An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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-Package Insert, Labeling-Container/Carton Labels	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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021747s005lbl.pdf
10/17/2014	SUPPL-5	Labeling-Container/Carton Labels	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

Top