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Serving hundreds of leading biopharmaceutical companies globally:

Merck
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Fish and Richardson
Federal Trade Commission
US Army
Colorcon
Baxter
Queensland Health
AstraZeneca

Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020126

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NDA 020126 describes ZONALON, which is a drug marketed by Mylan Pharms Inc and is included in one NDA. It is available from four suppliers. Additional details are available on the ZONALON profile page.

The generic ingredient in ZONALON is doxepin hydrochloride. There are seven drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.
Summary for 020126
Tradename:ZONALON
Applicant:Mylan Pharms Inc
Ingredient:doxepin hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Anxiolytics
Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 020126
Medical Subject Heading (MeSH) Categories for 020126
Suppliers and Packaging for NDA: 020126
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZONALON doxepin hydrochloride CREAM;TOPICAL 020126 NDA PharmaDerm A division of Fougera Pharmaceuticals Inc. 10337-804 N 10337-804-03
ZONALON doxepin hydrochloride CREAM;TOPICAL 020126 NDA PharmaDerm A division of Fougera Pharmaceuticals Inc. 10337-804 N 10337-804-45

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength5%
Approval Date:Apr 1, 1994TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Merck
Julphar
Chinese Patent Office
Fuji
Harvard Business School
Federal Trade Commission
QuintilesIMS
US Department of Justice

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