NDA 16861, held by Aaipharma LLC. Propoxyphene Napsylate.
As of Nov 13, 2026, NDA 16861 (Darvon-N), held by Aaipharma LLC, was first approved by FDA on Sep 9, 1971, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 9, 1971 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Darvon-N50MG/5ML · suspension;oral | Propoxyphene Napsylate | Discontinued |
| Aug 23, 1994 | Supplement 22Labeling · Standard review | Approved | None posted |
| Apr 5, 1994 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Sep 15, 1992 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Apr 16, 1987 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Oct 16, 1986 | Supplement 15Labeling · Standard review | Approved | None posted |
| Apr 21, 1986 | Supplement 11Labeling · Standard review | Approved | None posted |
| Aug 26, 1985 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Jul 10, 1985 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Aug 20, 1984 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Oct 28, 1981 | Supplement 9Labeling · Standard review | Approved | None posted |
| May 20, 1981 | Supplement 8Labeling · Standard review | Approved | None posted |
| Sep 26, 1979 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jan 11, 1978 | Supplement 5Labeling · Standard review | Approved | None posted |
| Sep 9, 1971 | 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
