NDA 17680, held by Bracco. Technetium Tc-99m Pyrophosphate Kit.
As of Nov 13, 2026, NDA 17680 (Phosphotec), held by Bracco, was first approved by FDA on Oct 20, 1976, with 12 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 20, 1976 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| PhosphotecN/A · injectable;injection | Technetium Tc-99m Pyrophosphate Kit | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 22, 2025 | Supplement 13Labeling · Standard review | Approved | |
| Dec 14, 1999 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Mar 21, 1994 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| May 9, 1988 | Supplement 10Labeling | Approved | None posted |
| Sep 30, 1985 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| May 6, 1983 | Supplement 6Labeling | Approved | None posted |
| Aug 30, 1982 | Supplement 8Labeling | Approved | None posted |
| Feb 4, 1982 | Supplement 5Labeling | Approved | None posted |
| Feb 4, 1982 | Supplement 4Labeling | Approved | None posted |
| Apr 17, 1978 | Supplement 2Labeling | Approved | None posted |
| Jul 14, 1977 | Supplement 3Labeling | Approved | None posted |
| Dec 20, 1976 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Oct 20, 1976 | Original applicationNew formulation or manufacturer · 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
