Details for New Drug Application (NDA): 019735

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NDA 019735 describes FLOXIN, which is a drug marketed by Ortho Mcneil Pharm, Janssen Pharms, and Daiichi, and is included in three NDAs. Additional details are available on the FLOXIN profile page.

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

Summary for 019735

Tradename:	FLOXIN
Applicant:	Janssen Pharms
Ingredient:	ofloxacin
Patents:	0

Medical Subject Heading (MeSH) Categories for 019735

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DISCN	Dosage:	TABLET;ORAL			Strength	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 28, 1990	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 28, 1990	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 28, 1990	TE:		RLD:	Yes

Expired US Patents for NDA 019735

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	FLOXIN	ofloxacin	TABLET;ORAL	019735-001	Dec 28, 1990	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	FLOXIN	ofloxacin	TABLET;ORAL	019735-003	Dec 28, 1990	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	FLOXIN	ofloxacin	TABLET;ORAL	019735-002	Dec 28, 1990	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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