Details for New Drug Application (NDA): 205579

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NDA 205579 describes RYANODEX, which is a drug marketed by Eagle Pharms and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the RYANODEX profile page.

The generic ingredient in RYANODEX is dantrolene sodium. There are five drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dantrolene sodium profile page.

Summary for 205579

Tradename:	RYANODEX
Applicant:	Eagle Pharms
Ingredient:	dantrolene sodium
Patents:	1

Pharmacology for NDA: 205579

Physiological Effect	Decreased Striated Muscle Contraction Decreased Striated Muscle Tone

Medical Subject Heading (MeSH) Categories for 205579

Muscle Relaxants, Central

Suppliers and Packaging for NDA: 205579

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RYANODEX	dantrolene sodium	FOR SUSPENSION;INTRAVENOUS	205579	NDA	Eagle Pharmaceuticals, Inc.	42367-540	42367-540-32	1 VIAL in 1 CARTON (42367-540-32) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;INTRAVENOUS			Strength	250MG/VIAL
Approval Date:	Jul 22, 2014	TE:		RLD:	Yes
Patent:	⤷ Subscribe	Patent Expiration:	Jun 30, 2025	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 205579

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eagle Pharms	RYANODEX	dantrolene sodium	FOR SUSPENSION;INTRAVENOUS	205579-001	Jul 22, 2014	⤷ Subscribe	⤷ Subscribe
Eagle Pharms	RYANODEX	dantrolene sodium	FOR SUSPENSION;INTRAVENOUS	205579-001	Jul 22, 2014	⤷ Subscribe	⤷ Subscribe
Eagle Pharms	RYANODEX	dantrolene sodium	FOR SUSPENSION;INTRAVENOUS	205579-001	Jul 22, 2014	⤷ Subscribe	⤷ Subscribe
Eagle Pharms	RYANODEX	dantrolene sodium	FOR SUSPENSION;INTRAVENOUS	205579-001	Jul 22, 2014	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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