NDA 20887, held by Cis Bio Intl SA. Technetium Tc-99m Apcitide.
As of Nov 13, 2026, NDA 20887 (Acutect), held by Cis Bio Intl SA, was first approved by FDA on Sep 14, 1998, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 14, 1998 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| AcutectN/A · injectable;injection | Technetium Tc-99m Apcitide | Discontinued |
| Jan 29, 2002 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Aug 1, 2001 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Apr 24, 2001 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Sep 14, 1998 | Original applicationNew molecular entity · Priority review | Approved |
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
