MONARCH PHARMS Application 050479

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CORTISPORIN	HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	SOLUTION/DROPS;OTIC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No