NDA 13790, held by Ina Pharms. Flurandrenolide.
As of Nov 14, 2026, NDA 13790 (Cordran), held by Ina Pharms, was first approved by FDA on Mar 19, 1963, with 12 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 19, 1963 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cordran0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · lotion;topical | Flurandrenolide | DiscontinuedReference drug |
| Jul 27, 2011 | Supplement 21Manufacturing · Standard review | Approved | |
| Oct 31, 2003 | Supplement 18Manufacturing · Standard review | Approved | |
| Sep 27, 2000 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Nov 6, 1998 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Nov 6, 1995 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Dec 18, 1987 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jun 3, 1987 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Jun 3, 1987 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Aug 6, 1982 | Supplement 10Labeling | Approved | None posted |
| Jun 17, 1980 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Sep 12, 1978 | Supplement 8Labeling | Approved | None posted |
| Feb 23, 1977 | Supplement 7Labeling | Approved | None posted |
| Mar 19, 1963 | 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
