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    01 Ambroxol Hydrochloride (1)

    02 Atorvastatin (1)

    03 Azithromycin (2)

    04 Beclomethasone Dipropionate (1)

    05 Betamethasone Acetate (1)

    06 Betamethasone Dipropionate (1)

    07 Betamethasone Sodium Phosphate (1)

    08 Betamethasone Valerate (1)

    09 Chloramphenicol (1)

    10 Chloramphenicol Palmitate (1)

    11 Clobetasol Propionate (1)

    12 Clobetasone Butyrate (1)

    13 Clopidogrel (1)

    14 Deflazacort (1)

    15 Dexamethasone Acetate (1)

    16 Dexamethasone Sodium Phosphate (1)

    17 Duloxetine (1)

    18 Erythromycin (2)

    19 Erythromycin Estolate (2)

    20 Erythromycin Ethyl Succinate (1)

    21 Erythromycin Propionate (1)

    22 Erythromycin Stearate (1)

    23 Fluconazole (1)

    24 Gliclazide (1)

    25 Levetiracetam (1)

    26 Losartan Potassium (1)

    27 Mometasone Furoate (1)

    28 Moxifloxacin (1)

    29 Olmesartan Medoxomil (1)

    30 Pantoprazole Sodium (1)

    31 Piperaquine Phosphate (1)

    32 Prednisolone (1)

    33 Prednisolone Acetate (1)

    34 Prednisolone Sodium Phosphate (1)

    35 Pregabalin (1)

    36 Pyrazinamide (1)

    37 Rabeprazole (1)

    38 Rosuvastatin (1)

    39 Simvastatin (1)

    40 Sulfadoxine (1)

    41 Telmisartan (1)

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    01 Inactive (2)

    02 Blank (42)

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    01 Valid (7)

    02 Withdrawn by Holder (1)

    03 Blank (36)

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    01 Blank (44)

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    01 WC-0086 (11)

    02 WC-0086A4 (2)

    03 Blank (31)

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    Erythromycin

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    USDMF

    Caution USDMF

    19676
    Inactive
    ERYTHROMYCIN USP
    2006-07-10
    CEP/COS

    Found CEP/COS

    CEP 2005-205 - Rev 11
    Valid
    Erythromycin
    2023-09-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0086
    Expired
    Erythromycin (BP/EP/USP)
    2020-03-18
    Application Number
    19676
    CEP 2005-205 - Rev 11
    Indian CDSCO WC-0086
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Expired
    2023-03-01
    Filing Details
    ERYTHROMYCIN USP
    Erythromycin
    Erythromycin (BP/EP/USP)
    Issue/Submission Date
    2006-07-10
    2023-09-14
    2020-03-18
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    Ambroxol Hydrochloride

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    CEP/COS

    Found CEP/COS

    CEP 2018-033 - Rev 01
    Valid
    Ambroxol hydrochloride
    2024-03-15
    Japanese DMF

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    Written Confirmation

    Caution WC

    Indian CDSCO WC-0086
    Expired
    Ambroxol Hydrochloride (BP/EP)
    2020-03-18
    Application Number
    CEP 2018-033 - Rev 01
    Indian CDSCO WC-0086
    Status
    Valid
     
    Expired
    2023-03-01
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    Ambroxol hydrochloride
    Ambroxol Hydrochloride (BP/EP)
    Issue/Submission Date
    2024-03-15
    2020-03-18
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    Azithromycin

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    USDMF

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    CEP/COS

    Found CEP/COS

    R0-CEP 2021-143 - Rev 00
    Valid
    Azithromycin
    2023-07-13
    Japanese DMF

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    Written Confirmation

    Caution WC

    Indian CDSCO WC-0086
    Expired
    Azithromycin (BP/EP/LISP)
    2020-03-18
    Application Number
    R0-CEP 2021-143 - Rev 00
    Indian CDSCO WC-0086
    Status
    Valid
     
    Expired
    2023-03-01
    Filing Details
    Azithromycin
    Azithromycin (BP/EP/LISP)
    Issue/Submission Date
    2023-07-13
    2020-03-18
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    Erythromycin Ethyl Succinate

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    USDMF

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    CEP/COS

    Found CEP/COS

    CEP 2007-235 - Rev 08
    Valid
    Erythromycin ethylsuccinate
    2023-11-14
    Japanese DMF

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    Written Confirmation

    Caution WC

    Indian CDSCO WC-0086
    Expired
    Erythromycin Ethyl Succinate (BP/EP...
    2020-03-18
    Application Number
    CEP 2007-235 - Rev 08
    Indian CDSCO WC-0086
    Status
    Valid
     
    Expired
    2023-03-01
    Filing Details
    Erythromycin ethylsuccinate
    Erythromycin Ethyl Succinate (BP/EP...
    Issue/Submission Date
    2023-11-14
    2020-03-18
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    Pyrazinamide

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2005-059 - Rev 03
    Valid
    Pyrazinamide
    2020-04-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0086
    Expired
    Pyrazinamide (BP/EP/USP)
    2020-03-18
    Application Number
    R1-CEP 2005-059 - Rev 03
    Indian CDSCO WC-0086
    Status
    Valid
     
    Expired
    2023-03-01
    Filing Details
    Pyrazinamide
    Pyrazinamide (BP/EP/USP)
    Issue/Submission Date
    2020-04-30
    2020-03-18
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    Sulfadoxine

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    USDMF

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    CEP/COS

    Found CEP/COS

    CEP 2022-457 - Rev 00
    Valid
    Sulfadoxine
    2024-02-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0086
    Expired
    Sulfadoxine (BP/EP)
    2020-03-18
    Application Number
    CEP 2022-457 - Rev 00
    Indian CDSCO WC-0086
    Status
    Valid
     
    Expired
    2023-03-01
    Filing Details
    Sulfadoxine
    Sulfadoxine (BP/EP)
    Issue/Submission Date
    2024-02-23
    2020-03-18
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    Gliclazide

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    USDMF

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    CEP/COS

    Found CEP/COS

    CEP 2021-398 - Rev 01
    Valid
    Gliclazide
    2023-12-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2021-398 - Rev 01
    Status
    Valid
     
    Filing Details
    Gliclazide
    Issue/Submission Date
    2023-12-20
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    Azithromycin

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0086A4
    Expired
    Azithromycin BP/EP
    2020-07-06
    Application Number
    Indian CDSCO WC-0086A4
    Status
     
    Expired
    2023-03-01
    Filing Details
    Azithromycin BP/EP
    Issue/Submission Date
    2020-07-06
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    Chloramphenicol

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0086
    Expired
    Chloramphenicol (BP/EP/USP)
    2020-03-18
    Application Number
    Indian CDSCO WC-0086
    Status
     
    Expired
    2023-03-01
    Filing Details
    Chloramphenicol (BP/EP/USP)
    Issue/Submission Date
    2020-03-18
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    Chloramphenicol Palmitate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0086
    Expired
    Chloramphenicol Palmitate (BP/EP/US...
    2020-03-18
    Application Number
    Indian CDSCO WC-0086
    Status
     
    Expired
    2023-03-01
    Filing Details
    Chloramphenicol Palmitate (BP/EP/US...
    Issue/Submission Date
    2020-03-18
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