Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 014715
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HYDROCHLORIDE; PERPHENAZINE 10MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No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HYDROCHLORIDE; PERPHENAZINE 25MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No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HYDROCHLORIDE; PERPHENAZINE 10MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No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HYDROCHLORIDE; PERPHENAZINE 25MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No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HYDROCHLORIDE; PERPHENAZINE 50MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No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.

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