Drugs@FDA: FDA-Approved Drugs
Company: VALIDUS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRENTAL | PENTOXIFYLLINE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 08/30/1984 | 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 |
|---|---|---|---|---|---|
| 01/15/2016 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018631s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018631Orig1s041ltr.pdf | |
| 02/13/2015 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018631s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018631Orig1s040ltr.pdf | |
| 07/05/2012 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018631s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018631s039ltr.pdf | |
| 04/17/2014 | SUPPL-36 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018631Orig1s036ltr.pdf |
| 04/07/2005 | SUPPL-34 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018631s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018631s034ltr.pdf | |
| 09/30/2003 | SUPPL-33 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18631slr033ltr.pdf |
| 11/03/1997 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1997 | SUPPL-30 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/018631_s030ap.pdf |
| 06/18/1996 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/09/1996 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/02/1996 | SUPPL-26 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/10/1995 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/04/1995 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/28/1995 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 07/25/1994 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 11/04/1994 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/24/1993 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/11/1993 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/16/1991 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/30/1991 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/1991 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/07/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 10/30/1990 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/07/1991 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 02/23/1990 | SUPPL-11 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/28/1989 | SUPPL-9 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 01/27/1988 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 09/03/1987 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/27/1986 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/24/1986 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 10/04/1985 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/13/1985 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/15/2016 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018631s041lbl.pdf | |
| 02/13/2015 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018631s040lbl.pdf | |
| 07/05/2012 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018631s039lbl.pdf | |
| 04/07/2005 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018631s034lbl.pdf |