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    01 Angiotensin II (1)

    02 Arginine Vasopressin (1)

    03 Atosiban (1)

    04 Buserelin Acetate (1)

    05 Calcitonin (1)

    06 Carbetocin Acetate (1)

    07 Cetrorelix Acetate (1)

    08 Corticotropin (1)

    09 Desmopressin Acetate (1)

    10 Exenatide (1)

    11 Ganirelix (1)

    12 Glucagon (1)

    13 Gonadorelin (1)

    14 Gonadorelin Acetate (1)

    15 Goserelin Acetate (1)

    16 Icatibant Acetate (1)

    17 Lanreotide Acetate (1)

    18 Leuprolide Acetate (2)

    19 Linaclotide (1)

    20 Lypressin (1)

    21 Natrecor (1)

    22 Octreotide Acetate (1)

    23 Pasireotide Diaspartate (1)

    24 Pramlintide (1)

    25 Secretin (1)

    26 Somatostatin (1)

    27 Teriparatide Acetate (1)

    28 Terlipressin Acetate (1)

    29 Tetracosactide (1)

    30 Thymalfasin (1)

    31 Thyrotropin-Releasing Hormone (1)

    32 Triptorelin Pamoate (1)

    33 Vapreotide (1)

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    01 Active (12)

    02 Blank (22)

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    01 Valid (7)

    02 Blank (27)

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    01 222MF10242 (1)

    02 223MF10073 (1)

    03 302MF10043 (1)

    04 305MF10023 (1)

    05 305MF10126 (1)

    06 Blank (29)

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    01 Blank (34)

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    • FDA
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    Calcitonin

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    USDMF

    Found USDMF

    19579
    Active
    SALMON CALCITONIN
    2006-07-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-226 - Rev 01
    Valid
    Calcitonin (salmon), Sterile - Synt...
    2009-02-09
    Japanese DMF

    Found JDMF

    223MF10073
    Elcatonin at Poligono industrial El...
    2011-05-27
    Written Confirmation

    Close WC

    Application Number
    19579
    R1-CEP 2001-226 - Rev 01
    223MF10073
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SALMON CALCITONIN
    Calcitonin (salmon), Sterile - Synt...
    Elcatonin at Poligono industrial El...
    Issue/Submission Date
    2006-07-05
    2009-02-09
    2011-05-27
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    Leuprolide Acetate

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    USDMF

    Found USDMF

    26716
    Active
    LEUPROLIDE (LEUPRORELIN)
    2012-12-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-078 - Rev 04
    Valid
    Leuprorelin, sterile
    2017-04-19
    Japanese DMF

    Found JDMF

    302MF10043
    Leuprorelin Acetate at Poligono ind...
    2020-04-02
    Written Confirmation

    Close WC

    Application Number
    26716
    R1-CEP 2000-078 - Rev 04
    302MF10043
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LEUPROLIDE (LEUPRORELIN)
    Leuprorelin, sterile
    Leuprorelin Acetate at Poligono ind...
    Issue/Submission Date
    2012-12-11
    2017-04-19
    2020-04-02
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    Buserelin Acetate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2007-034 - Rev 02
    Valid
    Buserelin
    2015-12-21
    Japanese DMF

    Found JDMF

    305MF10126
    Buserelin at Poligono industrial El...
    2023-11-29
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2007-034 - Rev 02
    305MF10126
    Status
    Valid
     
    Filing Details
    Buserelin
    Buserelin at Poligono industrial El...
    Issue/Submission Date
    2015-12-21
    2023-11-29
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    Desmopressin Acetate

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    USDMF

    Found USDMF

    19334
    Active
    DESMOPRESSIN ACETATE
    2006-04-06
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-058 - Rev 02
    Valid
    Desmopressin
    2008-09-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19334
    R1-CEP 2002-058 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DESMOPRESSIN ACETATE
    Desmopressin
    Issue/Submission Date
    2006-04-06
    2008-09-02
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    Tetracosactide

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    USDMF

    Found USDMF

    18963
    Active
    TETRACOSACTIDE
    2005-11-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10242
    Tetracosactide at Poligono industri...
    2010-10-13
    Written Confirmation

    Close WC

    Application Number
    18963
    222MF10242
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TETRACOSACTIDE
    Tetracosactide at Poligono industri...
    Issue/Submission Date
    2005-11-18
    2010-10-13
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    Angiotensin II

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    USDMF

    Found USDMF

    36370
    Active
    ANGIOTENSIN II
    2021-10-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36370
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ANGIOTENSIN II
    Issue/Submission Date
    2021-10-04
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    Arginine Vasopressin

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    USDMF

    Found USDMF

    25736
    Active
    VASOPRESSIN
    2012-01-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25736
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    VASOPRESSIN
    Issue/Submission Date
    2012-01-24
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    Cetrorelix Acetate

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    USDMF

    Found USDMF

    38264
    Active
    CETRORELIX
    2023-03-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38264
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CETRORELIX
    Issue/Submission Date
    2023-03-31
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    Ganirelix

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    USDMF

    Found USDMF

    29585
    Active
    GANIRELIX ACETATE
    2015-07-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    29585
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    GANIRELIX ACETATE
    Issue/Submission Date
    2015-07-24
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    Gonadorelin Acetate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10023
    Gonadorelin Diacetate at Poligono i...
    2023-02-08
    Written Confirmation

    Close WC

    Application Number
    305MF10023
    Status
     
    Filing Details
    Gonadorelin Diacetate at Poligono i...
    Issue/Submission Date
    2023-02-08
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