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    01 1AMNEAL PHARMS

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    01

    AMNEAL PHARMS

    U.S.A
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    AMNEAL PHARMS

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    RLD :

    TE Code :

    SODIUM OXYBATE

    Brand Name : SODIUM OXYBATE

    Dosage Form : SOLUTION;ORAL

    Dosage Strength : 500MG/ML

    Approval Date :

    Application Number : 203631

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    02

    AVADEL CNS

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    RLD : Yes

    TE Code :

    SODIUM OXYBATE

    Brand Name : LUMRYZ

    Dosage Form : FOR SUSPENSION, EXTENDED RELEASE;ORAL

    Dosage Strength : 4.5GM/PACKET

    Approval Date : 2023-05-01

    Application Number : 214755

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    03

    AVADEL CNS

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    RLD : Yes

    TE Code :

    SODIUM OXYBATE

    Brand Name : LUMRYZ

    Dosage Form : FOR SUSPENSION, EXTENDED RELEASE;ORAL

    Dosage Strength : 6GM/PACKET

    Approval Date : 2023-05-01

    Application Number : 214755

    RX/OTC/DISCN : RX

    RLD : Yes

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    04

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    RLD : Yes

    TE Code :

    SODIUM OXYBATE

    Brand Name : LUMRYZ

    Dosage Form : FOR SUSPENSION, EXTENDED RELEASE;ORAL

    Dosage Strength : 7.5GM/PACKET

    Approval Date : 2023-05-01

    Application Number : 214755

    RX/OTC/DISCN : RX

    RLD : Yes

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    05

    AVADEL CNS

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    RLD : Yes

    TE Code :

    SODIUM OXYBATE

    Brand Name : LUMRYZ

    Dosage Form : FOR SUSPENSION, EXTENDED RELEASE;ORAL

    Dosage Strength : 9GM/PACKET

    Approval Date : 2023-05-01

    Application Number : 214755

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    06

    HIKMA

    United Kingdom
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    RLD : No

    TE Code :

    SODIUM OXYBATE

    Brand Name : SODIUM OXYBATE

    Dosage Form : SOLUTION;ORAL

    Dosage Strength : 0.5GM/ML

    Approval Date : 2017-01-17

    Application Number : 202090

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    07

    JAZZ PHARMS

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    RLD : Yes

    TE Code :

    SODIUM OXYBATE

    Brand Name : XYREM

    Dosage Form : SOLUTION;ORAL

    Dosage Strength : 0.5GM/ML

    Approval Date : 2002-07-17

    Application Number : 21196

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    08

    JAZZ

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    RLD : Yes

    TE Code :

    CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE

    Brand Name : XYWAV

    Dosage Form : SOLUTION;ORAL

    Dosage Strength : 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML

    Approval Date : 2020-07-21

    Application Number : 212690

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    09

    OHM LABS INC

    India
    Pharmtech & Ingredients
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    OHM LABS INC

    India
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    RLD :

    TE Code :

    SODIUM OXYBATE

    Brand Name : SODIUM OXYBATE

    Dosage Form : SOLUTION;ORAL

    Dosage Strength : 500MG/ML

    Approval Date :

    Application Number : 203351

    RX/OTC/DISCN :

    RLD :

    TE Code :

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