Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022075
Company: KYOWA KIRIN

Products on NDA 22075

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NOURIANZ	ISTRADEFYLLINE	20MG	TABLET;ORAL	Prescription	None	Yes	No
NOURIANZ	ISTRADEFYLLINE	40MG	TABLET;ORAL	Prescription	None	Yes	Yes

Labels for NDA 022075

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/27/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022075s000lbl.pdf