RECORDATI RARE Application 211302

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYSTADROPS	CYSTEAMINE OPHTHALMIC SOLUTION	SOLUTION; OPHTHALMIC	3.8 MG/ML	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55292-410	CYSTADROPS	cysteamine hydrochloride	RECORDATI RARE DISEASES, INC.	NDA	Current
55292-410	CYSTADROPS	cysteamine hydrochloride	RECORDATI RARE DISEASES, INC.	NDA	Current