NDA 7936, held by Chattem. Selenium Sulfide.
As of Nov 14, 2026, NDA 7936 (Selsun), held by Chattem, was first approved by FDA on May 17, 1951, with 14 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 17, 1951 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Selsun2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · lotion/shampoo;topical | Selenium Sulfide | DiscontinuedReference drug |
| Jun 24, 1994 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Jan 19, 1993 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| May 17, 1988 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Sep 23, 1983 | Supplement 16Labeling | Approved | None posted |
| Jan 26, 1983 | Supplement 14Labeling | Approved | None posted |
| Sep 15, 1982 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Jan 9, 1981 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jan 16, 1979 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jan 15, 1979 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Sep 19, 1977 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Mar 7, 1977 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Mar 7, 1977 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1976 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jul 1, 1976 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| May 17, 1951 | 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