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Serving leading biopharmaceutical companies globally:

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Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074796

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NDA 074796 describes GUANFACINE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Impax Labs Inc, Mylan Pharms Inc, Sandoz Inc, Teva Pharms Usa, Twi Pharms Inc, Amneal Pharm, Epic Pharma Llc, Mylan, and Watson Labs, 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 074796
Tradename:GUANFACINE HYDROCHLORIDE
Applicant:Mylan
Ingredient:guanfacine hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Pharmacology for NDA: 074796
Mechanism of ActionAdrenergic alpha2-Agonists
Medical Subject Heading (MeSH) Categories for 074796
Suppliers and Packaging for NDA: 074796
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET;ORAL 074796 ANDA Mylan Pharmaceuticals Inc. 0378-1160 0378-1160-01 100 TABLET in 1 BOTTLE (0378-1160-01)
GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET;ORAL 074796 ANDA Mylan Pharmaceuticals Inc. 0378-1190 0378-1190-01 100 TABLET in 1 BOTTLE (0378-1190-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Jan 27, 1997TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2MG BASE
Approval Date:Jan 27, 1997TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Citi
UBS
Johnson and Johnson
Mallinckrodt
Harvard Business School
Cipla
Julphar
Argus Health

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