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    BRECKENRIDGE

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    RLD : No

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    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 500MCG

    Approval Date : 2018-10-03

    Application Number : 208236

    RX/OTC/DISCN : DISCN

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    Breckenridge Pharmaceutical

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    STRIDES PHARMA

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    RLD : No

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    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 500MCG

    Approval Date : 2020-03-30

    Application Number : 208247

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    RLD : No

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    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 250MCG

    Approval Date : 2023-10-19

    Application Number : 208236

    RX/OTC/DISCN : DISCN

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    Breckenridge Pharmaceutical

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    STRIDES PHARMA

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    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 250MCG

    Approval Date : 2023-06-20

    Application Number : 208247

    RX/OTC/DISCN : RX

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    RLD : Yes

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    ROFLUMILAST

    Brand Name : DALIRESP

    Dosage Form : TABLET;ORAL

    Dosage Strength : 500MCG

    Approval Date : 2011-02-28

    Application Number : 22522

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    ASTRAZENECA

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    RLD : Yes

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    ROFLUMILAST

    Brand Name : DALIRESP

    Dosage Form : TABLET;ORAL

    Dosage Strength : 250MCG

    Approval Date : 2018-01-23

    Application Number : 22522

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    HETERO LABS LTD III

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    RLD : No

    TE Code : AB

    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 500MCG

    Approval Date : 2018-11-23

    Application Number : 208213

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    RLD : No

    TE Code : AB

    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 250MCG

    Approval Date : 2023-04-18

    Application Number : 208213

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    MICRO LABS

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    RLD : No

    TE Code : AB

    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 500MCG

    Approval Date : 2019-03-22

    Application Number : 208180

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    MICRO LABS

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    RLD : No

    TE Code : AB

    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 250MCG

    Approval Date : 2023-04-18

    Application Number : 208180

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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