Drugs@FDA: FDA-Approved Drugs
Company: GE HEALTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TECHNETIUM TC 99M GENERATOR | TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR | 830-16600mCi/GENERATOR | SOLUTION;INTRAVENOUS, ORAL | Discontinued | None | No | No |
| TECHNETIUM TC 99M GENERATOR | TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR | 68-2703mCi/GENERATOR | SOLUTION;INTRAVENOUS, ORAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/15/1976 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/07/2015 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017693s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017693Orig1s029ltr.pdf | |
| 01/05/2015 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/14/2014 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017693s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017693Orig1s026ltr.pdf | |
| 12/13/2013 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/28/1998 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/24/1997 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/1993 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/1995 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/17/1995 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/16/1990 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/17/1989 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/30/1987 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1986 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/08/1987 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 06/01/1988 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/10/1984 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 02/09/1983 | SUPPL-9 | Efficacy |
Label is not available on this site. |
||
| 06/07/1982 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/28/1979 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/20/1978 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1979 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 02/13/1978 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 01/19/1978 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/19/1978 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/07/2015 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017693s029lbl.pdf | |
| 10/14/2014 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017693s026lbl.pdf |