Details for New Drug Application (NDA): 206743

NDA 206743 describes DARIFENACIN HYDROBROMIDE, which is a drug marketed by Alembic, Aurobindo Pharma, Cipla, Endo Operations, Jubilant Generics, Polygen Pharms, Torrent, and Xiromed, and is included in eight NDAs. It is available from eight suppliers. Additional details are available on the DARIFENACIN HYDROBROMIDE profile page.

The generic ingredient in DARIFENACIN HYDROBROMIDE is darifenacin hydrobromide. There are nineteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the darifenacin hydrobromide profile page.

Summary for 206743

Tradename:	DARIFENACIN HYDROBROMIDE
Applicant:	Aurobindo Pharma
Ingredient:	darifenacin hydrobromide
Patents:	0

Pharmacology for NDA: 206743

Mechanism of Action

Cholinergic Muscarinic Antagonists

Suppliers and Packaging for NDA: 206743

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DARIFENACIN HYDROBROMIDE	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	206743	ANDA	Rising Pharma Holdings, Inc.	16571-767	16571-767-03	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16571-767-03)
DARIFENACIN HYDROBROMIDE	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	206743	ANDA	Rising Pharma Holdings, Inc.	16571-767	16571-767-09	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16571-767-09)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 7.5MG BASE
Approval Date:	Sep 19, 2016	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 15MG BASE
Approval Date:	Sep 19, 2016	TE:	AB	RLD:	No

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