➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Harvard Business School

Last Updated: July 4, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018264

Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 018264 describes DANTRIUM, which is a drug marketed by Par Sterile Products and is included in two NDAs. It is available from one supplier. Additional details are available on the DANTRIUM profile page.

The generic ingredient in DANTRIUM 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 018264
Applicant:Par Sterile Products
Ingredient:dantrolene sodium
Formulation / Manufacturing:see details
Pharmacology for NDA: 018264
Medical Subject Heading (MeSH) Categories for 018264
Suppliers and Packaging for NDA: 018264
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DANTRIUM dantrolene sodium INJECTABLE;INJECTION 018264 NDA Par Pharmaceutical, Inc. 42023-123 42023-123-06 6 VIAL in 1 CARTON (42023-123-06) > 60 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:


Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.