NDA 18313, held by Otsuka Icu Medcl. Sterile Water For Irrigation.
As of Nov 13, 2026, NDA 18313 (Sterile Water In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on Feb 22, 1980, with 40 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Sterile Water for Irrigation, USP is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of sterile, nonpyrogenic, solute-free water.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 22, 1980 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sterile Water In Plastic Container100% · liquid;irrigation | Sterile Water For Irrigation | Rx |
| Apr 9, 2004 | Supplement 48Labeling | Approved | None posted |
| Aug 21, 1997 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Jun 11, 1997 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Mar 28, 1997 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1996 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Aug 29, 1996 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1996 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Aug 14, 1995 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Jan 28, 1992 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Sep 10, 1991 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1991 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1990 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1990 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Jun 14, 1989 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Jul 30, 1987 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Nov 26, 1986 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1986 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1986 | Supplement 22Labeling | Approved | None posted |
| Feb 22, 1986 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Feb 21, 1986 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1986 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Oct 29, 1985 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Sep 26, 1985 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1984 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1984 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Sep 22, 1984 | Supplement 13Labeling | Approved | None posted |
| Sep 22, 1984 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Mar 21, 1984 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1984 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1984 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Aug 26, 1982 | Supplement 4Labeling | Approved | None posted |
| Jul 26, 1982 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jun 9, 1982 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Feb 1, 1982 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Jan 8, 1982 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Sep 16, 1981 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1981 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Sep 15, 1980 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jul 3, 1980 | Supplement 2Labeling | Approved | None posted |
| Jul 3, 1980 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1980 | 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
