Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020394
Company: BOEHRINGER INGELHEIM
Company: BOEHRINGER INGELHEIM
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ATROVENT | IPRATROPIUM BROMIDE | 0.042MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED;NASAL | Discontinued | None | Yes | No |
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 |
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 |