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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Macleods Pharmaceuticals Limited

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    Macleods Pharmaceuticals Limited
    india-flag Flag
    Country
    Country
    India
    Address
    Address
    Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai - 400059
    Telephone
    Telephone
    91-22-6676-2800 
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.macleodspharma.com/
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    Aripiprazole

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    USDMF

    Found USDMF

    25472
    Active
    ARIPIPRAZOLE
    2012-01-10
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-282 - Rev 00
    Valid
    Aripiprazole, 1280
    2022-07-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Aripiprazole (EP/USP)
    2019-11-28
    Application Number
    25472
    R0-CEP 2021-282 - Rev 00
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    ARIPIPRAZOLE
    Aripiprazole, 1280
    Aripiprazole (EP/USP)
    Issue/Submission Date
    2012-01-10
    2022-07-12
    2019-11-28
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    Candesartan Cilexetil

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    USDMF

    Found USDMF

    24810
    Active
    CANDESARTAN CILEXETIL
    2011-03-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-042 - Rev 01
    Valid
    Candesartan cilexetil
    2023-01-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Candesartan Cilexetil (Ph. Eur./USP...
    2019-11-28
    Application Number
    24810
    R1-CEP 2014-042 - Rev 01
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    CANDESARTAN CILEXETIL
    Candesartan cilexetil
    Candesartan Cilexetil (Ph. Eur./USP...
    Issue/Submission Date
    2011-03-28
    2023-01-16
    2019-11-28
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    Celecoxib

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    USDMF

    Found USDMF

    25792
    Active
    CELECOXIB
    2012-06-29
    CEP/COS

    Found CEP/COS

    CEP 2015-195 - Rev 01
    Valid
    Celecoxib
    2023-09-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Celecoxib (Ph. Eur./USP)
    2019-11-28
    Application Number
    25792
    CEP 2015-195 - Rev 01
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    CELECOXIB
    Celecoxib
    Celecoxib (Ph. Eur./USP)
    Issue/Submission Date
    2012-06-29
    2023-09-27
    2019-11-28
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    Clopidogrel

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    USDMF

    Found USDMF

    24110
    Active
    CLOPIDOGREL BISULFATE USP
    2010-08-30
    CEP/COS

    Found CEP/COS

    CEP 2011-199 - Rev 06
    Valid
    Clopidogrel hydrogen sulfate
    2024-01-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Clopidogrel Bisulfate (Ph. Eur./USP...
    2019-11-28
    Application Number
    24110
    CEP 2011-199 - Rev 06
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    CLOPIDOGREL BISULFATE USP
    Clopidogrel hydrogen sulfate
    Clopidogrel Bisulfate (Ph. Eur./USP...
    Issue/Submission Date
    2010-08-30
    2024-01-05
    2019-11-28
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    • FDA
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    Duloxetine

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    USDMF

    Found USDMF

    25036
    Active
    DULOXETINE HYDROCHLORIDE
    2011-06-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-166 - Rev 00
    Valid
    Duloxetine hydrochloride
    2021-10-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Duloxetine Hydrochloride (EP/USP)
    2019-11-28
    Application Number
    25036
    R1-CEP 2015-166 - Rev 00
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    DULOXETINE HYDROCHLORIDE
    Duloxetine hydrochloride
    Duloxetine Hydrochloride (EP/USP)
    Issue/Submission Date
    2011-06-09
    2021-10-22
    2019-11-28
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    Entacapone

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    USDMF

    Found USDMF

    25410
    Active
    ENTACAPONE
    2011-10-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-125 - Rev 00
    Valid
    Entacapone
    2018-09-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Entacapone (Ph. Fur.)
    2019-11-28
    Application Number
    25410
    R1-CEP 2012-125 - Rev 00
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    ENTACAPONE
    Entacapone
    Entacapone (Ph. Fur.)
    Issue/Submission Date
    2011-10-21
    2018-09-13
    2019-11-28
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    Indomethacin

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    USDMF

    Found USDMF

    21740
    Active
    INDOMETHACIN
    2008-06-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-314 - Rev 00
    Valid
    Indometacin
    2016-04-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    lndomethacin (Ph. Eur./USP)
    2019-11-28
    Application Number
    21740
    R1-CEP 2009-314 - Rev 00
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    INDOMETHACIN
    Indometacin
    lndomethacin (Ph. Eur./USP)
    Issue/Submission Date
    2008-06-28
    2016-04-07
    2019-11-28
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    Irbesartan

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    USDMF

    Found USDMF

    23449
    Active
    IRBESARTAN
    2010-01-11
    CEP/COS

    Found CEP/COS

    CEP 2011-046 - Rev 05
    Valid
    Irbesartan
    2023-11-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079A2
    Expired
    Irbesartan EP/USP
    2021-04-09
    Application Number
    23449
    CEP 2011-046 - Rev 05
    Indian CDSCO WC-0079A2
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    IRBESARTAN
    Irbesartan
    Irbesartan EP/USP
    Issue/Submission Date
    2010-01-11
    2023-11-07
    2021-04-09
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    Lacosamide

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    USDMF

    Found USDMF

    28797
    Active
    LACOSAMIDE
    2014-11-24
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-151 - Rev 00
    Valid
    Lacosamide
    2019-12-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Lacosamide (IH)
    2019-11-28
    Application Number
    28797
    R0-CEP 2018-151 - Rev 00
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    LACOSAMIDE
    Lacosamide
    Lacosamide (IH)
    Issue/Submission Date
    2014-11-24
    2019-12-19
    2019-11-28
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    Montelukast Sodium

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    USDMF

    Found USDMF

    25104
    Active
    MONTELUKAST SODIUM
    2011-07-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-135 - Rev 00
    Valid
    Montelukast sodium
    2022-05-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Montelukast Sodium (Ph. Eur./USP)
    2019-11-28
    Application Number
    25104
    R1-CEP 2015-135 - Rev 00
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    MONTELUKAST SODIUM
    Montelukast sodium
    Montelukast Sodium (Ph. Eur./USP)
    Issue/Submission Date
    2011-07-04
    2022-05-30
    2019-11-28
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    Moxifloxacin Hydrochloride

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    USDMF

    Found USDMF

    29373
    Active
    MOXIFLOXACIN HYDROCHLORIDE
    2015-08-12
    CEP/COS

    Found CEP/COS

    CEP 2015-269 - Rev 02
    Valid
    Moxifloxacin hydrochloride, Monohyd...
    2024-01-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Moxifloxacin Hydrochloride (Ph. Eur...
    2019-11-28
    Application Number
    29373
    CEP 2015-269 - Rev 02
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    MOXIFLOXACIN HYDROCHLORIDE
    Moxifloxacin hydrochloride, Monohyd...
    Moxifloxacin Hydrochloride (Ph. Eur...
    Issue/Submission Date
    2015-08-12
    2024-01-25
    2019-11-28
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    Olanzapine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    24333
    Active
    OLANZAPINE USP
    2010-10-30
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-111 - Rev 00
    Valid
    Olanzapine
    2020-06-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Oianzapine (USP)
    2019-11-28
    Application Number
    24333
    R0-CEP 2018-111 - Rev 00
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    OLANZAPINE USP
    Olanzapine
    Oianzapine (USP)
    Issue/Submission Date
    2010-10-30
    2020-06-10
    2019-11-28
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    Olmesartan Medoxomil

    PDF Supplier PDF
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    USDMF

    Found USDMF

    26318
    Active
    OLMESARTAN MEDOXOMIL
    2012-09-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-196 - Rev 01
    Valid
    Olmesartan medoxomil
    2023-03-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079A3
    Expired
    Olmesartan medoximil EP/USP
    2021-04-09
    Application Number
    26318
    R1-CEP 2014-196 - Rev 01
    Indian CDSCO WC-0079A3
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    OLMESARTAN MEDOXOMIL
    Olmesartan medoxomil
    Olmesartan medoximil EP/USP
    Issue/Submission Date
    2012-09-22
    2023-03-13
    2021-04-09
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    Pantoprazole Sodium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    22264
    Active
    PANTOPRAZOLE SODIUM SESQUIHYDRATE
    2008-12-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-066 - Rev 00
    Valid
    Pantoprazole sodium sesquihydrate
    2016-05-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Pantoprazole Sodium (Ph. Eur./USP)
    2019-11-28
    Application Number
    22264
    R1-CEP 2010-066 - Rev 00
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    PANTOPRAZOLE SODIUM SESQUIHYDRATE
    Pantoprazole sodium sesquihydrate
    Pantoprazole Sodium (Ph. Eur./USP)
    Issue/Submission Date
    2008-12-04
    2016-05-09
    2019-11-28
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    Propylthiouracil

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29101
    Active
    PROPYLTHIOURACIL
    2015-04-28
    CEP/COS

    Found CEP/COS

    CEP 2015-125 - Rev 01
    Valid
    Propylthiouracil
    2023-10-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Propylthiouracil (BP/Ph. Eur./USP)
    2019-11-28
    Application Number
    29101
    CEP 2015-125 - Rev 01
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    PROPYLTHIOURACIL
    Propylthiouracil
    Propylthiouracil (BP/Ph. Eur./USP)
    Issue/Submission Date
    2015-04-28
    2023-10-02
    2019-11-28
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    Quetiapine Hemifumarate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    23620
    Active
    QUETIAPINE FUMARATE
    2010-03-11
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-017 - Rev 00
    Valid
    Quetiapine Fumarate
    2020-01-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Quetiapine Fumarate (Ph. Eur./USP)
    2019-11-28
    Application Number
    23620
    R0-CEP 2018-017 - Rev 00
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    QUETIAPINE FUMARATE
    Quetiapine Fumarate
    Quetiapine Fumarate (Ph. Eur./USP)
    Issue/Submission Date
    2010-03-11
    2020-01-28
    2019-11-28
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    Repaglinide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    22234
    Active
    REPAGLINIDE
    2008-11-18
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-375 - Rev 01
    Valid
    Repaglinide
    2016-01-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Repaglinide (Ph. Eur/USP)
    2019-11-28
    Application Number
    22234
    R1-CEP 2009-375 - Rev 01
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    REPAGLINIDE
    Repaglinide
    Repaglinide (Ph. Eur/USP)
    Issue/Submission Date
    2008-11-18
    2016-01-21
    2019-11-28
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    Rizatriptan Benzoate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    24552
    Active
    RIZATRIPTAN BENZOATE
    2011-01-15
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-290 - Rev 00
    Valid
    Rizatriptan benzoate
    2023-06-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Rizatriptan Benzoate (USP)
    2019-11-28
    Application Number
    24552
    R1-CEP 2015-290 - Rev 00
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    RIZATRIPTAN BENZOATE
    Rizatriptan benzoate
    Rizatriptan Benzoate (USP)
    Issue/Submission Date
    2011-01-15
    2023-06-15
    2019-11-28
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    Rosuvastatin Calcium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    28028
    Active
    ROSUVASTATIN CALCIUM
    2014-03-18
    CEP/COS

    Found CEP/COS

    CEP 2017-156 - Rev 01
    Valid
    Rosuvastatin calcium
    2024-03-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Rosuvastatin Calcium (IH)
    2019-11-28
    Application Number
    28028
    CEP 2017-156 - Rev 01
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    ROSUVASTATIN CALCIUM
    Rosuvastatin calcium
    Rosuvastatin Calcium (IH)
    Issue/Submission Date
    2014-03-18
    2024-03-13
    2019-11-28
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    Sildenafil Citrate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    23705
    Active
    SILDENAFIL CITRATE USP
    2010-04-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-050 - Rev 01
    Valid
    Sildenafil citrate
    2021-11-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Sildenafil Citrate (Ph. Eur./USP)
    2019-11-28
    Application Number
    23705
    R1-CEP 2014-050 - Rev 01
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    SILDENAFIL CITRATE USP
    Sildenafil citrate
    Sildenafil Citrate (Ph. Eur./USP)
    Issue/Submission Date
    2010-04-09
    2021-11-16
    2019-11-28
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    Tadalafil

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    26139
    Active
    TADALAFIL
    2013-04-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-190 - Rev 00
    Valid
    Tadalafil
    2023-02-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Tadalafil (Ph. Eur.)
    2019-11-28
    Application Number
    26139
    R1-CEP 2016-190 - Rev 00
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    TADALAFIL
    Tadalafil
    Tadalafil (Ph. Eur.)
    Issue/Submission Date
    2013-04-05
    2023-02-03
    2019-11-28
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    Telmisartan

    PDF Supplier PDF
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    USDMF

    Found USDMF

    24564
    Active
    TELMISARTAN
    2011-01-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-072 - Rev 00
    Valid
    Telmisartan
    2018-05-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Telmisartan (Ph. Eur./USP)
    2019-11-28
    Application Number
    24564
    R1-CEP 2011-072 - Rev 00
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    TELMISARTAN
    Telmisartan
    Telmisartan (Ph. Eur./USP)
    Issue/Submission Date
    2011-01-19
    2018-05-22
    2019-11-28
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    Tolterodine Tartrate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    23843
    Active
    TOLTERODINE TARTRATE USP
    2010-05-24
    CEP/COS

    Found CEP/COS

    R1-CEP 2017-007 - Rev 00
    Valid
    Tolterodine tartrate
    2023-05-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Tolterodine Tartrate (IH)
    2019-11-28
    Application Number
    23843
    R1-CEP 2017-007 - Rev 00
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    TOLTERODINE TARTRATE USP
    Tolterodine tartrate
    Tolterodine Tartrate (IH)
    Issue/Submission Date
    2010-05-24
    2023-05-25
    2019-11-28
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    Trospium Chloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    27532
    Active
    TROSPIUM CHLORIDE
    2013-09-21
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-013 - Rev 00
    Valid
    Trospium chloride
    2020-01-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Trospium Chloride (USP)
    2019-11-28
    Application Number
    27532
    R0-CEP 2018-013 - Rev 00
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    TROSPIUM CHLORIDE
    Trospium chloride
    Trospium Chloride (USP)
    Issue/Submission Date
    2013-09-21
    2020-01-10
    2019-11-28
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    Valsartan

    PDF Supplier PDF
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    USDMF

    Found USDMF

    24178
    Active
    VALSARTAN USP
    2010-09-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-180 - Rev 05
    Valid
    Valsartan
    2022-02-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Valsartan (Ph. Eur./USP)
    2019-11-28
    Application Number
    24178
    R1-CEP 2011-180 - Rev 05
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    VALSARTAN USP
    Valsartan
    Valsartan (Ph. Eur./USP)
    Issue/Submission Date
    2010-09-13
    2022-02-25
    2019-11-28
    ASK
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    your Marketing & Sales content
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    • FDA
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    Vardenafil Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    25795
    Active
    VARDENAFIL HYDROCHLORIDE TRIHYDRATE
    2012-04-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-207 - Rev 00
    Valid
    Vardenafil hydrochloride trihydrate
    2021-09-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079A1
    Expired
    Vardenafil Hydrochloride USP
    2020-07-22
    Application Number
    25795
    R1-CEP 2015-207 - Rev 00
    Indian CDSCO WC-0079A1
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    VARDENAFIL HYDROCHLORIDE TRIHYDRATE
    Vardenafil hydrochloride trihydrate
    Vardenafil Hydrochloride USP
    Issue/Submission Date
    2012-04-09
    2021-09-21
    2020-07-22
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    your Marketing & Sales content
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    Ziprasidone Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    25048
    Active
    ZIPRASIDONE HYDROCHLORIDE
    2011-06-14
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-196 - Rev 01
    Valid
    Ziprasidone hydrochloride monohydra...
    2020-07-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Ziprasidone Hydrochloride Monohydra...
    2019-11-28
    Application Number
    25048
    R1-CEP 2011-196 - Rev 01
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    ZIPRASIDONE HYDROCHLORIDE
    Ziprasidone hydrochloride monohydra...
    Ziprasidone Hydrochloride Monohydra...
    Issue/Submission Date
    2011-06-14
    2020-07-24
    2019-11-28
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    Atomoxetin Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    30754
    Active
    ATOMOXETINE HYDROCHLORIDE
    2016-09-01
    CEP/COS

    Found CEP/COS

    R0-CEP 2017-073 - Rev 01
    Valid
    Atomoxetine hydrochloride
    2020-07-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30754
    R0-CEP 2017-073 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ATOMOXETINE HYDROCHLORIDE
    Atomoxetine hydrochloride
    Issue/Submission Date
    2016-09-01
    2020-07-20
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    • FDA
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    Hydralazine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    30354
    Active
    HYDRALAZINE HYDROCHLORIDE
    2016-04-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-180 - Rev 00
    Valid
    Hydralazine hydrochloride
    2023-03-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30354
    R1-CEP 2016-180 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    HYDRALAZINE HYDROCHLORIDE
    Hydralazine hydrochloride
    Issue/Submission Date
    2016-04-07
    2023-03-27
    ASK
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    • FDA
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    Hydrochlorothiazide

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    33923
    Active
    HYDROCHLOROTHIAZIDE USP
    2019-06-29
    CEP/COS

    Found CEP/COS

    CEP 2021-088 - Rev 00
    Valid
    Hydrochlorothiazide
    2024-01-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33923
    CEP 2021-088 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    HYDROCHLOROTHIAZIDE USP
    Hydrochlorothiazide
    Issue/Submission Date
    2019-06-29
    2024-01-23
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    • FDA
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    Levothyroxine Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    31203
    Active
    LEVOTHYROXINE SODIUM USP
    2017-01-31
    CEP/COS

    Found CEP/COS

    R1-CEP 2017-040 - Rev 00
    Valid
    Levothyroxine sodium
    2023-04-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31203
    R1-CEP 2017-040 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LEVOTHYROXINE SODIUM USP
    Levothyroxine sodium
    Issue/Submission Date
    2017-01-31
    2023-04-03
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    • FDA
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    Nitrofurantoin

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    30285
    Active
    NITROFURANTOIN MONOHYDRATE
    2016-05-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-212 - Rev 00
    Valid
    Nitrofurantoin, Macrocrystal
    2023-06-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30285
    R1-CEP 2016-212 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    NITROFURANTOIN MONOHYDRATE
    Nitrofurantoin, Macrocrystal
    Issue/Submission Date
    2016-05-19
    2023-06-14
    ASK
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    • FDA
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    Pirfenidone

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    32657
    Active
    PIRFENIDONE
    2018-04-03
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-077 - Rev 00
    Valid
    Pirfenidone
    2022-06-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32657
    R0-CEP 2021-077 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    PIRFENIDONE
    Pirfenidone
    Issue/Submission Date
    2018-04-03
    2022-06-20
    ASK
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    • FDA
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    Pyrazinamide

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

    See Less

    USDMF

    Found USDMF

    30448
    Active
    PYRAZINAMIDE
    2016-05-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-138 - Rev 01
    Valid
    Pyrazinamide
    2023-03-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30448
    R1-CEP 2016-138 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    PYRAZINAMIDE
    Pyrazinamide
    Issue/Submission Date
    2016-05-25
    2023-03-27
    ASK
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    • FDA
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    Sitagliptin Phosphate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    30757
    Active
    SITAGLIPTIN PHOSPHATE (MONOHYDRATE)
    2016-11-09
    CEP/COS

    Found CEP/COS

    CEP 2023-205 - Rev 00
    Valid
    Sitagliptin phosphate monohydrate, ...
    2024-02-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30757
    CEP 2023-205 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SITAGLIPTIN PHOSPHATE (MONOHYDRATE)
    Sitagliptin phosphate monohydrate, ...
    Issue/Submission Date
    2016-11-09
    2024-02-12
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    • FDA
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    Tamsulosin

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    30450
    Active
    TAMSULOSIN HYDROCHLORIDE MODIFIED R...
    2016-04-12
    CEP/COS

    Found CEP/COS

    CEP 2022-185 - Rev 00
    Valid
    Tamsulosin hydrochloride
    2023-12-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30450
    CEP 2022-185 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    TAMSULOSIN HYDROCHLORIDE MODIFIED R...
    Tamsulosin hydrochloride
    Issue/Submission Date
    2016-04-12
    2023-12-06
    ASK
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    • FDA
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    Atorvastatin

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    24452
    Active
    ATORVASTATIN CALCIUM (AMORPHOUS)
    2010-12-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Atorvastatin Calcium Trihydrate (Ph...
    2019-11-28
    Application Number
    24452
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-02
    Filing Details
    ATORVASTATIN CALCIUM (AMORPHOUS)
    Atorvastatin Calcium Trihydrate (Ph...
    Issue/Submission Date
    2010-12-15
    2019-11-28
    ASK
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    • FDA
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    Donepezil

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    22380
    Active
    DONEPEZIL HCL
    2008-12-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Donepezil Hydrochloride (IH/USP)
    2019-11-28
    Application Number
    22380
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    DONEPEZIL HCL
    Donepezil Hydrochloride (IH/USP)
    Issue/Submission Date
    2008-12-26
    2019-11-28
    ASK
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    • FDA
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    Efavirenz

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    21666
    Active
    EFAVIRENZ
    2008-05-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Efavirenz (IH)
    2019-11-28
    Application Number
    21666
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-02
    Filing Details
    EFAVIRENZ
    Efavirenz (IH)
    Issue/Submission Date
    2008-05-28
    2019-11-28
    ASK
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    • FDA
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    Emtricitabine

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

    See Less

    USDMF

    Found USDMF

    25001
    Active
    EMTRICITABINE
    2011-05-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Emtricitabine (IH)
    2019-11-28
    Application Number
    25001
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-02
    Filing Details
    EMTRICITABINE
    Emtricitabine (IH)
    Issue/Submission Date
    2011-05-31
    2019-11-28
    ASK
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    • FDA
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    Escitalopram Oxalate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    22900
    Active
    ESCITALOPRAM OXALATE
    2009-06-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Escitalopram Oxalate (IH/USP)
    2019-11-28
    Application Number
    22900
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-02
    Filing Details
    ESCITALOPRAM OXALATE
    Escitalopram Oxalate (IH/USP)
    Issue/Submission Date
    2009-06-25
    2019-11-28
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    Famciclovir

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    22391
    Active
    FAMCICLOVIR
    2009-01-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Famciclovir (USP)
    2019-11-28
    Application Number
    22391
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-02
    Filing Details
    FAMCICLOVIR
    Famciclovir (USP)
    Issue/Submission Date
    2009-01-09
    2019-11-28
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    Lansoprazole

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    25794
    Active
    LANSOPRAZOLE
    2012-03-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Lansoprazole (USP)
    2019-11-28
    Application Number
    25794
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    LANSOPRAZOLE
    Lansoprazole (USP)
    Issue/Submission Date
    2012-03-14
    2019-11-28
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    Pioglitazone Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    23668
    Active
    PIOGLITAZONE HYDROCHLORIDE
    2010-03-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Pioglitazone Hydrochloride (USP)
    2019-11-28
    Application Number
    23668
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    PIOGLITAZONE HYDROCHLORIDE
    Pioglitazone Hydrochloride (USP)
    Issue/Submission Date
    2010-03-31
    2019-11-28
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    Pramipexole Dihydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    23163
    Active
    PRAMIPEXOLE DIHYDROCHLORIDE MONOHYD...
    2009-10-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Pramipexole dihydrochloride monohyd...
    2019-11-28
    Application Number
    23163
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    PRAMIPEXOLE DIHYDROCHLORIDE MONOHYD...
    Pramipexole dihydrochloride monohyd...
    Issue/Submission Date
    2009-10-07
    2019-11-28
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    Pregabalin

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    26317
    Active
    PREGABALIN USP
    2012-08-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Pregabalin (IH)
    2019-11-28
    Application Number
    26317
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    PREGABALIN USP
    Pregabalin (IH)
    Issue/Submission Date
    2012-08-27
    2019-11-28
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    Rabeprazole

    PDF Supplier PDF
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    USDMF

    Found USDMF

    25711
    Active
    RABEPRAZOLE SODIUM
    2012-02-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Rabeprazole Sodium (IH)
    2019-11-28
    Application Number
    25711
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    RABEPRAZOLE SODIUM
    Rabeprazole Sodium (IH)
    Issue/Submission Date
    2012-02-18
    2019-11-28
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    Rasagiline Mesylate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    26706
    Active
    RASAGILINE MESYLATE
    2012-12-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Rasagiline Mesylate (IH)
    2019-11-28
    Application Number
    26706
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    RASAGILINE MESYLATE
    Rasagiline Mesylate (IH)
    Issue/Submission Date
    2012-12-24
    2019-11-28
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    Risedronate Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    23738
    Active
    RISEDRONATE SODIUM
    2010-04-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Risedronate Sodium (USP)
    2019-11-28
    Application Number
    23738
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-02
    Filing Details
    RISEDRONATE SODIUM
    Risedronate Sodium (USP)
    Issue/Submission Date
    2010-04-17
    2019-11-28
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    Tenofovir Disoproxil Fumarate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    24764
    Active
    TENOFOVIR DISOPROXIL FUMARATE
    2011-03-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0079
    Expired
    Tenofovir Disoproxil Fumarate (IH)
    2019-11-28
    Application Number
    24764
    Indian CDSCO WC-0079
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-02
    Filing Details
    TENOFOVIR DISOPROXIL FUMARATE
    Tenofovir Disoproxil Fumarate (IH)
    Issue/Submission Date
    2011-03-15
    2019-11-28
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