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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 Twi Pharms Inc, Amneal Pharm, Impax Labs Inc, Watson Labs, Sandoz Inc, Epic Pharma Llc, Mylan Pharms Inc, Actavis Elizabeth, Teva Pharms Usa, and Mylan, and is included in eleven NDAs. It is available from eighteen 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 NDA: 074145

Watson Labs
guanfacine hydrochloride
Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 074145

Mechanism of ActionAdrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 074145

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
TABLET;ORAL 074145 ANDA Actavis Pharma, Inc. 0591-0453 0591-0453-01 100 TABLET in 1 BOTTLE (0591-0453-01)

Summary for product number 001

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

Summary for product number 002

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

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