Xylocaine 1.5% W/ Dextrose 7.5%

NDA 16297, held by Fresenius Kabi USA. Lidocaine Hydrochloride.

As of Nov 13, 2026, NDA 16297 (Xylocaine 1.5% W/ Dextrose 7.5%), held by Fresenius Kabi USA, was first approved by FDA on Nov 4, 1968, with 10 approved supplements and 0 published complete response letters.

First approved: Nov 4, 1968
Review: Priority
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Nov 4, 1968	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Xylocaine 1.5% W/ Dextrose 7.5%1.5% · injectable;spinal	Lidocaine Hydrochloride	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Feb 18, 1993	Supplement 12Manufacturing · Priority review	Approved	None posted
May 31, 1988	Supplement 11Labeling	Approved	None posted
Sep 16, 1987	Supplement 10Manufacturing · Priority review	Approved	None posted
Sep 19, 1984	Supplement 9Labeling	Approved	None posted
Jun 20, 1984	Supplement 8Manufacturing · Priority review	Approved	None posted
Mar 25, 1982	Supplement 7Manufacturing · Priority review	Approved	None posted
Aug 29, 1979	Supplement 6Labeling	Approved	None posted
May 15, 1978	Supplement 4Manufacturing · Priority review	Approved	None posted
Jun 28, 1977	Supplement 3Labeling	Approved	None posted
Dec 30, 1974	Supplement 1Labeling	Approved	None posted
Nov 4, 1968	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 16297
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