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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 217975

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NDA 217975 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 217975

Tradename:	DOXEPIN HYDROCHLORIDE
Applicant:	Pts Consulting
Ingredient:	doxepin hydrochloride
Patents:	0

Pharmacology for NDA: 217975

Medical Subject Heading (MeSH) Categories for 217975

Antidepressive Agents, Tricyclic
Histamine Antagonists
Sleep Aids, Pharmaceutical

Suppliers and Packaging for NDA: 217975

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	217975	ANDA	Rising Pharma Holdings, Inc.	64980-594	64980-594-01	100 CAPSULE in 1 BOTTLE (64980-594-01)
DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	217975	ANDA	Rising Pharma Holdings, Inc.	64980-595	64980-595-01	100 CAPSULE in 1 BOTTLE (64980-595-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 10MG BASE
Approval Date:	Aug 21, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 25MG BASE
Approval Date:	Aug 21, 2023	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 50MG BASE
Approval Date:	Aug 21, 2023	TE:	AB	RLD:	No

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