Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020393
Company: BOEHRINGER INGELHEIM
Company: BOEHRINGER INGELHEIM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ATROVENT | IPRATROPIUM BROMIDE | 0.021MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED;NASAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 05/11/2015 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/05/2015 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/02/2011 | SUPPL-11 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020393s011ltr.pdf |
| 12/04/2007 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020393s007,020394s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020393s007,020394s008ltr.pdf | |
| 05/23/2003 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20393slr004,20394slr005_atrovent_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20393slr004,20394slr005ltr.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. |
||
| 04/01/1998 | SUPPL-1 | Efficacy-New Indication |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20393ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/04/2007 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020393s007,020394s008lbl.pdf | |
| 05/23/2003 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20393slr004,20394slr005_atrovent_lbl.pdf |