Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012674
Company: ASPEN GLOBAL INC

Products on NDA 12674

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HEXADROL	DEXAMETHASONE	0.5MG/5ML	ELIXIR;ORAL	Discontinued	None	No	No

Labels for NDA 012674

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/05/2024	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/012674s010lbl.pdf