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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 019032


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NDA 019032 describes TENEX, which is a drug marketed by Promius Pharma and is included in one NDA. Additional details are available on the TENEX profile page.

The generic ingredient in TENEX is guanfacine hydrochloride. There are seven drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the guanfacine hydrochloride profile page.
Summary for 019032
Tradename:TENEX
Applicant:Promius Pharma
Ingredient:guanfacine hydrochloride
Patents:0
Medical Subject Heading (MeSH) Categories for 019032

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 27, 1986TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Nov 7, 1988TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Nov 7, 1988TE:RLD:No

Expired US Patents for NDA 019032

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Promius Pharma TENEX guanfacine hydrochloride TABLET;ORAL 019032-001 Oct 27, 1986 ⤷  Try a Trial ⤷  Try a Trial
Promius Pharma TENEX guanfacine hydrochloride TABLET;ORAL 019032-002 Nov 7, 1988 ⤷  Try a Trial ⤷  Try a Trial
Promius Pharma TENEX guanfacine hydrochloride TABLET;ORAL 019032-003 Nov 7, 1988 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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