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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 213474

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NDA 213474 describes DOXEPIN HYDROCHLORIDE, which is a drug marketed by Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Appco, Aurobindo Pharma Ltd, Chartwell Rx, Contract Pharmacal, Dava Pharms Inc, Edenbridge Pharms, 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 213474

Tradename:	DOXEPIN HYDROCHLORIDE
Applicant:	Contract Pharmacal
Ingredient:	doxepin hydrochloride
Patents:	0

Pharmacology for NDA: 213474

Medical Subject Heading (MeSH) Categories for 213474

Antidepressive Agents, Tricyclic
Histamine Antagonists
Sleep Aids, Pharmaceutical

Suppliers and Packaging for NDA: 213474

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	213474	ANDA	Contract Pharmacal Corp.	10267-5059	10267-5059-4	1000 CAPSULE in 1 BOTTLE (10267-5059-4)
DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	213474	ANDA	Contract Pharmacal Corp.	10267-5059	10267-5059-9	90 CAPSULE in 1 BOTTLE (10267-5059-9)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 10MG BASE
Approval Date:	Jul 28, 2020	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 25MG BASE
Approval Date:	Jul 28, 2020	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 50MG BASE
Approval Date:	Jul 28, 2020	TE:	AB	RLD:	No

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