Sinequan

NDA 17516, held by Pfizer. Doxepin Hydrochloride.

As of Nov 14, 2026, NDA 17516 (Sinequan), held by Pfizer, was first approved by FDA on Mar 11, 1974, with 16 approved supplements and 0 published complete response letters.

First approved: Mar 11, 1974
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Mar 11, 1974	Original applicationNew dosage form · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
SinequanEQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · concentrate;oral	Doxepin Hydrochloride	DiscontinuedReference drug

All 17 submissions, including labeling and manufacturing supplements


Jul 3, 2025	Supplement 26Labeling · Standard review	Approved	Letter Label Medication Guide
Jul 14, 2014	Supplement 25Labeling	Approved	Label Letter
Aug 2, 2007	Supplement 23Labeling · Standard review	Approved	Letter Label
Feb 18, 2005	Supplement 22Labeling · Standard review	Approved	Letter
Sep 30, 2003	Supplement 20Labeling · Standard review	Approved	Letter
Apr 10, 2000	Supplement 18Labeling · Standard review	Approved	None posted
Jul 21, 1994	Supplement 15Manufacturing · Standard review	Approved	None posted
Dec 4, 1989	Supplement 14Manufacturing · Standard review	Approved	None posted
Mar 22, 1988	Supplement 11Labeling	Approved	None posted
Sep 13, 1984	Supplement 10Labeling	Approved	None posted
May 1, 1984	Supplement 9Labeling	Approved	None posted
Nov 30, 1981	Supplement 8Manufacturing · Standard review	Approved	None posted
Jun 8, 1978	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 30, 1976	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 31, 1975	Supplement 3REMS · Standard review	Approved	None posted
Sep 23, 1974	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 11, 1974	Original applicationNew dosage form · Standard review	Approved	Review

Identifiers

Application: NDA 17516
Drugs@FDA: Overview at FDA
Company: Pfizer

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters