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    Strides Pharma Science

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    CPhI WW Frankfurt
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    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

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    Approval Date : 2020-03-30

    Application Number : 208247

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    Strides Pharma Science

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    CPhI WW Frankfurt
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    ROFLUMILAST

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    Approval Date : 2023-06-20

    Application Number : 208247

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    Strides Pharma Science

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    Roflumilast

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    04

    Alkem Laboratories

    India
    Europ. Pharma Outsourcing
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    Alkem Laboratories

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    Europ. Pharma Outsourcing
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    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

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    Approval Date : 2023-04-18

    Application Number : 212490

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    05

    AstraZeneca

    United Kingdom
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    Europ. Pharma Outsourcing
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    ROFLUMILAST

    Brand Name : DALIRESP

    Dosage Form : TABLET;ORAL

    Dosage Strength : 500MCG

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    Approval Date : 2011-02-28

    Application Number : 22522

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    Registration Country : USA

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    AstraZeneca

    United Kingdom
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    AstraZeneca

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    ROFLUMILAST

    Brand Name : DALIRESP

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    Approval Date : 2018-01-23

    Application Number : 22522

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    07

    Hetero Drugs

    India
    Europ. Pharma Outsourcing
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    Hetero Drugs

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    Europ. Pharma Outsourcing
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    ROFLUMILAST

    Brand Name : ROFLUMILAST

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    Approval Date : 2018-11-23

    Application Number : 208213

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    08

    Hetero Drugs

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    Hetero Drugs

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    Europ. Pharma Outsourcing
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    ROFLUMILAST

    Brand Name : ROFLUMILAST

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    Approval Date : 2023-04-18

    Application Number : 208213

    Regulatory Info : RX

    Registration Country : USA

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    09

    Micro Labs Limited

    India
    Europ. Pharma Outsourcing
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    Micro Labs Limited

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    Europ. Pharma Outsourcing
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    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 500MCG

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    Approval Date : 2019-03-22

    Application Number : 208180

    Regulatory Info : RX

    Registration Country : USA

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    10

    Micro Labs Limited

    India
    Europ. Pharma Outsourcing
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    Micro Labs Limited

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    Europ. Pharma Outsourcing
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    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 250MCG

    Packaging :

    Approval Date : 2023-04-18

    Application Number : 208180

    Regulatory Info : RX

    Registration Country : USA

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    11

    MSN Laboratories

    India
    Europ. Pharma Outsourcing
    Not Confirmed
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    MSN Laboratories

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    Europ. Pharma Outsourcing
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    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 250MCG

    Packaging :

    Approval Date : 2022-09-07

    Application Number : 208256

    Regulatory Info : RX

    Registration Country : USA

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    12

    MSN Laboratories

    India
    Europ. Pharma Outsourcing
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    MSN Laboratories

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    Europ. Pharma Outsourcing
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    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 500MCG

    Packaging :

    Approval Date : 2022-09-07

    Application Number : 208256

    Regulatory Info : RX

    Registration Country : USA

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    13

    Norvium

    U.S.A
    Europ. Pharma Outsourcing
    Not Confirmed
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    Norvium

    U.S.A
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    Europ. Pharma Outsourcing
    Not Confirmed
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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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    14

    Prinston

    U.S.A
    Europ. Pharma Outsourcing
    Not Confirmed
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    Prinston

    U.S.A
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    Europ. Pharma Outsourcing
    Not Confirmed
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    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 500MCG

    Packaging :

    Approval Date : 2022-05-10

    Application Number : 208299

    Regulatory Info : RX

    Registration Country : USA

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    15

    Senores Pharmaceuticals

    India
    Europ. Pharma Outsourcing
    Not Confirmed
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    Senores Pharmaceuticals

    India
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    Europ. Pharma Outsourcing
    Not Confirmed
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    Regulatory Info : DISCN

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    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 500MCG

    Packaging :

    Approval Date : 2018-10-03

    Application Number : 208236

    Regulatory Info : DISCN

    Registration Country : USA

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    16

    Senores Pharmaceuticals

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    Europ. Pharma Outsourcing
    Not Confirmed
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    Senores Pharmaceuticals

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    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 250MCG

    Packaging :

    Approval Date : 2023-10-19

    Application Number : 208236

    Regulatory Info : DISCN

    Registration Country : USA

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    17

    Torrent Pharmaceuticals Limited

    India
    Europ. Pharma Outsourcing
    Not Confirmed
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    Torrent Pharmaceuticals Limited

    India
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    Europ. Pharma Outsourcing
    Not Confirmed
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    ROFLUMILAST

    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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    18

    Torrent Pharmaceuticals Limited

    India
    Europ. Pharma Outsourcing
    Not Confirmed
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    Torrent Pharmaceuticals Limited

    India
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    Europ. Pharma Outsourcing
    Not Confirmed
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    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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    19

    Zydus Pharmaceuticals

    U.S.A
    Europ. Pharma Outsourcing
    Not Confirmed
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    Zydus Pharmaceuticals

    U.S.A
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    Europ. Pharma Outsourcing
    Not Confirmed
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    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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    20

    Zydus Pharmaceuticals

    U.S.A
    Europ. Pharma Outsourcing
    Not Confirmed
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    Zydus Pharmaceuticals

    U.S.A
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    Europ. Pharma Outsourcing
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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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