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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021730
Company: LUPIN

Products on NDA 021730

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021730

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/11/2005	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21730lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21730ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021730s000TOC.cfm

Supplements

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
01/22/2016	SUPPL-38	Manufacturing (CMC)		Label is not available on this site.
03/12/2015	SUPPL-36	Efficacy-Pediatric	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021730s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021730Orig1s036ltr.pdf
08/27/2014	SUPPL-35	Manufacturing (CMC)		Label is not available on this site.
11/25/2013	SUPPL-34	Manufacturing (CMC)		Label is not available on this site.
09/10/2013	SUPPL-33	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021730s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021730Orig1s033ltr.pdf
03/14/2013	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
01/09/2013	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
12/07/2012	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
07/30/2012	SUPPL-24	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021730s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021730Orig1s024ltr.pdf
02/05/2008	SUPPL-8	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021730s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021730s008ltr.pdf
04/04/2006	SUPPL-6	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021730s006ltr.pdf
09/15/2006	SUPPL-3	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021730s003ltr.pdf

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

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