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Details for New Drug Application (NDA): 014715

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NDA 014715 describes TRIAVIL 4-50, which is a drug marketed by New River and is included in one NDA. Additional details are available on the TRIAVIL 4-50 profile page.

The generic ingredient in TRIAVIL 4-50 is amitriptyline hydrochloride; perphenazine. There are thirteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride; perphenazine profile page.

Summary for NDA: 014715

Tradename:
TRIAVIL 2-10
Applicant:
New River
Ingredient:
amitriptyline hydrochloride; perphenazine
Patents:0
Formulation / Manufacturing:see details

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG;2MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG;4MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG;2MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Expired Orange Book Patents for NDA: 014715

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
New River
TRIAVIL 2-25
amitriptyline hydrochloride; perphenazine
TABLET;ORAL014715-002Approved Prior to Jan 1, 19823,428,735► subscribe
New River
TRIAVIL 4-50
amitriptyline hydrochloride; perphenazine
TABLET;ORAL014715-006Approved Prior to Jan 1, 19823,428,735► subscribe
New River
TRIAVIL 4-25
amitriptyline hydrochloride; perphenazine
TABLET;ORAL014715-005Approved Prior to Jan 1, 19823,428,735► subscribe
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