Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020228
Company: BOEHRINGER INGELHEIM
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| ATROVENT | IPRATROPIUM BROMIDE | 0.02% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INHALATION | Discontinued | None | Yes | No |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. |
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| 02/05/1996 | SUPPL-1 | Labeling |
Label is not available on this site. |