    Losartan potassium at “Zydus Towe...
    2011-08-30
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0095
    Expired
    Losartan Potassium EP/USP 6
    2019-07-08
    Application Number
    18153
    R1-CEP 2009-133 - Rev 08
    223MF10140
    Indian CDSCO WC-0095
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-07
    Filing Details
    LOSARTAN POTASSIUM USP
    Losartan potassium
    Losartan potassium at “Zydus Towe...
    Losartan Potassium EP/USP 6
    Issue/Submission Date
    2005-03-04
    2023-03-23
    2011-08-30
    2019-07-08
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    Amlodipine Besylate

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    USDMF

    Found USDMF

    18827
    Active
    AMLODIPINE BESILATE USP
    2005-09-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-280 - Rev 08
    Valid
    Amlodipine besilate
    2022-07-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0095
    Expired
    Amlodipine Besilate (BP/USP/EP)
    2019-07-08
    Application Number
    18827
    R1-CEP 2007-280 - Rev 08
    Indian CDSCO WC-0095
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-07
    Filing Details
    AMLODIPINE BESILATE USP
    Amlodipine besilate
    Amlodipine Besilate (BP/USP/EP)
    Issue/Submission Date
    2005-09-30
    2022-07-07
    2019-07-08
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    Aripiprazole

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    USDMF

    Found USDMF

    19841
    Active
    ARIPIPRAZOLE USP
    2006-10-09
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-002 - Rev 01
    Valid
    Aripiprazole
    2022-07-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0084
    Expired
    Aripiprazolelli
    2019-07-15
    Application Number
    19841
    R0-CEP 2019-002 - Rev 01
    Indian CDSCO WC-0084
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-14
    Filing Details
    ARIPIPRAZOLE USP
    Aripiprazole
    Aripiprazolelli
    Issue/Submission Date
    2006-10-09
    2022-07-11
    2019-07-15
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    Atenolol

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    USDMF

    Found USDMF

    14210
    Active
    ATENOLOL USP
    1999-06-14
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-169 - Rev 04
    Valid
    Atenolol
    2022-07-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0084
    Expired
    Atenolol (BP/USP/EP)
    2019-07-15
    Application Number
    14210
    R1-CEP 2004-169 - Rev 04
    Indian CDSCO WC-0084
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-14
    Filing Details
    ATENOLOL USP
    Atenolol
    Atenolol (BP/USP/EP)
    Issue/Submission Date
    1999-06-14
    2022-07-07
    2019-07-15
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    • FDA
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    Azelastine Hydrochloride

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    USDMF

    Found USDMF

    22919
    Active
    AZELASTINE HYDROCHLORIDE
    2009-07-02
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-018 - Rev 02
    Valid
    Azelastine hydrochloride
    2022-07-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0084
    Expired
    Azelastine Hydrochloride EP
    2019-07-15
    Application Number
    22919
    R0-CEP 2019-018 - Rev 02
    Indian CDSCO WC-0084
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-14
    Filing Details
    AZELASTINE HYDROCHLORIDE
    Azelastine hydrochloride
    Azelastine Hydrochloride EP
    Issue/Submission Date
    2009-07-02
    2022-07-11
    2019-07-15
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    • FDA
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    Benzoyl Peroxide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    23860
    Active
    BENZOYL PEROXIDE HYDROUS USP
    2010-06-04
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-300 - Rev 01
    Valid
    Benzoyl Peroxide, Hydrous
    2022-07-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0095
    Expired
    Benzoyl Peroxide Hydrous EP
    2019-07-08
    Application Number
    23860
    R0-CEP 2018-300 - Rev 01
    Indian CDSCO WC-0095
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-07
    Filing Details
    BENZOYL PEROXIDE HYDROUS USP
    Benzoyl Peroxide, Hydrous
    Benzoyl Peroxide Hydrous EP
    Issue/Submission Date
    2010-06-04
    2022-07-11
    2019-07-08
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    Carvedilol

    PDF Supplier PDF
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    USDMF

    Found USDMF

    17947
    Active
    CARVEDILOL USP
    2004-12-29
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-109 - Rev 00
    Valid
    Carvedilol
    2023-05-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0095
    Expired
    Carvedilol EP/USP/JP/BP
    2019-07-08
    Application Number
    17947
    R0-CEP 2021-109 - Rev 00
    Indian CDSCO WC-0095
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-07
    Filing Details
    CARVEDILOL USP
    Carvedilol
    Carvedilol EP/USP/JP/BP
    Issue/Submission Date
    2004-12-29
    2023-05-17
    2019-07-08
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    Esomeprazole Magnesium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    22363
    Active
    ESOMEPRAZOLE MAGNESIUM DIHYDRATE
    2008-12-29
    CEP/COS

    Found CEP/COS

    CEP 2022-294 - Rev 00
    Valid
    Esomeprazole magnesium dihydrate
    2024-02-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0095
    Expired
    Esomeprazole Magnesium IH
    2019-07-08
    Application Number
    22363
    CEP 2022-294 - Rev 00
    Indian CDSCO WC-0095
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-07
    Filing Details
    ESOMEPRAZOLE MAGNESIUM DIHYDRATE
    Esomeprazole magnesium dihydrate
    Esomeprazole Magnesium IH
    Issue/Submission Date
    2008-12-29
    2024-02-22
    2019-07-08
    ASK
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    • FDA
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    Hydroxychloroquine Sulphate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    14977
    Active
    HYDROXYCHLOROQUINE SULFATE USP
    2000-08-01
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-011 - Rev 01
    Valid
    Hydroxychloroquine sulfate
    2022-07-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0084A5
    Expired
    Hydroxychloroquine Sulphate EP
    2021-07-29
    Application Number
    14977
    R0-CEP 2019-011 - Rev 01
    Indian CDSCO WC-0084A5
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-14
    Filing Details
    HYDROXYCHLOROQUINE SULFATE USP
    Hydroxychloroquine sulfate
    Hydroxychloroquine Sulphate EP
    Issue/Submission Date
    2000-08-01
    2022-07-08
    2021-07-29
    ASK
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    Lamotrigine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    18090
    Active
    LAMOTRIGINE USP
    2005-02-17
    CEP/COS

    Found CEP/COS

    CEP 2018-295 - Rev 03
    Valid
    Lamotrigine
    2024-01-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0095
    Expired
    Lamotrigine USP
    2019-07-08
    Application Number
    18090
    CEP 2018-295 - Rev 03
    Indian CDSCO WC-0095
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-07
    Filing Details
    LAMOTRIGINE USP
    Lamotrigine
    Lamotrigine USP
    Issue/Submission Date
    2005-02-17
    2024-01-30
    2019-07-08
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    Lansoprazole

    PDF Supplier PDF
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    USDMF

    Found USDMF

    19794
    Active
    LANSOPRAZOLE USP
    2006-10-03
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-015 - Rev 02
    Valid
    Lansoprazole
    2022-07-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0095A2
    Expired
    lansoprazol EP/USP
    2020-10-23
    Application Number
    19794
    R0-CEP 2019-015 - Rev 02
    Indian CDSCO WC-0095A2
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-07
    Filing Details
    LANSOPRAZOLE USP
    Lansoprazole
    lansoprazol EP/USP
    Issue/Submission Date
    2006-10-03
    2022-07-11
    2020-10-23
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    Meloxicam

    PDF Supplier PDF
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    USDMF

    Found USDMF

    17358
    Active
    MELOXICAM USP
    2004-05-05
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-017 - Rev 03
    Valid
    Meloxicam
    2023-07-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0095
    Expired
    Meloxicam(USP/BP) Nicorandil IH
    2019-07-08
    Application Number
    17358
    R0-CEP 2019-017 - Rev 03
    Indian CDSCO WC-0095
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-07
    Filing Details
    MELOXICAM USP
    Meloxicam
    Meloxicam(USP/BP) Nicorandil IH
    Issue/Submission Date
    2004-05-05
    2023-07-17
    2019-07-08
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    Olmesartan Medoxomil

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    USDMF

    Found USDMF

    24644
    Active
    OLMESARTAN MEDOXOMIL USP
    2011-02-16
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-383 - Rev 00
    Valid
    Olmesartan medoxomil
    2023-02-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0084
    Expired
    Olmesartan Medoxomil IH
    2019-07-15
    Application Number
    24644
    R1-CEP 2015-383 - Rev 00
    Indian CDSCO WC-0084
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-14
    Filing Details
    OLMESARTAN MEDOXOMIL USP
    Olmesartan medoxomil
    Olmesartan Medoxomil IH
    Issue/Submission Date
    2011-02-16
    2023-02-03
    2019-07-15
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    Pitavastatin

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    USDMF

    Found USDMF

    27333
    Active
    PITAVASTATIN CALCIUM
    2013-07-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    224MF10187
    Pitavastatin calcium at “Zydus To...
    2012-09-03
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0084
    Expired
    Pitavastatin Calcium IH
    2019-07-15
    Application Number
    27333
    224MF10187
    Indian CDSCO WC-0084
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-14
    Filing Details
    PITAVASTATIN CALCIUM
    Pitavastatin calcium at “Zydus To...
    Pitavastatin Calcium IH
    Issue/Submission Date
    2013-07-31
    2012-09-03
    2019-07-15
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    Pregabalin

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    USDMF

    Caution USDMF

    22925
    Inactive
    PREGABALIN
    2009-07-08
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-019 - Rev 01
    Valid
    Pregabalin
    2022-07-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0080
    Valid
    Pregabalin (IH)
    2022-06-08
    Application Number
    22925
    R0-CEP 2019-019 - Rev 01
    Indian CDSCO WC-0080
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    PREGABALIN
    Pregabalin
    Pregabalin (IH)
    Issue/Submission Date
    2009-07-08
    2022-07-12
    2022-06-08
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    Risperidone

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    USDMF

    Found USDMF

    18068
    Active
    RISPERIDONE USP
    2005-02-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-078 - Rev 02
    Valid
    Risperidone
    2022-07-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0084
    Expired
    Risperidone (BP/EP)
    2019-07-15
    Application Number
    18068
    R1-CEP 2005-078 - Rev 02
    Indian CDSCO WC-0084
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-14
    Filing Details
    RISPERIDONE USP
    Risperidone
    Risperidone (BP/EP)
    Issue/Submission Date
    2005-02-09
    2022-07-08
    2019-07-15
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    Tamsulosin

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    USDMF

    Found USDMF

    17688
    Active
    TAMSULOSIN HYDROCHLORIDE USP
    2004-09-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-144 - Rev 04
    Valid
    Tamsulosin hydrochloride
    2022-12-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0084
    Expired
    Tamsulosin Hydrochloride IH
    2019-07-15
    Application Number
    17688
    R1-CEP 2010-144 - Rev 04
    Indian CDSCO WC-0084
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-14
    Filing Details
    TAMSULOSIN HYDROCHLORIDE USP
    Tamsulosin hydrochloride
    Tamsulosin Hydrochloride IH
    Issue/Submission Date
    2004-09-17
    2022-12-07
    2019-07-15
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    Telmisartan

    PDF Supplier PDF
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    USDMF

    Found USDMF

    22689
    Active
    TELMISARTAN USP
    2009-03-31
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-235 - Rev 02
    Valid
    Telmisartan
    2022-07-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0095
    Expired
    Telmisartan IH
    2019-07-08
    Application Number
    22689
    R1-CEP 2009-235 - Rev 02
    Indian CDSCO WC-0095
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-07
    Filing Details
    TELMISARTAN USP
    Telmisartan
    Telmisartan IH
    Issue/Submission Date
    2009-03-31
    2022-07-08
    2019-07-08
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    Topiramate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    18700
    Active
    TOPIRAMATE USP
    2005-08-25
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-419 - Rev 00
    Valid
    Topiramate
    2023-03-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0084
    Expired
    TopiramatelH
    2019-07-15
    Application Number
    18700
    R0-CEP 2021-419 - Rev 00
    Indian CDSCO WC-0084
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-14
    Filing Details
    TOPIRAMATE USP
    Topiramate
    TopiramatelH
    Issue/Submission Date
    2005-08-25
    2023-03-24
    2019-07-15
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    Venlafaxine Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    18211
    Active
    VENLAFAXINE HYDROCHLORIDE USP
    2005-03-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-262 - Rev 02
    Valid
    Venlafaxine hydrochloride
    2022-07-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0095
    Expired
    Venlafaxine HCl USP/EP/BP
    2019-07-08
    Application Number
    18211
    R1-CEP 2009-262 - Rev 02
    Indian CDSCO WC-0095
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-07
    Filing Details
    VENLAFAXINE HYDROCHLORIDE USP
    Venlafaxine hydrochloride
    Venlafaxine HCl USP/EP/BP
    Issue/Submission Date
    2005-03-28
    2022-07-08
    2019-07-08
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    Atorvastatin

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    23001
    Inactive
    ATORVASTATIN CALCIUM (CRYSTALLINE F...
    2009-07-31
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-079 - Rev 01
    Valid
    Atorvastatin calcium, Process-IV
    2022-07-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0095
    Expired
    Atorvastatin Calcium (USP)
    2019-07-08
    Application Number
    23001
    R0-CEP 2021-079 - Rev 01
    Indian CDSCO WC-0095
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-07
    Filing Details
    ATORVASTATIN CALCIUM (CRYSTALLINE F...
    Atorvastatin calcium, Process-IV
    Atorvastatin Calcium (USP)
    Issue/Submission Date
    2009-07-31
    2022-07-27
    2019-07-08
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    Candesartan Cilexetil

    PDF Supplier PDF
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    USDMF

    Found USDMF

    18828
    Active
    CANDESARTAN CILEXETIL USP
    2005-10-03
    CEP/COS

    Caution CEP/COS

    R1-CEP 2012-130 - Rev 01
    Withdrawn by Holder
    Candesartan cilexetil, Process II
    2019-10-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0095
    Expired
    Candesartan Cilexetil (EP/USP/JP)
    2019-07-08
    Application Number
    18828
    R1-CEP 2012-130 - Rev 01
    Indian CDSCO WC-0095
    Status
    Active
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Expired
    2022-07-07
    Filing Details
    CANDESARTAN CILEXETIL USP
    Candesartan cilexetil, Process II
    Candesartan Cilexetil (EP/USP/JP)
    Issue/Submission Date
    2005-10-03
    2019-10-03
    2019-07-08
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    Clopidogrel

    PDF Supplier PDF
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    See Less

    USDMF

    Caution USDMF

    20579
    Inactive
    CSA SALT OF CLOPIDOGREL
    2007-06-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-152 - Rev 03
    Valid
    Clopidogrel hydrogen sulfate
    2023-04-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0084
    Expired
    Clopidogrel Bisulfate (USP)
    2019-07-15
    Application Number
    20579
    R1-CEP 2011-152 - Rev 03
    Indian CDSCO WC-0084
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-14
    Filing Details
    CSA SALT OF CLOPIDOGREL
    Clopidogrel hydrogen sulfate
    Clopidogrel Bisulfate (USP)
    Issue/Submission Date
    2007-06-11
    2023-04-28
    2019-07-15
    ASK
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    Clopidogrel

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Caution USDMF

    20650
    Inactive
    CLOPIDOGREL BISULFATE USP (FORM-I)
    2007-07-06
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-292 - Rev 00
    Valid
    Clopidogrel hydrogen sulfate, Proce...
    2022-10-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0095
    Expired
    Clopidogrel Bisulfate USP
    2019-07-08
    Application Number
    20650
    R0-CEP 2021-292 - Rev 00
    Indian CDSCO WC-0095
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-07
    Filing Details
    CLOPIDOGREL BISULFATE USP (FORM-I)
    Clopidogrel hydrogen sulfate, Proce...
    Clopidogrel Bisulfate USP
    Issue/Submission Date
    2007-07-06
    2022-10-26
    2019-07-08
    ASK
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    • FDA
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    Duloxetine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Caution USDMF

    19631
    Inactive
    DULOXETINE HYDROCHLORIDE USP
    2006-07-25
    CEP/COS

    Found CEP/COS

    CEP 2015-369 - Rev 02
    Valid
    Duloxetine hydrochloride
    2024-02-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0084
    Expired
    Duloxetine Hydrochloride EP/USP
    2019-07-15
    Application Number
    19631
    CEP 2015-369 - Rev 02
    Indian CDSCO WC-0084
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-14
    Filing Details
    DULOXETINE HYDROCHLORIDE USP
    Duloxetine hydrochloride
    Duloxetine Hydrochloride EP/USP
    Issue/Submission Date
    2006-07-25
    2024-02-08
    2019-07-15
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    Etodolac

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    23688
    Active
    ETODOLAC USP
    2010-04-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2017-017 - Rev 00
    Valid
    Etodolac
    2023-01-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23688
    R1-CEP 2017-017 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ETODOLAC USP
    Etodolac
    Issue/Submission Date
    2010-04-05
    2023-01-19
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    Loratadine

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    15018
    Inactive
    LORATIDINE
    2000-08-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-254 - Rev 03
    Valid
    Loratadine
    2022-07-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0095
    Expired
    Loratidine EP/USP
    2019-07-08
    Application Number
    15018
    R1-CEP 2007-254 - Rev 03
    Indian CDSCO WC-0095
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-07
    Filing Details
    LORATIDINE
    Loratadine
    Loratidine EP/USP
    Issue/Submission Date
    2000-08-28
    2022-07-07
    2019-07-08
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    Omeprazole

    PDF Supplier PDF
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    USDMF

    Found USDMF

    21793
    Active
    OMEPRAZOLE USP (FORM-B)
    2008-07-14
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-162 - Rev 02
    Valid
    Omeprazole, Process II
    2022-07-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21793
    R1-CEP 2011-162 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    OMEPRAZOLE USP (FORM-B)
    Omeprazole, Process II
    Issue/Submission Date
    2008-07-14
    2022-07-08
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    Omeprazole

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    URL Supplier Web Content
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    USDMF

    Caution USDMF

    18501
    Inactive
    OMEPRAZOLE
    2005-07-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-102 - Rev 03
    Valid
    Omeprazole
    2022-07-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0095
    Expired
    Omeprazole (BP/USP/EP)
    2019-07-08
    Application Number
    18501
    R1-CEP 2003-102 - Rev 03
    Indian CDSCO WC-0095
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-07
    Filing Details
    OMEPRAZOLE
    Omeprazole
    Omeprazole (BP/USP/EP)
    Issue/Submission Date
    2005-07-11
    2022-07-07
    2019-07-08
    ASK
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    • FDA
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    Rosuvastatin Calcium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    26073
    Active
    ROSUVASTATIN CALCIUM USP
    2012-05-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0080
    Valid
    Rosuvastatin Calcium (IP)
    2022-06-08
    Application Number
    26073
    Indian CDSCO WC-0080
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    ROSUVASTATIN CALCIUM USP
    Rosuvastatin Calcium (IP)
    Issue/Submission Date
    2012-05-31
    2022-06-08
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    Trazodone Hydrochloride

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    32928
    Active
    TRAZODONE HYDROCHLORIDE USP
    2018-08-31
    CEP/COS

    Found CEP/COS

    CEP 2022-396 - Rev 00
    Valid
    Trazodone hydrochloride
    2024-02-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32928
    CEP 2022-396 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TRAZODONE HYDROCHLORIDE USP
    Trazodone hydrochloride
    Issue/Submission Date
    2018-08-31
    2024-02-28
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    Ziprasidone Hydrochloride

    PDF Supplier PDF
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    See Less

    USDMF

    Caution USDMF

    18952
    Inactive
    ZIPRASIDONE HYDROCHLORIDE ANHYDROUS
    2005-11-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-366 - Rev 01
    Valid
    Ziprasidone hydrochloride monohydra...
    2022-07-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0084
    Expired
    Ziprasidone Hydrochloride Monohydra...
    2019-07-15
    Application Number
    18952
    R1-CEP 2012-366 - Rev 01
    Indian CDSCO WC-0084
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-14
    Filing Details
    ZIPRASIDONE HYDROCHLORIDE ANHYDROUS
    Ziprasidone hydrochloride monohydra...
    Ziprasidone Hydrochloride Monohydra...
    Issue/Submission Date
    2005-11-11
    2022-07-07
    2019-07-15
    ASK
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    your Marketing & Sales content
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    • FDA
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    Clindamycin Phosphate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    26669
    Active
    CLINDAMYCIN PHOSPHATE USP
    2015-03-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0084
    Expired
    Clindamycin Phosphate USP/EP/BP
    2019-07-15
    Application Number
    26669
    Indian CDSCO WC-0084
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-14
    Filing Details
    CLINDAMYCIN PHOSPHATE USP
    Clindamycin Phosphate USP/EP/BP
    Issue/Submission Date
    2015-03-10
    2019-07-15
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    Donepezil

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    22233
    Active
    DONEPEZIL HYDROCHLORIDE USP
    2008-12-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0084
    Expired
    Donepezil Hydrochloride IH
    2019-07-15
    Application Number
    22233
    Indian CDSCO WC-0084
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-14
    Filing Details
    DONEPEZIL HYDROCHLORIDE USP
    Donepezil Hydrochloride IH
    Issue/Submission Date
    2008-12-01
    2019-07-15
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    Escitalopram Oxalate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    18119
    Active
    ESCITALOPRAM OXALATE USP
    2005-02-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0095
    Expired
    Escitalopram Oxalate USP
    2019-07-08
    Application Number
    18119
    Indian CDSCO WC-0095
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-07
    Filing Details
    ESCITALOPRAM OXALATE USP
    Escitalopram Oxalate USP
    Issue/Submission Date
    2005-02-25
    2019-07-08
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    • FDA
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    Famotidine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    18524
    Active
    FAMOTIDINE USP
    2005-07-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0084
    Expired
    Famotidine (BP/USP/EP)
    2019-07-15
    Application Number
    18524
    Indian CDSCO WC-0084
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-14
    Filing Details
    FAMOTIDINE USP
    Famotidine (BP/USP/EP)
    Issue/Submission Date
    2005-07-19
    2019-07-15
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    Fluconazole

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    16297
    Active
    FLUCONAZOLE USP
    2002-12-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0084
    Expired
    Fluconazole (BP)
    2019-07-15
    Application Number
    16297
    Indian CDSCO WC-0084
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-14
    Filing Details
    FLUCONAZOLE USP
    Fluconazole (BP)
    Issue/Submission Date
    2002-12-02
    2019-07-15
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    Hydrochlorothiazide

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    22027
    Active
    HYDROCHLOROTHIAZIDE USP
    2008-09-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0084
    Expired
    Hydrochlorothiazide (USP/EP)
    2019-07-15
    Application Number
    22027
    Indian CDSCO WC-0084
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-14
    Filing Details
    HYDROCHLOROTHIAZIDE USP
    Hydrochlorothiazide (USP/EP)
    Issue/Submission Date
    2008-09-24
    2019-07-15
    ASK
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    • FDA
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    Irbesartan

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    20361
    Active
    IRBESARTAN USP
    2007-03-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0084
    Expired
    Itbesartan IH
    2019-07-15
    Application Number
    20361
    Indian CDSCO WC-0084
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-14
    Filing Details
    IRBESARTAN USP
    Itbesartan IH
    Issue/Submission Date
    2007-03-22
    2019-07-15
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    Levofloxacin

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    18118
    Active
    LEVOFLOXACIN USP (HEMIHYDRATE)
    2005-02-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0095
    Expired
    Levofloxacin Hemihydrate USP
    2019-07-08
    Application Number
    18118
    Indian CDSCO WC-0095
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-07
    Filing Details
    LEVOFLOXACIN USP (HEMIHYDRATE)
    Levofloxacin Hemihydrate USP
    Issue/Submission Date
    2005-02-23
    2019-07-08
    ASK
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    Pioglitazone Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    22041
    Active
    PIOGLITAZONE HYDROCHLORIDE USP
    2008-09-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0084
    Expired
    Pioglitazone Hydrochloride USP/IP
    2019-07-15
    Application Number
    22041
    Indian CDSCO WC-0084
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-14
    Filing Details
    PIOGLITAZONE HYDROCHLORIDE USP
    Pioglitazone Hydrochloride USP/IP
    Issue/Submission Date
    2008-09-24
    2019-07-15
    ASK
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    Pramipexole Dihydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    20130
    Active
    PRAMIPEXOLE DIHYDROCHLORIDE USP (MO...
    2007-01-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0084
    Expired
    Pramipexole Dihydrochloride Monohyd...
    2019-07-15
    Application Number
    20130
    Indian CDSCO WC-0084
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-14
    Filing Details
    PRAMIPEXOLE DIHYDROCHLORIDE USP (MO...
    Pramipexole Dihydrochloride Monohyd...
    Issue/Submission Date
    2007-01-08
    2019-07-15
    ASK
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    your Marketing & Sales content
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    • FDA
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    Rivastigmine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    27516
    Active
    RIVASTIGMINE USP
    2013-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0084
    Expired
    Rivastigmine IH
    2019-07-15
    Application Number
    27516
    Indian CDSCO WC-0084
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-14
    Filing Details
    RIVASTIGMINE USP
    Rivastigmine IH
    Issue/Submission Date
    2013-09-30
    2019-07-15
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    • FDA
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    Silodosin

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

    See Less

    USDMF

    Found USDMF

    26251
    Active
    SILODOSIN
    2012-09-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0084
    Expired
    Sitodosin IH
    2019-07-15
    Application Number
    26251
    Indian CDSCO WC-0084
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-14
    Filing Details
    SILODOSIN
    Sitodosin IH
    Issue/Submission Date
    2012-09-10
    2019-07-15
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