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Generated: May 26, 2017

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Dantrolene sodium - Generic Drug Details

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What are the generic sources for dantrolene sodium and what is the scope of dantrolene sodium patent protection?

Dantrolene sodium
is the generic ingredient in four branded drugs marketed by Mylan Institutional, Par Sterile Products, Impax Labs, Us Worldmeds, Eagle Pharms, and Elite Labs Inc, and is included in seven NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dantrolene sodium has eight patent family members in five countries.

There are five drug master file entries for dantrolene sodium. Ten suppliers are listed for this compound.

Summary for Generic Name: dantrolene sodium

Drug Master File Entries: see list5
Suppliers / Packagers: see list10
Bulk Api Vendors: see list62
Clinical Trials: see list924
Patent Applications: see list3,126
Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:dantrolene sodium at DailyMed

Pharmacology for Ingredient: dantrolene sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Par Sterile Products
dantrolene sodium
CAPSULE;ORAL017443-002Approved Prior to Jan 1, 1982ABRXYesYes► Subscribe► Subscribe
Elite Labs Inc
dantrolene sodium
CAPSULE;ORAL076686-003Oct 24, 2005ABRXNoNo► Subscribe► Subscribe
Elite Labs Inc
dantrolene sodium
CAPSULE;ORAL076686-002Oct 24, 2005ABRXNoNo► Subscribe► Subscribe
Eagle Pharms
dantrolene sodium
FOR SUSPENSION;INTRAVENOUS205579-001Jul 22, 2014RXYesYes7,758,890► SubscribeY ► Subscribe
Impax Labs
dantrolene sodium
CAPSULE;ORAL076856-001Mar 1, 2005ABRXNoNo► Subscribe► Subscribe
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