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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Vasudha Pharma Chem

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    Vasudha Pharma Chem
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    Country
    Country
    India
    Address
    Address
    78 / A, Vengalrao Nagar, Telangana State, Hyderabad - 500038.
    Telephone
    Telephone
    + 91-40-4476 3666
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    enquiries@pharmacompass.com
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    https://www.vasudhapharma.com/
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    • FDA
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    Itraconazole

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    USDMF

    Found USDMF

    35261
    Active
    ITRACONAZOLE USP
    2020-10-09
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-265 - Rev 02
    Valid
    Itraconazole
    2023-02-03
    Japanese DMF

    Found JDMF

    303MF10166
    Itraconazole at 78/A, Bengalrao Nag...
    2021-11-25
    Written Confirmation

    Found WC

    Indian CDSCO WC-0287n
    Valid
    Itraconazole EP/USP
    2021-05-11
    Application Number
    35261
    R0-CEP 2020-265 - Rev 02
    303MF10166
    Indian CDSCO WC-0287n
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2024-04-16
    Filing Details
    ITRACONAZOLE USP
    Itraconazole
    Itraconazole at 78/A, Bengalrao Nag...
    Itraconazole EP/USP
    Issue/Submission Date
    2020-10-09
    2023-02-03
    2021-11-25
    2021-05-11
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    • FDA
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    Loperamide Hydrochloride

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    USDMF

    Found USDMF

    27731
    Active
    LOPERAMIDE HYDROCHLORIDE USP
    2013-12-06
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-341 - Rev 01
    Valid
    Loperamide hydrochloride, Process-I...
    2023-01-31
    Japanese DMF

    Found JDMF

    304MF10091
    Loperamide Hydrochloride at 78/A, B...
    2022-06-22
    Written Confirmation

    Found WC

    Indian CDSCO WC-0183nA2
    Valid
    Loperamide hydrochloride EP/USP
    2022-06-15
    Application Number
    27731
    R0-CEP 2021-341 - Rev 01
    304MF10091
    Indian CDSCO WC-0183nA2
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-14
    Filing Details
    LOPERAMIDE HYDROCHLORIDE USP
    Loperamide hydrochloride, Process-I...
    Loperamide Hydrochloride at 78/A, B...
    Loperamide hydrochloride EP/USP
    Issue/Submission Date
    2013-12-06
    2023-01-31
    2022-06-22
    2022-06-15
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    • FDA
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    Amitriptyline Hydrochloride

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    USDMF

    Found USDMF

    19635
    Active
    AMITRIPTYLINE HYDROCHLORIDE USP
    2006-07-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-323 - Rev 01
    Valid
    Amitriptyline hydrochloride
    2023-02-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0070
    Valid
    Amitriptyline Hydrochloride (BP/Ph....
    2022-06-14
    Application Number
    19635
    R1-CEP 2013-323 - Rev 01
    Indian CDSCO WC-0070
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-04
    Filing Details
    AMITRIPTYLINE HYDROCHLORIDE USP
    Amitriptyline hydrochloride
    Amitriptyline Hydrochloride (BP/Ph....
    Issue/Submission Date
    2006-07-28
    2023-02-02
    2022-06-14
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    • FDA
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    Desloratadine

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    USDMF

    Found USDMF

    28825
    Active
    DESLORATADINE USP
    2014-11-12
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-310 - Rev 02
    Valid
    Desloratadine
    2023-01-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0183nA2
    Valid
    Desloratadine EP/USP
    2022-06-15
    Application Number
    28825
    R1-CEP 2014-310 - Rev 02
    Indian CDSCO WC-0183nA2
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-14
    Filing Details
    DESLORATADINE USP
    Desloratadine
    Desloratadine EP/USP
    Issue/Submission Date
    2014-11-12
    2023-01-30
    2022-06-15
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    • FDA
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    Domperidone

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2020-315 - Rev 01
    Valid
    Domperidone, Process II
    2023-01-31
    Japanese DMF

    Found JDMF

    304MF10034
    Domperidone at 78/A, Bengalrao Naga...
    2022-02-10
    Written Confirmation

    Found WC

    Indian CDSCO WC-0183nA2
    Valid
    Domperidone BP/EP
    2022-06-15
    Application Number
    R0-CEP 2020-315 - Rev 01
    304MF10034
    Indian CDSCO WC-0183nA2
    Status
    Valid
     
    Valid
    2025-07-14
    Filing Details
    Domperidone, Process II
    Domperidone at 78/A, Bengalrao Naga...
    Domperidone BP/EP
    Issue/Submission Date
    2023-01-31
    2022-02-10
    2022-06-15
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    Domperidone

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2007-203 - Rev 04
    Valid
    Domperidone
    2020-09-03
    Japanese DMF

    Found JDMF

    220MF10225
    Domperidone V at 78/A,Vengalrao Nag...
    2008-11-10
    Written Confirmation

    Found WC

    Indian CDSCO WC-0070
    Valid
    Domperidone (BP/Ph. Eur.)
    2022-06-14
    Application Number
    R1-CEP 2007-203 - Rev 04
    220MF10225
    Indian CDSCO WC-0070
    Status
    Valid
     
    Valid
    2025-07-04
    Filing Details
    Domperidone
    Domperidone V at 78/A,Vengalrao Nag...
    Domperidone (BP/Ph. Eur.)
    Issue/Submission Date
    2020-09-03
    2008-11-10
    2022-06-14
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    • FDA
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    Donepezil

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    USDMF

    Found USDMF

    31976
    Active
    DONEPEZIL HYDROCHLORIDE MONOHYDRATE...
    2018-07-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10288
    Donepezil hydrochloride at 78/A,Ven...
    2015-12-15
    Written Confirmation

    Found WC

    Indian CDSCO WC-0070
    Valid
    Donepezil Hydrochloride (USP)Donepe...
    2022-06-14
    Application Number
    31976
    227MF10288
    Indian CDSCO WC-0070
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-04
    Filing Details
    DONEPEZIL HYDROCHLORIDE MONOHYDRATE...
    Donepezil hydrochloride at 78/A,Ven...
    Donepezil Hydrochloride (USP)Donepe...
    Issue/Submission Date
    2018-07-24
    2015-12-15
    2022-06-14
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    • FDA
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    Esomeprazole Magnesium

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    USDMF

    Found USDMF

    31975
    Active
    ESOMEPRAZOLE MAGNESIUM TRIHYDRATE U...
    2017-09-08
    CEP/COS

    Found CEP/COS

    CEP 2017-191 - Rev 02
    Valid
    Esomeprazole magnesium trihydrate
    2024-02-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0287n
    Valid
    Esomeprazole Magnesium USP/Esomepra...
    2021-05-11
    Application Number
    31975
    CEP 2017-191 - Rev 02
    Indian CDSCO WC-0287n
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2024-04-16
    Filing Details
    ESOMEPRAZOLE MAGNESIUM TRIHYDRATE U...
    Esomeprazole magnesium trihydrate
    Esomeprazole Magnesium USP/Esomepra...
    Issue/Submission Date
    2017-09-08
    2024-02-15
    2021-05-11
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    • FDA
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    Fexofenadine Hydrochloride

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    USDMF

    Found USDMF

    29740
    Active
    FEXOFENADINE HYDROCHLORIDE USP
    2015-09-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-234 - Rev 01
    Valid
    Fexofenadine hydrochloride
    2023-01-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0183nA2
    Valid
    Fexofenadine Hydrochloride USP/Ph ....
    2022-06-15
    Application Number
    29740
    R1-CEP 2015-234 - Rev 01
    Indian CDSCO WC-0183nA2
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-14
    Filing Details
    FEXOFENADINE HYDROCHLORIDE USP
    Fexofenadine hydrochloride
    Fexofenadine Hydrochloride USP/Ph ....
    Issue/Submission Date
    2015-09-25
    2023-01-31
    2022-06-15
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    • FDA
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    Ketorolac Trometamol

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    USDMF

    Found USDMF

    29015
    Active
    KETOROLAC TROMETHAMINE USP
    2015-01-14
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-369 - Rev 01
    Valid
    Ketorolac trometamol
    2023-03-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0070
    Valid
    Ketorolac trometamol (BP/Ph.Eur)/Ke...
    2022-06-14
    Application Number
    29015
    R1-CEP 2014-369 - Rev 01
    Indian CDSCO WC-0070
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-04
    Filing Details
    KETOROLAC TROMETHAMINE USP
    Ketorolac trometamol
    Ketorolac trometamol (BP/Ph.Eur)/Ke...
    Issue/Submission Date
    2015-01-14
    2023-03-03
    2022-06-14
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    • FDA
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    Loratadine

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    USDMF

    Found USDMF

    20367
    Active
    LORATADINE USP
    2007-03-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-009 - Rev 03
    Valid
    Loratadine
    2023-01-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0183nA2
    Valid
    Loratadine USP/Ph . Eur
    2022-06-15
    Application Number
    20367
    R1-CEP 2009-009 - Rev 03
    Indian CDSCO WC-0183nA2
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-14
    Filing Details
    LORATADINE USP
    Loratadine
    Loratadine USP/Ph . Eur
    Issue/Submission Date
    2007-03-20
    2023-01-30
    2022-06-15
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    • FDA
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    Losartan Potassium

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    USDMF

    Found USDMF

    32530
    Active
    LOSARTAN POTASSIUM USP
    2018-04-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-166 - Rev 05
    Valid
    Losartan potassium
    2023-02-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0183nA2
    Valid
    Losartan Potassium BP/USP/Ph . Eur
    2022-06-15
    Application Number
    32530
    R1-CEP 2013-166 - Rev 05
    Indian CDSCO WC-0183nA2
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-14
    Filing Details
    LOSARTAN POTASSIUM USP
    Losartan potassium
    Losartan Potassium BP/USP/Ph . Eur
    Issue/Submission Date
    2018-04-25
    2023-02-23
    2022-06-15
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    • FDA
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    Nortriptyline

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    USDMF

    Found USDMF

    31974
    Active
    NORTRIPTYLINE HYDROCHLORIDE USP
    2017-09-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2017-066 - Rev 00
    Valid
    Nortriptyline hydrochloride
    2023-07-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0287n
    Valid
    Nortriptyline hdrochloride BP/EP/US...
    2021-05-11
    Application Number
    31974
    R1-CEP 2017-066 - Rev 00
    Indian CDSCO WC-0287n
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2024-04-16
    Filing Details
    NORTRIPTYLINE HYDROCHLORIDE USP
    Nortriptyline hydrochloride
    Nortriptyline hdrochloride BP/EP/US...
    Issue/Submission Date
    2017-09-08
    2023-07-31
    2021-05-11
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    • FDA
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    Pantoprazole Sodium

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    USDMF

    Found USDMF

    29739
    Active
    PANTOPRAZOLE SODIUM USP
    2015-09-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-104 - Rev 04
    Valid
    Pantoprazole sodium sesquihydrate
    2023-04-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0183nA2
    Valid
    Pantoprazole Sodium Sesquihydrate I...
    2022-06-15
    Application Number
    29739
    R1-CEP 2012-104 - Rev 04
    Indian CDSCO WC-0183nA2
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-14
    Filing Details
    PANTOPRAZOLE SODIUM USP
    Pantoprazole sodium sesquihydrate
    Pantoprazole Sodium Sesquihydrate I...
    Issue/Submission Date
    2015-09-25
    2023-04-18
    2022-06-15
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    • FDA
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    Pimozide

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    USDMF

    Found USDMF

    27583
    Active
    PIMOZIDE USP
    2013-10-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-279 - Rev 00
    Valid
    Pimozide
    2021-08-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0070
    Valid
    Pimozide (BP/Ph. Eur./USP)
    2022-06-14
    Application Number
    27583
    R1-CEP 2013-279 - Rev 00
    Indian CDSCO WC-0070
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-04
    Filing Details
    PIMOZIDE USP
    Pimozide
    Pimozide (BP/Ph. Eur./USP)
    Issue/Submission Date
    2013-10-21
    2021-08-05
    2022-06-14
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    • FDA
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    Pregabalin

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    USDMF

    Found USDMF

    32531
    Active
    PREGABALIN USP
    2018-08-01
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-072 - Rev 01
    Valid
    Pregabalin
    2023-02-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0287n
    Valid
    Pregabalin USP/EP
    2021-05-11
    Application Number
    32531
    R0-CEP 2018-072 - Rev 01
    Indian CDSCO WC-0287n
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2024-04-16
    Filing Details
    PREGABALIN USP
    Pregabalin
    Pregabalin USP/EP
    Issue/Submission Date
    2018-08-01
    2023-02-03
    2021-05-11
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    • FDA
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    Quetiapine Hemifumarate

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    USDMF

    Found USDMF

    32874
    Active
    QUETIAPINE FUMARATE USP
    2018-08-18
    CEP/COS

    Found CEP/COS

    CEP 2019-035 - Rev 02
    Valid
    Quetiapine Fumarate
    2023-11-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0183nA2
    Valid
    Quetiapine Fumarate EP/USP
    2022-06-15
    Application Number
    32874
    CEP 2019-035 - Rev 02
    Indian CDSCO WC-0183nA2
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-14
    Filing Details
    QUETIAPINE FUMARATE USP
    Quetiapine Fumarate
    Quetiapine Fumarate EP/USP
    Issue/Submission Date
    2018-08-18
    2023-11-29
    2022-06-15
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    Rupatadine Fumarate

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    USDMF

    Found USDMF

    38451
    Active
    RUPATADINE FUMARATE
    2023-05-31
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-180 - Rev 02
    Valid
    Rupatadine fumarate
    2023-02-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0183nA2
    Valid
    Rupatadine Fumarate EP
    2022-06-15
    Application Number
    38451
    R0-CEP 2018-180 - Rev 02
    Indian CDSCO WC-0183nA2
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-14
    Filing Details
    RUPATADINE FUMARATE
    Rupatadine fumarate
    Rupatadine Fumarate EP
    Issue/Submission Date
    2023-05-31
    2023-02-02
    2022-06-15
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    • FDA
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    Olmesartan Medoxomil

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    USDMF

    Caution USDMF

    29113
    Inactive
    OLMESARTAN MEDOXOMIL USP
    2015-03-02
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-076 - Rev 02
    Valid
    Olmesartan medoxomil
    2023-01-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0070
    Valid
    Olmesartan Medoxomil (USP/BP/Ph.Eur...
    2022-06-14
    Application Number
    29113
    R1-CEP 2015-076 - Rev 02
    Indian CDSCO WC-0070
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-04
    Filing Details
    OLMESARTAN MEDOXOMIL USP
    Olmesartan medoxomil
    Olmesartan Medoxomil (USP/BP/Ph.Eur...
    Issue/Submission Date
    2015-03-02
    2023-01-31
    2022-06-14
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    Amidotrizoic Acid

    PDF Supplier PDF
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    USDMF

    Found USDMF

    32735
    Active
    DIATRIZOIC ACID DIHYDRATE USP
    2018-07-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0183nA2
    Valid
    Diatrizoic Acid Dihydrate USP
    2022-06-15
    Application Number
    32735
    Indian CDSCO WC-0183nA2
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-14
    Filing Details
    DIATRIZOIC ACID DIHYDRATE USP
    Diatrizoic Acid Dihydrate USP
    Issue/Submission Date
    2018-07-23
    2022-06-15
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    Cinnarizine

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-080 - Rev 01
    Valid
    Cinnarizine
    2023-02-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0287n
    Valid
    Cinnarazine BP/EP/IP
    2021-05-11
    Application Number
    R0-CEP 2019-080 - Rev 01
    Indian CDSCO WC-0287n
    Status
    Valid
     
    Valid
    2024-04-16
    Filing Details
    Cinnarizine
    Cinnarazine BP/EP/IP
    Issue/Submission Date
    2023-02-03
    2021-05-11
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    • FDA
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    Cisapride Monohydrate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    31230
    Active
    CISAPRIDE MONOHYDRATE USP
    2017-01-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0070
    Valid
    Cisapride Monohydrate (USP)
    2022-06-14
    Application Number
    31230
    Indian CDSCO WC-0070
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-04
    Filing Details
    CISAPRIDE MONOHYDRATE USP
    Cisapride Monohydrate (USP)
    Issue/Submission Date
    2017-01-11
    2022-06-14
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    Clopidogrel

    PDF Supplier PDF
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    USDMF

    Found USDMF

    32875
    Active
    CLOPIDOGREL BISULFATE USP
    2019-05-27
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-251 - Rev 01
    Valid
    Clopidogrel hydrogen sulfate
    2023-02-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32875
    R0-CEP 2019-251 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CLOPIDOGREL BISULFATE USP
    Clopidogrel hydrogen sulfate
    Issue/Submission Date
    2019-05-27
    2023-02-03
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    Cyclobenzaprine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    21779
    Active
    CYCLOBENZAPRINE HCL USP
    2008-07-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0070
    Valid
    Cyclobenzaprine Hydrochloride USP
    2022-06-14
    Application Number
    21779
    Indian CDSCO WC-0070
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-04
    Filing Details
    CYCLOBENZAPRINE HCL USP
    Cyclobenzaprine Hydrochloride USP
    Issue/Submission Date
    2008-07-08
    2022-06-14
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    Cyproheptadine Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    25456
    Active
    CYPROHEPTADINE HCL USP
    2011-10-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0183nA2
    Valid
    Cyproheptadine hydrochloride EP/US...
    2022-06-15
    Application Number
    25456
    Indian CDSCO WC-0183nA2
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-14
    Filing Details
    CYPROHEPTADINE HCL USP
    Cyproheptadine hydrochloride EP/US...
    Issue/Submission Date
    2011-10-10
    2022-06-15
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    Diatrizoate Meglumine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    32737
    Active
    DIATRIZOATE MEGLUMINE USP
    2018-07-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0183nA2
    Valid
    Diatrizoate Meglumine USP
    2022-06-15
    Application Number
    32737
    Indian CDSCO WC-0183nA2
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-14
    Filing Details
    DIATRIZOATE MEGLUMINE USP
    Diatrizoate Meglumine USP
    Issue/Submission Date
    2018-07-25
    2022-06-15
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    Diatrizoate Sodium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    32736
    Active
    DIATRIZOATE SODIUM USP
    2018-07-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0183nA2
    Valid
    Diatrizoate Sodium USP
    2022-06-15
    Application Number
    32736
    Indian CDSCO WC-0183nA2
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-14
    Filing Details
    DIATRIZOATE SODIUM USP
    Diatrizoate Sodium USP
    Issue/Submission Date
    2018-07-23
    2022-06-15
    ASK
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    Dimethyl Fumarate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    34259
    Active
    DIMETHYL FUMARATE IH
    2021-04-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0183nA2
    Valid
    Dimethyl Fumarate IH
    2022-06-15
    Application Number
    34259
    Indian CDSCO WC-0183nA2
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-14
    Filing Details
    DIMETHYL FUMARATE IH
    Dimethyl Fumarate IH
    Issue/Submission Date
    2021-04-01
    2022-06-15
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    Domperidone Maleate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2002-042 - Rev 08
    Valid
    Domperidone maleate
    2023-12-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0070
    Valid
    Domperidone Maleate (BP/Ph. Eur.)
    2022-06-14
    Application Number
    CEP 2002-042 - Rev 08
    Indian CDSCO WC-0070
    Status
    Valid
     
    Valid
    2025-07-04
    Filing Details
    Domperidone maleate
    Domperidone Maleate (BP/Ph. Eur.)
    Issue/Submission Date
    2023-12-20
    2022-06-14
    ASK
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    Ebastine

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2013-243 - Rev 02
    Valid
    Ebastine
    2023-01-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0070
    Valid
    Ebastine (BP/Ph. Eur.)
    2022-06-14
    Application Number
    R1-CEP 2013-243 - Rev 02
    Indian CDSCO WC-0070
    Status
    Valid
     
    Valid
    2025-07-04
    Filing Details
    Ebastine
    Ebastine (BP/Ph. Eur.)
    Issue/Submission Date
    2023-01-30
    2022-06-14
    ASK
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    Flunarizine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2020-224 - Rev 03
    Valid
    Flunarizine dihydrochloride
    2023-08-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0287n
    Valid
    Flunarizine Hydrochloride EP/CP
    2021-05-11
    Application Number
    R0-CEP 2020-224 - Rev 03
    Indian CDSCO WC-0287n
    Status
    Valid
     
    Valid
    2024-04-16
    Filing Details
    Flunarizine dihydrochloride
    Flunarizine Hydrochloride EP/CP
    Issue/Submission Date
    2023-08-18
    2021-05-11
    ASK
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    Loperamide Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2013-333 - Rev 03
    Valid
    Loperamide hydrochloride
    2024-03-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0070
    Valid
    Loperamide Hydrochloride (BP/Ph. Eu...
    2022-06-14
    Application Number
    CEP 2013-333 - Rev 03
    Indian CDSCO WC-0070
    Status
    Valid
     
    Valid
    2025-07-04
    Filing Details
    Loperamide hydrochloride
    Loperamide Hydrochloride (BP/Ph. Eu...
    Issue/Submission Date
    2024-03-11
    2022-06-14
    ASK
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    Loratadine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    34822
    Active
    LORATADINE USP (PROCESS-II)
    2020-05-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0070
    Valid
    Loratidine (USP/Ph. Eur.)
    2022-06-14
    Application Number
    34822
    Indian CDSCO WC-0070
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-04
    Filing Details
    LORATADINE USP (PROCESS-II)
    Loratidine (USP/Ph. Eur.)
    Issue/Submission Date
    2020-05-15
    2022-06-14
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    Mirabegron

    PDF Supplier PDF
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    USDMF

    Found USDMF

    36685
    Active
    MIRABEGRON IH
    2022-04-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0183nA2
    Valid
    Mirabegron IH
    2022-06-15
    Application Number
    36685
    Indian CDSCO WC-0183nA2
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-14
    Filing Details
    MIRABEGRON IH
    Mirabegron IH
    Issue/Submission Date
    2022-04-01
    2022-06-15
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    Rivaroxaban

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    38211
    Active
    RIVAROXABAN
    2023-03-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0183nA2
    Valid
    Rivaroxaban EP
    2022-06-15
    Application Number
    38211
    Indian CDSCO WC-0183nA2
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-14
    Filing Details
    RIVAROXABAN
    Rivaroxaban EP
    Issue/Submission Date
    2023-03-31
    2022-06-15
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    Tamsulosin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    37542
    Active
    TAMSULOSIN HYDROCHLORIDE USP
    2022-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0183nA2
    Valid
    Tamsulosin Hydrochloride EP/USP/BP
    2022-06-15
    Application Number
    37542
    Indian CDSCO WC-0183nA2
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-14
    Filing Details
    TAMSULOSIN HYDROCHLORIDE USP
    Tamsulosin Hydrochloride EP/USP/BP
    Issue/Submission Date
    2022-09-30
    2022-06-15
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    Amitriptyline Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2006-111 - Rev 00
    Expired
    Amitriptyline hydrochloride
    2008-05-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0287n
    Valid
    Amitriptyline Hydrochloride BP/EP/U...
    2021-05-11
    Application Number
    R0-CEP 2006-111 - Rev 00
    Indian CDSCO WC-0287n
    Status
    Expired
     
    Valid
    2024-04-16
    Filing Details
    Amitriptyline hydrochloride
    Amitriptyline Hydrochloride BP/EP/U...
    Issue/Submission Date
    2008-05-30
    2021-05-11
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    • FDA
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    Pantoprazole Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    38328
    Active
    PANTOPRAZOLE SODIUM USP (PROCESS-II...
    2023-06-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0183
    Expired
    Pantoprazole Sodium (IP/USP)/Pantop...
    2019-07-15
    Application Number
    38328
    Indian CDSCO WC-0183
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-14
    Filing Details
    PANTOPRAZOLE SODIUM USP (PROCESS-II...
    Pantoprazole Sodium (IP/USP)/Pantop...
    Issue/Submission Date
    2023-06-23
    2019-07-15
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    CAS 29676-71-9

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0183A3-4
    Valid
    Mirabegron Impurity 7
    2022-06-08
    Application Number
    Indian CDSCO WC-0183A3-4
    Status
     
    Valid
    2025-07-14
    Filing Details
    Mirabegron Impurity 7
    Issue/Submission Date
    2022-06-08
    ASK
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    • FDA
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    Desloratadine

    PDF Supplier PDF
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    See all info for this product

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0183A3-4
    Valid
    Desloratadine
    2022-06-08
    Application Number
    Indian CDSCO WC-0183A3-4
    Status
     
    Valid
    2025-07-14
    Filing Details
    Desloratadine
    Issue/Submission Date
    2022-06-08
    ASK
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    Diatrizoate Meglumine

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

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0183A3-4
    Valid
    Diatrizoate Meglumine
    2022-06-08
    Application Number
    Indian CDSCO WC-0183A3-4
    Status
     
    Valid
    2025-07-14
    Filing Details
    Diatrizoate Meglumine
    Issue/Submission Date
    2022-06-08
    ASK
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    • FDA
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    Diatrizoate Sodium

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

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0183A3-4
    Valid
    Diatrizoate Sodium
    2022-06-08
    Application Number
    Indian CDSCO WC-0183A3-4
    Status
     
    Valid
    2025-07-14
    Filing Details
    Diatrizoate Sodium
    Issue/Submission Date
    2022-06-08
    ASK
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    • FDA
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    Dibenzsuberone

    PDF Supplier PDF
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    USDMF

    Found USDMF

    32893
    Active
    DIBENZOSUBERONE
    2018-08-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32893
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DIBENZOSUBERONE
    Issue/Submission Date
    2018-08-31
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    Dimethyl Fumarate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0183A3-4
    Valid
    Dimethyl Fumarate
    2022-06-08
    Application Number
    Indian CDSCO WC-0183A3-4
    Status
     
    Valid
    2025-07-14
    Filing Details
    Dimethyl Fumarate
    Issue/Submission Date
    2022-06-08
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    Levetiracetam

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    USDMF

    Found USDMF

    38130
    Active
    LEVETIRACETAM USP
    2023-03-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38130
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LEVETIRACETAM USP
    Issue/Submission Date
    2023-03-09
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    Olmesartan Medoxomil

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    USDMF

    Found USDMF

    38015
    Active
    OLMESARTAN MEDOXOMIL USP
    2023-02-22
    CEP/COS

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    Japanese DMF

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    Written Confirmation

    Close WC

    Application Number
    38015
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    OLMESARTAN MEDOXOMIL USP
    Issue/Submission Date
    2023-02-22
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    Rivaroxaban

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    USDMF

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    CEP/COS

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    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0183A3-4
    Valid
    Rivaroxaban
    2022-06-08
    Application Number
    Indian CDSCO WC-0183A3-4
    Status
     
    Valid
    2025-07-14
    Filing Details
    Rivaroxaban
    Issue/Submission Date
    2022-06-08
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    Tamsulosin

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0183A3-4
    Valid
    Tamsulosin Hydrochloride
    2022-06-08
    Application Number
    Indian CDSCO WC-0183A3-4
    Status
     
    Valid
    2025-07-14
    Filing Details
    Tamsulosin Hydrochloride
    Issue/Submission Date
    2022-06-08
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    Telmisartan

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    USDMF

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    CEP/COS

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    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0183nA2
    Valid
    Telmisartan EP/USP/BP
    2022-06-15
    Application Number
    Indian CDSCO WC-0183nA2
    Status
     
    Valid
    2025-07-14
    Filing Details
    Telmisartan EP/USP/BP
    Issue/Submission Date
    2022-06-15
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    TELMISARTAN USP

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    USDMF

    Found USDMF

    38840
    Active
    TELMISARTAN USP
    2023-09-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Close WC

    Application Number
    38840
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TELMISARTAN USP
    Issue/Submission Date
    2023-09-08
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