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Serving 500+ biopharmaceutical companies globally:

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Generated: June 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202568

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NDA 202568 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-two 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-four suppliers are listed for this compound. Additional details are available on the guanfacine hydrochloride profile page.

Summary for NDA: 202568

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

Pharmacology for NDA: 202568

Mechanism of ActionAdrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 202568

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GUANFACINE HYDROCHLORIDE
guanfacine hydrochloride
TABLET, EXTENDED RELEASE;ORAL 202568 ANDA Sandoz Inc 0781-5451 0781-5451-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5451-01)
GUANFACINE HYDROCHLORIDE
guanfacine hydrochloride
TABLET, EXTENDED RELEASE;ORAL 202568 ANDA Sandoz Inc 0781-5451 0781-5451-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5451-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 1MG BASE
Approval Date:Jun 3, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 2MG BASE
Approval Date:Jun 3, 2015TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 3MG BASE
Approval Date:Jun 3, 2015TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Express Scripts
McKinsey
Colorcon
Daiichi Sankyo
Cipla
Deloitte
AstraZeneca
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Moodys
Medtronic

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