Drugs@FDA: FDA-Approved Drugs
Company: MALLINCKRODT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VASCORAY | IOTHALAMATE MEGLUMINE; IOTHALAMATE SODIUM | 52%;26% | 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 |
|---|---|---|---|---|---|---|---|
| 01/26/1971 | ORIG-1 | Approval | Type 4 - New Combination | 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 |
|---|---|---|---|---|---|
| 01/13/1995 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 08/28/1992 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/04/1992 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/30/1990 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/28/1989 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 12/01/1989 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/19/1988 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/23/1985 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 10/10/1989 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/04/1984 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/25/1984 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/03/1983 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 06/16/1982 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 01/25/1979 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/18/1978 | SUPPL-14 | Efficacy |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 05/14/1976 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 05/10/1976 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/23/1976 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/23/1976 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/30/1975 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |