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    Darifenacin Hydrobromide

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    01 2AbbVie Inc

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    AbbVie Inc

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    DARIFENACIN HYDROBROMIDE

    Brand Name : ENABLEX

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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    Approval Date : 2004-12-22

    Application Number : 21513

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    Aspen Pharmacare Holdings

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    Darifenacin Hydrobromide

    Brand Name : Enablex 7,5mg

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    DARIFENACIN HYDROBROMIDE

    Brand Name : ENABLEX

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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    Approval Date : 2004-12-22

    Application Number : 21513

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    Aspen Pharmacare Holdings

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    Darifenacin Hydrobromide

    Brand Name : Enablex 7,5mg

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    Darifenacin Hydrobromide

    Brand Name : Enablex 15mg

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    Alembic Pharmaceuticals Limited

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    DARIFENACIN HYDROBROMIDE

    Brand Name : DARIFENACIN HYDROBROMIDE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 7.5MG BASE

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    Approval Date : 2017-12-08

    Application Number : 207681

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    Alembic Pharmaceuticals Limited

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    Brand Name : DARIFENACIN HYDROBROMIDE

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    Dosage Strength : EQ 15MG BASE

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    Approval Date : 2017-12-08

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    Aurobindo Pharma Limited

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    Brand Name : DARIFENACIN HYDROBROMIDE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 7.5MG BASE

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    Approval Date : 2016-09-19

    Application Number : 206743

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    Registration Country : USA

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    Aurobindo Pharma Limited

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    DARIFENACIN HYDROBROMIDE

    Brand Name : DARIFENACIN HYDROBROMIDE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 15MG BASE

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    Approval Date : 2016-09-19

    Application Number : 206743

    Regulatory Info : RX

    Registration Country : USA

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    10

    Cipla

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    DARIFENACIN HYDROBROMIDE

    Brand Name : DARIFENACIN HYDROBROMIDE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 7.5MG BASE

    Packaging :

    Approval Date : 2016-09-01

    Application Number : 207664

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    Registration Country : USA

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    11

    Cipla

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    DARIFENACIN HYDROBROMIDE

    Brand Name : DARIFENACIN HYDROBROMIDE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 15MG BASE

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    Approval Date : 2016-09-01

    Application Number : 207664

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    12

    Jubilant Generics

    India
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    Jubilant Generics

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    DARIFENACIN HYDROBROMIDE

    Brand Name : DARIFENACIN HYDROBROMIDE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 7.5MG BASE

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    Approval Date : 2016-10-12

    Application Number : 205550

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    Registration Country : USA

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    13

    Jubilant Generics

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    DARIFENACIN HYDROBROMIDE

    Brand Name : DARIFENACIN HYDROBROMIDE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 15MG BASE

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    Approval Date : 2016-10-12

    Application Number : 205550

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    14

    Macleods Pharmaceuticals Limited

    India
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    DARIFENACIN HYDROBROMIDE

    Brand Name : DARIFENACIN

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 7.5MG BASE

    Packaging :

    Approval Date : 2017-07-28

    Application Number : 207302

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    15

    Macleods Pharmaceuticals Limited

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    Brand Name : DARIFENACIN

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 15MG BASE

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    Approval Date : 2017-07-28

    Application Number : 207302

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    16

    Macleods Pharmaceuticals Limited

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    Regulatory Info : Generic US CTD

    Registration Country : United Kingdom

    Darifenacin

    Brand Name :

    Dosage Form : ER TABLET

    Dosage Strength : 7.5MG

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    Application Number : 91190

    Regulatory Info : Generic US CTD

    Registration Country : United Kingdom

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    17

    Macleods Pharmaceuticals Limited

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    Regulatory Info : Generic US CTD

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    Darifenacin

    Brand Name :

    Dosage Form : ER TABLET

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    Application Number : 91190

    Regulatory Info : Generic US CTD

    Registration Country : United Kingdom

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    PolyGen Pharmaceuticals

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    PolyGen Pharmaceuticals

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    DARIFENACIN HYDROBROMIDE

    Brand Name : DARIFENACIN HYDROBROMIDE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 7.5MG BASE

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    Approval Date : 2020-01-06

    Application Number : 211045

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    19

    PolyGen Pharmaceuticals

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    PolyGen Pharmaceuticals

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    DARIFENACIN HYDROBROMIDE

    Brand Name : DARIFENACIN HYDROBROMIDE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 15MG BASE

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    Approval Date : 2020-01-06

    Application Number : 211045

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    20

    Torrent Pharmaceuticals Limited

    India
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    Regulatory Info : RX

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    DARIFENACIN HYDROBROMIDE

    Brand Name : DARIFENACIN HYDROBROMIDE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 7.5MG BASE

    Packaging :

    Approval Date : 2016-11-17

    Application Number : 205209

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    Registration Country : USA

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    21

    Torrent Pharmaceuticals Limited

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    Brand Name : DARIFENACIN HYDROBROMIDE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 15MG BASE

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    Approval Date : 2016-11-17

    Application Number : 205209

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    Registration Country : USA

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    22

    Xiromed

    U.S.A
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    Regulatory Info : DISCN

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    Brand Name : DARIFENACIN HYDROBROMIDE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 15MG BASE

    Packaging :

    Approval Date : 2019-10-22

    Application Number : 209571

    Regulatory Info : DISCN

    Registration Country : USA

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    Xiromed

    U.S.A
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    Xiromed

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    DARIFENACIN HYDROBROMIDE

    Brand Name : DARIFENACIN HYDROBROMIDE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 7.5MG BASE

    Packaging :

    Approval Date : 2019-10-22

    Application Number : 209571

    Regulatory Info : DISCN

    Registration Country : USA

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    ENDO OPERATIONS

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    Pharma, Lab & Chemical Expo
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    ENDO OPERATIONS

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    Regulatory Info : DISCN

    Registration Country : USA

    DARIFENACIN HYDROBROMIDE

    Brand Name : DARIFENACIN HYDROBROMIDE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 7.5MG BASE

    Packaging :

    Approval Date : 2015-03-13

    Application Number : 91190

    Regulatory Info : DISCN

    Registration Country : USA

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    ENDO OPERATIONS

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    Pharma, Lab & Chemical Expo
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    Regulatory Info : DISCN

    Registration Country : USA

    DARIFENACIN HYDROBROMIDE

    Brand Name : DARIFENACIN HYDROBROMIDE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 15MG BASE

    Packaging :

    Approval Date : 2015-03-13

    Application Number : 91190

    Regulatory Info : DISCN

    Registration Country : USA

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    Meru Labs Luxco S.à rl,

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    Regulatory Info :

    Registration Country : Sweden

    darifenacin hydrobromide

    Brand Name : Emselex

    Dosage Form : PROLONGED-RELEASE TABLET

    Dosage Strength : 7.5 MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    Meru Labs Luxco S.à rl,

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    Meru Labs Luxco S.à rl,

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    Regulatory Info :

    Registration Country : Sweden

    darifenacin hydrobromide

    Brand Name : Emselex

    Dosage Form : PROLONGED-RELEASE TABLET

    Dosage Strength : 15MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    Merus Labs Luxco S. à R. L.

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    Regulatory Info :

    Registration Country : Norway

    Darifenacin

    Brand Name : Emselex

    Dosage Form : Depottablett

    Dosage Strength : 15 mg

    Packaging : Blister

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    29

    Merus Labs Luxco S. à R. L.

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    Not Confirmed
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    Merus Labs Luxco S. à R. L.

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    Regulatory Info :

    Registration Country : Norway

    Darifenacin

    Brand Name : Emselex

    Dosage Form : Depottablett

    Dosage Strength : 15 mg

    Packaging : Blister

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    30

    Merus Labs Luxco S. à R. L.

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    Not Confirmed
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    Merus Labs Luxco S. à R. L.

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    Regulatory Info :

    Registration Country : Norway

    Darifenacin

    Brand Name : Emselex

    Dosage Form : Depottablett

    Dosage Strength : 15 mg

    Packaging : Blister

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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