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Drugs@FDA: FDA-Approved Drugs

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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

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
09/27/2020 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021747s020lbl.pdf
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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