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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204762
Company: HIKMA

Products on ANDA 204762

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DANTROLENE SODIUM	DANTROLENE SODIUM	20MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204762

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/19/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/18/2025	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204762

DANTROLENE SODIUM

INJECTABLE;INJECTION; 20MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DANTRIUM	DANTROLENE SODIUM	20MG/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	018264	PH HEALTH
DANTROLENE SODIUM	DANTROLENE SODIUM	20MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	204762	HIKMA
REVONTO	DANTROLENE SODIUM	20MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	078378	USWM

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