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,
14 6Merus Labs Luxco S. à R. L.
15 2PolyGen Pharmaceuticals
16 2SEARCHLIGHT PHARMA INC
17 2Torrent Pharmaceuticals Limited
18 2Xiromed
19 8Blank
01 6Depottablett
02 2ER TABLET
03 8ER Tablet
04 2Extended Release Tablet
05 2PROLONGED-RELEASE TABLET
06 4Ret Tabl
07 2SRT
08 3TAB
09 6TABLET (EXTENDED-RELEASE)
10 20TABLET, EXTENDED RELEASE;ORAL
01 2Countries Registered In: US (Filed 2013)
02 8DISCN
03 2Generic
04 2Generic US CTD
05 3Originator
06 6Prescription
07 12RX
08 6Registered in US
09 2US (Filed 2013)
10 12Blank
01 2APO-DARIFENACIN
02 2DARIFENACIN
03 16DARIFENACIN HYDROBROMIDE
04 4ENABLEX
05 12Emselex
06 1Enablex 15mg
07 2Enablex 7,5mg
08 1Floden CR 15 mg
09 1Floden CR 7.5 mg
10 2JAMP DARIFENACIN
11 12Blank
01 6Canada
02 8India
03 6Norway
04 5South Africa
05 2Sweden
06 4Switzerland
07 20USA
08 2United Kingdom
09 2Blank
Regulatory Info : DISCN
Registration Country : USA
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Dosage Strength : EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2004-12-22
Application Number : 21513
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Enablex 7,5mg
Dosage Form : TAB
Dosage Strength : 7.5mg
Packaging : 28X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : DISCN
Registration Country : USA
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Dosage Strength : EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2004-12-22
Application Number : 21513
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Enablex 7,5mg
Dosage Form : TAB
Dosage Strength : 7.5mg
Packaging : 14X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Enablex 15mg
Dosage Form : TAB
Dosage Strength : 15mg
Packaging : 28X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : RX
Registration Country : USA
Brand Name : DARIFENACIN HYDROBROMIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 7.5MG BASE
Packaging :
Approval Date : 2017-12-08
Application Number : 207681
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DARIFENACIN HYDROBROMIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 15MG BASE
Packaging :
Approval Date : 2017-12-08
Application Number : 207681
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
Brand Name : DARIFENACIN
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 15MG BASE
Packaging :
Approval Date : 2017-07-28
Application Number : 207302
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
Brand Name : DARIFENACIN HYDROBROMIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 15MG BASE
Packaging :
Approval Date : 2016-11-17
Application Number : 205209
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info : DISCN
Registration Country : USA
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : DISCN
Registration Country : USA
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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