Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209607
Company: PROGENICS PHARMS INC

Products on NDA 209607

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AZEDRA	IOBENGUANE I-131	15mCi/ML	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209607

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/30/2018	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209607s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209607Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209607Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/14/2023	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209607Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209607Orig1s002ltr.pdf
07/24/2019	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Labels for NDA 209607

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/14/2023	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209607Orig1s002lbl.pdf
02/14/2023	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209607Orig1s002lbl.pdf
07/30/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209607s000lbl.pdf