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Last Updated: June 10, 2023

Details for New Drug Application (NDA): 018264

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NDA 018264 describes DANTRIUM, which is a drug marketed by Par Sterile Products and is included in two NDAs. It is available from two suppliers. 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. Thirteen 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

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