Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021527
Company: BOEHRINGER INGELHEIM
Company: BOEHRINGER INGELHEIM
| 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 | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/30/2024 | SUPPL-42 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021527Orig1s042lbl.pdf | |
| 12/30/2024 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021527Orig1s042lbl.pdf | |
| 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 |