Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020899
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
09/16/2016 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
09/16/2016 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

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