Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085204
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SLO-PHYLLIN | THEOPHYLLINE | 200MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/14/1979 | 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 |
|---|---|---|---|---|---|
| 04/29/1999 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/27/1990 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 07/26/1990 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 06/18/1990 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1988 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 11/01/1985 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/30/1984 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/10/1984 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/10/1984 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1985 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/14/1983 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/15/1982 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/15/1982 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |