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Argus Health
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US Army
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Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076856

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NDA 076856 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 076856
Tradename:DANTROLENE SODIUM
Applicant:Impax Labs
Ingredient:dantrolene sodium
Patents:0
Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076856
Medical Subject Heading (MeSH) Categories for 076856
Suppliers and Packaging for NDA: 076856
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DANTROLENE SODIUM dantrolene sodium CAPSULE;ORAL 076856 ANDA Impax Generics 0115-4411 N 0115-4411-01
DANTROLENE SODIUM dantrolene sodium CAPSULE;ORAL 076856 ANDA Impax Generics 0115-4411 N 0115-4411-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Mar 1, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Mar 1, 2005TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Mar 1, 2005TE:ABRLD:No

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Johnson and Johnson
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