NDA 18315, held by Otsuka Icu Medcl. Glycine.
As of Nov 13, 2026, NDA 18315 (Glycine 1.5% In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on Feb 22, 1980, with 44 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE 1.5% Glycine Irrigation, USP is indicated for use as irrigating fluid during transurethral prostatic resection and other transurethral surgical procedures.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 22, 1980 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Glycine 1.5% In Plastic Container1.5GM/100ML · solution;irrigation | Glycine | Rx |
| Sep 24, 1999 | Supplement 47Labeling | Approved | None posted |
| Feb 12, 1999 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Aug 21, 1997 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Jun 11, 1997 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| May 5, 1997 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Mar 28, 1997 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1996 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1996 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Aug 14, 1995 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Dec 30, 1993 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Jan 28, 1992 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Sep 10, 1991 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1991 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Jun 1, 1990 | Supplement 34Labeling | Approved | None posted |
| Feb 22, 1990 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1990 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Sep 13, 1989 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Jun 14, 1989 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Jul 30, 1987 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Nov 26, 1986 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1986 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1986 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1986 | Supplement 23Labeling | Approved | None posted |
| Feb 21, 1986 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1986 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Oct 29, 1985 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Sep 26, 1985 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1984 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1984 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Sep 22, 1984 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Sep 22, 1984 | Supplement 12Labeling | Approved | None posted |
| Mar 21, 1984 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1984 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1984 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Feb 17, 1984 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Feb 17, 1983 | Supplement 2Labeling | Approved | None posted |
| Jul 26, 1982 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Jun 9, 1982 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Feb 1, 1982 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jan 8, 1982 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Sep 16, 1981 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Sep 2, 1981 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1981 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Sep 15, 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
