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Last Updated: March 1, 2024

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 are two patents 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:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 205579
Medical Subject Heading (MeSH) Categories for 205579
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:RXDosage:FOR SUSPENSION;INTRAVENOUSStrength250MG/VIAL
Approval Date:Jul 22, 2014TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Jun 30, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Feb 15, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:FOR USE IN THE TREATMENT OF MALIGNANT HYPERTHERMIA IN CONJUNCTION WITH APPROPRIATE SUPPORTIVE MEASURES AND FOR THE PREVENTION OF MALIGNANT HYPERTHERMIA IN PATIENTS AT HIGH RISK.

Expired US Patents for NDA 205579

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

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