LYNE Application 203378

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	OIL/DROPS;OTIC	0.01%	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64980-329	Fluocinolone Acetonide	Fluocinolone Acetonide Oil	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-329	Fluocinolone Acetonide	Fluocinolone Acetonide Oil	Rising Pharmaceuticals, Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
32417	ORIG	2016-04-28