Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011683
Company: IMMUNEX
Company: IMMUNEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| THIOTEPA | THIOTEPA | 15MG/VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 03/09/1959 | 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 |
|---|---|---|---|---|---|
| 02/23/1993 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 12/18/1990 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/17/1986 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 02/14/1986 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/24/1981 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/16/1978 | SUPPL-11 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 09/21/1978 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/1978 | SUPPL-9 | Unspecified |
Label is not available on this site. |
||
| 09/15/1975 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |