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    Enforcement Report - Week of January 1, 2025

    01 Jan 2025

    // FDA

    Breckenridge Receives FDA Approval for Methadone HCl Injection

    18 Dec 2024

    // PR NEWSWIRE

    Enforcement Report - Week of June 26, 2024

    26 Jun 2024

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    01 2ACETAZOLAMIDE

    02 6AMITRIPTYLINE HYDROCHLORIDE

    03 2APIXABAN

    04 6ARIPIPRAZOLE

    05 3ASENAPINE MALEATE

    06 2BENDAMUSTINE HYDROCHLORIDE

    07 1BRETYLIUM TOSYLATE

    08 1CABAZITAXEL

    09 2CARFILZOMIB

    10 2DABIGATRAN ETEXILATE MESYLATE

    11 4DULOXETINE HYDROCHLORIDE

    12 2ENTECAVIR

    13 1EPINASTINE HYDROCHLORIDE

    14 2EPLERENONE

    15 2ESTRADIOL; NORETHINDRONE ACETATE

    16 7EVEROLIMUS

    17 1EXEMESTANE

    18 1LAMIVUDINE

    19 2METHSCOPOLAMINE BROMIDE

    20 1METHYLERGONOVINE MALEATE

    21 1MIGLUSTAT

    22 1MONTELUKAST SODIUM

    23 1NOREPINEPHRINE BITARTRATE

    24 3OMEPRAZOLE

    25 3OXCARBAZEPINE

    26 1PENICILLAMINE

    27 2PIROXICAM

    28 1POLYETHYLENE GLYCOL 3350

    29 4POMALIDOMIDE

    30 2POTASSIUM CHLORIDE

    31 3RIVASTIGMINE

    32 2ROFLUMILAST

    33 2SOLIFENACIN SUCCINATE

    34 1SUCCINYLCHOLINE CHLORIDE

    35 1TERBINAFINE HYDROCHLORIDE

    36 2TERIFLUNOMIDE

    37 2TETRACYCLINE HYDROCHLORIDE

    38 1TOFACITINIB

    39 3TRIMIPRAMINE MALEATE

    40 1ZOLEDRONIC ACID

    41 2ZOLPIDEM TARTRATE

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    01

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    ACETAZOLAMIDE

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    Dosage Form : TABLET;ORAL

    Brand Name : ACETAZOLAMIDE

    Dosage Strength : 125MG

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    Approval Date : 2020-04-30

    Application Number : 207503

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    Dosage Form : TABLET;ORAL

    Brand Name : ACETAZOLAMIDE

    Dosage Strength : 250MG

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    Approval Date : 2020-04-30

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    Dosage Form : TABLET;ORAL

    Brand Name : AMITRIPTYLINE HYDROCHLORI...

    Dosage Strength : 10MG

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    Approval Date : 2022-06-06

    Application Number : 216243

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    Dosage Strength : 25MG

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    Approval Date : 2022-06-06

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    Dosage Form : TABLET;ORAL

    Brand Name : AMITRIPTYLINE HYDROCHLORI...

    Dosage Strength : 50MG

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    Brand Name : AMITRIPTYLINE HYDROCHLORI...

    Dosage Strength : 75MG

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    Approval Date : 2022-06-06

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    Dosage Strength : 100MG

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    Dosage Strength : 150MG

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    APIXABAN

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    Dosage Form : TABLET;ORAL

    Brand Name : APIXABAN

    Dosage Strength : 2.5MG

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    Approval Date : 2021-07-26

    Application Number : 209845

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    Brand Name : APIXABAN

    Dosage Strength : 5MG

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    Approval Date : 2021-07-26

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