Last Updated: November 8, 2026

Details for New Drug Application (NDA): 210675

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NDA 210675 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 210675

Tradename:	DOXEPIN HYDROCHLORIDE
Applicant:	Epic Pharma Llc
Ingredient:	doxepin hydrochloride
Patents:	0

Pharmacology for NDA: 210675

Medical Subject Heading (MeSH) Categories for 210675

Antidepressive Agents, Tricyclic
Histamine Antagonists
Sleep Aids, Pharmaceutical

Suppliers and Packaging for NDA: 210675

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	210675	ANDA	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	24658-793	24658-793-01	100 CAPSULE in 1 BOTTLE (24658-793-01)
DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	210675	ANDA	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	24658-793	24658-793-10	1000 CAPSULE in 1 BOTTLE (24658-793-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 10MG BASE
Approval Date:	Oct 16, 2020	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 25MG BASE
Approval Date:	Oct 16, 2020	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 100MG BASE
Approval Date:	Oct 16, 2020	TE:	AB	RLD:	No

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