Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018264
Company: PH HEALTH

Products on NDA 18264

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DANTRIUM	DANTROLENE SODIUM	20MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Labels for NDA 018264

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/02/2024	SUPPL-42	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018264s042lbl.pdf
10/09/2008	SUPPL-25	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018264s025lbl.pdf