Paradione

NDA 6800, held by Abbvie. Paramethadione.

As of Nov 13, 2026, NDA 6800 (Paradione), held by Abbvie, was first approved by FDA on Jun 15, 1949, with 7 approved supplements and 0 published complete response letters.

First approved: Jun 15, 1949
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jun 15, 1949	Original application	Approved	None posted

Products

3 strengths and forms


Paradione300MG · capsule;oral	Paramethadione	Discontinued
Paradione300MG/ML · solution;oral	Paramethadione	Discontinued
Paradione150MG · capsule;oral	Paramethadione	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Mar 24, 1989	Supplement 15Manufacturing	Approved	None posted
Dec 2, 1987	Supplement 14Manufacturing	Approved	None posted
Dec 7, 1984	Supplement 13Manufacturing	Approved	None posted
Jun 28, 1982	Supplement 12Manufacturing	Approved	None posted
Jul 14, 1980	Supplement 10Labeling	Approved	None posted
Oct 24, 1979	Supplement 8Manufacturing	Approved	None posted
Jul 29, 1975	Supplement 5Manufacturing	Approved	None posted
Jun 15, 1949	Original application	Approved	None posted

Identifiers

Application: NDA 6800
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