Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020831
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FORADIL FORMOTEROL FUMARATE 0.012MG/INH POWDER;INHALATION Discontinued None Yes No
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.

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English