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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021747
Company: BOEHRINGER INGELHEIM

Summary Review

Products on NDA 021747

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021747

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
09/27/2020	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021747s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021747Orig1s020ltr.pdf
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

Labels for NDA 021747

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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