Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202153
Company: JUBILANT

Products on NDA 202153

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RUBY-FILL	RUBIDIUM CHLORIDE RB-82	N/A	SOLUTION;INTRAVENOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202153

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/30/2016	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202153s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202153Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/202153Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/26/2019	SUPPL-12	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202153s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202153Orig1s012ltr.pdf

Labels for NDA 202153

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/26/2019	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202153s012lbl.pdf
04/26/2019	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202153s012lbl.pdf
09/30/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202153s000lbl.pdf