Drugs@FDA: FDA-Approved Drugs
Company: LANTHEUS MEDCL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TECHNELITE | TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR | 0.0083-2.7 CI/GENERATOR | SOLUTION;INTRAVENOUS | Discontinued | None | No | No |
| TECHNELITE | TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR | 1-20 CI/GENERATOR | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/16/1976 | 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 |
|---|---|---|---|---|---|
| 01/20/2023 | SUPPL-44 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017771Orig1s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017771Orig1s044ltr.pdf | |
| 11/15/2016 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/2015 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/2016 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/09/2015 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/2014 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017771s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017771Orig1s035ltr.pdf | |
| 11/16/2012 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/2009 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-24 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/02/2004 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/05/2001 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/06/2000 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/29/2000 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/11/2000 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 02/04/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/15/1997 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1997 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1996 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/1996 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/11/1996 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/23/1995 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/12/1993 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/12/1993 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/1985 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 05/13/1983 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/18/1983 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/21/1978 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 06/07/1978 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/11/1978 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/20/2023 | SUPPL-44 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017771Orig1s044lbl.pdf | |
| 01/20/2023 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017771Orig1s044lbl.pdf | |
| 02/12/2014 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017771s035lbl.pdf |