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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020899
Company: GE HEALTHCARE

Other Important Information from FDA

Products on NDA 020899

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020899

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
05/09/2025	SUPPL-25	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020899s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020899Orig1s025ltr.pdf
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-Package Insert, Labeling-Container/Carton Labels	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.

Labels for NDA 020899

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/09/2025	SUPPL-25	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020899s025lbl.pdf
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

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