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Generated: November 12, 2018

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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 five 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. Twenty-eight 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
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 Mylan Pharmaceuticals Inc. 0378-8130 0378-8130-45 1 TUBE in 1 CARTON (0378-8130-45) > 45 g in 1 TUBE
ZONALON doxepin hydrochloride CREAM;TOPICAL 020126 NDA PharmaDerm A division of Fougera Pharmaceuticals Inc. 10337-804 10337-804-03 1 TUBE in 1 CARTON (10337-804-03) > 30 g in 1 TUBE

Profile for product number 001

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

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