Last Updated: June 24, 2026

Details for New Drug Application (NDA): 211618

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NDA 211618 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, Sun Pharma Canada, Actavis Elizabeth, Rk Pharma, and Strides Pharma Intl, and is included in seventy-nine NDAs. It is available from forty-nine 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-one suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.

Summary for 211618

Tradename:	DOXEPIN HYDROCHLORIDE
Applicant:	Velzen Pharma Pvt
Ingredient:	doxepin hydrochloride
Patents:	0

Pharmacology for NDA: 211618

Medical Subject Heading (MeSH) Categories for 211618

Antidepressive Agents, Tricyclic
Histamine Antagonists
Sleep Aids, Pharmaceutical

Suppliers and Packaging for NDA: 211618

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	211618	ANDA	Leading Pharma, LLC	69315-163	69315-163-01	100 CAPSULE in 1 PACKAGE (69315-163-01)
DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	211618	ANDA	Leading Pharma, LLC	69315-163	69315-163-05	500 CAPSULE in 1 PACKAGE (69315-163-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 150MG BASE
Approval Date:	Mar 1, 2021	TE:	AB	RLD:	No

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