Application 012827

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROBINUL	GLYCOPYRROLATE	TABLET;ORAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	ROBINUL FORTE	GLYCOPYRROLATE	TABLET;ORAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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
16571-743	Glycopyrrolate	Glycopyrrolate	Rising Pharma Holdings, Inc.	NDA AUTHORIZED GENERIC	Current
16571-743	Glycopyrrolate	Glycopyrrolate	Rising Pharma Holdings, Inc.	NDA AUTHORIZED GENERIC	Current
16571-744	Glycopyrrolate	Glycopyrrolate	Rising Pharma Holdings, Inc.	NDA AUTHORIZED GENERIC	Current
16571-744	Glycopyrrolate	Glycopyrrolate	Rising Pharma Holdings, Inc.	NDA AUTHORIZED GENERIC	Current
59630-200	Robinul	Glycopyrrolate	Shionogi Inc.	NDA	Current
59630-205	Robinul Forte	Glycopyrrolate	Shionogi Inc.	NDA	Current
68788-8279	Glycopyrrolate	Glycopyrrolate	Preferred Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
70199-007	Robinul	Glycopyrrolate	Casper Pharma LLC	NDA	Current
70199-007	Robinul	Glycopyrrolate	Casper Pharma LLC	NDA	Current
70199-008	Robinul Forte	Glycopyrrolate	Casper Pharma LLC	NDA	Current
70199-008	Robinul Forte	Glycopyrrolate	Casper Pharma LLC	NDA	Current