Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 014694
Company: ASPEN GLOBAL INC

• Safety Labeling Change Order Letter

Products on NDA 14694

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HEXADROL	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No
HEXADROL	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No
HEXADROL	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Labels for NDA 014694

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/05/2024	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/014694s031lbl.pdf
07/16/2014	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014694s030lbl.pdf