Unisom

NDA 18066, held by Chattem. Doxylamine Succinate.

As of Nov 13, 2026, NDA 18066 (Unisom), held by Chattem, was first approved by FDA on Oct 18, 1978, with 16 approved supplements and 0 published complete response letters.

First approved: Oct 18, 1978
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
Oct 18, 1978	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Unisom25MG · tablet;oral	Doxylamine Succinate	OTCReference drug

All 17 submissions, including labeling and manufacturing supplements


Dec 1, 2022	Supplement 21Labeling · Standard review	Approved	Label Letter
Sep 12, 2013	Supplement 20Labeling · Standard review	Approved	Label Letter
Dec 20, 2002	Supplement 14Manufacturing · Standard review	Approved	None posted
May 30, 2002	Supplement 11Labeling · Standard review	Approved	Letter
May 30, 2002	Supplement 13Labeling · Standard review	Approved	Letter
Apr 26, 2002	Supplement 12Manufacturing · Standard review	Approved	None posted
May 30, 1989	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 12, 1987	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 24, 1984	Supplement 10Manufacturing · Standard review	Approved	None posted
Feb 23, 1984	Supplement 8Manufacturing · Standard review	Approved	None posted
Mar 11, 1983	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 5, 1982	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 5, 1982	Supplement 5Manufacturing · Standard review	Approved	None posted
Dec 21, 1981	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 31, 1981	Supplement 2Manufacturing · Standard review	Approved	None posted
Oct 18, 1978	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted
Feb 13, 1978	Supplement 1Manufacturing · Standard review	Approved	None posted

Identifiers

Application: NDA 18066
Drugs@FDA: Overview at FDA
Company: Chattem, Inc.

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