Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207302
Company: MACLEODS PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DARIFENACIN DARIFENACIN HYDROBROMIDE EQ 7.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
DARIFENACIN DARIFENACIN HYDROBROMIDE EQ 15MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/28/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

DARIFENACIN

TABLET, EXTENDED RELEASE;ORAL; EQ 7.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DARIFENACIN DARIFENACIN HYDROBROMIDE EQ 7.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207302 MACLEODS PHARMS LTD
DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE EQ 7.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209571 ALAN LABS INC
DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE EQ 7.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207681 ALEMBIC PHARMS LTD
DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE EQ 7.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091190 ANCHEN PHARMS
DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE EQ 7.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206743 AUROBINDO PHARMA LTD
DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE EQ 7.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207664 CIPLA
DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE EQ 7.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205550 JUBILANT GENERICS
DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE EQ 7.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205209 TORRENT
ENABLEX DARIFENACIN HYDROBROMIDE EQ 7.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021513 APIL

TABLET, EXTENDED RELEASE;ORAL; EQ 15MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DARIFENACIN DARIFENACIN HYDROBROMIDE EQ 15MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207302 MACLEODS PHARMS LTD
DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE EQ 15MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209571 ALAN LABS INC
DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE EQ 15MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207681 ALEMBIC PHARMS LTD
DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE EQ 15MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091190 ANCHEN PHARMS
DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE EQ 15MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206743 AUROBINDO PHARMA LTD
DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE EQ 15MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207664 CIPLA
DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE EQ 15MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205550 JUBILANT GENERICS
DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE EQ 15MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205209 TORRENT
ENABLEX DARIFENACIN HYDROBROMIDE EQ 15MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021513 APIL

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