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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076686

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NDA 076686 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 076686
Tradename:DANTROLENE SODIUM
Applicant:Elite Labs Inc
Ingredient:dantrolene sodium
Patents:0
Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 076686

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Oct 24, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Oct 24, 2005TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Oct 24, 2005TE:ABRLD:No

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