Application 202727

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LANSOPRAZOLE	LANSOPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	15MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21130-019	Lansoprazole	Lansoprazole	Safeway, Inc.	ANDA	Current
30142-019	Lansoprazole	Lansoprazole	The Kroger Co.	ANDA	Current
55315-019	Lansoprazole	Lansoprazole	Freds Inc	ANDA	Current
55648-140	Lansoprazole	Lansoprazole	Wockhardt Limited	ANDA	Current
59726-019	Lansoprazole	Lansoprazole	P and L Development of New York Corporation	ANDA	Current
59726-019	Lansoprazole	Lansoprazole	P & L Development, LLC	ANDA	Current
63868-008	Lansoprazole	Lansoprazole	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
63868-008	Lansoprazole	Lansoprazole	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
64679-140	Lansoprazole	Lansoprazole	Wockhardt USA LLC.	ANDA	Current
64679-140	Lansoprazole	Lansoprazole	Wockhardt USA LLC.	ANDA	Current
68016-132	Lansoprazole	Lansoprazole	Chain Drug Consortium, LLC	ANDA	Current
68196-019	Lansoprazole	Lansoprazole	SIMPLY RIGHT (Sam's West, Inc.)	ANDA	Current
68196-019	Lansoprazole	Lansoprazole	Sam's West, Inc	ANDA	Current
70253-019	Heartburn Relief 24 hour	Lansoprazole	OUR FAMILY (Nash Finch Company)	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
22895	ORIG	2015-07-20
32293	ORIG	2012-05-22