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    Darifenacin Hydrobromide

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    01 2AbbVie Inc

    02 3Aspen Pharmacare Holdings

    03 2Alembic Pharmaceuticals Limited

    04 2Apotex Inc

    05 2Aurobindo Pharma Limited

    06 4CPS Cito Pharma Services GmbH

    07 2Cipla

    08 2ENDO OPERATIONS

    09 2Inventia Healthcare Limited

    10 2JAMP PHARMA

    11 2Jubilant Generics

    12 6Macleods Pharmaceuticals Limited

    13 2Meru Labs Luxco S.à rl,

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    01

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    Dosage Strength : EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

    Regulatory Info : DISCN

    Registration Country : USA

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    Aspen Pharmacare Holdings

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    Darifenacin Hydrobromide

    Brand Name : Enablex 7,5mg

    Dosage Form : TAB

    Dosage Strength : 7.5mg

    Packaging : 28X1mg

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    03

    AbbVie Inc

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    Dosage Strength : EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

    Regulatory Info : DISCN

    Registration Country : USA

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    Aspen Pharmacare Holdings

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    Darifenacin Hydrobromide

    Brand Name : Enablex 7,5mg

    Dosage Form : TAB

    Dosage Strength : 7.5mg

    Packaging : 14X1mg

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    Aspen Pharmacare Holdings

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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

    Regulatory Info : RX

    Registration Country : USA

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    07

    Alembic Pharmaceuticals 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 : 2017-12-08

    Application Number : 207681

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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 7.5MG BASE

    Packaging :

    Approval Date : 2016-09-19

    Application Number : 206743

    Regulatory Info : RX

    Registration Country : USA

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    09

    Aurobindo Pharma Limited

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    DARIFENACIN HYDROBROMIDE

    Brand Name : DARIFENACIN HYDROBROMIDE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 15MG BASE

    Packaging :

    Approval Date : 2016-09-19

    Application Number : 206743

    Regulatory Info : RX

    Registration Country : USA

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    10

    Cipla

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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 : 2016-09-01

    Application Number : 207664

    Regulatory Info : RX

    Registration Country : USA

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    11

    Cipla

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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 15MG BASE

    Packaging :

    Approval Date : 2016-09-01

    Application Number : 207664

    Regulatory Info : RX

    Registration Country : USA

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    12

    Jubilant Generics

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    Jubilant Generics

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    Regulatory Info : DISCN

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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 : 2016-10-12

    Application Number : 205550

    Regulatory Info : DISCN

    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

    Packaging :

    Approval Date : 2016-10-12

    Application Number : 205550

    Regulatory Info : DISCN

    Registration Country : USA

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    14

    Macleods Pharmaceuticals Limited

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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

    Regulatory Info : RX

    Registration Country : USA

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    15

    Macleods Pharmaceuticals Limited

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    DARIFENACIN HYDROBROMIDE

    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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    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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    Approval Date :

    Application Number : 91190

    Regulatory Info : Generic US CTD

    Registration Country : United Kingdom

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    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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    DARIFENACIN HYDROBROMIDE

    Brand Name : DARIFENACIN HYDROBROMIDE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 7.5MG BASE

    Packaging :

    Approval Date : 2020-01-06

    Application Number : 211045

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    Registration Country : USA

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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

    Regulatory Info : RX

    Registration Country : USA

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    Torrent Pharmaceuticals Limited

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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

    Regulatory Info : RX

    Registration Country : USA

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    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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    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

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    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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    Regulatory Info : DISCN

    Registration Country : USA

    DARIFENACIN HYDROBROMIDE

    Brand Name : DARIFENACIN HYDROBROMIDE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 7.5MG BASE

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    Approval Date : 2015-03-13

    Application Number : 91190

    Regulatory Info : DISCN

    Registration Country : USA

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    ENDO OPERATIONS

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    Regulatory Info : DISCN

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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 : 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

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    Regulatory Info :

    Registration Country : Sweden

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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

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    Approval Date :

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    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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    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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    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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