Penetrex

NDA 19616, held by Sanofi Aventis US. Enoxacin.

As of Nov 14, 2026, NDA 19616 (Penetrex), held by Sanofi Aventis US, was first approved by FDA on Dec 31, 1991, with 7 approved supplements and 0 published complete response letters.

First approved: Dec 31, 1991
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Dec 31, 1991	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

2 strengths and forms


Penetrex200MG · tablet;oral	Enoxacin	Discontinued
Penetrex400MG · tablet;oral	Enoxacin	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Aug 21, 2002	Supplement 4Labeling · Standard review	Approved	Letter
Aug 21, 2002	Supplement 5Labeling · Standard review	Approved	Letter
Aug 21, 2002	Supplement 6Labeling · Standard review	Approved	Letter
Apr 3, 2000	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 24, 1997	Supplement 2Labeling · Standard review	Approved	None posted
Jun 3, 1996	Supplement 3Labeling · Standard review	Approved	None posted
Mar 10, 1995	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 31, 1991	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 19616
Drugs@FDA: Overview at FDA
Company: sanofi-aventis US

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