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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022290
Company: GE HEALTHCARE

Summary Review

Products on NDA 022290

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADREVIEW	IOBENGUANE SULFATE I-123	10mCi/5ML (2mCi/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022290

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/19/2008	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/22290lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022290s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022290s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022290s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/05/2020	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022290s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022290Orig1s005ltr.pdf
06/06/2016	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/20/2013	SUPPL-1	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022290s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022290Orig1s001ltr.pdf

Labels for NDA 022290

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/05/2020	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022290s005lbl.pdf
03/20/2013	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022290s001lbl.pdf
09/19/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/22290lbl.pdf

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