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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205209
Company: TORRENT

Products on ANDA 205209

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DARIFENACIN HYDROBROMIDE	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
DARIFENACIN HYDROBROMIDE	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205209

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/17/2016	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 205209

DARIFENACIN HYDROBROMIDE

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	207681	ALEMBIC
DARIFENACIN HYDROBROMIDE	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	206743	AUROBINDO PHARMA
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	211045	POLYGEN PHARMS
DARIFENACIN HYDROBROMIDE	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205209	TORRENT

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	207681	ALEMBIC
DARIFENACIN HYDROBROMIDE	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	206743	AUROBINDO PHARMA
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	211045	POLYGEN PHARMS
DARIFENACIN HYDROBROMIDE	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205209	TORRENT

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