Drugs@FDA: FDA-Approved Drugs
Company: BOEHRINGER INGELHEIM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ATROVENT | IPRATROPIUM BROMIDE | 0.018MG/INH | AEROSOL, METERED;INHALATION | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 12/29/1986 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019085Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/13/2009 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 08/27/2001 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/22/2000 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/18/1999 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/03/1998 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 11/26/1997 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/03/1996 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 01/29/1996 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 01/31/1994 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/13/1994 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 05/19/1994 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/15/1997 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/10/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1994 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 01/04/1995 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/25/1992 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/1989 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 04/10/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/1988 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/27/1988 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |