Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074284
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ETOPOSIDE | ETOPOSIDE | 20MG/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 |
|---|---|---|---|---|---|---|---|
| 02/10/1994 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/11/2002 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 02/23/1999 | SUPPL-17 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 06/16/1998 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 06/16/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/1998 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1997 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 06/20/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/27/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 04/25/1996 | SUPPL-7 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 04/25/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/1996 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 09/16/1994 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 08/23/1995 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 08/23/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/16/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |