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Generated: May 26, 2019

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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-eight 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
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25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 ➤ Sign Up ➤ Sign Up
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-003 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-007 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-005 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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