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Serving hundreds of leading biopharmaceutical companies globally:

Merck
UBS
McKesson
Citi
Moodys
Chinese Patent Office
Covington
Mallinckrodt
Chubb

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 016798

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NDA 016798 describes SINEQUAN, which is a drug marketed by Pfizer and is included in two NDAs. Additional details are available on the SINEQUAN profile page.

The generic ingredient in SINEQUAN is doxepin hydrochloride. There are seven drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.
Summary for 016798
Tradename:SINEQUAN
Applicant:Pfizer
Ingredient:doxepin hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Anxiolytics
Dermatological Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 016798

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Expired US Patents for NDA 016798

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-002 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-006 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-005 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-003 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Dow
Cerilliant
AstraZeneca
Moodys
Fuji
Express Scripts
Daiichi Sankyo
QuintilesIMS

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