← FDA DRUG APPROVALS

FDA ANDA · ANDA074601

DIPYRIDAMOLE

Sponsor: HOSPIRA

APPLICATION
ANDA074601
TYPE
ANDA
ORIGINAL APPROVAL
1997-12-19
LATEST ACTION
2002-01-04
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

DIPYRIDAMOLEDiscontinued
DIPYRIDAMOLE 5MG/ML · INJECTABLE · INJECTION

Approval history

2002-01-04Manufacturing (CMC) · Supplement 4AP
2002-01-04Manufacturing (CMC) · Supplement 5AP
2002-01-04Labeling · Supplement 3AP
2000-05-01Manufacturing (CMC) · Supplement 7AP
2000-03-22Manufacturing (CMC) · Supplement 6AP
1998-10-23Labeling · Supplement 2AP
1998-10-23Manufacturing (CMC) · Supplement 1AP
1997-12-19OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →