Drugs@FDA: FDA-Approved Drugs
Company: NEW RIVER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIAVIL 2-10 | AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE | 10MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |
| TRIAVIL 2-25 | AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE | 25MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |
| TRIAVIL 4-10 | AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE | 10MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |
| TRIAVIL 4-25 | AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE | 25MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |
| TRIAVIL 4-50 | AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE | 50MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 08/23/1965 | ORIG-1 | Approval | Type 4 - New Combination | 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 |
|---|---|---|---|---|---|
| 03/13/2009 | SUPPL-80 | Labeling |
Label is not available on this site. |
||
| 12/28/1994 | SUPPL-79 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/07/1994 | SUPPL-78 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/1989 | SUPPL-77 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-76 | Labeling |
Label is not available on this site. |
||
| 08/09/1988 | SUPPL-75 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/08/1988 | SUPPL-74 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/28/1989 | SUPPL-73 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-72 | Labeling |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-71 | Labeling |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-69 | Labeling |
Label is not available on this site. |
||
| 12/05/1985 | SUPPL-68 | Labeling |
Label is not available on this site. |
||
| 08/06/1985 | SUPPL-67 | Labeling |
Label is not available on this site. |
||
| 08/06/1985 | SUPPL-66 | Labeling |
Label is not available on this site. |
||
| 08/06/1985 | SUPPL-65 | Labeling |
Label is not available on this site. |
||
| 09/13/1984 | SUPPL-64 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/29/1980 | SUPPL-63 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/14/1984 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/1986 | SUPPL-61 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/15/1983 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 05/20/1983 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-58 | Labeling |
Label is not available on this site. |
||
| 05/21/1984 | SUPPL-57 | Labeling |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 06/25/1981 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 11/07/1980 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 06/23/1980 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 03/02/1981 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/03/1981 | SUPPL-48 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/11/1980 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 03/02/1981 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/1984 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/29/1979 | SUPPL-44 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 10/18/1977 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/15/1978 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 03/15/1978 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/15/1978 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 03/01/1977 | SUPPL-34 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 03/09/1981 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 01/20/1976 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-26 | Labeling |
Label is not available on this site. |