Product Details for NDA 014715
TRIAVIL 2-10 (AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE)
10MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
25MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
25MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
50MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Proprietary Name: TRIAVIL 2-10
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N014715
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: NEW RIVER PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
TRIAVIL 2-25 (AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE)
Proprietary Name: TRIAVIL 2-10
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N014715
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: NEW RIVER PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
25MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Proprietary Name: TRIAVIL 2-25
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N014715
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: NEW RIVER PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
TRIAVIL 4-10 (AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE)
Proprietary Name: TRIAVIL 2-25
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N014715
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: NEW RIVER PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
10MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Proprietary Name: TRIAVIL 4-10
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N014715
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: NEW RIVER PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
TRIAVIL 4-25 (AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE)
Proprietary Name: TRIAVIL 4-10
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N014715
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: NEW RIVER PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
25MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Proprietary Name: TRIAVIL 4-25
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N014715
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: NEW RIVER PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
TRIAVIL 4-50 (AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE)
Proprietary Name: TRIAVIL 4-25
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N014715
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: NEW RIVER PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
50MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Proprietary Name: TRIAVIL 4-50
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N014715
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: NEW RIVER PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: TRIAVIL 4-50
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N014715
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: NEW RIVER PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information