Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017098
Company: MALLINCKRODT
Company: MALLINCKRODT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SELENOMETHIONINE SE 75 | SELENOMETHIONINE SE-75 | 100uCi/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 |
|---|---|---|---|---|---|---|---|
| 05/07/1973 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 03/13/1984 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 10/05/1982 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/07/1982 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/01/1979 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/23/1977 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1977 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |