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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 212997

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NDA 212997 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 212997

Tradename:	DOXEPIN HYDROCHLORIDE
Applicant:	Lannett Co Inc
Ingredient:	doxepin hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 212997

Antidepressive Agents, Tricyclic
Histamine Antagonists
Sleep Aids, Pharmaceutical

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 10MG BASE
Approval Date:	Jul 24, 2020	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 25MG BASE
Approval Date:	Jul 24, 2020	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 50MG BASE
Approval Date:	Jul 24, 2020	TE:		RLD:	No

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