Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 009410
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOTUSATE | TALBUTAL | 120MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/21/1954 | 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 |
|---|---|---|---|---|---|
| 10/29/1985 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/15/1982 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 04/02/1980 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 05/12/1998 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 05/12/1998 | SUPPL-3 | Labeling |
Label is not available on this site. |