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 | 1MG/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 03/25/1974 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
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-24 | Efficacy-New Patient Population |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 03/23/1998 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/03/1988 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 05/30/1989 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/24/1986 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 06/25/1985 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 11/02/1983 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 03/01/1983 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 07/08/1982 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/02/1982 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/19/1981 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 11/24/1980 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 03/03/1981 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 11/09/1979 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 08/07/1979 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 10/12/1978 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 12/21/1976 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-5 | Efficacy |
Label is not available on this site. |
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| 10/03/1975 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 07/21/1975 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |