Application 018655

Type: NDA
Sponsor: GD SEARLE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NORPACE CR	DISOPYRAMIDE PHOSPHATE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 100MG BASE	Yes	No
002	NORPACE CR	DISOPYRAMIDE PHOSPHATE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 150MG BASE	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0025-2732	Norpace CR	disopyramide phosphate	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-2732	Norpace CR	disopyramide phosphate	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-2732	Norpace CR	disopyramide phosphate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2732	Norpace CR	disopyramide phosphate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2732	Norpace CR	disopyramide phosphate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2732	Norpace CR	disopyramide phosphate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2732	Norpace CR	disopyramide phosphate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2732	Norpace CR	disopyramide phosphate	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-2742	Norpace CR	disopyramide phosphate	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-2742	Norpace CR	disopyramide phosphate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2742	Norpace CR	disopyramide phosphate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2742	Norpace CR	disopyramide phosphate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2742	Norpace CR	disopyramide phosphate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2742	Norpace CR	disopyramide phosphate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2742	Norpace CR	disopyramide phosphate	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-2742	Norpace CR	disopyramide phosphate	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
68151-0526	Norpace	disopyramide phosphate	Carilion Materials Management	NDA	Current
68151-0527	Norpace	disopyramide phosphate	Carilion Materials Management	NDA	Current