NDA 19981, held by Curium. Technetium Tc-99m Red Blood Cell Kit.
As of Nov 13, 2026, NDA 19981 (Ultratag), held by Curium, was first approved by FDA on Jun 10, 1991, with 7 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Technetium Tc 99m red blood cells are used for blood pool imaging, including cardiac first pass and gated equilibrium imaging and for detection of sites of gastrointestinal bleeding.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 10, 1991 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| UltratagN/A · injectable;injection | Technetium Tc-99m Red Blood Cell Kit | RxReference drug |
| Jun 27, 2025 | Supplement 11Manufacturing | Approved | |
| Sep 9, 2014 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Apr 18, 2000 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Apr 8, 1998 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jan 23, 1998 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 30, 1993 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Aug 25, 1992 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1991 | 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
