Dipyridamole

As of Nov 15, 2026, ANDA 87716 (Dipyridamole), held by Barr, was first approved by FDA on Oct 3, 1990, with 23 approved supplements and 0 published complete response letters.

First approved: Oct 3, 1990
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
Oct 3, 1990	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dipyridamole50MG · tablet;oral	Dipyridamole	Rx

All 24 submissions, including labeling and manufacturing supplements


Aug 18, 2006	Supplement 41Labeling	Approved	None posted
Oct 5, 2005	Supplement 37Labeling	Approved	None posted
May 15, 2002	Supplement 33Manufacturing	Approved	None posted
May 15, 2002	Supplement 34Manufacturing	Approved	None posted
May 15, 2002	Supplement 35Manufacturing	Approved	None posted
Dec 21, 1999	Supplement 32Manufacturing	Approved	None posted
May 20, 1999	Supplement 31Manufacturing	Approved	None posted
Dec 1, 1998	Supplement 30Manufacturing	Approved	None posted
Mar 30, 1998	Supplement 29Manufacturing	Approved	None posted
Feb 10, 1997	Supplement 28Manufacturing	Approved	None posted
Aug 13, 1996	Supplement 26Manufacturing	Approved	None posted
Apr 17, 1996	Supplement 27Manufacturing	Approved	None posted
Aug 13, 1992	Supplement 22Labeling	Approved	None posted
Apr 3, 1992	Supplement 19Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 21Manufacturing	Approved	None posted
Aug 30, 1991	Supplement 18Manufacturing	Approved	None posted
Oct 3, 1990	Original application	Approved	None posted
Oct 3, 1990	Supplement 12Labeling	Approved	None posted
Mar 29, 1990	Supplement 17Bioequivalence	Approved	None posted
Jan 7, 1988	Supplement 16Manufacturing	Approved	None posted
Sep 28, 1987	Supplement 14Manufacturing	Approved	None posted
Sep 28, 1987	Supplement 15Manufacturing	Approved	None posted
Mar 25, 1987	Supplement 11Manufacturing	Approved	None posted
Aug 15, 1984	Supplement 1Manufacturing	Approved	None posted

Identifiers

Application: ANDA 87716
Drugs@FDA: Overview at FDA
Company: Barr Laboratories

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