You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Details for New Drug Application (NDA): 016798


✉ Email this page to a colleague

« Back to Dashboard


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. Forty-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25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 016798-003 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-007 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-005 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.