Drugs@FDA: FDA-Approved Drugs
Company: CORDEN PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VEPESID | ETOPOSIDE | 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 11/10/1983 | 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 |
|---|---|---|---|---|---|
| 10/25/2000 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/2002 | SUPPL-45 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/019557s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18768slr045,19557slr028ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018768_S045_VEPESIDE.pdf | |
| 02/02/2000 | SUPPL-44 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/02/1999 | SUPPL-41 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18768S041_VePesid.pdf |
| 12/15/1998 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/11/1995 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/08/1995 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/27/1995 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/30/1993 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/20/1993 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1993 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 08/24/1993 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/17/1995 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/01/1991 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 11/01/1991 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 09/04/1990 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/04/1990 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/1989 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/11/1988 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/25/1988 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 05/20/1987 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 04/28/1988 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/19/1987 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/1986 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 10/29/1986 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/30/1986 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/26/1986 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 11/06/1986 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/04/1986 | SUPPL-7 | Efficacy-New Indication |
Label is not available on this site. |
||
| 03/12/1985 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/06/1985 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/06/1985 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 03/06/1985 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 03/06/1985 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 08/21/1984 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/05/2002 | SUPPL-45 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/019557s028lbl.pdf |