Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089540
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SLO-BID | THEOPHYLLINE | 125MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/10/1989 | 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-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/19/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1990 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 08/10/1990 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 05/30/1990 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1990 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1990 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1989 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/1990 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |