Drugs@FDA: FDA-Approved Drugs
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SLO-BID | THEOPHYLLINE | 300MG | CAPSULE, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 01/31/1985 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/01/1998 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/19/1996 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/28/1991 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 07/26/1990 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 03/27/1990 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/1990 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/1990 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/07/1989 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/07/1989 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/1987 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/19/1988 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/31/1986 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/31/1986 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1985 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/14/1986 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/23/1985 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/31/1986 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/18/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/18/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/18/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/18/1985 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |