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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Teva API

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    Teva API
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    Amitriptyline Hydrochloride

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    USDMF

    Found USDMF

    2719
    Active
    AMITRIPTYLINE HCL USP DRUG SUBSTANC...
    1976-08-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-432 - Rev 04
    Valid
    Amitriptyline hydrochloride
    2022-02-04
    Japanese DMF

    Found JDMF

    302MF10137
    Amitriptyline Hydrochloride "Teva /...
    2020-11-26
    Written Confirmation

    Found WC

    Indian CDSCO WC-0001
    Valid
    Amitriptyline Hydrochloride EP
    2022-06-22
    Application Number
    2719
    R1-CEP 2001-432 - Rev 04
    302MF10137
    Indian CDSCO WC-0001
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-05-20
    Filing Details
    AMITRIPTYLINE HCL USP DRUG SUBSTANC...
    Amitriptyline hydrochloride
    Amitriptyline Hydrochloride "Teva /...
    Amitriptyline Hydrochloride EP
    Issue/Submission Date
    1976-08-09
    2022-02-04
    2020-11-26
    2022-06-22
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    Losartan Potassium

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    USDMF

    Found USDMF

    16996
    Active
    LOSARTAN POTASSIUM
    2003-12-03
    CEP/COS

    Found CEP/COS

    R0-CEP 2023-006 - Rev 00
    Valid
    Losartan potassium, Process 3
    2023-07-06
    Japanese DMF

    Found JDMF

    230MF10060
    Losartan potassium "Teva / Malanpur...
    2018-05-08
    Written Confirmation

    Found WC

    Indian CDSCO WC-0001
    Valid
    Losartan Potassium EP
    2022-06-22
    Application Number
    16996
    R0-CEP 2023-006 - Rev 00
    230MF10060
    Indian CDSCO WC-0001
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-05-20
    Filing Details
    LOSARTAN POTASSIUM
    Losartan potassium, Process 3
    Losartan potassium "Teva / Malanpur...
    Losartan Potassium EP
    Issue/Submission Date
    2003-12-03
    2023-07-06
    2018-05-08
    2022-06-22
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    Montelukast Sodium

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    USDMF

    Found USDMF

    19829
    Active
    MONTELUKAST SODIUM
    2006-10-04
    CEP/COS

    Found CEP/COS

    CEP 2017-131 - Rev 04
    Valid
    Montelukast sodium, ID 6177
    2024-03-19
    Japanese DMF

    Found JDMF

    305MF10076
    Montelukast sodium “Teva 2” at ...
    2023-07-05
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0002
    Expired
    Montelukast Sodium (IH)
    2019-06-17
    Application Number
    19829
    CEP 2017-131 - Rev 04
    305MF10076
    Indian CDSCO WC-0002
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-05-26
    Filing Details
    MONTELUKAST SODIUM
    Montelukast sodium, ID 6177
    Montelukast sodium “Teva 2” at ...
    Montelukast Sodium (IH)
    Issue/Submission Date
    2006-10-04
    2024-03-19
    2023-07-05
    2019-06-17
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    • FDA
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    Pregabalin

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    USDMF

    Found USDMF

    22242
    Active
    PREGABALIN DRUG SUBSTANCE
    2008-12-01
    CEP/COS

    Found CEP/COS

    CEP 2020-375 - Rev 02
    Valid
    Pregabalin, ID 3636/9111
    2024-02-08
    Japanese DMF

    Found JDMF

    230MF10103
    Pregabalin "Teva" at Plot No. 2G, 2...
    2018-08-08
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0002
    Expired
    Pregabalin (IH/USP)
    2019-06-17
    Application Number
    22242
    CEP 2020-375 - Rev 02
    230MF10103
    Indian CDSCO WC-0002
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-05-26
    Filing Details
    PREGABALIN DRUG SUBSTANCE
    Pregabalin, ID 3636/9111
    Pregabalin "Teva" at Plot No. 2G, 2...
    Pregabalin (IH/USP)
    Issue/Submission Date
    2008-12-01
    2024-02-08
    2018-08-08
    2019-06-17
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    Anastrozole

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    USDMF

    Found USDMF

    19034
    Active
    ANASTROZOLE
    2005-12-16
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-099 - Rev 01
    Valid
    Anastrozole
    2021-12-20
    Japanese DMF

    Found JDMF

    222MF10277
    Anastrozole at Ostravska 29/305, 74...
    2010-12-17
    Written Confirmation

    Close WC

    Application Number
    19034
    R1-CEP 2014-099 - Rev 01
    222MF10277
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ANASTROZOLE
    Anastrozole
    Anastrozole at Ostravska 29/305, 74...
    Issue/Submission Date
    2005-12-16
    2021-12-20
    2010-12-17
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    Atenolol

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    USDMF

    Found USDMF

    6213
    Active
    ATENOLOL
    1986-03-05
    CEP/COS

    Found CEP/COS

    CEP 2004-030 - Rev 08
    Valid
    Atenolol
    2024-03-06
    Japanese DMF

    Found JDMF

    227MF10251
    Atenolol "Teva / TPC" at No. 1889, ...
    2015-10-08
    Written Confirmation

    Close WC

    Application Number
    6213
    CEP 2004-030 - Rev 08
    227MF10251
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ATENOLOL
    Atenolol
    Atenolol "Teva / TPC" at No. 1889, ...
    Issue/Submission Date
    1986-03-05
    2024-03-06
    2015-10-08
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    Bromocriptine Mesylate

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    USDMF

    Found USDMF

    14768
    Active
    BROMOCRIPTINE MESYLATE
    2000-03-03
    CEP/COS

    Found CEP/COS

    CEP 2006-281 - Rev 03
    Valid
    Bromocriptine mesilate
    2024-02-05
    Japanese DMF

    Found JDMF

    218MF10573
    Bromocriptine mesylate at Ostravska...
    2006-06-15
    Written Confirmation

    Close WC

    Application Number
    14768
    CEP 2006-281 - Rev 03
    218MF10573
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BROMOCRIPTINE MESYLATE
    Bromocriptine mesilate
    Bromocriptine mesylate at Ostravska...
    Issue/Submission Date
    2000-03-03
    2024-02-05
    2006-06-15
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    Cabergoline

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    USDMF

    Found USDMF

    18113
    Active
    CABERGOLINE
    2005-02-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-170 - Rev 03
    Valid
    Cabergoline
    2021-02-04
    Japanese DMF

    Found JDMF

    217MF11279
    Cabergoline at Ostravska 305/29, Ko...
    2005-12-20
    Written Confirmation

    Close WC

    Application Number
    18113
    R1-CEP 2006-170 - Rev 03
    217MF11279
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CABERGOLINE
    Cabergoline
    Cabergoline at Ostravska 305/29, Ko...
    Issue/Submission Date
    2005-02-21
    2021-02-04
    2005-12-20
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    Clopidogrel

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    USDMF

    Found USDMF

    17009
    Active
    CLOPIDOGREL BISULFATE USP
    2003-12-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2017-260 - Rev 00
    Valid
    Clopidogrel hydrogen sulfate, Form ...
    2023-03-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0001
    Valid
    Clopidogrel Bisulphate FormII IH/EP...
    2022-06-22
    Application Number
    17009
    R1-CEP 2017-260 - Rev 00
    Indian CDSCO WC-0001
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-05-20
    Filing Details
    CLOPIDOGREL BISULFATE USP
    Clopidogrel hydrogen sulfate, Form ...
    Clopidogrel Bisulphate FormII IH/EP...
    Issue/Submission Date
    2003-12-05
    2023-03-30
    2022-06-22
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    Cyclosporine

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    USDMF

    Found USDMF

    12932
    Active
    CYCLOSPORINE
    1998-04-02
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-152 - Rev 06
    Valid
    Ciclosporin
    2023-06-21
    Japanese DMF

    Found JDMF

    305MF10110
    Cyclosporine at Ostravska 305/29, ...
    2023-09-20
    Written Confirmation

    Close WC

    Application Number
    12932
    R1-CEP 2002-152 - Rev 06
    305MF10110
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CYCLOSPORINE
    Ciclosporin
    Cyclosporine at Ostravska 305/29, ...
    Issue/Submission Date
    1998-04-02
    2023-06-21
    2023-09-20
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    • FDA
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    Ergotamine Tartrate

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    USDMF

    Found USDMF

    24782
    Active
    ERGOTAMINE TARTRATE
    2011-03-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-328 - Rev 03
    Valid
    Ergotamine Tartrate
    2020-02-06
    Japanese DMF

    Found JDMF

    220MF10122
    Ergotamine tartrate "Teva" at Ostra...
    2008-04-28
    Written Confirmation

    Close WC

    Application Number
    24782
    R1-CEP 2007-328 - Rev 03
    220MF10122
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ERGOTAMINE TARTRATE
    Ergotamine Tartrate
    Ergotamine tartrate "Teva" at Ostra...
    Issue/Submission Date
    2011-03-23
    2020-02-06
    2008-04-28
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    Imipramine Hydrochloride

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    USDMF

    Found USDMF

    1906
    Active
    IMIPRAMINE HYDROCHLORIDE USP
    1972-03-08
    CEP/COS

    Found CEP/COS

    CEP 2002-051 - Rev 04
    Valid
    Imipramine hydrochloride
    2024-01-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0001
    Valid
    Imipramine Hydrochloride EP
    2022-06-22
    Application Number
    1906
    CEP 2002-051 - Rev 04
    Indian CDSCO WC-0001
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-05-20
    Filing Details
    IMIPRAMINE HYDROCHLORIDE USP
    Imipramine hydrochloride
    Imipramine Hydrochloride EP
    Issue/Submission Date
    1972-03-08
    2024-01-30
    2022-06-22
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    Irbesartan

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    USDMF

    Found USDMF

    17394
    Active
    IRBESARTAN
    2004-05-18
    CEP/COS

    Found CEP/COS

    CEP 2022-046 - Rev 01
    Valid
    Irbesartan, Process 2
    2024-03-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0001
    Valid
    Irbesartan EP
    2022-06-22
    Application Number
    17394
    CEP 2022-046 - Rev 01
    Indian CDSCO WC-0001
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-05-20
    Filing Details
    IRBESARTAN
    Irbesartan, Process 2
    Irbesartan EP
    Issue/Submission Date
    2004-05-18
    2024-03-04
    2022-06-22
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    Methyldopa

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    USDMF

    Found USDMF

    5991
    Active
    ALPHA METHYLDOPA USP
    1985-09-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-182 - Rev 03
    Valid
    Methyldopa
    2022-03-24
    Japanese DMF

    Found JDMF

    227MF10141
    Methyldopa "Teva" at No. 1889, Jing...
    2015-05-14
    Written Confirmation

    Close WC

    Application Number
    5991
    R1-CEP 2010-182 - Rev 03
    227MF10141
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ALPHA METHYLDOPA USP
    Methyldopa
    Methyldopa "Teva" at No. 1889, Jing...
    Issue/Submission Date
    1985-09-03
    2022-03-24
    2015-05-14
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    Mupirocin Calcium

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    USDMF

    Found USDMF

    20041
    Active
    MUPIROCIN CALCIUM
    2006-12-14
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-158 - Rev 03
    Valid
    Mupirocin calcium
    2022-04-01
    Japanese DMF

    Found JDMF

    229MF10219
    Mupirocin calcium "Teva" at 13 Pall...
    2017-12-12
    Written Confirmation

    Close WC

    Application Number
    20041
    R1-CEP 2008-158 - Rev 03
    229MF10219
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MUPIROCIN CALCIUM
    Mupirocin calcium
    Mupirocin calcium "Teva" at 13 Pall...
    Issue/Submission Date
    2006-12-14
    2022-04-01
    2017-12-12
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    Mycophenolate Mofetil

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    USDMF

    Found USDMF

    20072
    Active
    MYCOPHENOLATE MOFETIL DRUG SUBSTANC...
    2006-12-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-239 - Rev 04
    Valid
    Mycophenolate mofetil
    2020-11-27
    Japanese DMF

    Found JDMF

    224MF10107
    Mycophenolate mofetil "Teva" at Ost...
    2012-06-22
    Written Confirmation

    Close WC

    Application Number
    20072
    R1-CEP 2005-239 - Rev 04
    224MF10107
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MYCOPHENOLATE MOFETIL DRUG SUBSTANC...
    Mycophenolate mofetil
    Mycophenolate mofetil "Teva" at Ost...
    Issue/Submission Date
    2006-12-20
    2020-11-27
    2012-06-22
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    Olmesartan Medoxomil

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    USDMF

    Found USDMF

    21931
    Active
    OLMESARTAN MEDOXOMIL USP
    2008-09-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-170 - Rev 01
    Valid
    Olmesartan medoxomil
    2022-05-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0001
    Valid
    Olmesartan Medoxomil IH
    2022-06-22
    Application Number
    21931
    R1-CEP 2012-170 - Rev 01
    Indian CDSCO WC-0001
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-05-20
    Filing Details
    OLMESARTAN MEDOXOMIL USP
    Olmesartan medoxomil
    Olmesartan Medoxomil IH
    Issue/Submission Date
    2008-09-04
    2022-05-25
    2022-06-22
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    Paclitaxel

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    USDMF

    Found USDMF

    16701
    Active
    PACLITAXEL
    2003-07-08
    CEP/COS

    Found CEP/COS

    CEP 2009-236 - Rev 04
    Valid
    Paclitaxel, Produced by semi-synthe...
    2024-02-27
    Japanese DMF

    Found JDMF

    305MF10109
    Paclitaxel at Ostravska 305/29, Ko...
    2023-09-20
    Written Confirmation

    Close WC

    Application Number
    16701
    CEP 2009-236 - Rev 04
    305MF10109
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    PACLITAXEL
    Paclitaxel, Produced by semi-synthe...
    Paclitaxel at Ostravska 305/29, Ko...
    Issue/Submission Date
    2003-07-08
    2024-02-27
    2023-09-20
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    Quetiapine Hemifumarate

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    USDMF

    Found USDMF

    18341
    Active
    QUETIAPINE FUMARATE DRUG SUBSTANCE
    2005-05-09
    CEP/COS

    Found CEP/COS

    CEP 2020-234 - Rev 02
    Valid
    Quetiapine Fumarate, ID 3871
    2023-12-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0001
    Valid
    Quetiapine Fumarate IH
    2022-06-22
    Application Number
    18341
    CEP 2020-234 - Rev 02
    Indian CDSCO WC-0001
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-05-20
    Filing Details
    QUETIAPINE FUMARATE DRUG SUBSTANCE
    Quetiapine Fumarate, ID 3871
    Quetiapine Fumarate IH
    Issue/Submission Date
    2005-05-09
    2023-12-19
    2022-06-22
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    Simvastatin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    14599
    Active
    SIMVASTATIN
    1999-11-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-216 - Rev 03
    Valid
    Simvastatin, Ethanol/acetonitrile p...
    2022-11-28
    Japanese DMF

    Found JDMF

    218MF10581
    Simvastatin "Teva" at 13 Pallagi u(...
    2006-06-22
    Written Confirmation

    Close WC

    Application Number
    14599
    R1-CEP 2013-216 - Rev 03
    218MF10581
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    SIMVASTATIN
    Simvastatin, Ethanol/acetonitrile p...
    Simvastatin "Teva" at 13 Pallagi u(...
    Issue/Submission Date
    1999-11-29
    2022-11-28
    2006-06-22
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    Tacrolimus

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    USDMF

    Found USDMF

    28524
    Active
    TACROLIMUS
    2014-08-24
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-233 - Rev 03
    Valid
    Tacrolimus monohydrate
    2022-11-25
    Japanese DMF

    Found JDMF

    222MF10265
    Tacrolimus hydrate "Teva" at Ostrav...
    2010-12-08
    Written Confirmation

    Close WC

    Application Number
    28524
    R0-CEP 2018-233 - Rev 03
    222MF10265
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TACROLIMUS
    Tacrolimus monohydrate
    Tacrolimus hydrate "Teva" at Ostrav...
    Issue/Submission Date
    2014-08-24
    2022-11-25
    2010-12-08
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    Ticagrelor

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    USDMF

    Found USDMF

    28880
    Active
    TICAGRELOR
    2015-01-21
    CEP/COS

    Found CEP/COS

    CEP 2021-225 - Rev 00
    Valid
    Ticagrelor
    2023-11-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0001
    Valid
    Ticagrelor IH
    2022-06-22
    Application Number
    28880
    CEP 2021-225 - Rev 00
    Indian CDSCO WC-0001
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-05-20
    Filing Details
    TICAGRELOR
    Ticagrelor
    Ticagrelor IH
    Issue/Submission Date
    2015-01-21
    2023-11-23
    2022-06-22
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    Atorvastatin

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    USDMF

    Caution USDMF

    19880
    Inactive
    ATORVASTATIN CALCIUM
    2006-10-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-035 - Rev 02
    Valid
    Atorvastatin calcium
    2022-08-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0001
    Valid
    Atorvastatin Calcium EP
    2022-06-22
    Application Number
    19880
    R1-CEP 2012-035 - Rev 02
    Indian CDSCO WC-0001
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-05-20
    Filing Details
    ATORVASTATIN CALCIUM
    Atorvastatin calcium
    Atorvastatin Calcium EP
    Issue/Submission Date
    2006-10-17
    2022-08-22
    2022-06-22
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    Cyclosporine

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    USDMF

    Found USDMF

    13799
    Active
    CYCLOSPORINE
    1998-09-01
    CEP/COS

    Caution CEP/COS

    R1-CEP 1997-045 - Rev 05
    Withdrawn by Holder
    Ciclosporin
    2017-11-02
    Japanese DMF

    Found JDMF

    305MF10106
    Cyclosporine at Ostravska 305/29, ...
    2023-09-06
    Written Confirmation

    Close WC

    Application Number
    13799
    R1-CEP 1997-045 - Rev 05
    305MF10106
    Status
    Active
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    CYCLOSPORINE
    Ciclosporin
    Cyclosporine at Ostravska 305/29, ...
    Issue/Submission Date
    1998-09-01
    2017-11-02
    2023-09-06
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    Diltiazem Hydrochloride

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    USDMF

    Found USDMF

    7239
    Active
    DILTIAZEM HYDROCHLORIDE USP
    1987-11-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10001
    Diltiazem hydrochloride "Teva / TIG...
    2013-01-15
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0002
    Expired
    Diltiazem Hydrochloride (IH/USP/EP)
    2019-06-17
    Application Number
    7239
    225MF10001
    Indian CDSCO WC-0002
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-05-26
    Filing Details
    DILTIAZEM HYDROCHLORIDE USP
    Diltiazem hydrochloride "Teva / TIG...
    Diltiazem Hydrochloride (IH/USP/EP)
    Issue/Submission Date
    1987-11-30
    2013-01-15
    2019-06-17
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    Ezetimibe

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    USDMF

    Found USDMF

    20039
    Active
    EZETIMIBE
    2006-12-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    231MF10028
    Ezetimibe "Teva" at Plot No. 2G, 2H...
    2019-02-05
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0002
    Expired
    Ezetimibe (IH)
    2019-06-17
    Application Number
    20039
    231MF10028
    Indian CDSCO WC-0002
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-05-26
    Filing Details
    EZETIMIBE
    Ezetimibe "Teva" at Plot No. 2G, 2H...
    Ezetimibe (IH)
    Issue/Submission Date
    2006-12-13
    2019-02-05
    2019-06-17
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    Fluvastatin Sodium

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    USDMF

    Found USDMF

    19296
    Active
    FLUVASTATIN SODIUM
    2006-03-24
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-201 - Rev 02
    Valid
    Fluvastatin sodium
    2023-05-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0002
    Expired
    Fluvastatin Sodium (IH/USP)
    2019-06-17
    Application Number
    19296
    R1-CEP 2010-201 - Rev 02
    Indian CDSCO WC-0002
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-05-26
    Filing Details
    FLUVASTATIN SODIUM
    Fluvastatin sodium
    Fluvastatin Sodium (IH/USP)
    Issue/Submission Date
    2006-03-24
    2023-05-05
    2019-06-17
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    Irbesartan

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    USDMF

    Found USDMF

    25483
    Active
    IRBESARTAN USP
    2011-11-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-322 - Rev 02
    Valid
    Irbesartan
    2022-03-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0002
    Expired
    Irbessartan (IH/USP/EP)
    2019-06-17
    Application Number
    25483
    R1-CEP 2010-322 - Rev 02
    Indian CDSCO WC-0002
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-05-26
    Filing Details
    IRBESARTAN USP
    Irbesartan
    Irbessartan (IH/USP/EP)
    Issue/Submission Date
    2011-11-08
    2022-03-07
    2019-06-17
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    Losartan Potassium

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    USDMF

    Found USDMF

    25654
    Active
    LOSARTAN POTASSIUM
    2012-01-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-332 - Rev 04
    Valid
    Losartan potassium
    2022-03-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0002
    Expired
    Losartan Potassium (IH/USP)
    2019-06-17
    Application Number
    25654
    R1-CEP 2009-332 - Rev 04
    Indian CDSCO WC-0002
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-05-26
    Filing Details
    LOSARTAN POTASSIUM
    Losartan potassium
    Losartan Potassium (IH/USP)
    Issue/Submission Date
    2012-01-03
    2022-03-25
    2019-06-17
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    Pergolide Mesylate

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    USDMF

    Caution USDMF

    24323
    Inactive
    PERGOLIDE MESYLATE
    2010-10-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-200 - Rev 02
    Valid
    Pergolide mesilate
    2020-01-31
    Japanese DMF

    Found JDMF

    218MF10839
    Pergolide mesylate at Ostravska 29/...
    2006-10-20
    Written Confirmation

    Close WC

    Application Number
    24323
    R1-CEP 2003-200 - Rev 02
    218MF10839
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    PERGOLIDE MESYLATE
    Pergolide mesilate
    Pergolide mesylate at Ostravska 29/...
    Issue/Submission Date
    2010-10-28
    2020-01-31
    2006-10-20
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    Pioglitazone Hydrochloride

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    USDMF

    Found USDMF

    16688
    Active
    PIOGLITAZONE HYDROCHLORIDE
    2003-07-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10094
    Pioglitazone hydrochloride "Teva" a...
    2015-03-20
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0002
    Expired
    Pioglitazone Hydrochloride (IH/USP)
    2019-06-17
    Application Number
    16688
    227MF10094
    Indian CDSCO WC-0002
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-05-26
    Filing Details
    PIOGLITAZONE HYDROCHLORIDE
    Pioglitazone hydrochloride "Teva" a...
    Pioglitazone Hydrochloride (IH/USP)
    Issue/Submission Date
    2003-07-08
    2015-03-20
    2019-06-17
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    Rosuvastatin Calcium

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    USDMF

    Found USDMF

    20671
    Active
    ROSUVASTATIN CALCIUM (BULK)
    2007-07-12
    CEP/COS

    Found CEP/COS

    R1-CEP 2017-018 - Rev 00
    Valid
    Rosuvastatin calcium, Process G 241...
    2022-05-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0002
    Expired
    Rosuvastatin Calcium EP/IH
    2019-06-17
    Application Number
    20671
    R1-CEP 2017-018 - Rev 00
    Indian CDSCO WC-0002
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-05-26
    Filing Details
    ROSUVASTATIN CALCIUM (BULK)
    Rosuvastatin calcium, Process G 241...
    Rosuvastatin Calcium EP/IH
    Issue/Submission Date
    2007-07-12
    2022-05-20
    2019-06-17
    ASK
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    Valsartan

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    17909
    Inactive
    VALSARTAN
    2004-12-16
    CEP/COS

    Caution CEP/COS

    R1-CEP 2010-207 - Rev 00
    Withdrawn by Holder
    Valsartan
    2017-09-29
    Japanese DMF

    Found JDMF

    225MF10043
    Valsartan "Teva" at Plot No. 2G, 2H...
    2013-03-05
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0002
    Expired
    Valsartan (IH/USP/EP)
    2019-06-17
    Application Number
    17909
    R1-CEP 2010-207 - Rev 00
    225MF10043
    Indian CDSCO WC-0002
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Expired
    2022-05-26
    Filing Details
    VALSARTAN
    Valsartan
    Valsartan "Teva" at Plot No. 2G, 2H...
    Valsartan (IH/USP/EP)
    Issue/Submission Date
    2004-12-16
    2017-09-29
    2013-03-05
    2019-06-17
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    Atracurium Besylate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    11742
    Active
    ATRACURIUM BESYLATE
    1995-11-14
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-044 - Rev 06
    Valid
    Atracurium besilate
    2021-11-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11742
    R1-CEP 2006-044 - Rev 06
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ATRACURIUM BESYLATE
    Atracurium besilate
    Issue/Submission Date
    1995-11-14
    2021-11-22
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    Bleomycin

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    USDMF

    Found USDMF

    13784
    Active
    BLEOMYCIN SULFATE
    1998-09-01
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-272 - Rev 00
    Valid
    Bleomycin Sulfate
    2023-08-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13784
    R0-CEP 2021-272 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BLEOMYCIN SULFATE
    Bleomycin Sulfate
    Issue/Submission Date
    1998-09-01
    2023-08-31
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    Budesonide

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    USDMF

    Found USDMF

    10976
    Active
    BUDESONIDE
    1994-07-11
    CEP/COS

    Found CEP/COS

    R1-CEP 1997-067 - Rev 09
    Valid
    Budesonide
    2021-12-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10976
    R1-CEP 1997-067 - Rev 09
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BUDESONIDE
    Budesonide
    Issue/Submission Date
    1994-07-11
    2021-12-20
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    Calcitriol

    PDF Supplier PDF
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    USDMF

    Found USDMF

    12417
    Active
    CALCITRIOL USP
    1997-03-14
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-055 - Rev 06
    Valid
    Calcitriol
    2021-12-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12417
    R1-CEP 1998-055 - Rev 06
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CALCITRIOL USP
    Calcitriol
    Issue/Submission Date
    1997-03-14
    2021-12-20
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    Clarithromycin

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    15276
    Active
    CLARITHROMYCIN USP
    2001-02-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0001
    Valid
    Clarithromycin EP
    2022-06-22
    Application Number
    15276
    Indian CDSCO WC-0001
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-05-20
    Filing Details
    CLARITHROMYCIN USP
    Clarithromycin EP
    Issue/Submission Date
    2001-02-06
    2022-06-22
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    • FDA
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    Daunorubicin HCl

    PDF Supplier PDF
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    USDMF

    Found USDMF

    13786
    Active
    DAUNORUBICIN HYDROCHLORIDE
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-284 - Rev 03
    Valid
    Daunorubicin Hydrochloride
    2022-07-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13786
    R1-CEP 2001-284 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DAUNORUBICIN HYDROCHLORIDE
    Daunorubicin Hydrochloride
    Issue/Submission Date
    1998-09-01
    2022-07-26
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    • FDA
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    Deferoxamine Mesylate

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    12241
    Active
    DEFEROXAMINE MESYLATE
    1996-12-02
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-160 - Rev 04
    Valid
    Deferoxamine mesilate, Produced by ...
    2022-06-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12241
    R1-CEP 2000-160 - Rev 04
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    DEFEROXAMINE MESYLATE
    Deferoxamine mesilate, Produced by ...
    Issue/Submission Date
    1996-12-02
    2022-06-17
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    • FDA
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    Dihydroergotamine Mesylate

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    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    14944
    Active
    DIHYDROERGOTAMINE MESYLATE
    2000-06-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-107 - Rev 02
    Valid
    Dihydroergotamine mesilate
    2022-11-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14944
    R1-CEP 2005-107 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DIHYDROERGOTAMINE MESYLATE
    Dihydroergotamine mesilate
    Issue/Submission Date
    2000-06-28
    2022-11-07
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    • FDA
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    Etodolac

    PDF Supplier PDF
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    USDMF

    Found USDMF

    11766
    Active
    ETODOLAC
    1995-12-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-331 - Rev 06
    Valid
    Etodolac
    2014-04-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11766
    R1-CEP 2000-331 - Rev 06
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ETODOLAC
    Etodolac
    Issue/Submission Date
    1995-12-11
    2014-04-29
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    Fluoxetine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    12146
    Active
    FLUOXETINE HCI
    1996-10-02
    CEP/COS

    Found CEP/COS

    R1-CEP 1997-042 - Rev 11
    Valid
    Fluoxetine hydrochloride
    2023-06-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12146
    R1-CEP 1997-042 - Rev 11
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    FLUOXETINE HCI
    Fluoxetine hydrochloride
    Issue/Submission Date
    1996-10-02
    2023-06-22
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    Mometasone Furoate

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    USDMF

    Found USDMF

    15063
    Active
    MOMETASONE FUROATE USP
    2000-09-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-198 - Rev 03
    Valid
    Mometasone furoate
    2023-04-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15063
    R1-CEP 2009-198 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MOMETASONE FUROATE USP
    Mometasone furoate
    Issue/Submission Date
    2000-09-29
    2023-04-06
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    • FDA
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    Mupirocin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    14040
    Active
    MUPIROCIN
    1999-03-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2017-011 - Rev 00
    Valid
    Mupirocin, Isobutyl acetate process
    2022-06-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14040
    R1-CEP 2017-011 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    MUPIROCIN
    Mupirocin, Isobutyl acetate process
    Issue/Submission Date
    1999-03-11
    2022-06-02
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    Ondansetron Hydrochloride

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    USDMF

    Found USDMF

    15642
    Active
    ONDANSETRON HCL DIHYDRATE
    2001-10-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10022
    Ondansetron hydrochloride "Teva" at...
    2007-01-22
    Written Confirmation

    Close WC

    Application Number
    15642
    219MF10022
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ONDANSETRON HCL DIHYDRATE
    Ondansetron hydrochloride "Teva" at...
    Issue/Submission Date
    2001-10-01
    2007-01-22
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    Pravastatin

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    USDMF

    Found USDMF

    14729
    Active
    PRAVASTATIN SODIUM
    2000-02-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10727
    Pravastatin sodium "Teva" at 13 Pal...
    2006-09-06
    Written Confirmation

    Close WC

    Application Number
    14729
    218MF10727
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PRAVASTATIN SODIUM
    Pravastatin sodium "Teva" at 13 Pal...
    Issue/Submission Date
    2000-02-25
    2006-09-06
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    Risperidone

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    USDMF

    Found USDMF

    15604
    Active
    RISPERIDONE USP
    2001-08-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-110 - Rev 05
    Valid
    Risperidone
    2023-05-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15604
    R1-CEP 2003-110 - Rev 05
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    RISPERIDONE USP
    Risperidone
    Issue/Submission Date
    2001-08-29
    2023-05-02
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    Terazosin HCl

    PDF Supplier PDF
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    USDMF

    Found USDMF

    11300
    Active
    TERAZOSIN HYDROCHLORIDE
    1995-01-16
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-207 - Rev 05
    Valid
    Terazosin hydrochloride dihydrate
    2022-04-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11300
    R1-CEP 2007-207 - Rev 05
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TERAZOSIN HYDROCHLORIDE
    Terazosin hydrochloride dihydrate
    Issue/Submission Date
    1995-01-16
    2022-04-19
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    Tobramycin

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    USDMF

    Found USDMF

    13713
    Active
    TOBRAMYCIN
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10146
    Tobramycin "Teva" at 13 Pallagi u(...
    2007-04-27
    Written Confirmation

    Close WC

    Application Number
    13713
    219MF10146
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TOBRAMYCIN
    Tobramycin "Teva" at 13 Pallagi u(...
    Issue/Submission Date
    1998-09-01
    2007-04-27
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