Dipyridamole

Prevents postoperative thromboembolic complications of cardiac valve replacement. ANDA 40782, held by Impax Labs. Dipyridamole.

As of Nov 15, 2026, ANDA 40782 (Dipyridamole), held by Impax Labs, was first approved by FDA on Jul 18, 2007, with 1 approved supplement and 0 published complete response letters.

First approved: Jul 18, 2007
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Dipyridamole tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jul 18, 2007	Original application	Approved	None posted

Products

3 strengths and forms


Dipyridamole25MG · tablet;oral	Dipyridamole	Rx
Dipyridamole50MG · tablet;oral	Dipyridamole	Rx
Dipyridamole75MG · tablet;oral	Dipyridamole	Rx

All 2 submissions, including labeling and manufacturing supplements


Mar 31, 2022	Supplement 14Labeling · Standard review	Approved	None posted
Jul 18, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 40782
Drugs@FDA: Overview at FDA
Company: Impax 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