NDA 18405, held by Duramed Res. Norethindrone Acetate.
As of Nov 13, 2026, NDA 18405 (Aygestin), held by Duramed Res, was first approved by FDA on Apr 21, 1982, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 21, 1982 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Aygestin5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Norethindrone Acetate | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 5, 2007 | Supplement 23Manufacturing · Standard review | Approved | |
| Nov 6, 2002 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Apr 12, 2000 | Supplement 16Labeling · Standard review | Approved | None posted |
| Nov 11, 1997 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Mar 27, 1991 | Supplement 12Labeling | Approved | None posted |
| Sep 20, 1990 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Dec 20, 1988 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Dec 28, 1987 | Supplement 10Labeling | Approved | None posted |
| Aug 26, 1987 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Feb 19, 1986 | Supplement 7Labeling | Approved | None posted |
| Nov 8, 1983 | Supplement 3Labeling | Approved | None posted |
| Apr 21, 1982 | 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
