Details for New Drug Application (NDA): 020126

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NDA 020126 describes ZONALON, which is a drug marketed by Mylan and is included in one NDA. It is available from one supplier. 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. Forty-two suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.

Summary for 020126

Tradename:	ZONALON
Applicant:	Mylan
Ingredient:	doxepin hydrochloride
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020126

Medical Subject Heading (MeSH) Categories for 020126

Antidepressive Agents, Tricyclic
Histamine Antagonists
Sleep Aids, Pharmaceutical

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 AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	0378-8117	0378-8117-45	1 TUBE in 1 CARTON (0378-8117-45) / 45 g in 1 TUBE
ZONALON	doxepin hydrochloride	CREAM;TOPICAL	020126	NDA	Mylan Pharmaceuticals Inc.	0378-8123	0378-8123-30	1 TUBE in 1 CARTON (0378-8123-30) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	5%
Approval Date:	Apr 1, 1994	TE:		RLD:	Yes

Expired US Patents for NDA 020126

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan	ZONALON	doxepin hydrochloride	CREAM;TOPICAL	020126-001	Apr 1, 1994	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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