Application 020254

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VOLTAREN-XR	DICLOFENAC SODIUM	TABLET, EXTENDED RELEASE;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-1381	Diclofenac Sodium	Diclofenac Sodium	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
33358-451	Diclofenac Sodium	Diclofenac Sodium	RxChange Co.	NDA AUTHORIZED GENERIC	Current
63187-041	Diclofenac Sodium	Diclofenac Sodium	Proficient Rx LP	ANDA	Current
63629-5096	Diclofenac Sodium	Diclofenac Sodium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-5096	Diclofenac Sodium	Diclofenac Sodium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
68788-9389	Diclofenac Sodium	Diclofenac Sodium	Preferred Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
68788-9389	Diclofenac Sodium	Diclofenac Sodium	Preferred Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current