Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 009166
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROXYSTILBAMIDINE ISETHIONATE | HYDROXYSTILBAMIDINE ISETHIONATE | 225MG/AMP | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 12/22/1953 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 03/19/1987 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/12/1980 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/1980 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 04/12/1980 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |