Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021730
Company: LUPIN

Products on NDA 21730

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XOPENEX HFA	LEVALBUTEROL TARTRATE	EQ 0.045MG BASE/INH	AEROSOL, METERED;INHALATION	Prescription	None	Yes	Yes

Labels for NDA 021730

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/27/2017	SUPPL-39	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021730s039lbl.pdf
03/12/2015	SUPPL-36	Efficacy-Pediatric	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021730s036lbl.pdf
09/10/2013	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021730s033lbl.pdf
07/30/2012	SUPPL-24	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021730s024lbl.pdf
02/05/2008	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021730s008lbl.pdf
02/05/2008	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021730s008lbl.pdf
03/11/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21730lbl.pdf