Iv Persantine

NDA 19817, held by Boehringer Ingelheim. Dipyridamole.

As of Nov 13, 2026, NDA 19817 (Iv Persantine), held by Boehringer Ingelheim, was first approved by FDA on Dec 13, 1990, with 13 approved supplements and 0 published complete response letters.

First approved: Dec 13, 1990
Review: Priority
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Dec 13, 1990	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Iv Persantine5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Dipyridamole	DiscontinuedReference drug

All 14 submissions, including labeling and manufacturing supplements


Jun 20, 2002	Supplement 15Manufacturing · Priority review	Approved	None posted
Feb 8, 2002	Supplement 14Manufacturing · Priority review	Approved	None posted
Oct 17, 2000	Supplement 12Manufacturing · Priority review	Approved	None posted
Mar 22, 2000	Supplement 11Manufacturing · Priority review	Approved	None posted
Oct 5, 1999	Supplement 10Manufacturing · Priority review	Approved	None posted
May 15, 1997	Supplement 9Manufacturing · Priority review	Approved	None posted
Jun 9, 1995	Supplement 8Labeling · Priority review	Approved	None posted
Mar 3, 1995	Supplement 7Manufacturing · Priority review	Approved	None posted
Dec 9, 1994	Supplement 5Manufacturing · Priority review	Approved	None posted
Apr 14, 1993	Supplement 4Manufacturing · Priority review	Approved	None posted
Jun 5, 1991	Supplement 2Labeling · Priority review	Approved	None posted
Apr 30, 1991	Supplement 3Labeling · Priority review	Approved	None posted
Feb 7, 1991	Supplement 1Manufacturing · Priority review	Approved	None posted
Dec 13, 1990	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 19817
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