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Details for New Drug Application (NDA): 022036

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NDA 022036 describes SILENOR, which is a drug marketed by Pernix Theraps Llc and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SILENOR profile page.

The generic ingredient in SILENOR is doxepin hydrochloride. There are seven drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.

Summary for 022036

Tradename:	SILENOR
Applicant:	Pernix Theraps Llc
Ingredient:	doxepin hydrochloride
Patents:	9
Formulation / Manufacturing:	see details

Pharmacology for NDA: 022036

Medical Subject Heading (MeSH) Categories for 022036

Antidepressive Agents, Tricyclic

Histamine Antagonists

Sleep Aids, Pharmaceutical

Suppliers and Packaging for NDA: 022036

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SILENOR	doxepin hydrochloride	TABLET;ORAL	022036	NDA	Pernix Therapeutics, LLC	42847-103	42847-103-03	30 TABLET in 1 BLISTER PACK (42847-103-03)
SILENOR	doxepin hydrochloride	TABLET;ORAL	022036	NDA	Pernix Therapeutics, LLC	42847-103	42847-103-10	100 TABLET in 1 BOTTLE (42847-103-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 3MG BASE
Approval Date:	Mar 17, 2010	TE:		RLD:	Yes
Patent:		Patent Expiration:	Feb 17, 2020	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF INSOMNIA
Patent:		Patent Expiration:	Aug 24, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF INSOMNIA
Patent:		Patent Expiration:	Sep 7, 2030	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF INSOMNIA

Expired US Patents for NDA 022036

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pernix Theraps Llc	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010
Pernix Theraps Llc	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010
Pernix Theraps Llc	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010
Pernix Theraps Llc	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010
Pernix Theraps Llc	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010
Pernix Theraps Llc	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010
Pernix Theraps Llc	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010

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