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Drugs@FDA: FDA-Approved Drugs

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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	AP	Yes	Yes
RADICAVA	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	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

Therapeutic Equivalents for NDA 209176

RADICAVA

SOLUTION;INTRAVENOUS; 30MG/100ML (0.3MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EDARAVONE	EDARAVONE	30MG/100ML (0.3MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216199	GLAND PHARMA LTD
EDARAVONE	EDARAVONE	30MG/100ML (0.3MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	215508	HIKMA
EDARAVONE	EDARAVONE	30MG/100ML (0.3MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	218354	LONG GROVE PHARMS
RADICAVA	EDARAVONE	30MG/100ML (0.3MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	209176	MITSUBISHI TANABE

SOLUTION;INTRAVENOUS; 60MG/100ML (0.6MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EDARAVONE	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	215917	DR REDDYS
EDARAVONE	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216199	GLAND PHARMA LTD
RADICAVA	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	209176	MITSUBISHI TANABE

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