Last Updated: November 13, 2026

Details for New Drug Application (NDA): 077098

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NDA 077098 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, Micro Labs, Sandoz, Sentiss, Somerset, Bausch And Lomb Inc, Hikma, Somerset Theraps Llc, Cadila Pharms Ltd, Chartwell Rx, Dr Reddys Labs Ltd, Ranbaxy Labs Ltd, and Teva, and is included in thirty NDAs. It is available from thirty-one suppliers. Additional details are available on the OFLOXACIN profile page.

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

Summary for 077098

Tradename:	OFLOXACIN
Applicant:	Dr Reddys Labs Ltd
Ingredient:	ofloxacin
Patents:	0

Medical Subject Heading (MeSH) Categories for 077098

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Feb 10, 2006	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Feb 10, 2006	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Feb 10, 2006	TE:	AB	RLD:	No

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