Xylocaine, Xylocaine W/ Epinephrine

NDA 10418, held by Astrazeneca. Lidocaine Hydrochloride, Epinephrine; Lidocaine Hydrochloride.

As of Nov 14, 2026, NDA 10418 (Xylocaine, Xylocaine W/ Epinephrine), held by Astrazeneca, was not approved, with 5 approved supplements and 0 published complete response letters.

First approved: Not approved
Supplements approved: 5
Complete response letters: 0

Products

6 strengths and forms


Xylocaine1% · injectable;injection	Lidocaine Hydrochloride	Discontinued
Xylocaine W/ Epinephrine0.005MG/ML;1% · injectable;injection	Epinephrine; Lidocaine Hydrochloride	Discontinued
Xylocaine2% · injectable;injection	Lidocaine Hydrochloride	Discontinued
Xylocaine W/ Epinephrine0.005MG/ML;2% · injectable;injection	Epinephrine; Lidocaine Hydrochloride	Discontinued
Xylocaine1.5% · injectable;injection	Lidocaine Hydrochloride	Discontinued
Xylocaine W/ Epinephrine0.005MG/ML;1.5% · injectable;injection	Epinephrine; Lidocaine Hydrochloride	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Oct 17, 1985	Supplement 4Labeling	Approved	None posted
Mar 25, 1982	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 9, 1981	Supplement 3Labeling	Approved	None posted
Jul 16, 1975	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 28, 1972	Supplement 1Labeling	Approved	None posted

Identifiers

Application: NDA 10418
Drugs@FDA: Overview at FDA
Company: AstraZeneca Pharmaceuticals LP

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