Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 009519
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DORIDEN | GLUTETHIMIDE | 250MG | TABLET;ORAL | Discontinued | None | No | No |
| DORIDEN | GLUTETHIMIDE | 500MG | TABLET;ORAL | Discontinued | None | No | No |
| DORIDEN | GLUTETHIMIDE | 500MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 04/16/1957 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/15/1982 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/08/1979 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 03/10/1976 | SUPPL-7 | Labeling |
Label is not available on this site. |