Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020899
Company: GE HEALTHCARE
Company: GE HEALTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OPTISON | ALBUMIN HUMAN | 10MG/ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
12/31/1997 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
09/16/2021 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020899s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020899Orig1s024ltr.pdf | |
09/01/2021 | SUPPL-23 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020899Orig1s023ltr.pdf |
09/16/2016 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020899s018s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020899Orig1s018,s019ltr.pdf | |
09/16/2016 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020899s018s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020899Orig1s018,s019ltr.pdf | |
04/15/2016 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/15/2013 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/17/2012 | SUPPL-15 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020899s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020899Orig1s015ltr.pdf | |
06/06/2008 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020899s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020899s011ltr.pdf | |
11/08/2007 | SUPPL-10 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020899s010ltr.pdf |
05/10/2002 | SUPPL-7 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/020899s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20899scm007ltr.pdf | |
12/18/2000 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/06/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/04/2000 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/14/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
02/01/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/31/1998 | 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 |
---|---|---|---|---|---|
09/16/2021 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020899s024lbl.pdf | |
09/16/2016 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020899s018s019lbl.pdf | |
09/16/2016 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020899s018s019lbl.pdf | |
08/17/2012 | SUPPL-15 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020899s015lbl.pdf | |
06/06/2008 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020899s011lbl.pdf | |
05/10/2002 | SUPPL-7 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/020899s007lbl.pdf |