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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 211619

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NDA 211619 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, Pts Consulting, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Industries, Taro, 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 211619

Tradename:	DOXEPIN HYDROCHLORIDE
Applicant:	Ixora Lifescience
Ingredient:	doxepin hydrochloride
Patents:	0

Pharmacology for NDA: 211619

Medical Subject Heading (MeSH) Categories for 211619

Antidepressive Agents, Tricyclic
Histamine Antagonists
Sleep Aids, Pharmaceutical

Suppliers and Packaging for NDA: 211619

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	211619	ANDA	Leading Pharma, LLC	69315-158	69315-158-01	100 CAPSULE in 1 PACKAGE (69315-158-01)
DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	211619	ANDA	Leading Pharma, LLC	69315-158	69315-158-10	1000 CAPSULE in 1 PACKAGE (69315-158-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 10MG BASE
Approval Date:	Mar 9, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 25MG BASE
Approval Date:	Mar 9, 2021	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 50MG BASE
Approval Date:	Mar 9, 2021	TE:	AB	RLD:	No

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