Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020228
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATROVENT IPRATROPIUM BROMIDE 0.02% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;INHALATION Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/29/1993 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020228_LBL_ATROVENT.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/18/1999 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1998 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

07/16/1998 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

02/05/1996 SUPPL-1 Labeling

Label is not available on this site.

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