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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 017443

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NDA 017443 describes DANTRIUM, which is a drug marketed by Endo Operations 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. Twelve suppliers are listed for this compound. Additional details are available on the dantrolene sodium profile page.

Summary for 017443

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

Pharmacology for NDA: 017443

Physiological Effect	Decreased Striated Muscle Contraction Decreased Striated Muscle Tone

Medical Subject Heading (MeSH) Categories for 017443

Muscle Relaxants, Central

Suppliers and Packaging for NDA: 017443

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443	NDA	Endo USA, Inc.	42023-124	42023-124-01	100 CAPSULE in 1 BOTTLE (42023-124-01)
DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443	NDA AUTHORIZED GENERIC	Endo USA, Inc.	49884-362	49884-362-01	100 CAPSULE in 1 BOTTLE (49884-362-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Expired US Patents for NDA 017443

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-001	Approved Prior to Jan 1, 1982	3,415,821	⤷ Get Started Free
Endo Operations	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-002	Approved Prior to Jan 1, 1982	3,415,821	⤷ Get Started Free
Endo Operations	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-003	Approved Prior to Jan 1, 1982	3,415,821	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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