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    01 Amlodipine Besylate (1)

    02 Amoxicillin Trihydrate (1)

    03 Ampicillin Trihydrate (1)

    04 Apixaban (1)

    05 Atenolol (2)

    06 Azithromycin (1)

    07 Azithromycin Dihydrate (1)

    08 Biapenem (1)

    09 Canagliflozin (1)

    10 Cefepime (1)

    11 Cefotaxime (1)

    12 Ceftriaxone (1)

    13 Clarithromycin (1)

    14 Cloxacillin Sodium (1)

    15 Dapagliflozin (1)

    16 Doripenem (1)

    17 Empagliflozin (1)

    18 Ertapenem Sodium (1)

    19 Faropenem (1)

    20 Imipenem (1)

    21 Lymecycline (1)

    22 Meropenem (1)

    23 Metoprolol Succinate (1)

    24 Metoprolol Tartrate (1)

    25 Nitroxinil (1)

    26 Pregabalin (2)

    27 Rivaroxaban (1)

    28 Roxithromycin (1)

    29 Tebipenem Pivoxil Hydrobromide (1)

    30 Ticagrelor (1)

    31 Blank (1)

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    01 Active (5)

    02 Inactive (8)

    03 Blank (20)

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    01 Expired (1)

    02 Valid (5)

    03 Withdrawn by Holder (1)

    04 Blank (26)

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    01 Blank (33)

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    01 WC-0090 (9)

    02 WC-0090A3 (1)

    03 Blank (23)

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    Atenolol

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    USDMF

    Found USDMF

    33007
    Active
    ATENOLOL USP
    2018-07-27
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-017 - Rev 06
    Valid
    Atenolol
    2021-03-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0090A3
    Expired
    Atenolol USP
    2021-10-05
    Application Number
    33007
    R1-CEP 1998-017 - Rev 06
    Indian CDSCO WC-0090A3
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Expired
    2022-07-14
    Filing Details
    ATENOLOL USP
    Atenolol
    Atenolol USP
    Issue/Submission Date
    2018-07-27
    2021-03-12
    2021-10-05
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    Atenolol

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    USDMF

    Caution USDMF

    25010
    Inactive
    ATENOLOL
    2011-05-20
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-479 - Rev 00
    Valid
    Atenolol, ALA route
    2022-07-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0090
    Valid
    Atenolol (EP)
    2022-08-31
    Application Number
    25010
    R0-CEP 2021-479 - Rev 00
    Indian CDSCO WC-0090
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Valid
    2025-07-14
    Filing Details
    ATENOLOL
    Atenolol, ALA route
    Atenolol (EP)
    Issue/Submission Date
    2011-05-20
    2022-07-27
    2022-08-31
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    Pregabalin

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    USDMF

    Caution USDMF

    26062
    Inactive
    PREGABALIN
    2012-05-02
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-080 - Rev 02
    Valid
    Pregabalin
    2022-09-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0090
    Valid
    Pregabalin (IH)
    2022-08-31
    Application Number
    26062
    R0-CEP 2018-080 - Rev 02
    Indian CDSCO WC-0090
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Valid
    2025-07-14
    Filing Details
    PREGABALIN
    Pregabalin
    Pregabalin (IH)
    Issue/Submission Date
    2012-05-02
    2022-09-16
    2022-08-31
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    Azithromycin Dihydrate

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    USDMF

    Found USDMF

    34853
    Active
    AZITHROMYCIN DIHYDRATE USP
    2020-05-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-230 - Rev 02
    Valid
    Azithromycin, Dihydrate
    2020-06-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34853
    R1-CEP 2005-230 - Rev 02
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    AZITHROMYCIN DIHYDRATE USP
    Azithromycin, Dihydrate
    Issue/Submission Date
    2020-05-21
    2020-06-30
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    Roxithromycin

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2001-309 - Rev 03
    Valid
    Roxithromycin
    2021-02-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0090
    Valid
    Roxithromycin (EP)
    2022-08-31
    Application Number
    R1-CEP 2001-309 - Rev 03
    Indian CDSCO WC-0090
    Status
    Valid
     
    Valid
    2025-07-14
    Filing Details
    Roxithromycin
    Roxithromycin (EP)
    Issue/Submission Date
    2021-02-17
    2022-08-31
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    Cefotaxime

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2001-223 - Rev 01
    Withdrawn by Holder
    Cefotaxime sodium
    2006-11-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0090
    Valid
    Cefotaxime Sodium (EP/USP)
    2022-08-31
    Application Number
    R0-CEP 2001-223 - Rev 01
    Indian CDSCO WC-0090
    Status
    Withdrawn by Holder
     
    Valid
    2025-07-14
    Filing Details
    Cefotaxime sodium
    Cefotaxime Sodium (EP/USP)
    Issue/Submission Date
    2006-11-06
    2022-08-31
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    Ceftriaxone

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2001-222 - Rev 02
    Expired
    Ceftriaxone sodium
    2005-08-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0090
    Valid
    Ceftriaxone Sodium (USP)
    2022-08-31
    Application Number
    R0-CEP 2001-222 - Rev 02
    Indian CDSCO WC-0090
    Status
    Expired
     
    Valid
    2025-07-14
    Filing Details
    Ceftriaxone sodium
    Ceftriaxone Sodium (USP)
    Issue/Submission Date
    2005-08-22
    2022-08-31
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    Azithromycin

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0090
    Valid
    Azithromycin (EP)
    2022-08-31
    Application Number
    Indian CDSCO WC-0090
    Status
     
    Valid
    2025-07-14
    Filing Details
    Azithromycin (EP)
    Issue/Submission Date
    2022-08-31
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    Cefepime

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0090
    Valid
    Cefepime for Injection (USP)
    2022-08-31
    Application Number
    Indian CDSCO WC-0090
    Status
     
    Valid
    2025-07-14
    Filing Details
    Cefepime for Injection (USP)
    Issue/Submission Date
    2022-08-31
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    Meropenem

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0090
    Valid
    Meropenem For Injection USP
    2022-08-31
    Application Number
    Indian CDSCO WC-0090
    Status
     
    Valid
    2025-07-14
    Filing Details
    Meropenem For Injection USP
    Issue/Submission Date
    2022-08-31
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