NDA 21012, held by Cis Bio Intl SA. Technetium Tc-99m Depreotide.
As of Nov 13, 2026, NDA 21012 (Neo Tect Kit), held by Cis Bio Intl SA, was first approved by FDA on Aug 3, 1999, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 3, 1999 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Neo Tect KitN/A **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Technetium Tc-99m Depreotide | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 1, 2004 | Supplement 7Manufacturing · Priority review | Approved | |
| Jan 30, 2002 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Apr 26, 2001 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Apr 11, 2001 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Aug 3, 1999 | 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
