Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

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

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

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
11/15/2018 SUPPL-7 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209176Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209176Orig1s007ltr.pdf
08/17/2018 SUPPL-5 Labeling-Container/Carton Labels

Label is not available on this site.

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English