Pre-Op, Pre-Op Ii

NDA 17433, held by Davis And Geck. Hexachlorophene.

As of Nov 14, 2026, NDA 17433 (Pre-Op, Pre-Op Ii), held by Davis And Geck, was first approved by FDA on Oct 12, 1978, with 15 approved supplements and 0 published complete response letters.

First approved: Oct 12, 1978
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
Oct 12, 1978	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


Pre-Op480MG · sponge;topical	Hexachlorophene	RxReference drug
Pre-Op Ii480MG · sponge;topical	Hexachlorophene	RxReference drug

All 16 submissions, including labeling and manufacturing supplements


May 7, 1992	Supplement 16Manufacturing · Standard review	Approved	None posted
Apr 1, 1992	Supplement 15Manufacturing · Standard review	Approved	None posted
Nov 28, 1989	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 30, 1985	Supplement 13Manufacturing · Standard review	Approved	None posted
Jul 23, 1985	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 25, 1985	Supplement 11Manufacturing · Standard review	Approved	None posted
Feb 5, 1985	Supplement 10Manufacturing · Standard review	Approved	None posted
Mar 28, 1983	Supplement 9Manufacturing · Standard review	Approved	None posted
Mar 28, 1983	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 29, 1982	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 30, 1982	Supplement 6Manufacturing · Standard review	Approved	None posted
Dec 1, 1980	Supplement 5Manufacturing · Standard review	Approved	None posted
Dec 1, 1980	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 26, 1980	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 11, 1980	Supplement 2Labeling	Approved	None posted
Oct 12, 1978	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17433
Drugs@FDA: Overview at FDA
Company: Davis & Geck

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