Last Updated: May 3, 2026

Details for New Drug Application (NDA): 216041

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NDA 216041 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 216041

Tradename:	DOXEPIN HYDROCHLORIDE
Applicant:	Aurobindo Pharma Ltd
Ingredient:	doxepin hydrochloride
Patents:	0

Pharmacology for NDA: 216041

Medical Subject Heading (MeSH) Categories for 216041

Antidepressive Agents, Tricyclic
Histamine Antagonists
Sleep Aids, Pharmaceutical

Suppliers and Packaging for NDA: 216041

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	TABLET;ORAL	216041	ANDA	Aurobindo Pharma Limited	59651-844	59651-844-30	30 TABLET in 1 BOTTLE (59651-844-30)
DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	TABLET;ORAL	216041	ANDA	Aurobindo Pharma Limited	59651-845	59651-845-30	30 TABLET in 1 BOTTLE (59651-845-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 3MG BASE
Approval Date:	Jul 25, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 6MG BASE
Approval Date:	Jul 25, 2024	TE:	AB	RLD:	No

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