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    Breckenridge Gets FDA Nod For Everolimus Oral Suspension

    29 Jan 2025

    // PR NEWSWIRE

    Enforcement Report - Week of January 1, 2025

    01 Jan 2025

    // FDA

    Breckenridge Receives FDA Approval for Methadone HCl Injection

    18 Dec 2024

    // PR NEWSWIRE

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    01 2ACETAZOLAMIDE

    02 6AMITRIPTYLINE HYDROCHLORIDE

    03 2APIXABAN

    04 3ASENAPINE MALEATE

    05 2BENDAMUSTINE HYDROCHLORIDE

    06 1BRETYLIUM TOSYLATE

    07 1CABAZITAXEL

    08 2CARFILZOMIB

    09 3DABIGATRAN ETEXILATE MESYLATE

    10 4DULOXETINE HYDROCHLORIDE

    11 2ENTECAVIR

    12 2EPLERENONE

    13 2ESTRADIOL; NORETHINDRONE ACETATE

    14 7EVEROLIMUS

    15 1EXEMESTANE

    16 4FLUPHENAZINE HYDROCHLORIDE

    17 1LAMIVUDINE

    18 1METHADONE HYDROCHLORIDE

    19 2METHSCOPOLAMINE BROMIDE

    20 1METHYLERGONOVINE MALEATE

    21 1MONTELUKAST SODIUM

    22 1NOREPINEPHRINE BITARTRATE

    23 3OMEPRAZOLE

    24 3OXCARBAZEPINE

    25 1PENICILLAMINE

    26 2PIROXICAM

    27 1POLYETHYLENE GLYCOL 3350

    28 4POMALIDOMIDE

    29 2POTASSIUM CHLORIDE

    30 3RIVAROXABAN

    31 3RIVASTIGMINE

    32 2SOLIFENACIN SUCCINATE

    33 1SUCCINYLCHOLINE CHLORIDE

    34 1TERBINAFINE HYDROCHLORIDE

    35 2TERIFLUNOMIDE

    36 2TETRACYCLINE HYDROCHLORIDE

    37 1TOFACITINIB

    38 2TRIAZOLAM

    39 3TRIMIPRAMINE MALEATE

    40 1ZOLEDRONIC ACID

    41 2ZOLPIDEM TARTRATE

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    01

    Brand Name : ACETAZOLAMIDE

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    ACETAZOLAMIDE

    Breckenridge Pharmaceutical

    Dosage Form : TABLET;ORAL

    Brand Name : ACETAZOLAMIDE

    Dosage Strength : 125MG

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    Approval Date : 2020-04-30

    Application Number : 207503

    Regulatory Info : DISCN

    Registration Country : USA

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    ACETAZOLAMIDE

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    Dosage Form : TABLET;ORAL

    Brand Name : ACETAZOLAMIDE

    Dosage Strength : 250MG

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    Approval Date : 2020-04-30

    Application Number : 207503

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    03

    Brand Name : AMITRIPTYLINE HYDROC...

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    AMITRIPTYLINE HYDROCHLORIDE

    Breckenridge Pharmaceutical

    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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    Brand Name : AMITRIPTYLINE HYDROCHLORI...

    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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    Approval Date : 2022-06-06

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    Dosage Form : TABLET;ORAL

    Brand Name : AMITRIPTYLINE HYDROCHLORI...

    Dosage Strength : 75MG

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    Approval Date : 2022-06-06

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    Dosage Form : TABLET;ORAL

    Brand Name : AMITRIPTYLINE HYDROCHLORI...

    Dosage Strength : 100MG

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    Approval Date : 2022-06-06

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    Dosage Form : TABLET;ORAL

    Brand Name : AMITRIPTYLINE HYDROCHLORI...

    Dosage Strength : 150MG

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    Approval Date : 2022-06-06

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    Brand Name : APIXABAN

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    APIXABAN

    Breckenridge Pharmaceutical

    Dosage Form : TABLET;ORAL

    Brand Name : APIXABAN

    Dosage Strength : 2.5MG

    Packaging :

    Approval Date : 2021-07-26

    Application Number : 209845

    Regulatory Info : DISCN

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    APIXABAN

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    Dosage Form : TABLET;ORAL

    Brand Name : APIXABAN

    Dosage Strength : 5MG

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    Approval Date : 2021-07-26

    Application Number : 209845

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