Floxin In Dextrose 5%, Floxin, Floxin In Dextrose 5% In Plastic Container

NDA 20087, held by Ortho Mcneil Pharm. Ofloxacin.

As of Nov 13, 2026, NDA 20087 (Floxin In Dextrose 5%, Floxin, Floxin In Dextrose 5% In Plastic Container), held by Ortho Mcneil Pharm, was first approved by FDA on Mar 31, 1992, with 15 approved supplements and 0 published complete response letters.

First approved: Mar 31, 1992
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Dec 19, 1996	Supplement 17Efficacy (new indication or use) · Standard review	Approved	None posted
Mar 31, 1992	Original applicationNew dosage form · Standard review	Approved	None posted

Products

5 strengths and forms

Product	Active ingredient	Marketing
Floxin In Dextrose 5%400MG/100ML · injectable;injection	Ofloxacin	Discontinued
Floxin20MG/ML · injectable;injection	Ofloxacin	Discontinued
Floxin40MG/ML · injectable;injection	Ofloxacin	Discontinued
Floxin In Dextrose 5% In Plastic Container4MG/ML · injectable;injection	Ofloxacin	Discontinued
Floxin In Dextrose 5% In Plastic Container400MG/100ML · injectable;injection	Ofloxacin	Discontinued

All 16 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 8, 1999	Supplement 24Labeling · Standard review	Approved	None posted
Dec 8, 1999	Supplement 23Labeling · Standard review	Approved	None posted
Dec 8, 1999	Supplement 21Labeling · Standard review	Approved	None posted
Mar 25, 1999	Supplement 22Manufacturing · Standard review	Approved	None posted
Oct 20, 1998	Supplement 20Manufacturing · Standard review	Approved	None posted
May 12, 1998	Supplement 19Manufacturing · Standard review	Approved	None posted
Aug 11, 1997	Supplement 16Labeling · Standard review	Approved	None posted
Apr 16, 1997	Supplement 18Manufacturing · Standard review	Approved	None posted
Dec 19, 1996	Supplement 17Efficacy (new indication or use) · Standard review	Approved	None posted
Sep 11, 1996	Supplement 15Labeling · Standard review	Approved	None posted
Mar 22, 1994	Supplement 13Manufacturing · Standard review	Approved	None posted
Dec 27, 1993	Supplement 12Manufacturing · Standard review	Approved	None posted
Dec 7, 1993	Supplement 11Manufacturing · Standard review	Approved	None posted
May 10, 1993	Supplement 2Manufacturing · Standard review	Approved	None posted
May 19, 1992	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 31, 1992	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20087
Drugs@FDA: Overview at FDA
Company: Ortho-McNeil Pharmaceutical

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters