Details for New Drug Application (NDA): 018264

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NDA 018264 describes DANTRIUM, which is a drug marketed by Endo Operations and is included in two NDAs. It is available from three 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. Twelve suppliers are listed for this compound. Additional details are available on the dantrolene sodium profile page.

Summary for 018264

Tradename:	DANTRIUM
Applicant:	Endo Operations
Ingredient:	dantrolene sodium
Patents:	0

Pharmacology for NDA: 018264

Physiological Effect	Decreased Striated Muscle Contraction Decreased Striated Muscle Tone

Medical Subject Heading (MeSH) Categories for 018264

Muscle Relaxants, Central

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	ENDO USA, 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:	RX	Dosage:	INJECTABLE;INJECTION			Strength	20MG/VIAL
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

Expired US Patents for NDA 018264

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	DANTRIUM	dantrolene sodium	INJECTABLE;INJECTION	018264-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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