Drugs@FDA: FDA Approved Drug Products

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

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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