Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019548
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TORNALATE | BITOLTEROL MESYLATE | 0.2% | SOLUTION;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 |
---|---|---|---|---|---|---|---|
02/19/1992 | 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 |
---|---|---|---|---|---|
12/07/2007 | SUPPL-4 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-3 | Labeling |
Label is not available on this site. |
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09/21/1994 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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02/02/1994 | SUPPL-1 | Labeling |
Label is not available on this site. |