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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020394
Company: BOEHRINGER INGELHEIM

Approval PAckage

Products on NDA 020394

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ATROVENT	IPRATROPIUM BROMIDE	0.042MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED;NASAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020394

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/20/1995	ORIG-1	Approval	Type 3 - New Dosage Form	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
02/18/2011	SUPPL-12	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020394s012ltr.pdf
10/14/2008	SUPPL-8	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020394s008ltr.pdf
05/23/2003	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020394s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20393slr004,20394slr005ltr.pdf
10/27/2000	SUPPL-4	Efficacy-New Indication	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020394 Orig1s004.pdf
08/18/1999	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
01/27/2000	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
11/09/1998	SUPPL-1	Efficacy-New Indication	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20394s01ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20394-S001_Atrovent.pdf

Labels for NDA 020394

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/23/2003	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020394s005lbl.pdf

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