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    Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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    Darifenacin Hydrobromide

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    01 2AbbVie Inc

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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    Dosage Strength : EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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    Dosage Strength : EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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    04

    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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    Registration Country : South Africa

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    Aspen Pharmacare Holdings

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    Darifenacin Hydrobromide

    Brand Name : Enablex 15mg

    Dosage Form : TAB

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    Packaging : 28X1mg

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    06

    Alembic Pharmaceuticals Limited

    India
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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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    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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    08

    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

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    Approval Date : 2016-09-19

    Application Number : 206743

    Regulatory Info : RX

    Registration Country : USA

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    09

    Aurobindo Pharma Limited

    India
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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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    Brand Name : DARIFENACIN HYDROBROMIDE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 7.5MG BASE

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    Approval Date : 2016-09-01

    Application Number : 207664

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    Registration Country : USA

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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

    Regulatory Info : RX

    Registration Country : USA

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    12

    Jubilant Generics

    India
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    Jubilant Generics

    India
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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

    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

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    Registration Country : USA

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    14

    Macleods Pharmaceuticals Limited

    India
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    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

    Regulatory Info : RX

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    16

    Torrent Pharmaceuticals Limited

    India
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    Torrent Pharmaceuticals 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 : 2016-11-17

    Application Number : 205209

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    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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    18

    Xiromed

    U.S.A
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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 : 2019-10-22

    Application Number : 209571

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    Registration Country : USA

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    PH HEALTH

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    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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    PH HEALTH

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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 : 2015-03-13

    Application Number : 91190

    Regulatory Info : DISCN

    Registration Country : USA

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