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Generated: November 20, 2018

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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 five 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. Eight 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:5
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
Regulatory Exclusivity Expiration:Jul 22, 2021
Regulatory Exclusivity Use:TREATMENT OF MALIGNANT HYPERTHERMIA IN CONJUNCTION WITH APPROPRIATE SUPPORTIVE MEASURES AND FOR THE PREVENTION OF MALIGNANT HYPERTHERMIA IN PATIENTS AT HIGH RISK
Patent:➤ Sign UpPatent Expiration:Jul 1, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Dec 24, 2022Product Flag?YSubstance Flag?Delist Request?

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