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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 213796

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NDA 213796 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, Endo Operations, Epic Pharma Llc, Jubilant Cadista, Lannett Co Inc, Leading, Mankind Pharma, Micro Labs, MSN, Mylan Pharms Inc, New River, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Industries, Taro, Unique Pharm, Velzen Pharma Pvt, Watson Labs, Watson Labs Teva, Zydus Lifesciences, Pharm Assoc, Pharmobedient Cnsltg, Teva Pharms, Amneal, Actavis Elizabeth, Rk Pharma, and Strides Pharma, and is included in seventy-seven 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 213796

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

Pharmacology for NDA: 213796

Medical Subject Heading (MeSH) Categories for 213796

Antidepressive Agents, Tricyclic
Histamine Antagonists
Sleep Aids, Pharmaceutical

Suppliers and Packaging for NDA: 213796

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	213796	ANDA	Edenbridge Pharmaceuticals LLC.	42799-935	42799-935-01	100 CAPSULE in 1 BOTTLE (42799-935-01)
DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	213796	ANDA	Edenbridge Pharmaceuticals LLC.	42799-935	42799-935-02	500 CAPSULE in 1 BOTTLE (42799-935-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 150MG BASE
Approval Date:	Apr 19, 2022	TE:	AB	RLD:	No

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