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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021912
Company: LUPIN

Medication Guide

Other Important Information from FDA

Summary Review

Products on NDA 021912

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BROVANA	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION;INHALATION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021912

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/06/2006	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021912lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021912s000tr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021912_brovana_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021912s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/29/2019	SUPPL-32	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021912Orig1s032lblrpl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021912Orig1s032ltr.pdf
12/12/2016	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
07/11/2016	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
11/06/2015	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
09/16/2015	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
08/11/2015	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
09/25/2014	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
02/27/2014	SUPPL-23	Labeling-Package Insert, Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021912s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021912Orig1s023ltr.pdf
02/26/2013	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
01/14/2013	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
08/09/2012	SUPPL-20	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021912Orig1s018,s020ltr.pdf
08/09/2012	SUPPL-18		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021912Orig1s018,s020ltr.pdf
09/02/2011	SUPPL-16	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021912s016ltr.pdf
02/16/2011	SUPPL-15	REMS-Modified, Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021912s015ltr.pdf
02/01/2011	SUPPL-12	REMS-Proposal	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021912s012ltr.pdf
06/02/2010	SUPPL-11	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021912s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021912s011ltr.pdf
06/22/2010	SUPPL-8	Labeling-Medication Guide		Label is not available on this site.
07/14/2011	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021912s006ltr.pdf
12/20/2007	SUPPL-1	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021912s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021912s001ltr.pdf

Labels for NDA 021912

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/29/2019	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021912Orig1s032lblrpl.pdf
02/27/2014	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021912s013lbl.pdf
02/27/2014	SUPPL-23	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021912s013lbl.pdf
07/14/2011	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s006lbl.pdf
02/16/2011	SUPPL-15	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s015lbl.pdf
02/16/2011	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s015lbl.pdf
06/02/2010	SUPPL-11	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021912s011lbl.pdf
12/20/2007	SUPPL-1	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021912s001lbl.pdf
10/06/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021912lbl.pdf

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