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
01 20TABLET, EXTENDED RELEASE;ORAL
01 8DISCN
02 12RX
01 2DARIFENACIN
02 16DARIFENACIN HYDROBROMIDE
03 2ENABLEX
01 18No
02 2Yes
RLD : Yes
TE Code :
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Dosage Strength : EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 :
RLD : Yes
TE Code :
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Dosage Strength : EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 :
RLD : No
TE Code : AB
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
RLD : No
TE Code : AB
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
RLD : No
TE Code :
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 :
RLD : No
TE Code :
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 :
RLD : No
TE Code :
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 :
RLD : No
TE Code :
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 :
RLD : No
TE Code : AB
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
RLD : No
TE Code : AB
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
