Drugs@FDA: FDA-Approved Drugs
Company: SANOFI AVENTIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TORNALATE | BITOLTEROL MESYLATE | 0.37MG/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 |
---|---|---|---|---|---|---|---|
12/28/1984 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
---|---|---|---|---|---|
01/20/1999 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/07/2007 | SUPPL-16 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-15 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-14 | Labeling |
Label is not available on this site. |
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07/09/1991 | SUPPL-13 | Labeling |
Label is not available on this site. |
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04/11/1994 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/07/2007 | SUPPL-11 | Efficacy-New Patient Population |
Label is not available on this site. |
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09/24/1986 | SUPPL-10 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
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08/06/1986 | SUPPL-7 | Labeling |
Label is not available on this site. |
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01/09/1986 | SUPPL-5 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-4 | Efficacy-New Indication |
Label is not available on this site. |
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01/17/1986 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/14/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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03/11/1985 | SUPPL-1 | Labeling |
Label is not available on this site. |