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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. It is available from one supplier. 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. Twenty-one suppliers are listed for this compound. Additional details are available on the guanfacine hydrochloride profile page.

Summary for NDA: 019032

Promius Pharma
guanfacine hydrochloride
Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 019032

Mechanism of ActionAdrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 019032

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
guanfacine hydrochloride
TABLET;ORAL 019032 NDA Promius Pharma, LLC 67857-705 67857-705-01 100 TABLET in 1 BOTTLE, PLASTIC (67857-705-01)
guanfacine hydrochloride
TABLET;ORAL 019032 NDA Promius Pharma, LLC 67857-705 67857-705-05 500 TABLET in 1 BOTTLE, PLASTIC (67857-705-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Oct 27, 1986TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2MG BASE
Approval Date:Nov 7, 1988TE:ABRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 3MG BASE
Approval Date:Nov 7, 1988TE:RLD:No

Expired Orange Book Patents for NDA: 019032

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Promius Pharma
guanfacine hydrochloride
TABLET;ORAL019032-001Oct 27, 19863,632,645► subscribe
Promius Pharma
guanfacine hydrochloride
TABLET;ORAL019032-002Nov 7, 19883,632,645► subscribe
Promius Pharma
guanfacine hydrochloride
TABLET;ORAL019032-003Nov 7, 19883,632,645► subscribe
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