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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 212357

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NDA 212357 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-seven 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. Forty-nine suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.

Summary for 212357

Tradename:	DOXEPIN HYDROCHLORIDE
Applicant:	Amneal
Ingredient:	doxepin hydrochloride
Patents:	0

Pharmacology for NDA: 212357

Medical Subject Heading (MeSH) Categories for 212357

Antidepressive Agents, Tricyclic
Histamine Antagonists
Sleep Aids, Pharmaceutical

Suppliers and Packaging for NDA: 212357

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CREAM;TOPICAL	212357	ANDA	Amneal Pharmaceuticals NY LLC	69238-1733	69238-1733-6	1 TUBE in 1 CARTON (69238-1733-6) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	5%
Approval Date:	Aug 16, 2023	TE:	AB	RLD:	No

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