Tonocard

NDA 18257, held by Astrazeneca. Tocainide Hydrochloride.

As of Nov 14, 2026, NDA 18257 (Tonocard), held by Astrazeneca, was first approved by FDA on Nov 9, 1984, with 27 approved supplements and 0 published complete response letters.

First approved: Nov 9, 1984
Review: Priority
Supplements approved: 27
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below

Date	Submission	Status	Documents
Nov 9, 1984	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms


Tonocard400MG · tablet;oral	Tocainide Hydrochloride	Discontinued
Tonocard600MG · tablet;oral	Tocainide Hydrochloride	Discontinued

All 28 submissions, including labeling and manufacturing supplements


Oct 24, 2001	Supplement 29Labeling · Priority review	Approved	None posted
Jan 18, 2001	Supplement 28Manufacturing · Priority review	Approved	None posted
Jun 2, 2000	Supplement 27Manufacturing · Priority review	Approved	None posted
Jul 7, 1999	Supplement 26Labeling · Priority review	Approved	None posted
Nov 10, 1997	Supplement 24Manufacturing · Priority review	Approved	None posted
Oct 27, 1997	Supplement 25Manufacturing · Priority review	Approved	None posted
Nov 28, 1995	Supplement 23Labeling · Priority review	Approved	None posted
Oct 8, 1992	Supplement 22Manufacturing · Priority review	Approved	None posted
Sep 16, 1992	Supplement 20Labeling · Priority review	Approved	None posted
Dec 7, 1989	Supplement 18Manufacturing · Priority review	Approved	None posted
Jul 10, 1989	Supplement 19Labeling · Priority review	Approved	None posted
Aug 15, 1988	Supplement 12Manufacturing · Priority review	Approved	None posted
Apr 7, 1988	Supplement 17Manufacturing · Priority review	Approved	None posted
Aug 28, 1987	Supplement 14Labeling · Priority review	Approved	None posted
Jul 7, 1987	Supplement 16Manufacturing · Priority review	Approved	None posted
Jun 1, 1987	Supplement 15Manufacturing · Priority review	Approved	None posted
Jan 21, 1987	Supplement 13Manufacturing · Priority review	Approved	None posted
Apr 17, 1986	Supplement 8Labeling · Priority review	Approved	None posted
Feb 28, 1986	Supplement 11Manufacturing · Priority review	Approved	None posted
Sep 13, 1985	Supplement 9Manufacturing · Priority review	Approved	None posted
May 13, 1985	Supplement 7Labeling · Priority review	Approved	None posted
May 13, 1985	Supplement 6Labeling · Priority review	Approved	None posted
Feb 26, 1985	Supplement 3Manufacturing · Priority review	Approved	None posted
Feb 25, 1985	Supplement 2Labeling · Priority review	Approved	None posted
Feb 25, 1985	Supplement 1Labeling · Priority review	Approved	None posted
Jan 30, 1985	Supplement 5Manufacturing · Priority review	Approved	None posted
Jan 30, 1985	Supplement 4Manufacturing · Priority review	Approved	None posted
Nov 9, 1984	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 18257
Drugs@FDA: Overview at FDA
Company: AstraZeneca Pharmaceuticals LP

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