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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022454
Company: GE HLTHCARE INC

Dear Health Professional Letter

Summary Review

Products on NDA 022454

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DATSCAN	IOFLUPANE I-123	5mCi/2.5ML (2mCi/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022454

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/14/2011	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022454Orig1s000Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022454s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022454sOrig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022454sOrig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/30/2022	SUPPL-11	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022454Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022454Orig1s011ltr.pdf
11/01/2022	SUPPL-10	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022454s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022454Orig1s010ltr.pdf
03/25/2020	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022454s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022454Orig1s007ltr.pdf
09/11/2015	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022454Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022454Orig1s004ltr.pdf

Labels for NDA 022454

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/30/2022	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022454Orig1s011lbl.pdf
11/30/2022	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022454Orig1s011lbl.pdf
11/01/2022	SUPPL-10	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022454s010lbl.pdf
03/25/2020	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022454s007lbl.pdf
09/11/2015	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022454Orig1s004lbl.pdf
01/14/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022454Orig1s000Lbl.pdf

Therapeutic Equivalents for NDA 022454

DATSCAN

SOLUTION;INTRAVENOUS; 5mCi/2.5ML (2mCi/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DATSCAN	IOFLUPANE I-123	5mCi/2.5ML (2mCi/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	022454	GE HLTHCARE INC
IOFLUPANE I-123	IOFLUPANE I-123	5mCi/2.5ML (2mCi/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	213792	CURIUM

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