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Generated: October 20, 2018

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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
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:RXDosage:TABLET;ORALStrengthEQ 3MG BASE
Approval Date:Mar 17, 2010TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Feb 17, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF INSOMNIA
Patent:➤ Try a Free TrialPatent Expiration:Aug 24, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF INSOMNIA
Patent:➤ Try a Free TrialPatent Expiration:Sep 7, 2030Product 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 ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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