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Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205239

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NDA 205239 describes DANTROLENE SODIUM, which is a drug marketed by Elite Labs Inc, Impax Labs, Hikma Pharms, and Mylan Institutional, and is included in four NDAs. It is available from six suppliers. Additional details are available on the DANTROLENE SODIUM profile page.

The generic ingredient in DANTROLENE SODIUM is dantrolene sodium. There are five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dantrolene sodium profile page.
Summary for 205239
Tradename:DANTROLENE SODIUM
Applicant:Mylan Institutional
Ingredient:dantrolene sodium
Patents:0
Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 205239

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/VIAL
Approval Date:Feb 18, 2016TE:APRLD:No

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