Last Updated: September 5, 2026

Details for New Drug Application (NDA): 203189

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NDA 203189 describes GATIFLOXACIN, which is a drug marketed by Apotex Inc, Caplin, Hikma, Lupin, Rising, and Sandoz, and is included in six NDAs. It is available from three suppliers. Additional details are available on the GATIFLOXACIN profile page.

The generic ingredient in GATIFLOXACIN is gatifloxacin. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the gatifloxacin profile page.

Summary for 203189

Tradename:	GATIFLOXACIN
Applicant:	Hikma
Ingredient:	gatifloxacin
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.5%
Approval Date:	Sep 3, 2014	TE:		RLD:	No

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