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    01 Abaloparatide Acetate (1)

    02 Atosiban (1)

    03 Bivalirudin (1)

    04 Calcitonin (1)

    05 Carbetocin Acetate (1)

    06 Cetrorelix Acetate (1)

    07 Degarelix Acetate (1)

    08 Desmopressin Acetate (1)

    09 Eptifibatide (1)

    10 Exenatide (1)

    11 Ganirelix (1)

    12 Glatiramer (1)

    13 Glatiramer Acetate (1)

    14 Glucagon (1)

    15 Leuprolide Acetate (1)

    16 Linaclotide (2)

    17 Liraglutide (2)

    18 Natriuretic Peptide, Brain (1)

    19 Octreotide Acetate (1)

    20 Oxytocin (1)

    21 Plecanatide (1)

    22 Semaglutide (1)

    23 Somatostatin (1)

    24 Teriparatide (2)

    25 Terlipressin Acetate (1)

    26 Thymalfasin (1)

    27 Thyrotropin-Releasing Hormone (1)

    28 Tirzepatide (1)

    29 Ziconotide (1)

    30 Blank (3)

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    01 Active (17)

    02 Inactive (1)

    03 Blank (17)

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    01 Valid (5)

    02 Blank (30)

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    01 230MF10067 (1)

    02 Blank (34)

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    01 Blank (35)

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    Desmopressin Acetate

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    USDMF

    Found USDMF

    31889
    Active
    DESMOPRESSIN ACETATE
    2017-07-28
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-221 - Rev 00
    Valid
    Desmopressin
    2022-11-14
    Japanese DMF

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    Written Confirmation

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    Application Number
    31889
    R0-CEP 2021-221 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DESMOPRESSIN ACETATE
    Desmopressin
    Issue/Submission Date
    2017-07-28
    2022-11-14
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    Ganirelix

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    USDMF

    Found USDMF

    30800
    Active
    GANIRELIX ACETATE NON-STERILE BULK ...
    2016-07-28
    CEP/COS

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    Japanese DMF

    Found JDMF

    230MF10067
    Ganirelix Acetate at Hybio Medicine...
    2018-05-31
    Written Confirmation

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    Application Number
    30800
    230MF10067
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    GANIRELIX ACETATE NON-STERILE BULK ...
    Ganirelix Acetate at Hybio Medicine...
    Issue/Submission Date
    2016-07-28
    2018-05-31
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    Oxytocin

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    USDMF

    Found USDMF

    34916
    Active
    OXYTOCIN NON STERILE BULK DRUG SUBS...
    2020-07-20
    CEP/COS

    Found CEP/COS

    CEP 2020-322 - Rev 01
    Valid
    Oxytocin
    2024-01-17
    Japanese DMF

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    Written Confirmation

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    Application Number
    34916
    CEP 2020-322 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    OXYTOCIN NON STERILE BULK DRUG SUBS...
    Oxytocin
    Issue/Submission Date
    2020-07-20
    2024-01-17
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    Cetrorelix Acetate

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    USDMF

    Found USDMF

    37082
    Active
    CETRORELIX ACETATE, NON-STERILE DRU...
    2022-04-29
    CEP/COS

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    Application Number
    37082
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CETRORELIX ACETATE, NON-STERILE DRU...
    Issue/Submission Date
    2022-04-29
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    Eptifibatide

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    USDMF

    Found USDMF

    26453
    Active
    EPTIFIBATIDE ACETATE, NON-STERILE B...
    2012-09-20
    CEP/COS

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    Japanese DMF

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    Application Number
    26453
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    EPTIFIBATIDE ACETATE, NON-STERILE B...
    Issue/Submission Date
    2012-09-20
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    Glatiramer Acetate

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    USDMF

    Found USDMF

    28989
    Active
    GLATIRAMER ACETATE, NON-STERILE BUL...
    2014-12-25
    CEP/COS

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    Application Number
    28989
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    GLATIRAMER ACETATE, NON-STERILE BUL...
    Issue/Submission Date
    2014-12-25
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    Leuprolide Acetate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-016 - Rev 00
    Valid
    Leuprorelin
    2020-04-23
    Japanese DMF

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    Written Confirmation

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    Application Number
    R0-CEP 2019-016 - Rev 00
    Status
    Valid
     
    Filing Details
    Leuprorelin
    Issue/Submission Date
    2020-04-23
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    Linaclotide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    32314
    Active
    LINACLOTIDE (NON-STERILE BULK DRUG ...
    2017-12-28
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    32314
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LINACLOTIDE (NON-STERILE BULK DRUG ...
    Issue/Submission Date
    2017-12-28
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    Linaclotide

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    USDMF

    Found USDMF

    37370
    Active
    LINACLOTIDE NON-STERILE DRUG SUBSTA...
    2022-08-17
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    37370
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LINACLOTIDE NON-STERILE DRUG SUBSTA...
    Issue/Submission Date
    2022-08-17
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    Liraglutide

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    USDMF

    Found USDMF

    30095
    Active
    LIRAGLUTIDE NON-STERILE BULK DRUG S...
    2015-12-07
    CEP/COS

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    Japanese DMF

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    Application Number
    30095
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LIRAGLUTIDE NON-STERILE BULK DRUG S...
    Issue/Submission Date
    2015-12-07
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