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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021527
Company: BOEHRINGER INGELHEIM

Products on NDA 021527

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ATROVENT HFA	IPRATROPIUM BROMIDE	0.021MG/INH	AEROSOL, METERED;INHALATION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021527

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/17/2004	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21527lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21527ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021527s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/10/2020	SUPPL-33	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021527s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021527Orig1s033ltr.pdf
08/11/2016	SUPPL-27	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021527Orig1s027ltr.pdf
04/29/2016	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
05/09/2014	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
04/29/2015	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
08/30/2012	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021527s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021527Orig1s021ltr.pdf
10/06/2011	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021527s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021527s019ltr.pdf
12/23/2010	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021527s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021527s016ltr.pdf
10/14/2008	SUPPL-11	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021527s011ltr.pdf
09/05/2006	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021527s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021527s005_ltr.pdf
03/23/2006	SUPPL-3	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021527S003ltr.pdf

Labels for NDA 021527

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/10/2020	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021527s033lbl.pdf
08/30/2012	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021527s021lbl.pdf
10/06/2011	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021527s019lbl.pdf
12/23/2010	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021527s016lbl.pdf
09/05/2006	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021527s005lbl.pdf
11/17/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21527lbl.pdf

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