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Approved Drug Products containing Darifenacin Hydrobromide listed in the FDA Orange Book. Original Data : FDA Website

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01 2ABBVIE

02 2ALEMBIC

03 2AUROBINDO PHARMA

04 2CIPLA

05 2ENDO OPERATIONS

06 2JUBILANT GENERICS

07 2MACLEODS PHARMS LTD

08 2POLYGEN PHARMS

09 2TORRENT

10 2XIROMED

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PharmaCompass

01

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Not Confirmed

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Dosage Strength : EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2004-12-22

Application Number : 21513

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Abbvie Company Banner

02

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Luxepack
Not Confirmed

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Dosage Strength : EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2004-12-22

Application Number : 21513

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Abbvie Company Banner

03

Luxepack
Not Confirmed
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Not Confirmed

DARIFENACIN HYDROBROMIDE

Brand Name : DARIFENACIN HYDROBROMIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 7.5MG BASE

Approval Date : 2016-09-19

Application Number : 206743

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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04

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Not Confirmed
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Not Confirmed

DARIFENACIN HYDROBROMIDE

Brand Name : DARIFENACIN HYDROBROMIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 15MG BASE

Approval Date : 2016-09-19

Application Number : 206743

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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05

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

DARIFENACIN HYDROBROMIDE

Brand Name : DARIFENACIN HYDROBROMIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 7.5MG BASE

Approval Date : 2016-10-12

Application Number : 205550

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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06

Luxepack
Not Confirmed
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Not Confirmed

DARIFENACIN HYDROBROMIDE

Brand Name : DARIFENACIN HYDROBROMIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 15MG BASE

Approval Date : 2016-10-12

Application Number : 205550

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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07

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

DARIFENACIN HYDROBROMIDE

Brand Name : DARIFENACIN HYDROBROMIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 7.5MG BASE

Approval Date : 2016-11-17

Application Number : 205209

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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08

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Not Confirmed
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Luxepack
Not Confirmed

DARIFENACIN HYDROBROMIDE

Brand Name : DARIFENACIN HYDROBROMIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 15MG BASE

Approval Date : 2016-11-17

Application Number : 205209

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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09

ENDO OPERATIONS

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Not Confirmed
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ENDO OPERATIONS

Country
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Luxepack
Not Confirmed

DARIFENACIN HYDROBROMIDE

Brand Name : DARIFENACIN HYDROBROMIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 7.5MG BASE

Approval Date : 2015-03-13

Application Number : 91190

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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10

ENDO OPERATIONS

Country
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Not Confirmed
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ENDO OPERATIONS

Country
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Luxepack
Not Confirmed

DARIFENACIN HYDROBROMIDE

Brand Name : DARIFENACIN HYDROBROMIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 15MG BASE

Approval Date : 2015-03-13

Application Number : 91190

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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