NDA 16801, held by Fresenius Kabi USA. Lidocaine Hydrochloride.
As of Nov 13, 2026, NDA 16801 (Xylocaine Preservative Free), held by Fresenius Kabi USA, was first approved by FDA on Oct 6, 1969, with 32 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 6, 1969 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Xylocaine Preservative Free2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Lidocaine Hydrochloride | DiscontinuedReference drug |
| Xylocaine Preservative Free4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Lidocaine Hydrochloride | DiscontinuedReference drug |
| Xylocaine Preservative Free10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Lidocaine Hydrochloride | Discontinued |
| Xylocaine Preservative Free20% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Lidocaine Hydrochloride | DiscontinuedReference drug |
| Xylocaine Preservative Free1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Lidocaine Hydrochloride | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 18, 2013 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Mar 28, 2013 | Supplement 41Labeling · Standard review | Approved | None posted |
| Dec 8, 2000 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Feb 20, 1997 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Feb 4, 1997 | Supplement 33Labeling · Standard review | Approved | None posted |
| May 31, 1995 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Jul 15, 1994 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Feb 18, 1993 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Jul 11, 1989 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Aug 26, 1988 | Supplement 28Labeling | Approved | None posted |
| Jan 19, 1988 | Supplement 27Labeling | Approved | None posted |
| Sep 16, 1987 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Sep 4, 1986 | Supplement 25Labeling | Approved | None posted |
| Sep 4, 1986 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Apr 3, 1986 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Sep 2, 1983 | Supplement 22Labeling | Approved | None posted |
| Apr 27, 1983 | Supplement 18Labeling | Approved | None posted |
| Jul 22, 1982 | Supplement 17Labeling | Approved | None posted |
| Jul 22, 1982 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Jul 8, 1982 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Mar 25, 1982 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1982 | Supplement 19Labeling | Approved | None posted |
| Dec 15, 1980 | Supplement 15Labeling | Approved | None posted |
| Dec 28, 1979 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1979 | Supplement 14Labeling | Approved | None posted |
| Dec 7, 1979 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Oct 12, 1978 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Sep 29, 1978 | Supplement 9Labeling | Approved | None posted |
| Sep 29, 1978 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| May 27, 1976 | Supplement 7Labeling | Approved | None posted |
| Apr 15, 1976 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Feb 12, 1975 | Supplement 4Labeling | Approved | None posted |
| Oct 6, 1969 | Original applicationNew formulation or manufacturer · Standard review | 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
