Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010787
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IRON DEXTRAN | FERRIC OXYHYDROXIDE | EQ 50MG IRON/ML | 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 |
|---|---|---|---|---|---|---|---|
| 04/25/1957 | ORIG-1 | Approval | Type 2 - New Active Ingredient | 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 |
|---|---|---|---|---|---|
| 09/19/1991 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/06/1989 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/25/1988 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/27/1987 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/23/1986 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 11/20/1984 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/20/1983 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 12/29/1982 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 06/23/1982 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 08/18/1982 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/04/1981 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/02/1981 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/13/1980 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 11/12/1976 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 11/04/1976 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/18/1975 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/06/1981 | SUPPL-9 | Unspecified |
Label is not available on this site. |