MEDLEY PHARMS Application 214346

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NYSTATIN	NYSTATIN	SUSPENSION;ORAL	100,000 UNITS/ML	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42934-400	NYSTATIN	NYSTATIN	Medley Pharmaceuticals Limited	ANDA	Current
69315-504	NYSTATIN	NYSTATIN	Leading Pharma, LLC	ANDA	Current