NDA 17771, held by Shine. Technetium Tc-99m Sodium Pertechnetate Generator.
As of Nov 13, 2026, NDA 17771 (Technelite), held by Shine, was first approved by FDA on Nov 16, 1976, with 29 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE: The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: Thyroid Imaging Salivary Gland Imaging Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux. Nasolacrimal Drainage System Imaging Sodium Pertechnetate Tc 99m Injection is used IN CHILDREN as an agent for: Thyroid Imaging Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 16, 1976 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Technelite0.0083-2.7 CI/GENERATOR · solution;intravenous | Technetium Tc-99m Sodium Pertechnetate Generator | Discontinued |
| Technelite1-20 CI/GENERATOR · solution;intravenous | Technetium Tc-99m Sodium Pertechnetate Generator | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 20, 2023 | Supplement 44Labeling · Standard review | Approved | |
| Nov 15, 2016 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Feb 12, 2016 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Aug 27, 2015 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Feb 9, 2015 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Feb 12, 2014 | Supplement 35Labeling · Standard review | Approved | |
| Nov 16, 2012 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Mar 25, 2009 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Dec 7, 2007 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Sep 2, 2004 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Dec 5, 2001 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Dec 6, 2000 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Aug 11, 2000 | Supplement 19Labeling · Standard review | Approved | None posted |
| Feb 29, 2000 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Feb 4, 1998 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Dec 15, 1997 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Nov 5, 1997 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Apr 5, 1996 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Jan 24, 1996 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1996 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| May 23, 1995 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Aug 12, 1993 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jan 12, 1993 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1985 | Supplement 9Labeling | Approved | None posted |
| May 13, 1983 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Apr 18, 1983 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Nov 21, 1978 | Supplement 5Labeling | Approved | None posted |
| Oct 11, 1978 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jun 7, 1978 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Nov 16, 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
