NDA 6488, held by Fresenius Kabi USA. Lidocaine Hydrochloride, Epinephrine; Lidocaine Hydrochloride.
As of Nov 13, 2026, NDA 6488 (Xylocaine, Xylocaine W/ Epinephrine), held by Fresenius Kabi USA, was first approved by FDA on Nov 19, 1948, with 75 approved supplements and 0 published complete response letters.
INDICATIONS & USAGE Xylocaine (lidocaine HCl) Injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 19, 1948 | Original application | Approved | None posted |
| Xylocaine2% · injectable;injection | Lidocaine Hydrochloride | RxReference drug |
| Xylocaine W/ Epinephrine0.01MG/ML;2% · injectable;injection | Epinephrine; Lidocaine Hydrochloride | DiscontinuedReference drug |
| Xylocaine W/ Epinephrine0.01MG/ML;1% · injectable;injection | Epinephrine; Lidocaine Hydrochloride | RxReference drug |
| Xylocaine W/ Epinephrine0.02MG/ML;2% · injectable;injection | Epinephrine; Lidocaine Hydrochloride | RxReference drug |
| Xylocaine1% · injectable;injection | Lidocaine Hydrochloride | RxReference drug |
| Xylocaine0.5% · injectable;injection | Lidocaine Hydrochloride | RxReference drug |
| Xylocaine1.5% · injectable;injection | Lidocaine Hydrochloride | RxReference drug |
| Xylocaine W/ Epinephrine0.005MG/ML;0.5% · injectable;injection | Epinephrine; Lidocaine Hydrochloride | RxReference drug |
| Xylocaine W/ Epinephrine0.005MG/ML;1.5% · injectable;injection | Epinephrine; Lidocaine Hydrochloride | RxReference drug |
| Xylocaine W/ Epinephrine0.005MG/ML;1% · injectable;injection | Epinephrine; Lidocaine Hydrochloride | RxReference drug |
| Xylocaine W/ Epinephrine0.005MG/ML;2% · injectable;injection | Epinephrine; Lidocaine Hydrochloride | RxReference drug |
| Oct 30, 2024 | Supplement 100Labeling · Standard review | Approved | |
| Nov 2, 2018 | Supplement 97Labeling · Standard review | Approved | |
| Dec 22, 2017 | Supplement 90Labeling · Standard review | Approved | |
| Dec 22, 2017 | Supplement 95Manufacturing · Standard review | Approved | |
| Mar 17, 2016 | Supplement 91Manufacturing | Approved | None posted |
| Mar 3, 2015 | Supplement 89Manufacturing | Approved | None posted |
| Dec 26, 2013 | Supplement 88Manufacturing | Approved | None posted |
| Oct 29, 2013 | Supplement 79Manufacturing | Approved | None posted |
| Jul 22, 2013 | Supplement 87Manufacturing | Approved | None posted |
| Jun 11, 2013 | Supplement 76Manufacturing | Approved | None posted |
| Apr 9, 2013 | Supplement 78Manufacturing | Approved | None posted |
| Mar 28, 2013 | Supplement 84Labeling · Standard review | Approved | None posted |
| Feb 20, 2013 | Supplement 86Manufacturing | Approved | None posted |
| Feb 16, 2013 | Supplement 83Manufacturing | Approved | None posted |
| Feb 13, 2013 | Supplement 85Manufacturing | Approved | None posted |
| Feb 19, 2010 | Supplement 74Labeling | Approved | |
| Jul 17, 2002 | Supplement 66Manufacturing | Approved | None posted |
| Dec 14, 2000 | Supplement 64Manufacturing | Approved | None posted |
| Dec 8, 2000 | Supplement 65Manufacturing | Approved | None posted |
| May 26, 1999 | Supplement 61Labeling · Standard review | Approved | None posted |
| Mar 6, 1998 | Supplement 62Manufacturing | Approved | None posted |
| Dec 8, 1997 | Supplement 57Manufacturing | Approved | None posted |
| May 31, 1996 | Supplement 59Manufacturing | Approved | None posted |
| May 2, 1996 | Supplement 60Manufacturing | Approved | None posted |
| Jan 3, 1996 | Supplement 58Manufacturing | Approved | None posted |
| Jul 18, 1995 | Supplement 56Manufacturing | Approved | None posted |
| Jul 11, 1995 | Supplement 55Manufacturing | Approved | None posted |
| Nov 21, 1994 | Supplement 54Manufacturing | Approved | None posted |
| Oct 20, 1993 | Supplement 51Manufacturing | Approved | None posted |
| Apr 13, 1993 | Supplement 53Manufacturing | Approved | None posted |
| Feb 18, 1993 | Supplement 52Manufacturing | Approved | None posted |
| Mar 21, 1991 | Supplement 35Manufacturing | Approved | None posted |
| Mar 21, 1991 | Supplement 36Labeling | Approved | None posted |
| Oct 2, 1990 | Supplement 50Manufacturing | Approved | None posted |
| Jul 11, 1989 | Supplement 49Manufacturing | Approved | None posted |
| Dec 2, 1988 | Supplement 47Manufacturing | Approved | None posted |
| Dec 2, 1988 | Supplement 48Labeling | Approved | None posted |
| Sep 16, 1987 | Supplement 43Manufacturing | Approved | None posted |
| Sep 11, 1987 | Supplement 45Manufacturing | Approved | None posted |
| Sep 11, 1987 | Supplement 46Labeling | Approved | None posted |
| Mar 18, 1987 | Supplement 44Labeling | Approved | None posted |
| Nov 13, 1986 | Supplement 37Manufacturing | Approved | None posted |
| Nov 13, 1986 | Supplement 38Labeling | Approved | None posted |
| Aug 29, 1986 | Supplement 39Manufacturing | Approved | None posted |
| Aug 29, 1986 | Supplement 40Labeling | Approved | None posted |
| May 19, 1986 | Supplement 42Labeling | Approved | None posted |
| Feb 27, 1986 | Supplement 41Labeling | Approved | None posted |
| Feb 22, 1986 | Supplement 28Manufacturing | Approved | None posted |
| Feb 22, 1986 | Supplement 29Labeling | Approved | None posted |
| Mar 22, 1985 | Supplement 33Manufacturing | Approved | None posted |
| Mar 22, 1985 | Supplement 34Labeling | Approved | None posted |
| Dec 12, 1984 | Supplement 27Labeling | Approved | |
| Dec 3, 1984 | Supplement 32Labeling | Approved | None posted |
| Jul 26, 1982 | Supplement 24Manufacturing | Approved | None posted |
| Jul 26, 1982 | Supplement 25Labeling | Approved | None posted |
| Jun 28, 1982 | Supplement 31Manufacturing | Approved | None posted |
| Mar 25, 1982 | Supplement 30Manufacturing | Approved | None posted |
| Oct 1, 1981 | Supplement 23Manufacturing | Approved | None posted |
| Oct 1, 1981 | Supplement 26Labeling | Approved | None posted |
| Dec 31, 1980 | Supplement 20Labeling | Approved | None posted |
| Apr 17, 1980 | Supplement 22Manufacturing | Approved | None posted |
| Aug 29, 1979 | Supplement 21Labeling | Approved | None posted |
| Apr 9, 1979 | Supplement 17Manufacturing | Approved | None posted |
| Apr 9, 1979 | Supplement 18Labeling | Approved | None posted |
| Mar 26, 1979 | Supplement 16Manufacturing | Approved | None posted |
| Feb 27, 1979 | Supplement 19Manufacturing | Approved | |
| May 17, 1978 | Supplement 15Labeling | Approved | None posted |
| Feb 2, 1976 | Supplement 13Manufacturing | Approved | None posted |
| Oct 9, 1975 | Supplement 11Labeling | Approved | None posted |
| Aug 28, 1975 | Supplement 8Labeling | Approved | None posted |
| Aug 28, 1975 | Supplement 9Manufacturing | Approved | None posted |
| Jul 16, 1975 | Supplement 10Manufacturing | Approved | None posted |
| Jun 24, 1974 | Supplement 6 | Approved | None posted |
| May 20, 1974 | Supplement 5Manufacturing | Approved | None posted |
| Dec 4, 1972 | Supplement 2Labeling | Approved | None posted |
| Nov 19, 1948 | Original application | Approved | None posted |
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
