Tridione

NDA 5856, held by Abbvie. Trimethadione.

As of Nov 14, 2026, NDA 5856 (Tridione), held by Abbvie, was first approved by FDA on Jan 25, 1946, with 13 approved supplements and 0 published complete response letters.

First approved: Jan 25, 1946
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Jan 25, 1946	Original application	Approved	None posted

Products

3 strengths and forms


Tridione200MG/5ML · solution;oral	Trimethadione	Discontinued
Tridione300MG · capsule;oral	Trimethadione	Discontinued
Tridione150MG · tablet;oral	Trimethadione	DiscontinuedReference drug

All 14 submissions, including labeling and manufacturing supplements


Jun 7, 2016	Supplement 23Manufacturing	Approved	None posted
Jun 6, 2012	Supplement 21Labeling · Standard review	Approved	Label Letter
Apr 23, 2009	Supplement 20Labeling	Approved	Letter
Dec 10, 2002	Supplement 18Manufacturing	Approved	None posted
Sep 26, 2002	Supplement 19Manufacturing	Approved	None posted
Jul 22, 1997	Supplement 17Manufacturing	Approved	None posted
Oct 28, 1983	Supplement 16Manufacturing	Approved	None posted
Feb 11, 1982	Supplement 15Manufacturing	Approved	None posted
Sep 22, 1981	Supplement 14Manufacturing	Approved	None posted
Oct 24, 1979	Supplement 12Manufacturing	Approved	None posted
Jun 7, 1979	Supplement 8Manufacturing	Approved	None posted
Oct 6, 1978	Supplement 9Manufacturing	Approved	None posted
Jul 31, 1975	Supplement 5Manufacturing	Approved	None posted
Jan 25, 1946	Original application	Approved	None posted

Identifiers

Application: NDA 5856
Drugs@FDA: Overview at FDA
Company: AbbVie

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