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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205579
Company: EAGLE PHARMS

Summary Review

Products on NDA 205579

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RYANODEX	DANTROLENE SODIUM	250MG/VIAL	FOR SUSPENSION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205579

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/22/2014	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205579s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205579Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205579Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205579Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/02/2024	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205579s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205579Orig1s011ltr.pdf
08/25/2020	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205579s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205579Orig1s007ltr.pdf
10/01/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 205579

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/02/2024	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205579s011lbl.pdf
08/25/2020	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205579s007lbl.pdf
07/22/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205579s000lbl.pdf

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