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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203971
Company: BAYER HLTHCARE

Summary Review

Products on NDA 203971

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XOFIGO	RADIUM RA-223 DICHLORIDE	162mCi/6ML (27mCi/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203971

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/15/2013	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/2013/203971lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203971Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203971Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203971Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/10/2019	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203971s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203971Orig1s016ltr.pdf
08/31/2018	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203971s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203971Orig1s014ltr.pdf
02/02/2018	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203971s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203971Orig1s012ltr.pdf
05/12/2016	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
04/29/2016	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
01/22/2016	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
03/18/2016	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203971s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203971Orig1s007ltr.pdf
09/10/2015	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
05/12/2015	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/16/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 203971

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/10/2019	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203971s016lbl.pdf
08/31/2018	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203971s014lbl.pdf
02/02/2018	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203971s012lbl.pdf
03/18/2016	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203971s007lbl.pdf
05/15/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203971lbl.pdf

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