Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021747
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COMBIVENT RESPIMAT ALBUTEROL SULFATE; IPRATROPIUM BROMIDE EQ 0.1MG BASE/INH;0.02MG/INH SPRAY, 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
10/07/2011 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/2011/021747s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021747s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021747_combivent_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021747Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/17/2016 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/09/2016 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021747s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021747Orig1s013ltr.pdf
04/15/2016 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/29/2016 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021747s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021747Orig1s010ltr.pdf
07/09/2015 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/09/2015 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/17/2014 SUPPL-5 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021747s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021747Orig1s005ltr.pdf
06/19/2014 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/14/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/09/2013 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/29/2012 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021747s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021747Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/09/2016 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021747s013lbl.pdf
01/29/2016 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021747s010lbl.pdf
10/17/2014 SUPPL-5 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021747s005lbl.pdf
10/17/2014 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021747s005lbl.pdf
08/29/2012 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021747s001lbl.pdf
10/07/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021747s000lbl.pdf

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