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    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 500MCG

    Packaging :

    Approval Date : 2018-08-06

    Application Number : 208272

    Regulatory Info : DISCN

    Registration Country : USA

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    Torrent Pharmaceuticals Limited

    India
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    Torrent Pharmaceuticals Limited

    India
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    Regulatory Info : RX

    Registration Country : USA

    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 250MCG

    Packaging :

    Approval Date : 2024-10-18

    Application Number : 208272

    Regulatory Info : RX

    Registration Country : USA

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    Zydus Pharmaceuticals

    U.S.A
    Cophex
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    Zydus Pharmaceuticals

    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 500MCG

    Packaging :

    Approval Date : 2022-02-10

    Application Number : 208303

    Regulatory Info : RX

    Registration Country : USA

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    29

    Zydus Pharmaceuticals

    U.S.A
    Cophex
    Not Confirmed
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    Zydus Pharmaceuticals

    U.S.A
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    • EDQM
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    Regulatory Info : RX

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    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 250MCG

    Packaging :

    Approval Date : 2023-04-18

    Application Number : 208303

    Regulatory Info : RX

    Registration Country : USA

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    NORVIUM BIOSCIENCE

    Country
    Cophex
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    NORVIUM BIOSCIENCE

    Country
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    Regulatory Info : RX

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    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 500MCG

    Packaging :

    Approval Date : 2018-07-13

    Application Number : 208257

    Regulatory Info : RX

    Registration Country : USA

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