Last Updated: November 8, 2026

Details for New Drug Application (NDA): 075924

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NDA 075924 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, Jubilant Cadista, Lannett Co Inc, Leading, 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 is one drug master file entry for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.

Summary for 075924

Tradename:	DOXEPIN HYDROCHLORIDE
Applicant:	Pharm Assoc
Ingredient:	doxepin hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 075924

Antidepressive Agents, Tricyclic
Histamine Antagonists
Sleep Aids, Pharmaceutical

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CONCENTRATE;ORAL			Strength	EQ 10MG BASE/ML
Approval Date:	Jan 15, 2004	TE:		RLD:	No

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