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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 218564

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NDA 218564 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 218564

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

Pharmacology for NDA: 218564

Medical Subject Heading (MeSH) Categories for 218564

Antidepressive Agents, Tricyclic
Histamine Antagonists
Sleep Aids, Pharmaceutical

Suppliers and Packaging for NDA: 218564

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	TABLET;ORAL	218564	ANDA	Ajanta Pharma USA Inc.	27241-280	27241-280-30	30 TABLET in 1 BOTTLE (27241-280-30)
DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	TABLET;ORAL	218564	ANDA	Ajanta Pharma USA Inc.	27241-281	27241-281-30	30 TABLET in 1 BOTTLE (27241-281-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 3MG BASE
Approval Date:	Jul 1, 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 1, 2024	TE:	AB	RLD:	No

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