Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213637
Company: BWXT MEDCL

Products on ANDA 213637

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IOBENGUANE I-123	IOBENGUANE SULFATE I-123	10mCi/5ML (2mCi/ML)	SOLUTION;INTRAVENOUS	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213637

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/09/2024	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213637Orig1s000ltr.pdf