Application 020051

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLYNASE	GLYBURIDE	TABLET;ORAL	1.5MG	Yes	No
002	GLYNASE	GLYBURIDE	TABLET;ORAL	3MG	Yes	No
003	GLYNASE	GLYBURIDE	TABLET;ORAL	4.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	GLYNASE	GLYBURIDE	TABLET;ORAL	6MG	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-0341	Glynase	glyburide	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0352	Glynase	glyburide	Pharmacia and Upjohn Company LLC	NDA	Current
0009-3449	Glynase	glyburide	Pharmacia and Upjohn Company LLC	NDA	Current