NDA 17656, held by Otsuka Icu Medcl. Acetic Acid, Glacial.
As of Nov 13, 2026, NDA 17656 (Acetic Acid 0.25% In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on Jun 2, 1976, with 36 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 2, 1976 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetic Acid 0.25% In Plastic Container250MG/100ML · solution;irrigation, urethral | Acetic Acid, Glacial | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 12, 2014 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Feb 9, 2000 | Supplement 41Labeling · Standard review | Approved | None posted |
| Feb 4, 1998 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Nov 19, 1997 | Supplement 39Labeling · Standard review | Approved | None posted |
| Aug 27, 1996 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Aug 24, 1993 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Jun 30, 1992 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Nov 25, 1988 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Jan 18, 1986 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Oct 29, 1985 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1984 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Aug 25, 1984 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Mar 15, 1984 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1984 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Jun 24, 1982 | Supplement 23Labeling | Approved | None posted |
| Jun 10, 1982 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Nov 6, 1981 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Jul 21, 1981 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Oct 1, 1980 | Supplement 22Labeling | Approved | None posted |
| Sep 8, 1980 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Jun 11, 1980 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Jun 6, 1980 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| May 23, 1980 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Mar 20, 1980 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Oct 4, 1979 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Jul 31, 1979 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jul 18, 1979 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| May 1, 1979 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Feb 16, 1979 | Supplement 9Labeling | Approved | None posted |
| Jan 26, 1979 | Supplement 8Labeling | Approved | None posted |
| Nov 22, 1978 | Supplement 6Labeling | Approved | None posted |
| Nov 22, 1978 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Aug 29, 1978 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jul 21, 1977 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| May 9, 1977 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Aug 13, 1976 | Supplement 1Labeling | Approved | None posted |
| Jun 2, 1976 | 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
