Doxylamine Succinate

ANDA 88900, held by Copley Pharm. Doxylamine Succinate.

As of Nov 15, 2026, ANDA 88900 (Doxylamine Succinate), held by Copley Pharm, was first approved by FDA on Oct 8, 1985, with 20 approved supplements and 0 published complete response letters.

First approved: Oct 8, 1985
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Oct 8, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Doxylamine Succinate25MG · tablet;oral	Doxylamine Succinate	Discontinued

All 21 submissions, including labeling and manufacturing supplements


Apr 2, 2001	Supplement 23Manufacturing	Approved	None posted
Apr 2, 2001	Supplement 22Manufacturing	Approved	None posted
Apr 2, 2001	Supplement 21Manufacturing	Approved	None posted
Apr 2, 2001	Supplement 20Manufacturing	Approved	None posted
Apr 2, 2001	Supplement 19Manufacturing	Approved	None posted
Apr 2, 2001	Supplement 18Manufacturing	Approved	None posted
Apr 2, 2001	Supplement 17Manufacturing	Approved	None posted
Mar 23, 1999	Supplement 16Manufacturing	Approved	None posted
Jun 11, 1998	Supplement 15Manufacturing	Approved	None posted
Mar 10, 1998	Supplement 14Manufacturing	Approved	None posted
Mar 10, 1998	Supplement 13Manufacturing	Approved	None posted
May 31, 1996	Supplement 12Manufacturing	Approved	None posted
Jun 26, 1989	Supplement 11Manufacturing	Approved	None posted
Feb 12, 1988	Supplement 9Manufacturing	Approved	None posted
Feb 12, 1988	Supplement 8Manufacturing	Approved	None posted
Jul 10, 1987	Supplement 7Manufacturing	Approved	None posted
Aug 7, 1986	Supplement 5Manufacturing	Approved	None posted
Aug 7, 1986	Supplement 4Manufacturing	Approved	None posted
Aug 7, 1986	Supplement 3Manufacturing	Approved	None posted
Aug 7, 1986	Supplement 1Manufacturing	Approved	None posted
Oct 8, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 88900
Drugs@FDA: Overview at FDA
Company: Copley Pharmaceutical

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