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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020291
Company: BOEHRINGER INGELHEIM

Products on NDA 020291

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020291

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.

Labels for NDA 020291

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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