Xylocaine Viscous

NDA 9470, held by Fresenius Kabi USA. Lidocaine Hydrochloride.

As of Nov 13, 2026, NDA 9470 (Xylocaine Viscous), held by Fresenius Kabi USA, was first approved by FDA on Sep 2, 1954, with 20 approved supplements and 0 published complete response letters.

First approved: Sep 2, 1954
Review: Priority
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Sep 2, 1954	Original applicationNew dosage form · Priority review	Approved	Other

Products

1 strengths and forms

Product	Active ingredient	Marketing
Xylocaine Viscous2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;oral	Lidocaine Hydrochloride	DiscontinuedReference drug

All 21 submissions, including labeling and manufacturing supplements


Sep 24, 2014	Supplement 25Labeling	Approved	Label Letter
May 31, 1996	Supplement 22Manufacturing · Priority review	Approved	None posted
Apr 29, 1996	Supplement 21Manufacturing · Priority review	Approved	None posted
Apr 18, 1994	Supplement 20Labeling · Standard review	Approved	None posted
Oct 26, 1993	Supplement 18Manufacturing · Priority review	Approved	None posted
Feb 18, 1993	Supplement 19Manufacturing · Priority review	Approved	None posted
Sep 14, 1989	Supplement 17Manufacturing · Priority review	Approved	None posted
Sep 16, 1987	Supplement 16Manufacturing · Priority review	Approved	None posted
Jun 20, 1984	Supplement 15Manufacturing · Priority review	Approved	None posted
Jul 29, 1983	Supplement 12Labeling	Approved	None posted
Mar 25, 1982	Supplement 13Manufacturing · Priority review	Approved	None posted
Feb 11, 1981	Supplement 11Manufacturing · Priority review	Approved	None posted
May 5, 1980	Supplement 10Labeling	Approved	None posted
May 5, 1980	Supplement 9Manufacturing · Priority review	Approved	None posted
Dec 14, 1978	Supplement 8Manufacturing · Priority review	Approved	None posted
Feb 3, 1977	Supplement 5Labeling	Approved	None posted
Jan 12, 1977	Supplement 4Manufacturing · Priority review	Approved	None posted
May 27, 1976	Supplement 3Manufacturing · Priority review	Approved	None posted
Mar 5, 1976	Supplement 2Labeling	Approved	None posted
May 3, 1972	Supplement 1Labeling	Approved	None posted
Sep 2, 1954	Original applicationNew dosage form · Priority review	Approved	Other

Identifiers

Application: NDA 9470
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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