Details for New Drug Application (NDA): 020087

NDA 020087 describes FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Ortho Mcneil Pharm and is included in one NDA. Additional details are available on the FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER profile page.

The generic ingredient in FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER 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 020087

Tradename:	FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Applicant:	Ortho Mcneil Pharm
Ingredient:	ofloxacin
Patents:	0

Medical Subject Heading (MeSH) Categories for 020087

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:	INJECTABLE;INJECTION			Strength	400MG/100ML
Approval Date:	Mar 31, 1992	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	20MG/ML
Approval Date:	Mar 31, 1992	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	40MG/ML
Approval Date:	Mar 31, 1992	TE:		RLD:	No

Expired US Patents for NDA 020087

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	ofloxacin	INJECTABLE;INJECTION	020087-005	Mar 31, 1992
Ortho Mcneil Pharm	FLOXIN	ofloxacin	INJECTABLE;INJECTION	020087-002	Mar 31, 1992
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	ofloxacin	INJECTABLE;INJECTION	020087-004	Mar 31, 1992
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5%	ofloxacin	INJECTABLE;INJECTION	020087-001	Mar 31, 1992
Ortho Mcneil Pharm	FLOXIN	ofloxacin	INJECTABLE;INJECTION	020087-003	Mar 31, 1992

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