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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Amphastar Pharmaceuticals

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    Amphastar Pharmaceuticals
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    11570 6th Street, Rancho Cucamonga, California 91730
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    1-800-423-4136
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    Arginine Vasopressin

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    USDMF

    Found USDMF

    32769
    Active
    VASOPRESSIN USP
    2018-05-05
    CEP/COS

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    Application Number
    32769
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    VASOPRESSIN USP
    Issue/Submission Date
    2018-05-05
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    Beclomethasone Dipropionate

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    USDMF

    Found USDMF

    27837
    Active
    BECLOMETHASONE DIPROPIONATE
    2014-03-06
    CEP/COS

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    Application Number
    27837
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BECLOMETHASONE DIPROPIONATE
    Issue/Submission Date
    2014-03-06
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    Budesonide

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    USDMF

    Found USDMF

    33714
    Active
    BUDESONIDE USP
    2019-08-22
    CEP/COS

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    Application Number
    33714
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BUDESONIDE USP
    Issue/Submission Date
    2019-08-22
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    Epinephrine

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    USDMF

    Found USDMF

    33036
    Active
    EPINEPHRINE USP
    2018-08-08
    CEP/COS

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    Application Number
    33036
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    EPINEPHRINE USP
    Issue/Submission Date
    2018-08-08
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    Fluticasone Propionate

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    USDMF

    Found USDMF

    29454
    Active
    FLUTICASONE PROPIONATE, USP
    2015-06-29
    CEP/COS

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    Application Number
    29454
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FLUTICASONE PROPIONATE, USP
    Issue/Submission Date
    2015-06-29
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    Formoterol Fumarate

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    USDMF

    Found USDMF

    33913
    Active
    FORMOTEROL FUMARATE USP
    2019-08-09
    CEP/COS

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    Application Number
    33913
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FORMOTEROL FUMARATE USP
    Issue/Submission Date
    2019-08-09
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    Heparin Sodium

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    USDMF

    Found USDMF

    26059
    Active
    SEMI-PURIFIED HEPARIN SODIUM
    2012-05-25
    CEP/COS

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    Japanese DMF

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    Application Number
    26059
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SEMI-PURIFIED HEPARIN SODIUM
    Issue/Submission Date
    2012-05-25
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    Heparin Sodium

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    USDMF

    Found USDMF

    26070
    Active
    HEPARIN SODIUM USP
    2012-06-15
    CEP/COS

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    Application Number
    26070
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    HEPARIN SODIUM USP
    Issue/Submission Date
    2012-06-15
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    Insulin (Human) Recombinant

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    USDMF

    Found USDMF

    15262
    Active
    RECOMBINANT HUMAN INSULIN
    2001-02-05
    CEP/COS

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    Application Number
    15262
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    RECOMBINANT HUMAN INSULIN
    Issue/Submission Date
    2001-02-05
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    Insulin aspart

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    USDMF

    Found USDMF

    32700
    Active
    INSULIN ASPART USP
    2018-05-16
    CEP/COS

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    Application Number
    32700
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    INSULIN ASPART USP
    Issue/Submission Date
    2018-05-16
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    Ipratropium Bromide

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    USDMF

    Found USDMF

    31036
    Active
    IPRATROPIUM BROMIDE USP
    2017-11-28
    CEP/COS

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    Application Number
    31036
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    IPRATROPIUM BROMIDE USP
    Issue/Submission Date
    2017-11-28
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    Isoproterenol Hydrochloride

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    USDMF

    Found USDMF

    29876
    Active
    ISOPROTERENOL HYDROCHLORIDE USP
    2015-11-09
    CEP/COS

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    Application Number
    29876
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ISOPROTERENOL HYDROCHLORIDE USP
    Issue/Submission Date
    2015-11-09
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    Liraglutide

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    USDMF

    Found USDMF

    33912
    Active
    LIRAGLUTIDE
    2019-06-30
    CEP/COS

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    Application Number
    33912
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LIRAGLUTIDE
    Issue/Submission Date
    2019-06-30
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    Medroxyprogesterone Acetate

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    USDMF

    Found USDMF

    32282
    Active
    MEDROXYPROGESTERONE ACETATE, USP
    2018-02-08
    CEP/COS

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    Application Number
    32282
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MEDROXYPROGESTERONE ACETATE, USP
    Issue/Submission Date
    2018-02-08
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    Protamine Sulfate

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    USDMF

    Found USDMF

    30429
    Active
    PROTAMINE SULFATE USP
    2016-09-16
    CEP/COS

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    Application Number
    30429
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PROTAMINE SULFATE USP
    Issue/Submission Date
    2016-09-16
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    Salmeterol Xinafoate

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    USDMF

    Found USDMF

    29491
    Active
    SALMETEROL XINAFOATE, USP
    2015-08-11
    CEP/COS

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    Application Number
    29491
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SALMETEROL XINAFOATE, USP
    Issue/Submission Date
    2015-08-11
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    Sodium Nitroprusside

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    USDMF

    Found USDMF

    29871
    Active
    SODIUM NITROPRUSSIDE USP
    2015-11-03
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    29871
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SODIUM NITROPRUSSIDE USP
    Issue/Submission Date
    2015-11-03
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    Teriparatide

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    USDMF

    Found USDMF

    33857
    Active
    TERIPARATIDE USP
    2019-05-19
    CEP/COS

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    Application Number
    33857
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TERIPARATIDE USP
    Issue/Submission Date
    2019-05-19
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    Vitamin K1

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    USDMF

    Found USDMF

    37953
    Active
    PHYTONADIONE USP
    2023-09-30
    CEP/COS

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    Written Confirmation

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    Application Number
    37953
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PHYTONADIONE USP
    Issue/Submission Date
    2023-09-30
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    • FDA
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    Salbutamol Sulphate

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    USDMF

    Caution USDMF

    31034
    Inactive
    ALBUTEROL USP
    2016-12-01
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    31034
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ALBUTEROL USP
    Issue/Submission Date
    2016-12-01
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    Sodium Nitrite

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    USDMF

    Caution USDMF

    19016
    Inactive
    SODIUM NITRITE INJECTION USP, 30 MG...
    2005-12-06
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    19016
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    SODIUM NITRITE INJECTION USP, 30 MG...
    Issue/Submission Date
    2005-12-06
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    • FDA
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    BIOPIK

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    USDMF

    Caution USDMF

    21607
    Inactive
    BIOPIK
    2008-06-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    21607
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    BIOPIK
    Issue/Submission Date
    2008-06-16
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