Dipyridamole

ANDA 74601, held by Hospira. Dipyridamole.

As of Nov 15, 2026, ANDA 74601 (Dipyridamole), held by Hospira, was first approved by FDA on Dec 19, 1997, with 7 approved supplements and 0 published complete response letters.

First approved: Dec 19, 1997
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Dec 19, 1997	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dipyridamole5MG/ML · injectable;injection	Dipyridamole	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Jan 4, 2002	Supplement 5Manufacturing	Approved	None posted
Jan 4, 2002	Supplement 4Manufacturing	Approved	None posted
Jan 4, 2002	Supplement 3Labeling	Approved	None posted
May 1, 2000	Supplement 7Manufacturing	Approved	None posted
Mar 22, 2000	Supplement 6Manufacturing	Approved	None posted
Oct 23, 1998	Supplement 2Labeling	Approved	None posted
Oct 23, 1998	Supplement 1Manufacturing	Approved	None posted
Dec 19, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74601
Drugs@FDA: Overview at FDA
Company: Hospira

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