Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021527
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATROVENT HFA IPRATROPIUM BROMIDE 0.021MG/INH AEROSOL, METERED;INHALATION Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/17/2004 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21527lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21527ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021527s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/29/2016 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

05/09/2014 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

04/29/2015 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

08/30/2012 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021527s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021527Orig1s021ltr.pdf
10/06/2011 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021527s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021527s019ltr.pdf
12/23/2010 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021527s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021527s016ltr.pdf
10/14/2008 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021527s011ltr.pdf
09/05/2006 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021527s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021527s005_ltr.pdf
03/23/2006 SUPPL-3 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021527S003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/30/2012 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021527s021lbl.pdf
10/06/2011 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021527s019lbl.pdf
12/23/2010 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021527s016lbl.pdf
09/05/2006 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021527s005lbl.pdf
11/17/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21527lbl.pdf

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