Details for New Drug Application (NDA): 207681

NDA 207681 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 207681

Tradename:	DARIFENACIN HYDROBROMIDE
Applicant:	Alembic
Ingredient:	darifenacin hydrobromide
Patents:	0

Pharmacology for NDA: 207681

Mechanism of Action

Cholinergic Muscarinic Antagonists

Suppliers and Packaging for NDA: 207681

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DARIFENACIN HYDROBROMIDE	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	207681	ANDA	Alembic Pharmaceuticals Limited	46708-223	46708-223-08	8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (46708-223-08)
DARIFENACIN HYDROBROMIDE	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	207681	ANDA	Alembic Pharmaceuticals Limited	46708-223	46708-223-30	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-223-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 7.5MG BASE
Approval Date:	Dec 8, 2017	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:	Dec 8, 2017	TE:	AB	RLD:	No

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