Persantine

NDA 12836, held by Boehringer Ingelheim. Dipyridamole.

As of Nov 14, 2026, NDA 12836 (Persantine), held by Boehringer Ingelheim, was first approved by FDA on Dec 6, 1961, with 22 approved supplements and 0 published complete response letters.

First approved: Dec 6, 1961
Review: Standard
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below


Dec 22, 1986	Supplement 14Efficacy (new indication or use)	Approved	None posted
Dec 6, 1961	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

3 strengths and forms


Persantine25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Dipyridamole	DiscontinuedReference drug
Persantine50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Dipyridamole	DiscontinuedReference drug
Persantine75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Dipyridamole	DiscontinuedReference drug

All 23 submissions, including labeling and manufacturing supplements


Dec 11, 2019	Supplement 61Labeling · Standard review	Approved	Letter Label
Jul 29, 2015	Supplement 60Manufacturing · Standard review	Approved	None posted
May 8, 2014	Supplement 59Manufacturing · Standard review	Approved	None posted
Aug 1, 2005	Supplement 57Labeling · Standard review	Approved	Letter Label
Aug 5, 2004	Supplement 54Labeling · Standard review	Approved	Letter
Jun 20, 2002	Supplement 56Manufacturing · Standard review	Approved	None posted
Feb 8, 2002	Supplement 55Manufacturing · Standard review	Approved	None posted
May 24, 2001	Supplement 53Manufacturing · Standard review	Approved	None posted
Feb 8, 2000	Supplement 52Manufacturing · Standard review	Approved	None posted
Jul 3, 1997	Supplement 51Labeling · Standard review	Approved	None posted
Feb 21, 1995	Supplement 46Manufacturing · Standard review	Approved	None posted
May 18, 1994	Supplement 50Manufacturing · Standard review	Approved	None posted
Feb 18, 1994	Supplement 49Labeling · Standard review	Approved	None posted
Mar 26, 1991	Supplement 47Labeling	Approved	None posted
Aug 30, 1989	Supplement 44Manufacturing · Standard review	Approved	None posted
Dec 12, 1988	Supplement 42Manufacturing · Standard review	Approved	None posted
Nov 8, 1988	Supplement 45Labeling	Approved	None posted
Feb 24, 1988	Supplement 41Labeling	Approved	None posted
Feb 6, 1987	Supplement 40Manufacturing · Standard review	Approved	None posted
Dec 22, 1986	Supplement 14Efficacy (new indication or use)	Approved	None posted
Dec 22, 1986	Supplement 38Labeling	Approved	None posted
Oct 8, 1982	Supplement 32Manufacturing · Standard review	Approved	None posted
Dec 6, 1961	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 12836
Drugs@FDA: Overview at FDA
Company: Boehringer Ingelheim Pharmaceuticals, Inc.

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