Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016792
Company: ODYSSEY PHARMS
Company: ODYSSEY PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SURMONTIL | TRIMIPRAMINE MALEATE | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| SURMONTIL | TRIMIPRAMINE MALEATE | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| SURMONTIL | TRIMIPRAMINE MALEATE | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 06/12/1979 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 07/17/2014 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016792s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016792Orig1s037ltr.pdf | |
| 09/30/2014 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/2013 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/03/2012 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016792s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016792Orig1s034ltr.pdf | |
| 08/01/2007 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016792s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016792s025ltr.pdf | |
| 01/12/2005 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/16792s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16792s024ltr.pdf | |
| 05/01/2000 | SUPPL-20 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/16792S020.pdf |
| 04/27/2000 | SUPPL-19 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/16792S015.pdf |
| 04/27/2000 | SUPPL-18 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/16792S015.pdf |
| 04/03/1992 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/2000 | SUPPL-15 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/16792S015.pdf |
| 12/16/1991 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/20/1988 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/1988 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/24/1987 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/02/1987 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/12/1982 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/05/1982 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/24/1981 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/15/1982 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/26/1981 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/08/1980 | 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 |
|---|---|---|---|---|---|
| 07/17/2014 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016792s037lbl.pdf | |
| 12/03/2012 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016792s034lbl.pdf | |
| 08/01/2007 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016792s025lbl.pdf | |
| 01/12/2005 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/16792s024lbl.pdf |