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    Approval Date : 2012-01-31

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    Approval Date : 2016-09-28

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    Dosage Form : GRANULE;ORAL

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    Approval Date : 2015-03-17

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    Vertex Pharmaceuticals

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    Dosage Form : GRANULE;ORAL

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    Approval Date : 2015-03-17

    Application Number : 207925

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    Vertex Pharmaceuticals

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    IVACAFTOR

    Brand Name : KALYDECO

    Dosage Form : GRANULE;ORAL

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    Approval Date : 2019-04-29

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    Vertex Pharmaceuticals

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    Brand Name : KALYDECO

    Dosage Form : GRANULE;ORAL

    Dosage Strength : 5.8MG/PACKET

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    Approval Date : 2023-05-03

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    Brand Name : KALYDECO

    Dosage Form : GRANULE;ORAL

    Dosage Strength : 13.4MG/PACKET

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    Approval Date : 2023-05-03

    Application Number : 207925

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    Vertex Pharmaceuticals

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    IVACAFTOR; IVACAFTOR, TEZACAFTOR

    Brand Name : SYMDEKO (COPACKAGED)

    Dosage Form : TABLET;ORAL

    Dosage Strength : 150MG;150MG, 100MG

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    Approval Date : 2018-02-12

    Application Number : 210491

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    14

    Vertex Pharmaceuticals

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    IVACAFTOR; IVACAFTOR, TEZACAFTOR

    Brand Name : SYMDEKO (COPACKAGED)

    Dosage Form : TABLET;ORAL

    Dosage Strength : 75MG;75MG, 50MG

    Packaging :

    Approval Date : 2019-06-21

    Application Number : 210491

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    Vertex Pharmaceuticals

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    Brand Name : ORKAMBI

    Dosage Form : GRANULE;ORAL

    Dosage Strength : 125MG/PACKET;100MG/PACKET

    Packaging :

    Approval Date : 2018-08-07

    Application Number : 211358

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    IVACAFTOR; LUMACAFTOR

    Brand Name : ORKAMBI

    Dosage Form : GRANULE;ORAL

    Dosage Strength : 188MG/PACKET;150MG/PACKET

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    Approval Date : 2018-08-07

    Application Number : 211358

    Regulatory Info : RX

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    17

    Vertex Pharmaceuticals

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    IVACAFTOR; LUMACAFTOR

    Brand Name : ORKAMBI

    Dosage Form : GRANULE;ORAL

    Dosage Strength : 94MG/PACKET;75MG/PACKET

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    Approval Date : 2022-09-02

    Application Number : 211358

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    Vertex Pharmaceuticals

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    ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR

    Brand Name : TRIKAFTA (COPACKAGED)

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG,75MG,50MG; 150MG

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    Approval Date : 2019-10-21

    Application Number : 212273

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    Vertex Pharmaceuticals

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    ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR

    Brand Name : TRIKAFTA (COPACKAGED)

    Dosage Form : TABLET;ORAL

    Dosage Strength : 50MG,37.5MG,25MG; 75MG

    Packaging :

    Approval Date : 2021-06-08

    Application Number : 212273

    Regulatory Info : RX

    Registration Country : USA

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    Vertex Pharmaceuticals

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    ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR

    Brand Name : TRIKAFTA (COPACKAGED)

    Dosage Form : GRANULES;ORAL

    Dosage Strength : 80MG, 60MG, 40MG;59.5MG

    Packaging :

    Approval Date : 2023-04-26

    Application Number : 217660

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    Registration Country : USA

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