NDA 16796, held by Rising. Droperidol.
As of Nov 14, 2026, NDA 16796 (Inapsine), held by Rising, was first approved by FDA on Jun 11, 1970, with 26 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 11, 1970 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Inapsine2.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Droperidol | DiscontinuedReference drug |
| Nov 26, 2001 | Supplement 39Labeling · Standard review | Approved | |
| Dec 14, 2000 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Apr 12, 2000 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Feb 18, 2000 | Supplement 35Labeling · Standard review | Approved | None posted |
| Sep 29, 1998 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Mar 15, 1995 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1995 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Jun 29, 1994 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Mar 2, 1994 | Supplement 30Labeling · Standard review | Approved | None posted |
| Oct 28, 1992 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Oct 5, 1990 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Dec 6, 1988 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Dec 31, 1987 | Supplement 20Labeling | Approved | None posted |
| Dec 31, 1987 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Jul 17, 1987 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Apr 2, 1987 | Supplement 22Labeling | Approved | None posted |
| Dec 15, 1986 | Supplement 24Labeling | Approved | None posted |
| Dec 15, 1986 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Mar 15, 1985 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Aug 13, 1982 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Jul 28, 1982 | Supplement 13Labeling | Approved | None posted |
| Jul 28, 1982 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Jan 20, 1982 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| May 23, 1980 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Nov 8, 1976 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Aug 29, 1974 | Supplement 5Labeling | Approved | None posted |
| Jun 11, 1970 | Original applicationNew dosage form · 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
