Last Updated: May 3, 2026

Details for New Drug Application (NDA): 202761

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NDA 202761 describes DOXEPIN HYDROCHLORIDE, which is a drug marketed by Adaptis, Aiping Pharm Inc, Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Appco, Aurobindo Pharma Ltd, Chartwell Rx, Dava Pharms Inc, Epic Pharma Llc, Ixora Lifescience, Jubilant Cadista, Lannett Co Inc, Mankind Pharma, Micro Labs, MSN, Mylan Pharms Inc, New River, Ph Health, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Industries, Taro, Unique, Velzen Pharma Pvt, Watson Labs, Watson Labs Teva, Zydus Lifesciences, Pharm Assoc, Pharmobedient Cnsltg, Teva Pharms, Amneal, Actavis Elizabeth, Rk Pharma, and Strides Pharma Intl, and is included in seventy-eight NDAs. It is available from forty-eight suppliers. Additional details are available on the DOXEPIN HYDROCHLORIDE profile page.

The generic ingredient in DOXEPIN HYDROCHLORIDE 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 202761

Tradename:	DOXEPIN HYDROCHLORIDE
Applicant:	Zydus Lifesciences
Ingredient:	doxepin hydrochloride
Patents:	0

Pharmacology for NDA: 202761

Medical Subject Heading (MeSH) Categories for 202761

Antidepressive Agents, Tricyclic
Histamine Antagonists
Sleep Aids, Pharmaceutical

Suppliers and Packaging for NDA: 202761

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	TABLET;ORAL	202761	ANDA	Zydus Lifesciences Limited	70771-1528	70771-1528-0	1000 TABLET in 1 BOTTLE (70771-1528-0)
DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	TABLET;ORAL	202761	ANDA	Zydus Lifesciences Limited	70771-1528	70771-1528-1	100 TABLET in 1 BOTTLE (70771-1528-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 3MG BASE
Approval Date:	Aug 16, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 6MG BASE
Approval Date:	Aug 16, 2023	TE:	AB	RLD:	No

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