Drugs@FDA: FDA-Approved Drugs
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BRICANYL | TERBUTALINE SULFATE | 2.5MG | TABLET;ORAL | Discontinued | None | No | No |
| BRICANYL | TERBUTALINE SULFATE | 5MG | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 04/22/1975 | 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 |
|---|---|---|---|---|---|
| 10/08/1997 | SUPPL-36 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 12/24/1997 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/03/1988 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 05/03/1991 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/30/1989 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/10/1986 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 07/15/1986 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/30/1984 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/27/1985 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 02/22/1986 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 02/22/1986 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 09/13/1978 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-20 | Efficacy |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-19 | Efficacy |
Label is not available on this site. |
||
| 06/22/1977 | SUPPL-18 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/24/1976 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/1976 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/30/1976 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 06/30/1976 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 06/24/1976 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/13/1976 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 12/10/1975 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/04/1975 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 11/04/1975 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/10/1975 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/04/1975 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 11/04/1975 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 07/21/1975 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/21/1975 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/18/1975 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 06/18/1975 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |