HI-TECH PHARMA CO Application 203189

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GATIFLOXACIN	GATIFLOXACIN	SOLUTION/DROPS;OPHTHALMIC	0.5%	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50383-189	Gatifloxacin	Gatifloxacin	Akorn	ANDA	Current
50383-189	Gatifloxacin	Gatifloxacin	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-189	Gatifloxacin	Gatifloxacin	Hi-Tech Pharmacal Co., Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
32390	ORIG	2014-09-05