You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: March 26, 2026

Details for New Drug Application (NDA): 020126

✉ Email this page to a colleague

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. Fifty 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

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:	AB	RLD:	Yes

Expired US Patents for NDA 020126

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan	ZONALON	doxepin hydrochloride	CREAM;TOPICAL	020126-001	Apr 1, 1994	4,395,420	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.