Last Updated: May 5, 2026

Details for New Drug Application (NDA): 215113

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NDA 215113 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, 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, 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 215113

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

Pharmacology for NDA: 215113

Medical Subject Heading (MeSH) Categories for 215113

Antidepressive Agents, Tricyclic
Histamine Antagonists
Sleep Aids, Pharmaceutical

Suppliers and Packaging for NDA: 215113

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	215113	ANDA	A-S Medication Solutions	50090-7819	50090-7819-1	30 CAPSULE in 1 BOTTLE (50090-7819-1)
DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	215113	ANDA	REMEDYREPACK INC.	70518-4179	70518-4179-0	30 CAPSULE in 1 BLISTER PACK (70518-4179-0)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 10MG BASE
Approval Date:	Jun 24, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 25MG BASE
Approval Date:	Jun 24, 2022	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 50MG BASE
Approval Date:	Jun 24, 2022	TE:	AB	RLD:	No

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