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Last Updated: August 4, 2021

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Details for New Drug Application (NDA): 074145

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NDA 074145 describes GUANFACINE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Apotex, Impax Labs Inc, Mylan, Sandoz Inc, Sun Pharm, Teva Pharms Usa, Twi Pharms, Yichang Humanwell, Amneal Pharm, Epic Pharma Llc, Unichem, and Watson Labs, and is included in fifteen NDAs. It is available from nineteen suppliers. Additional details are available on the GUANFACINE HYDROCHLORIDE profile page.

The generic ingredient in GUANFACINE HYDROCHLORIDE is guanfacine hydrochloride. There are seven drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the guanfacine hydrochloride profile page.
Summary for 074145
Applicant:Watson Labs
Ingredient:guanfacine hydrochloride
Pharmacology for NDA: 074145
Mechanism of ActionAdrenergic alpha2-Agonists
Medical Subject Heading (MeSH) Categories for 074145
Suppliers and Packaging for NDA: 074145
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET;ORAL 074145 ANDA Actavis Pharma, Inc. 0591-0444 0591-0444-01 100 TABLET in 1 BOTTLE, PLASTIC (0591-0444-01)
GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET;ORAL 074145 ANDA Actavis Pharma, Inc. 0591-0453 0591-0453-01 100 TABLET in 1 BOTTLE (0591-0453-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Oct 17, 1995TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2MG BASE
Approval Date:Oct 17, 1995TE:ABRLD:No

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