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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 076231

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NDA 076231 describes OFLOXACIN, which is a drug marketed by Bedford, Altaire Pharms Inc, Alvogen, Amneal, Apotex Inc, Bausch And Lomb, Caplin, Epic Pharma Llc, Fdc Ltd, Mankind Pharma, Sandoz, Sentiss, Somerset, Hikma, Cadila Pharms Ltd, Chartwell Rx, Dr Reddys Labs Ltd, Ranbaxy Labs Ltd, and Teva, and is included in twenty-eight NDAs. It is available from thirty suppliers. Additional details are available on the OFLOXACIN profile page.

The generic ingredient in OFLOXACIN is ofloxacin. There are seventy-eight drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.

Summary for 076231

Tradename:	OFLOXACIN
Applicant:	Sandoz
Ingredient:	ofloxacin
Patents:	0

Medical Subject Heading (MeSH) Categories for 076231

Anti-Bacterial Agents
Anti-Infective Agents, Urinary
Cytochrome P-450 CYP1A2 Inhibitors
Topoisomerase II Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.3%
Approval Date:	May 14, 2004	TE:		RLD:	No

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