Dynacirc

NDA 19546, held by Smithkline Beecham. Isradipine.

As of Nov 13, 2026, NDA 19546 (Dynacirc), held by Smithkline Beecham, was first approved by FDA on Dec 20, 1990, with 23 approved supplements and 0 published complete response letters.

First approved: Dec 20, 1990
Review: Standard
Supplements approved: 23
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Dec 20, 1990	Original applicationNew molecular entity · Standard review	Approved	Review

Products

2 strengths and forms

Product	Active ingredient	Marketing
Dynacirc2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Isradipine	DiscontinuedReference drug
Dynacirc5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Isradipine	DiscontinuedReference drug

All 24 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 18, 2005	Supplement 31Labeling · Standard review	Approved	Letter
Jun 14, 2002	Supplement 26Manufacturing · Standard review	Approved	None posted
Apr 29, 2002	Supplement 25Manufacturing · Standard review	Approved	None posted
May 30, 2001	Supplement 24Manufacturing · Standard review	Approved	None posted
Dec 14, 1999	Supplement 23Manufacturing · Standard review	Approved	None posted
May 7, 1999	Supplement 22Manufacturing · Standard review	Approved	None posted
Apr 28, 1999	Supplement 21Manufacturing · Standard review	Approved	None posted
Jan 14, 1997	Supplement 20Manufacturing · Standard review	Approved	None posted
Nov 27, 1995	Supplement 17Manufacturing · Standard review	Approved	None posted
Nov 2, 1995	Supplement 16Manufacturing · Standard review	Approved	None posted
May 4, 1995	Supplement 13Labeling · Standard review	Approved	None posted
Apr 4, 1995	Supplement 15Manufacturing · Standard review	Approved	None posted
Nov 3, 1993	Supplement 12Labeling · Standard review	Approved	None posted
Mar 23, 1993	Supplement 11Manufacturing · Standard review	Approved	None posted
Feb 8, 1993	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 17, 1992	Supplement 9Manufacturing · Standard review	Approved	None posted
Nov 6, 1991	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 6, 1991	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 5, 1991	Supplement 6Manufacturing · Standard review	Approved	None posted
Jun 13, 1991	Supplement 5Labeling · Standard review	Approved	None posted
Jun 13, 1991	Supplement 2Labeling · Standard review	Approved	None posted
Jun 12, 1991	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 30, 1991	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 20, 1990	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 19546
Drugs@FDA: Overview at FDA
Company: SmithKline Beecham

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