APPLICATION
ANDA091682
TYPE
ANDA
ORIGINAL APPROVAL
2011-06-08
LATEST ACTION
2020-09-29
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
HEPARIN SODIUMPrescription
HEPARIN SODIUM 5,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUMPrescription
HEPARIN SODIUM 1,000 UNITS/ML · INJECTABLE · INJECTION
Approval history
2020-09-29Labeling · Supplement 13 · standardAP
2020-06-08Labeling · Supplement 7 · standardAP
2012-10-12Labeling · Supplement 1AP
2011-06-08Not Applicable · OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.