NDA 18233, held by Otsuka Icu Medcl. Sterile Water For Injection.
As of Nov 13, 2026, NDA 18233 (Sterile Water For Injection In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on Feb 18, 1980, with 55 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Sterile Water for Injection, USP is indicated for use only as a solvent or diluent vehicle for parenterally administered drugs or solutions and as a source of water for parenteral fluid replenishment after suitable additives are introduced. For intravenous administration, an osmolar concentration not less than two-fifths of the normal osmolarity of the extracellular fluid (280 mOsmol/liter) is essential to avoid intravascular hemolysis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 18, 1980 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sterile Water For Injection In Plastic Container100% · liquid;n/a | Sterile Water For Injection | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 5, 2013 | Supplement 80Manufacturing · Standard review | Approved | None posted |
| Nov 2, 2007 | Supplement 68Manufacturing | Approved | |
| Jan 19, 2005 | Supplement 63Labeling · Standard review | Approved | |
| Jan 24, 2003 | Supplement 62Manufacturing · Standard review | Approved | |
| Oct 15, 2002 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Jun 14, 2000 | Supplement 57Labeling · Standard review | Approved | None posted |
| Jun 4, 1999 | Supplement 60Manufacturing · Standard review | Approved | None posted |
| Oct 29, 1998 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Jun 11, 1997 | Supplement 58Manufacturing · Standard review | Approved | None posted |
| Aug 29, 1996 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1996 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Aug 6, 1996 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Mar 4, 1996 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Aug 14, 1995 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Jan 28, 1992 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Sep 10, 1991 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1991 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1990 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1990 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Jul 30, 1987 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Nov 26, 1986 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1986 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1986 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1985 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1985 | Supplement 26Labeling | Approved | None posted |
| Oct 29, 1985 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1985 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1985 | Supplement 34Labeling | Approved | None posted |
| Sep 26, 1985 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1985 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| May 3, 1985 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1984 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1984 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1984 | Supplement 18Labeling | Approved | None posted |
| Oct 10, 1984 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Apr 9, 1984 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Mar 21, 1984 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1984 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Dec 8, 1983 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Nov 7, 1983 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Feb 15, 1983 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Jul 26, 1982 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Jul 8, 1982 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jun 9, 1982 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Mar 12, 1982 | Supplement 8Labeling | Approved | None posted |
| Jan 8, 1982 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Oct 7, 1981 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Mar 2, 1981 | Supplement 9Labeling | Approved | None posted |
| Mar 2, 1981 | Supplement 7Labeling | Approved | None posted |
| Mar 2, 1981 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jan 7, 1981 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Sep 15, 1980 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| May 28, 1980 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| May 23, 1980 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| May 14, 1980 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Feb 18, 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
