An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 209176
Company: MITSUBISHI TANABE

Products on NDA 209176

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RADICAVA	EDARAVONE	30MG/100ML (0.3MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
RADICAVA	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209176

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/05/2017	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209176lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209176Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209176Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/18/2022	SUPPL-12	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209176s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209176Orig1s012ltr.pdf
03/15/2021	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209176s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209176Orig1s010ltr.pdf
11/01/2019	SUPPL-9	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209176s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209176Orig1s009ltr.pdf
11/15/2018	SUPPL-7	Manufacturing (CMC)-Formulation	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209176Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209176Orig1s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209176Orig1s007.pdf
08/17/2018	SUPPL-5	Labeling-Container/Carton Labels		Label is not available on this site.

Labels for NDA 209176

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/18/2022	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209176s012lbl.pdf
11/18/2022	SUPPL-12	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209176s012lbl.pdf
03/15/2021	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209176s010lbl.pdf
11/01/2019	SUPPL-9	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209176s009lbl.pdf
11/01/2019	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209176s009lbl.pdf
11/15/2018	SUPPL-7	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209176Orig1s007lbl.pdf
05/05/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209176lbl.pdf

Top