Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 017881
Company: DRAXIMAGE
Company: DRAXIMAGE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT | TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT | N/A | INJECTABLE;INJECTION | Prescription | None | No | 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 |
---|---|---|---|---|---|---|---|
12/30/1987 | ORIG-1 | Approval | N/A |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/01/2023 | SUPPL-30 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017881s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017881Orig1s030ltr.pdf | |
10/20/2017 | SUPPL-26 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017881s026lbl.pdf | |
06/09/2016 | SUPPL-25 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017881Orig1s025ltr.pdf |
03/01/2016 | SUPPL-24 | Supplement |
Label is not available on this site. |
||
05/11/2015 | SUPPL-23 | Supplement |
Label is not available on this site. |
||
03/04/2013 | SUPPL-22 | Supplement |
Label is not available on this site. |
||
09/23/2011 | SUPPL-16 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017881s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017881s016ltr.pdf | |
06/05/2009 | SUPPL-10 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017881s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017881s010ltr.pdf | |
10/17/2008 | SUPPL-9 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017881s009ltr.pdf |
07/23/2002 | SUPPL-4 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17881scm004ltr.pdf |
04/02/1999 | SUPPL-3 | Supplement |
Label is not available on this site. |
||
04/02/1999 | SUPPL-2 | Supplement |
Label is not available on this site. |
||
07/17/1989 | SUPPL-1 | Supplement |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/01/2023 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017881s030lbl.pdf | |
12/01/2023 | SUPPL-30 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017881s030lbl.pdf | |
10/20/2017 | SUPPL-26 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017881s026lbl.pdf | |
09/23/2011 | SUPPL-16 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017881s016lbl.pdf | |
06/05/2009 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017881s010lbl.pdf | |
06/05/2009 | SUPPL-10 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017881s010lbl.pdf |
TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT
There are no Therapeutic Equivalents.