NDA 18316, held by Otsuka Icu Medcl. Mannitol; Sorbitol.
As of Nov 13, 2026, NDA 18316 (Sorbitol-Mannitol In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on Feb 22, 1980, with 42 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Sorbitol-Mannitol Irrigation is indicated for use as a urologic 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 |
|---|---|---|
| Sorbitol-Mannitol In Plastic Container540MG/100ML;2.7GM/100ML · solution;irrigation | Mannitol; Sorbitol | RxReference drug |
| Jan 5, 1999 | Supplement 46Labeling | Approved | None posted |
| Aug 21, 1997 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Jun 11, 1997 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Mar 28, 1997 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1996 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Aug 14, 1995 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Jan 28, 1992 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Sep 10, 1991 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1991 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1990 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1990 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Sep 13, 1989 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Jul 30, 1987 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Nov 26, 1986 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Aug 29, 1986 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1986 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1986 | Supplement 25Labeling | Approved | None posted |
| Feb 22, 1986 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Feb 21, 1986 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1986 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Oct 29, 1985 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Sep 26, 1985 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Jun 17, 1985 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1984 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1984 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Sep 22, 1984 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Sep 22, 1984 | Supplement 13Labeling | Approved | None posted |
| Sep 21, 1984 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Mar 21, 1984 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1984 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1984 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Feb 17, 1984 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Jul 26, 1982 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jun 14, 1982 | Supplement 5Labeling | 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 6Manufacturing · Standard review | Approved | None posted |
| Sep 15, 1980 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jun 16, 1980 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jun 12, 1980 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jun 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
