NDA 18310, held by Covidien. Isosulfan Blue.
As of Nov 14, 2026, NDA 18310 (Lymphazurin), held by Covidien, was first approved by FDA on Jul 29, 1981, with 9 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 29, 1981 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lymphazurin50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;subcutaneous | Isosulfan Blue | DiscontinuedReference drug |
| Oct 29, 2007 | Supplement 11Labeling · Standard review | Approved | |
| Jul 26, 2001 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Oct 18, 1995 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jul 13, 1990 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1987 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1987 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| May 31, 1983 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jul 27, 1982 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Feb 17, 1982 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jul 29, 1981 | Original applicationNew molecular entity · 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
