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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020831
Company: NOVARTIS

Medication Guide

Other Important Information from FDA

Products on NDA 020831

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FORADIL	FORMOTEROL FUMARATE	0.012MG/INH Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER;INHALATION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020831

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/16/2001	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20831_Foradil_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20831_Foradil_approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20831_Foradil.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/02/2016	SUPPL-34	Manufacturing (CMC)		Label is not available on this site.
12/13/2013	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
03/29/2013	SUPPL-32	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020831s029,s032ltr.pdf
04/17/2013	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
02/08/2013	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
03/29/2013	SUPPL-29	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020831s029,s032ltr.pdf
09/27/2012	SUPPL-28	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020831s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020831Orig1s028ltr.pdf
03/20/2012	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020831s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020831s027ltr.pdf
05/03/2011	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020831s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020831s025ltr.pdf
02/09/2011	SUPPL-24	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020831s024ltr.pdf
05/18/2011	SUPPL-22	REMS-Proposal	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020831s022ltr.pdf
06/02/2010	SUPPL-21	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020831s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020831s021,021592s003ltr.pdf
06/19/2006	SUPPL-9	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020831s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020831s009LTR.pdf
06/27/2003	SUPPL-5	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20831se5-005_foradil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20831se5-005ltr.pdf
05/17/2002	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
11/21/2001	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/25/2001	SUPPL-2	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20831s2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21279ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020831_S002_FORADIL_AP.pdf
04/25/2001	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020831

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/27/2012	SUPPL-28	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020831s028lbl.pdf
03/20/2012	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020831s027lbl.pdf
05/03/2011	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020831s025lbl.pdf
06/02/2010	SUPPL-21	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020831s021lbl.pdf
06/19/2006	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020831s009lbl.pdf
06/27/2003	SUPPL-5	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20831se5-005_foradil_lbl.pdf
09/25/2001	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20831s2lbl.pdf
02/16/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20831_Foradil_prntlbl.pdf

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