Trovan Preservative Free

NDA 20760, held by Pfizer. Alatrofloxacin Mesylate.

As of Nov 13, 2026, NDA 20760 (Trovan Preservative Free), held by Pfizer, was first approved by FDA on Dec 18, 1997, with 6 approved supplements and 0 published complete response letters.

First approved: Dec 18, 1997
Review: Standard
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Dec 18, 1997	Original applicationNew molecular entity · Standard review	Approved	Review

Products

2 strengths and forms


Trovan Preservative FreeEQ 200MG BASE/VIAL · injectable;injection	Alatrofloxacin Mesylate	Discontinued
Trovan Preservative FreeEQ 300MG BASE/VIAL · injectable;injection	Alatrofloxacin Mesylate	Discontinued

All 7 submissions, including labeling and manufacturing supplements


May 17, 2000	Supplement 3Labeling · Standard review	Approved	None posted
May 17, 2000	Supplement 4Labeling · Standard review	Approved	None posted
May 17, 2000	Supplement 5Labeling · Standard review	Approved	None posted
May 17, 2000	Supplement 6Labeling · Standard review	Approved	None posted
Mar 2, 1999	Supplement 2Manufacturing · Standard review	Approved	None posted
Sep 23, 1998	Supplement 1Labeling · Standard review	Approved	None posted
Dec 18, 1997	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 20760
Drugs@FDA: Overview at FDA
Company: Pfizer

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