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Generated: September 22, 2017

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Details for New Drug Application (NDA): 200881

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NDA 200881 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 twenty-three 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-five suppliers are listed for this compound. Additional details are available on the guanfacine hydrochloride profile page.

Summary for NDA: 200881

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 200881

Mechanism of ActionAdrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 200881

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GUANFACINE HYDROCHLORIDE
guanfacine hydrochloride
TABLET, EXTENDED RELEASE;ORAL 200881 ANDA Actavis Pharma, Inc. 0228-2850 0228-2850-11 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-2850-11)
GUANFACINE HYDROCHLORIDE
guanfacine hydrochloride
TABLET, EXTENDED RELEASE;ORAL 200881 ANDA Actavis Pharma, Inc. 0228-2850 0228-2850-50 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-2850-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 1MG BASE
Approval Date:Oct 5, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 2MG BASE
Approval Date:Oct 5, 2012TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 3MG BASE
Approval Date:Oct 5, 2012TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Novartis
Cerilliant
QuintilesIMS
Medtronic
Moodys
Accenture
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UBS
Colorcon
Harvard Business School

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