Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 213792
Company: CURIUM

Products on ANDA 213792

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IOFLUPANE I-123	IOFLUPANE I-123	5mCi/2.5ML (2mCi/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213792

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/30/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213792Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/12/2023	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 213792

IOFLUPANE I-123

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