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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Pfizer Centreone

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    01 16-Alpha-Hydroxy Prednisolone (1)

    02 Dexamethasone (1)

    03 Dexamethasone 9,11-Epoxide (1)

    04 Dexamethasone Acetate (1)

    05 Dexamethasone Sodium Phosphate (1)

    06 Dinoprost Tromethamine (1)

    07 Epoprostenol Sodium (1)

    08 Heparin Sodium (1)

    09 Hydrocortisone (1)

    10 Hydrocortisone Acetate (1)

    11 Hydrocortisone Hemisuccinate Hydrate (1)

    12 Medroxyprogesterone Acetate (1)

    13 Megestrol Acetate (2)

    14 Myristyl-Gamma-Picolinium Chloride (1)

    15 Neomycin Sulfate (1)

    16 Nicergoline (1)

    17 Novobiocin Sodium (1)

    18 Prasterone Acetate (1)

    19 Progesterone (2)

    20 Testosterone (1)

    21 Testosterone Cypionate (1)

    22 Testosterone Propionate (1)

    23 Testosterone Undecanoate (1)

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    01 Active (19)

    02 Blank (6)

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    01 Valid (11)

    02 Blank (14)

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    01 217MF10976 (1)

    02 217MF10978 (1)

    03 222MF10138 (1)

    04 Blank (22)

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    01 Blank (25)

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    • FDA
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    Hydrocortisone

    PDF Supplier PDF
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    USDMF

    Found USDMF

    1413
    Active
    HYDROCORTISONE MICRONIZED AND NON-M...
    1969-09-02
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-220 - Rev 02
    Valid
    Hydrocortisone, Non-micronised, mic...
    2023-03-23
    Japanese DMF

    Found JDMF

    222MF10138
    Hydrocortisone at 235 East 42nd Str...
    2010-04-14
    Written Confirmation

    Close WC

    Application Number
    1413
    R1-CEP 2002-220 - Rev 02
    222MF10138
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    HYDROCORTISONE MICRONIZED AND NON-M...
    Hydrocortisone, Non-micronised, mic...
    Hydrocortisone at 235 East 42nd Str...
    Issue/Submission Date
    1969-09-02
    2023-03-23
    2010-04-14
    Pfizer centreOne

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    Hydrocortisone Acetate

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    USDMF

    Found USDMF

    5498
    Active
    HYDROCORTISONE ACETATE USP, MICRO &...
    1984-06-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-160 - Rev 04
    Valid
    Hydrocortisone acetate
    2019-01-29
    Japanese DMF

    Found JDMF

    217MF10978
    Hydrocortisone Acetate at 235 East ...
    2005-11-14
    Written Confirmation

    Close WC

    Application Number
    5498
    R1-CEP 2002-160 - Rev 04
    217MF10978
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    HYDROCORTISONE ACETATE USP, MICRO &...
    Hydrocortisone acetate
    Hydrocortisone Acetate at 235 East ...
    Issue/Submission Date
    1984-06-11
    2019-01-29
    2005-11-14
    Pfizer centreOne

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    Neomycin Sulfate

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    USDMF

    Found USDMF

    13378
    Active
    NEOMYCIN SULFATE USP
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-184 - Rev 03
    Valid
    Neomycin sulfate, Micronised and no...
    2020-04-21
    Japanese DMF

    Found JDMF

    217MF10976
    Neomycin Sulfate (Fradiomycin Sulfa...
    2005-11-14
    Written Confirmation

    Close WC

    Application Number
    13378
    R1-CEP 1999-184 - Rev 03
    217MF10976
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    NEOMYCIN SULFATE USP
    Neomycin sulfate, Micronised and no...
    Neomycin Sulfate (Fradiomycin Sulfa...
    Issue/Submission Date
    1998-09-01
    2020-04-21
    2005-11-14
    Pfizer centreOne

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    Dexamethasone

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    USDMF

    Found USDMF

    4524
    Active
    DEXAMETHASONE USP MICRONIZED
    1982-05-10
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-261 - Rev 05
    Valid
    Dexamethasone, Micronised
    2022-09-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4524
    R1-CEP 2000-261 - Rev 05
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DEXAMETHASONE USP MICRONIZED
    Dexamethasone, Micronised
    Issue/Submission Date
    1982-05-10
    2022-09-02
    Pfizer centreOne

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    Dexamethasone Sodium Phosphate

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    USDMF

    Found USDMF

    6525
    Active
    DEXAMETHASONE SODIUM PHOSPHATE USP
    1986-08-11
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-154 - Rev 06
    Valid
    Dexamethasone sodium phosphate
    2021-07-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6525
    R1-CEP 1998-154 - Rev 06
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DEXAMETHASONE SODIUM PHOSPHATE USP
    Dexamethasone sodium phosphate
    Issue/Submission Date
    1986-08-11
    2021-07-07
    Pfizer centreOne

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    Dinoprost Tromethamine

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    USDMF

    Found USDMF

    5319
    Active
    DINOPROST TROMETHAMINE
    1984-04-06
    CEP/COS

    Found CEP/COS

    CEP 2016-337 - Rev 01
    Valid
    Dinoprost trometamol
    2024-01-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5319
    CEP 2016-337 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    DINOPROST TROMETHAMINE
    Dinoprost trometamol
    Issue/Submission Date
    1984-04-06
    2024-01-09
    Pfizer centreOne

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    Progesterone

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    USDMF

    Found USDMF

    1418
    Active
    PROGESTERONE MICRONIZED AND CRYSTAL...
    1969-09-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-299 - Rev 02
    Valid
    Progesterone, Micronised, non-micro...
    2019-08-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    1418
    R1-CEP 2005-299 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    PROGESTERONE MICRONIZED AND CRYSTAL...
    Progesterone, Micronised, non-micro...
    Issue/Submission Date
    1969-09-04
    2019-08-02
    Pfizer centreOne

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    Progesterone

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    USDMF

    Found USDMF

    32099
    Active
    PROGESTERONE USP
    2017-12-28
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-200 - Rev 01
    Valid
    Progesterone, Process 2, micronised...
    2022-02-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32099
    R0-CEP 2018-200 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    PROGESTERONE USP
    Progesterone, Process 2, micronised...
    Issue/Submission Date
    2017-12-28
    2022-02-02
    Pfizer centreOne

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    Testosterone

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    USDMF

    Found USDMF

    3190
    Active
    TESTOSTERONE, USP
    1978-04-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-307 - Rev 03
    Valid
    Testosterone, Non-micronised, micro...
    2021-02-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    3190
    R1-CEP 2000-307 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TESTOSTERONE, USP
    Testosterone, Non-micronised, micro...
    Issue/Submission Date
    1978-04-28
    2021-02-10
    Pfizer centreOne

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    16-Alpha-Hydroxy Prednisolone

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    USDMF

    Found USDMF

    9653
    Active
    16A-HYDROXYPREDNISOLONE
    1992-04-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    9653
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    16A-HYDROXYPREDNISOLONE
    Issue/Submission Date
    1992-04-23
    Pfizer centreOne

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