Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020291
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COMBIVENT ALBUTEROL SULFATE; IPRATROPIUM BROMIDE EQ 0.09MG BASE/INH;0.018MG/INH AEROSOL, METERED;INHALATION Discontinued None No 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
10/24/1996 ORIG-1 Approval Type 4 - New Combination STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/20/2012 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020291s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020291Orig1s031ltr.pdf
09/17/2012 SUPPL-30 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020291Orig1s030ltr.pdf
04/01/2011 SUPPL-29 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020291s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020291s029ltr.pdf
06/02/2009 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020291s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020291s027ltr.pdf
05/07/2009 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020291s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020291s026ltr.pdf
11/10/2008 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020291s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020291s023ltr.pdf
06/01/2006 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020291s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020291s020LTR.pdf
07/23/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/16/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/18/1999 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/19/1998 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

03/23/1999 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

11/26/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/14/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/08/1997 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
08/20/2012 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020291s031lbl.pdf
04/01/2011 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020291s029lbl.pdf
06/02/2009 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020291s027lbl.pdf
05/07/2009 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020291s026lbl.pdf
11/10/2008 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020291s023lbl.pdf
06/01/2006 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020291s020lbl.pdf

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